PCS 137 - SERVICES

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Stephanie Muth, Executive Commissioner

Invitation for Bids (IFB) for

Printing of Newborn Screening (NBS) blood specimen collection devices for

DSHS

IFB No. # HHS0017275

NIGP Class/Item No(s): 948-52 Infant Mortality Reduction Initiative

Procurement Schedule - All Times are Central Time Reference Section 2 for further information

IFB Date Posted to ESBD July 8, 2026

Questions or Clarifications Submission Deadline July 17, 2026, 5:00 PM

Responses to Questions or Clarifications - Addendum posted on the ESBD July 22, 2026

Response Deadline: Responses to this IFB must be received July 29, 2026, 10:30 AM

Anticipated Contract Start Date September 1, 2026

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Table of Contents 1 Introduction and Purpose of IFB

1.1 Authority

1.2 Historical Monetary Value

1.3 No Guarantee of Volume, Usage or Compensation

1.4 Negotiation, Exceptions or Assumptions

1.5 IFB Components

2 Procurement Schedule 3 Withdrawal or Amendment of Response 4 HHSC Overview 5 Definitions 6 General IFB Information

6.1 Sole Point of Contact and Communications

6.2 Exception to the Sole Point of Contact

6.3 Binding Offer Period

6.4 Costs Incurred

6.5 Changes, Modifications and Cancellation

6.6 Ambiguity, Conflict, Discrepancy

6.7 IFB Questions or Clarifications

6.8 Notification of Addenda or Cancellation

7 Scope of Work (SOW)

7.1 Scope of Services to be Performed

8 HUB Subcontracting Plan (HSP) Requirements

8.1 HUB Subcontracting Plan (HSP)

9 Pricing Information

9.1 Pricing Structure

9.2 Price Adjustments

10 Changes to The Contract 11 Contract Term

11.1 Term of Contract

11.2 Initial Contract Term:

11.3 Renewal Option(s)

11.4 Extension Option

12 Contract Administration/ Purchase Order Administration

12.1 Contract Manager/Program Lead

12.2 Performed Services Monitoring

12.3 Performance Reporting

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12.4 Contractor Response to Notification of Non-Material Deficiency

12.5 Corrective Action Plan (The Plan)

12.6 Performance Issues

12.7 Public Information Act – Bidder Requirements Regarding Disclosure

12.8 Bidder Waiver – Intellectual Property

13 Invoicing and Payment

13.1 Bill-to Address

13.2 Invoice Information

13.3 Payment

13.4 Invoice Submission

13.5 Disputed Invoice(s)

14 Insurance Requirements

14.1 Specific Insurance Requirements

14.2 Alternative Insurability

15 Screening of Responses

15.1 Administrative Screening

15.2 Irregularities

16 Evaluation

16.1 Evaluation of Responses

16.2 Conformance with State Law for Evaluation

16.3 Specific Evaluation Criteria

17 Award 18 Standards of Conduct for Vendors 19 Disclosure of Interested Parties 20 Protest Procedures Appendix A – Submission Instructions and Response Checklist

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1 Introduction and Purpose of IFB The Texas Health and Human Services Commission (HHSC) is an agency within the Texas Health and Human Services (HHS) system. The Procurement and Contracting Services (PCS) division of HHSC administers IFBs for HHS.

HHSC PCS is seeking competitive bids to establish a contract for providing Newborn Screening (NBS) blood specimen collection devices, in accordance with the specifications stated in this solicitation.

Both HHS Agencies, HHSC and DSHS, will be entitled to use any contract awarded as a result of this IFB.

To be considered for award, Bidders must submit a comprehensive Response which includes all required information and documentation as outlined in this IFB to ensure the Bidder meets all requirements, possesses the required experience and qualifications, and has the capacity to provide the services described in this IFB. See Appendix A, Submission Instructions and Response Checklist.

1.1 Authority

HHSC or DSHS is soliciting the services stated in this IFB under Texas Government Code

2156.063. Solicitation of Bids.

1.2 Historical Monetary Value

Historical spend for the same or similar services is $870,173.00 for the period September 1, 2023, to March 31, 2026.

1.3 No Guarantee of Volume, Usage or Compensation

HHS Agency does not guarantee any volume, usage, or compensation to be paid to any Contractor under any Contract resulting from this IFB. Additionally, all HHS Agency contracts are subject to appropriations, the availability of funds, and termination.

The estimated historical spend included in Section 1.2 is provided only as a guideline for preparing the pricing response and should not be construed as representing anticipated or actual quantities that will be required.

1.4 Negotiation, Exceptions or Assumptions

Negotiations are prohibited under the IFB procurement method under most circumstances, and even then, the scope of permissible negotiations is limited and may not result in a material change to the scope of work or specifications as advertised in this IFB.

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Bidders should NOT submit exceptions to this IFB which could result in disqualification of a Response. No changes to a Response can be made after the submission deadline.

No assumptions should be included in a Response. The inclusion of assumptions could result in disqualification of a Response. Instead, a Bidder should advance assumptions and seek clarification of a section of this IFB, any Exhibits or attachments, in the form and manner required in Section 6.7 IFB Questions or Clarifications.

1.5 IFB Components

This IFB includes the following items:

• PCS 137 IFB (this document)

• Exhibit A – HHS Solicitation Affirmations

• Exhibit B – PCS 111-Contract Affirmations and HHS Uniform Terms and Conditions (UTCs)

• Exhibit C – Pricing Sheet

• Exhibit D – Bidder Reference and Contractor Qualifications Form

• Exhibit E – HHS Online Bid Room Information

• Exhibit E-1- PCS Map

• Exhibit F – Sample Product Specifications

2 Procurement Schedule The Procurement Schedule dates on the cover page of this IFB are subject to change. HHSC reserves the right to modify these dates at any time by issuing an addendum. Any events listed in the Procurement Schedule after the Response Deadline will occur at the discretion of HHSC.

Responses must be received by HHSC prior to the Response Deadline as indicated in the Procurement Schedule. Every Bidder is solely responsible for ensuring its Response is received by HHSC before the Response Deadline in accordance with all requirements regarding submission. HHSC is not responsible for lost, misdirected or late Responses.

By submitting a Response, the Bidder represents and warrants that the individual submitting the Response, inclusive of the documents made part of the Response, is authorized to sign on behalf of the Bidder, and to bind the Bidder under any Contract that may result from this IFB.

3 Withdrawal or Amendment of Response Bidders may withdraw or amend their Responses at any time prior to the Response Deadline by e-mailing the point of contact listed in Section 6.1 (Sole Point of Contact and Communications).

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The e-mail subject line for withdrawal or response amendment should contain the IFB number as indicated on the cover page of this IFB. The Bidder is solely responsible for ensuring the email is received by HHSC before the Response Deadline. HHSC is not responsible for lost or misdirected e-mails.

4 HHSC Overview The Health and Human Services Commission (HHSC) was created in 1991 to oversee and coordinate the planning and delivery of health and human services in Texas. It is established pursuant to Chapter 523, Texas Government Code and is responsible for oversight of Texas Health and Human Services agencies.

PCS administers the procurement process, which includes IFB announcement and publication, Bidder communications, receipt of Responses, screening of timely received responses, and facilitating the evaluation of qualified Responses. PCS, in coordination with each HHS program, manages the execution of the award, through issuance of Purchase Order(s) or other Contract document, resulting from this IFB.

5 Definitions Unless the context clearly indicates otherwise, throughout this IFB, the definition given to a term below applies whenever the term appears in this IFB, in any Response (Bid) submitted in response to this IFB, and in any Contract awarded as a result of this IFB. All other terms have their ordinary and common meaning.

a) Addendum – A written clarification or revision to this IFB issued by HHSC.

b) Bidder – The entity or individual that submits a response to this IFB. Includes anyone acting on behalf of the entity or individual that submits a response, such as an agent, employee, or representative. See also Respondent below.

c) Calender - to press (cloth, rubber, paper, etc.) between rollers or plates in order to smooth and glaze or to thin into sheets.

d) Contract –The signed Purchase Order or Signature Document, the Uniform Terms and Conditions, Affirmations, along with any Attachments, Exhibits and any Amendments, purchase orders, or Work Orders that may be issued by HHSC, to be incorporated by reference for all purposes as a result of this IFB.

e) Contractor - Each Bidder, business entity or individual, if any, awarded a Purchase Order or other Contract to provide the services or goods as a result of this IFB.

f) Contract Term – The period of time during which the Purchase Order or Contract is in effect from the start date through the end date and may include renewal or extension periods.

https://statutes.capitol.texas.gov/?tab=1&code=GV&chapter=GV.523&artSec=

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g) Debarment – An exclusion from contracting or subcontracting with state agencies on the basis of cause pursuant to Title 34, Part 1, Chapter 20, Subchapter G of the Texas Administrative Code, and the Federal System for Award Management (SAM).

h) Deliverables – The services or goods specified in this IFB and any resulting Contract that the Contractor shall perform or deliver to the HHS Agency.

i) Electronic State Business Daily (ESBD) - The electronic online directory, administered by the Comptroller of Public Accounts, Statewide Procurement Division (SPD), for publishing procurement opportunities which exceed $25,000 in total estimated value and for providing public notice of contract awards. The ESBD may be accessed through the CPA web site at: https://www.txsmartbuy.gov/esbd.

Note: The Texas Comptroller of Public Accounts (CPA) recommends utilizing Google Chrome when navigating CPA websites.

j) Exhibit – A document, included as an attachment to this IFB, which provides terms and conditions, additional requirements and information related to this IFB.

k) HHS Agency - HHSC or any of the agencies of the State of Texas that are overseen by HHSC under authority granted under state law and the officers, employees, authorized representatives, and designees of those agencies. These agencies include: HHSC and the Department of State Health Services (DSHS), separately or combined. May also be referred to as System Agency.

l) IFB - This document, including all exhibits, attachments, appendices, or Addenda (if applicable). May also be referred to as Invitation for Bids.

m) NIGP (The National Institute of Governmental Purchasing (NIGP) Commodity Book) – The Class-Item numbering and descriptions used by state agencies to properly code services or products for a procurement.

n) Purchase Order – A legally enforceable agreement issued by HHSC indicating types, quantities, and agreed pricing for services and goods the Contractor will provide under any Contract resulting from this IFB.

o) Response – All information and materials submitted by a Bidder in response to this IFB.

May also be referred to as Bid or Bid Response.

p) Respondent – A term interchangeable with Bidder.

q) Scope of Work – The description of requirements, services, specifications for goods which may be required, and deliverables as provided in this IFB and any resulting Contract which the Contractor is required to provide.

r) Subcontractor - Any entity or individual that enters into a contract with the Contractor to perform part or all of the obligations of the Contractor under the Contract.

s) Texas Identification Number (TIN) – The 11-digit identification number set up through the Texas Comptroller of Public Accounts which is required for any entity or individual to http://www.txsmartbuy.com/sp https://www.txsmartbuy.gov/esbd

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https://fmx.cpa.texas.gov/fm/pubs/payment/gen_prov/index.php?s=payee_numreq&p =payee_numreq.

t) Unit of Measure – The set unit of measure (UOM), included on the Pricing Sheet, used for payment of the services under the Contract or Purchase Order. May be hourly, daily, weekly, monthly, etc.

u) Unit Rate – The set rate per the unit of measure (UOM) used for payment of the services, included on the Price Sheet, under the Contract or Purchase Order. May be hourly, daily, weekly, monthly, etc.

v) Vendor – A business entity or individual that supplies services or goods and may be a potential Bidder to this IFB.

6 General IFB Information

6.1 Sole Point of Contact and Communications

The HHSC PCS Sole Point of Contact for inquiries concerning this IFB is:

Jeramy Keil CTCD, CTCM

Procurement and Contracting Services Building 1100 W 49th St. MC: 2020 Austin, TX 78756

512-776-2992

Jeramy.keil@hhs.texas.gov

Bidders shall NOT use the e-mail address above for submission of a Response to this IFB. See Appendix A for submission requirements.

Bidders shall direct all communications, including questions or clarifications relating to this IFB, by e-mail to the HHSC PCS Sole Point of Contact named in Section 6.1 (Sole Point of Contact and Communications); communications by phone will not be accepted except for purposes such as instructing a potential Respondent through an IT system or website referenced in this Solicitation.

All other communications between a Bidder and HHS agency staff concerning this IFB are prohibited. In no instance is a Bidder to discuss cost information regarding this IFB with the HHSC PCS Sole Point of Contact or any other HHS staff. Failure to comply with these requirements may result in disqualification of the Response.

The Sole Point of Contact will authorize a secondary Sole Point of Contact in the event of their absence and, in such an event, will include the contact information for the secondary Sole Point https://fmx.cpa.texas.gov/fm/pubs/payment/gen_prov/index.php?s=payee_numreq&p=payee_numreq https://fmx.cpa.texas.gov/fm/pubs/payment/gen_prov/index.php?s=payee_numreq&p=payee_numreq

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This restriction (as to only communicating in writing with the HHSC Sole Point of Contact identified above) does not preclude discussions between Bidder and agency personnel for the purposes of conducting business unrelated to this IFB.

6.2 Exception to the Sole Point of Contact

The only exceptions to the Sole Point of Contact are the HUB Coordinator, or, if expressly directed by the Sole Point of Contact, another designated System Agency representative.

6.3 Binding Offer Period

By submitting a Response to this IFB, Bidder agrees that its Response will remain a firm and binding offer for 240 days, as stated in the HHS Solicitation Affirmations (Exhibit A).

Bidder may extend the time for which its Response will be firm and binding and include the extended period in the Response.

6.4 Costs Incurred

Bidder understands that issuance of this IFB or retention of responses in no way constitutes a commitment by HHSC to award a Contract. HHSC accepts no obligations for costs incurred in preparing and submitting a response, including, but not limited to, preparing for or participating in a vendor conference or site visit.

Responses shall be submitted at the sole expense of the Bidder. All responses shall be prepared simply and economically, providing a straightforward, concise delineation of the Bidder’s capabilities to satisfy the requirements of this IFB.

6.5 Changes, Modifications and Cancellation

HHSC reserves the right to change, amend, or modify this IFB prior to the Response Deadline indicated in the Procurement Schedule (cover page of this IFB). Changes, amendments, and modifications will be processed through one or more Addendum. The notification for any Addendum will be processed in accordance with Section 6.8.

HHSC reserves the right to cancel this IFB at any time. The notice of cancellation will be in accordance with Section 6.8.

6.6 Ambiguity, Conflict, Discrepancy

Bidders must notify the Sole Point of Contact, Section 6.1, of any ambiguity, conflict, discrepancy, exclusionary specification, omission, or other error in the IFB in the manner and by the deadline for submitting questions.

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If Bidder fails to properly and timely notify the Sole Point of Contact, Section 6.1, of any ambiguity, conflict, discrepancy, exclusionary specification, omission or other error in the IFB, the Bidder, whether awarded a contract or not:

a) shall have waived any claim of error or ambiguity in the IFB and any resulting contract,

b) shall not contest the interpretation by HHSC of such provision(s), and

c) shall not be entitled to additional compensation, relief, or time by reason of ambiguity, conflict, discrepancy, exclusionary specification, omission, or other error or its later correction.

6.7 IFB Questions or Clarifications

HHSC will allow questions and requests for clarification regarding this IFB if submitted by e-mail to the Sole Point of Contact, Section 6.1, by the deadline established in the Procurement Schedule (cover page of this IFB) or deadlines established in subsequent Addenda. Responses to questions or other written requests for clarification will not be provided individually to requestors but will be consolidated in one or more Addenda.

HHSC reserves the right to amend the answers to questions or clarifications prior to the Response Deadline (cover page of this IFB) through a new Addendum. The notification will be processed in accordance with Section 6.8 (Notification of Addenda or Cancellation).

6.7.1 Submission of Questions or Clarifications

All questions and requests for clarification must be submitted by e-mail and include the following information:

a) IFB Number and Title of IFB (cover page of this IFB) must be included in the e-mail subject line and in the e-mail body;

b) Section or Paragraph number from this IFB;

c) Page Number of this IFB;

d) Exhibit name, Section or Paragraph, page number from the Exhibit;

e) Language, Topic, Section Heading being questioned or requested for clarification;

f) Requestor Contact Information must be included in the body of the e-mail.

Questions or requests for clarification received after the deadline set in the Procurement Schedule (cover page of this IFB), or deadlines established in subsequent Addenda, may be reviewed by HHSC but will not be answered.

6.8 Notification of Addenda or Cancellation

6.8.1 Addenda Notification

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All addenda will be posted to the ESBD. It is the responsibility of each potential Bidder to monitor the ESBD for any Addenda affecting this IFB. Failure to check the ESBD will in no way release any potential Bidder or awarded Contractor from the requirements of posted Addenda.

No HHS Agency will be responsible or liable in any regard for the failure of any Bidder or awarded Contractor to stay informed of all postings to the ESBD. If the Bidder fails to monitor the ESBD for any changes or modifications to this IFB, such failure will not relieve the Bidder or Contractor of its obligation to fulfill the requirements as posted.

Bidder must acknowledge receipt of any addenda by signing and returning SOLICITATION ADDENDUM ACKNOWLEDGEMENT FORM posted to the ESBD with your solicitation response in accordance with the submission options outlined in the solicitation.

6.8.2 Cancellation Notification

HHSC reserves the right to cancel this IFB at any time. Notice of the cancellation will be posted on the ESBD. Bidders are responsible for monitoring the ESBD frequently for notices regarding this IFB.

7 Scope of Work (SOW)

7.1 Scope of Services to be Performed

The required services to be provided are providing Newborn Screening (NBS) blood specimen collection devices, in accordance with the specifications stated in this solicitation.

A. The Contractor must ensure that the Texas Newborn Screening (NBS) seven (7) part interleaved “snap-out” specimen collection medical devices consist of the following parts (see Exhibit F - Sample Product Specifications):

a. Part 1 = Texas Newborn Screening Parent Information (Parent Copy) [two sided with English on front and Spanish on back]

b. Part 2 = Storage and Use of Newborn Screening Blood Spot Cards [two sided with English on front and Spanish on back]

c. Part 3 = White sheet: patient demographic information

d. Part 4 = Canary sheet: patient demographic information

e. Part 5 = Manila sheet

f. Part 6 = Eastern Business Forms (EBF) 903TM, PerkinElmer 226TM, or equivalent filter paper sheet

g. Part 7 = Instructions and wrap around cover

B. Contractor shall agree that any potential increase in quantity of devices for Item 1, Medicaid – NBS3 device or Item 2, Paid – NBS4 forms (see Section 7.1, Subsection H) will be submitted to the Contractor by DSHS in the form of a Contract Amendment.

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C. Each order of kits printed may require the device serial numbers, expiration dates, revision date, device color, and minor text modifications to be updated per Texas DSHS instructions for each additional order/shipment.

D. Contractor must conform to current good manufacturing practice (CGMP) requirements of the quality management system regulation (QMSR) for medical devices as the collection paper is registered as a medical device with the Food and Drug Administration (FDA) for the collection and clinical testing of human body fluids. CFR - Code of Federal Regulations Title 21 (ecfr.gov).

E. Printing and Form Construction Requirements

a. Contractor must ensure printing press used in production of the product is absolutely clean to ensure that no contaminants are absorbed into the collection paper.

b. Contractor must ensure that attachment of collection paper to device must be done in a way to prevent Calendering of the collection paper as it is pulled through the glue press. Calendering will affect the absorbency of the collection paper.

c. Contractor shall ensure that the production process must not alter, in any way, the absorbency of the collection paper.

d. Contractor shall ensure that attachment of collection paper to device must be done in a way to prevent loose edges that can snag on backside of device causing detachment of collection paper.

e. Contractor shall ensure that the stub overlap on left is glued firmly from left edge to perforations.

f. Contractor must confirm that finished product order consists of a single lot of 903TM, PerkinElmer 226™, or equivalent, collection paper.

g. Contractor must provide to DSHS with a full .pdf mock-up of device for approval prior to printing.

h. Contractor shall ensure that the boxes for hand-written characters on Parts 3 and 4 (See Section 7.1) to be as indicated for machine reading with drop out ink color (specified PMS 185 Blind Red) except for black serial number, barcode, and as shown on Exhibit F - Sample Product Specifications.

i. Contractor shall ensure the finished products meet the following barcode requirements:

i. Barcode code 128C with a mod 10 check digit on Parts 1, 2, 3 and 5 are to correspond with serial number on each device and are to be of same height, weight, and intensity as given on sample(s). Barcodes must be http://www.ecfr.gov/

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ii. Check character to be supplied as last bar-coded character on right side of all barcodes. Contractor will coordinate with DSHS on the size, font, and coloring of the printed check digit.

iii. All barcodes have a maximum number of twelve (12) digits plus a check digit and reflect the device serial number. The Barcode/Serial number does NOT include “TX” as a prefix.

iv. All barcodes must have a minimum height of 2/8” (except for the barcode on Part 1 which must have a height of 3/8”) and a maximum barcode density of 0.1125 characters per inch.

F. Quality Assurance (QA) Requirements

a. Collection filter paper must be cleared for marketing in the United States by the

FDA for blood collection and meet, at minimum, the currently approved Clinical and Laboratory Standards Institute (CLSI) guidelines for filter paper used for neonatal screening. Collection filter paper must have demonstrated a satisfactory performance under routine criteria evaluated at the Centers for Disease Control (CDC).

b. Post-printing Quality Control Requirements: After completion of the printing and collating of the devices, the Contractor shall conduct the following quality checks:

i. Visual inspection: The Contractor shall verify that the layout and printed information match the approved printer’s proof. The Contractor shall sample in accordance with ANSI/ASQ Z1.4-2003, AQL 1.0%, Level S-3 for the following characteristics:

1. Dimensions match the approved printer’s proof;

2. Barcode readability; and

3. Registration of printed circles front and back.

ii. Functional Inspection: The Contractor shall sample in accordance with

ANSI/ASQ Z1.4-2003, AQL 1.0%, Level S-3 for the following characteristics:

1. Blood absorbency time measured for blood spots produced by 100 μL aliquots of blood (hematocrit 55+ or -1%). Acceptable absorbency time average of 10 seconds or less for each Medicaid and each Paid shipment of forms.

https://clsi.org/ https://clsi.org/ https://webstore.ansi.org/standards/asq/ansiasqz12003?ad_acct=0000&gad_source=1&gad_campaignid=2490971&gbraid=0AAAAAD_gXFXoJAo9y-dIH_3DI2nG1sRql&gclid=EAIaIQobChMI-7ekoJD1kwMVNUB_AB03-hehEAAYASAAEgK3vvD_BwE https://webstore.ansi.org/standards/asq/ansiasqz12003?ad_acct=0000&gad_source=1&gad_campaignid=2490971&gbraid=0AAAAAD_gXFXoJAo9y-dIH_3DI2nG1sRql&gclid=EAIaIQobChMI-7ekoJD1kwMVNUB_AB03-hehEAAYASAAEgK3vvD_BwE

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2. Aliquot diameter measured for blood spots produced by 100 μL aliquots of blood (hematocrit 55+ or -1%). Refer to currently approved CLSI specifications.

3. Contractor shall caliper measure to demonstrate that the printing process did not Calender the paper. The target and range must be the same as the specifications of the paper before printing.

c. Contractor must maintain quality records demonstrating conformance to the requirements of the order and make them available to DSHS upon request.

d. Contractor must provide DSHS with a Quality Assurance (QA) data package for each separately produced shipment to document pre- and post- manufacturing quality assurance. The package should consist of the following items:

i. A certificate for the specific collection paper lot number used in the order indicating the satisfactory pre-printing process collection paper performance characteristics as evaluated at CDC.

ii. A copy of the manufacturer’s FDA device establishment registration.

iii. A certification that the supplier complies with the FDA Quality

Management System Regulation, Title 21 Code of Federal Regulations Part 820.

iv. A certification that the specimen collection paper conforms to the following CLSI specifications:

1. The paper is made of 100% pure cotton fiber with no wet strength additives.

2. The basis weight is 110 pounds + or -5% per ream.

3. The pH is 5.7 to 7.5.

4. The ash content is 0.1% maximum.

e. A detailed certification that the specimen collection paper lot conforms to the following physical property requirements: absorption capacity, homogeneity of the lot, circle diameter of the dried blood aliquot, and absorption time for a 100 μL blood aliquot.

f. A detailed certification that the post-printing visual and functional tests have been satisfactorily conducted. Include the specific QA data obtained during the post-printing tests, providing at minimum the mean, standard deviation (SD), and range of the data that is directly related to the set of devices.

g. A list of the device numbers that require reprinting for any reason to maintain consecutive numbering, including those selected and pulled for quality control.

h. A copy of any package insert used or supplied as part of the order.

i. Contractor shall ship the QA data package to the attention of:

i. D’Andra Luna https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820

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ii. Texas Department of State Health Services, Laboratory Services Section

iii. MC 1947, Newborn Screening Laboratory Group

iv. PO Box 149347

v. Austin, TX 78714-9347

j. If the package is delivered via courier send to:

i. D’Andra Luna

ii. Texas Department of State Health Services, Laboratory Services Section

iii. MC 1947, Newborn Screening Laboratory Group

iv. 1100 W. 49th St, Austin, TX 78756

k. Provide educational brochures/posters, in both English and Spanish, addressing the proper specimen collection and handling techniques for neonatal screening, as requested by DSHS and free of charge.

l. Provide educational brochures/posters, in both English and Spanish, addressing neonatal dry blood spot specimen quality requirements (acceptable specimen) and potential quality problems (unacceptable specimen), as requested by DSHS and free of charge.

G. Device Specifications and Requirements Item 1: Newborn Screening Blood Specimen Collection Devices: Medicaid – NBS3 device estimated fiscal year 2027 (September 1, 2026 to August 31, 2027) quantity = 422,400 devices

a. Guaranteed serially numbered in complete sequence.

b. Format of the device Serial Number must be YY-#######. A check digit is to be printed directly to the right of the device serial number when printed in conjunction with the serial number barcode. “TX” to be printed directly to the left of the form serial number (but NOT included in the barcode serial number), as indicated on the examples.

c. Serial Numbers of the forms are to begin with 27- 0000001 and run consecutively through 27- 0422400 with guaranteed no missing numbers. (In the event of Contract Amendment or renewal, Texas DSHS will determine the quantity of devices and the serial numbers of the devices.)

d. The serial number on each device must match the serial number on the collection paper tip. Size and font of serial number must be identical on each device and collection paper tip.

e. Serial number on collection paper tip is to be easily read without lifting Parts 1, 2, 3 and 4.

f. Font throughout kit must adhere to HHS Brand Guide requirements, as appropriate. Final font will be determined by DSHS with awarded Contractor.

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g. Text on Parent Copy (Part 1 front and back), Storage and Use page (Part 2 front and back), and Instructions (Part 7) to be printed in black ink with all remaining pages in PMS 185 Blind Red Ink except as indicated in specifications and samples.

h. Device serial number and barcode to appear in black ink on all sheets as indicated in samples and specifications, including collection paper.

i. Serial number to be printed in close proximity to the barcode on parts 1, 2, 3, and 5 must be at least 1/6” distance from barcode and be printed in a font no smaller than 10 characters per inch. Serial number near barcode must include a printed check digit on at minimum Parts 1, 2, 3, and 5. Serial numbers appearing in other locations on the form do not require inclusion of the check digit. Layout of the form is illustrated on sample devices. Details for printing of check digit to be finalized by DSHS with awarded Contractor.

j. The newborn screening blood collection device is a 7-part interleaved "snap-out" device consisting of the following parts:

See Exhibit F – Sample Product Specifications for an example of each part listed below:

i. Part 1: Texas Newborn Screening Parent Information (Parent Copy)

1. Information sheet on carbonless paper consisting of 20-pound white bond with English text on front and Spanish text on back.

Using Brown PMS 1535, screen at 100% text (e.g., “Parent Copy”) on front and back. Using Brown PMS 1535, screen at approximately 20% highlighted areas (center right and left sides of information block on front, and title bar on back). See reference example. The exact intensity of ink will be finalized by DSHS with the awarded Contractor.

2. Size: Approximately 9-1/8” long x 4-1/4" wide (±1/16”) (~7/16" to be used in stub overlap at left end).

3. On the right end of the form the words “MEDICAID / CHIP/ UNFUNDED” printed in as large a font as possible.

ii. Required Revisions Prior to Each Printing of Part 1 (front/English):

1. Update device serial number in both human readable and barcodes per requirements listed earlier in “Device Specification Requirements” (see Section 7.1, Subsection H).

2. In the box with the “Kit Expires MM/DD/YYYY” the date should be as follows:

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3. “Kit Expires mm/dd/yyyy” where yyyy = 5 years following date of manufacture or longer if allowed by CLSI Guidelines. (Example:

device manufactured in January 2027 will show an expiration date of 01/31/2032).

4. Insert NBS QR code to link to Texas NBS lab website at https://www.dshs.texas.gov/laboratory-services/programs-laboratories/newborn-screening-laboratory. Link will be confirmed by DSHS with awarded Contractor. Possible location to be 2” to 3” from lower-right side of form.

5. Adjust text on Part 1 to encourage scanning and accommodate QR code.

iii. Part 2: Parent Decision Form for Storage and Use of Newborn Screening Blood Spot Cards

1. Storage and Use of Newborn Screening Blood Spot Cards sheet.

One carbonless paper consisting of 20-pound white bond paper with English text on front and Spanish text on back. Text to be screened at 100% and highlights to be screened at approximately 20% in Brown PMS 1535 on both sides as shown in the reference examples. The exact intensity of ink will be finalized by DSHS with awarded Contractor.

2. Size: Approximately 9-3/8” long x 4-1/4” wide (±1/16”) (~7/16 to be used in stub overlap at left end).

3. Barcode with serial number including check digit required on part 2 front. Barcode with serial number NOT required on part 2 back.

4. Paper used for Part 2 must not allow information written on the form to show through onto Parts 3, 4, or the manila tag Part 5.

iv. Required Revisions Prior to Each Printing of Part 2 (front/English):

1. Update device serial number in both human readable and barcodes per requirements listed earlier in “Device Specification Requirements” (see Section 7.1, Subsection H).

2. Insert NBS QR code to link to Texas NBS website https://www.dshs.texas.gov/laboratory-services/programs-laboratories/newborn-screening-laboratory/newborn-screening-use-storage. Link will be confirmed with the awarded Contractor.

Possible location to be 1” to 2” from upper-right side of form.

3. Adjust text on Part 2 to accommodate QR code.

https://www.dshs.texas.gov/laboratory-services/programs-laboratories/newborn-screening-laboratory https://www.dshs.texas.gov/laboratory-services/programs-laboratories/newborn-screening-laboratory https://www.dshs.texas.gov/laboratory-services/programs-laboratories/newborn-screening-laboratory/newborn-screening-use-storage https://www.dshs.texas.gov/laboratory-services/programs-laboratories/newborn-screening-laboratory/newborn-screening-use-storage https://www.dshs.texas.gov/laboratory-services/programs-laboratories/newborn-screening-laboratory/newborn-screening-use-storage

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v. Parts 3 (White) and 4 (Canary): Demographic Information Sheet

1. Laboratory specimen demographic information sheet. Two carbonless papers consisting of 16# white CB and 14# canary CFB from first to last copy.

2. Size: Approximately 9-3/8” long x 4-1/4” wide (±1/16”) (~7/16” to be used in stub overlap at left end).

3. Barcode with serial number including check digit required on part

3. Barcode with serial number including check digit not required on part 4.

4. Paper used for Part 4 must not allow information written on the sheet to show through on to the manila tag (Part 5).

5. Area for application of mailing label must be at minimum: 1” tall by 3” long.

6. Part 3 (white) only: On left side of sheet include dashed outline as shown in the reference examples. Outline area to be 4” x 2” using PMS 185 Blind Red Ink. The top of the outline area will be below the “Maiden Name” field, and the bottom of the outline area will be above the “Physician Phone No.” field.

7. Part 3 (white) only: Text below device serial number reads “DSHS Copy” using PMS 185 Blind Red Ink.

8. Part 3 (white) only: Text box (~1” x 1”) in the lower right corner, which includes a smaller box that can be checked by the physician to verify that the parent information and decision sheets have been provided. Text is “Check to verify parent information & decision form distributed”. Example layout is provided in the reference examples. Location of text box must not interfere with the device serial number placement and alignment on Parts 3, 4, and the filter paper (Part 6).

9. Part 4 (canary) only: Text at lower edge, left of center, reads “Submitter Copy – Retain for Your Records” using PMS 185 Blind Red Ink.

vi. Required Revisions Prior to Each Printing of Parts 3 and 4:

1. Update device serial number in both human readable and barcodes per requirements listed earlier in “Device Specification Requirements”.

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2. Update expiration date to match requirements listed above for Part 1.

3. “Mother information – Social Security #”: DSHS is considering reducing to last four digits or removing entirely. Awarded Contractor shall confirm with DSHS final wording for the field.

4. Add date of transfusion (new field) to form. Exact wording, format, and location on form to be determined by DSHS with the awarded Contractor. In addition, the possible inclusion of “Type of Transfusion” is to be determined after award.

vii. Part 5: Manila Tag and Part 6: Collection Filter Paper Tip

1. Combined Parts 5 and 6 Size: Approximately 11” long x 4-1/4” wide (±1/16”)

2. Manila Tag (Part 5): (100-pound weight)

a. Size: 9-3/8” long x 4-1/4” wide (±1/16”) (~7/16”) to be used in stub overlap at left side).

b. CF ink spot required on top right face of Manila Tag (Part

5) to align under blank square area indicated as “For Texas DSHS Use Only” located on Parts 3 and 4.

c. Include two barcodes and corresponding form serial number including check digit on Manila Tag. Location of one barcode should be to the left side of the CF ink spot.

Location of the other barcode should be centered at the right end of the manila sheet as shown in the reference examples.

3. Collection Filter Paper Tip (Part 6):

a. A 2-1/2” long x 4-1/4” (±1/16”) wide strip of 903TM, PerkinElmer 226 TM, or Equivalent collection paper is to be attached to the Manila Tag (~7/8” to be used for attachment).

b. The location of the circles corresponds with their placement on both sides of the designated collection paper and must be made with biologically inactive ink.

c. Half inch (½”) circles must be located exactly so that the distance from the right edge of collection paper to the circle is 13 mm and must be dashed as opposed to solid

Version 2.10 Page 20 of 51 Revised 03/18/2026 lines and configured into a T-shape as illustrated in Exhibit F - Sample Product Specifications.

d. Serial # printed on collection filter paper tip (front) should align with serial # printed on the right end of parts 3 & 4, such that the numbers are directly above/below one other.

4. Required Revisions Prior to Each Printing of Parts 5 and 6:

a. Update device serial number format in both human readable and barcodes per requirements listed earlier in “Device Specification Requirements” (see Section 7.1 Subsection H).

b. Update expiration date on front of the filter paper (part 6) to match requirements listed above for Part 1, 3 and 4.

c. Update the Lot # of the 903™ (or equivalent) filter paper (back – Part 6).

viii. Part 7: Screening Instructions and Protective Fold Over Cover Flap

1. A 12-15/16” long x 4-1/4” wide (±1/16”) 28-pound white ledger paper to protect and contain the collected specimen includes:

~7/16” to be used in stub overlap at left end and a 1-3/4” fold over cover flap.

2. Must meet the Department of Transportation, Hazardous Materials: Revision to Standards for Infectious Substances; Final Rule effective June 12, 2003.

3. Must cover both sides of the Dried Blood Spot specimen.

4. Perforated for easy removal from kit.

5. Print international two-color biohazard symbol on front of flap that will cover the dried specimen.

6. On the end of the kit just below the DSHS address print the words

“MEDICAID / CHIP / UNFUNDED”.

ix. Required Revisions Prior to Each Printing of Part 7:

1. Update Lot# of 903TM (or equivalent) filter paper on the stub (back of Part 7).

2. Update Revision # on the stub (back of Part 7).

3. Update the expiration date on the stub (back of Part 7) to match requirements listed above for Part 1, 3, and 4.

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x. Required Revisions to Current Device Which Affect Multiple Parts Are:

1. Change “Kit Expires" date on form Parts 1, 3, 4, on the front of the filter paper (Part 6) and the stub of Part 7 to match requirements listed for Part 1 above.

2. Update Lot # of 903TM (or equivalent) filter paper on the back of the 903TM filter paper (part 6) and on the stub (back of part 7)

Item 2: Newborn Screening Blood Specimen Collection Devices: Paid – NBS4 forms, estimated fiscal year 2027 (September 1, 2027 to August 31, 2028) quantity = 354,000 forms.

a. Device specification requirements are the same as Item 1, except for the following:

b. Serial numbers of the forms are to begin with TX 27- 2000001 and run consecutively through TX 27- 2354000 with guaranteed no missing numbers. (In the event of Contract Amendment or renewal Texas DSHS will determine the quantity of forms and the serial numbers of the forms.)

i. Part 1: Texas Newborn Screening Parent Information (Parent Copy)

3. Same as listed above for Item 1, Medicaid – NBS 3 device, except:

a. On right end of form change “MEDICAID / CHIP / UNFUNDED” to “INSURANCE / SELF-PAY”.

b. Information sheet on carbonless paper consisting of 20-pound white bond with English text on front and Spanish text on back. Using Brown PMS 1535, screen at 100% text (e.g., “Parent Copy”) on front and back. Using Brown PMS 1535, screen at approximately 20% highlighted areas (center right and left sides of information block on front, and title bar on back). See reference example. The exact intensity of ink will be finalized by DSHS with awarded Contractor.

ii. Part 2: Storage and Use of Newborn Screening Blood Spot Cards

4. Same as listed above for Item 1, Medicaid – NBS 3 device.

iii. Parts 3 and 4: Demographic Information Sheet (white and canary)

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5. Same as listed above for Item 1, Medicaid – NBS 3 device, except:

6. In the header: the word "MEDICAID" to be replaced with the word

“INSURANCE”.

7. In the header: the word "CHIP/UNFUNDED" to be replaced with the word “SELF-PAY”.

8. The word “NBS 3” to be replaced with “NBS 4”

9. In Black ink, add the letter "P" to the right side of the Device Serial

Number along the lower edge of the sheet.

10. Remove blocks in “MOTHER INFORMATION” section labeled

"Medicaid Eligible" and "Medicaid No."

iv. Part 5: Manila Tag and Part 6: Collection Filter Paper Tip

11. Same as listed above for Item 1, Medicaid – NBS 3 device.

v. Part 7: Screening Instructions and Protective Fold Over Cover Flap

12. The words “MEDICAID / CHIP / UNFUNDED” at the end of the kit replaced with the words “INSURANCE / SELF-PAY”

H. Packaging, Shipping, and Delivery Requirements

a. 100 Forms per individually wrapped package suitable for mailing with approximately 1,200 forms per case. Total shipping box weight not to exceed 40 pounds per box.

b. Packing material used for 100 form units should be of loose clear cellophane wrap, should not be shrink-wrapped, and should not tear easily during routine shipping and handling.

c. Packages are to be packed with consecutively numbered forms with no missing numbers. Label each package with enclosed first and last serial number of collection forms (i.e., 27- 0000001 – 27- 0000100), device type (Medicaid -Item 1 or Paid -Item 2) and the barcode of the first device serial number. Label any packages with missing kits, pulled for vendor QC, with list of the missing serial numbers.

d. Any package labeling on the cellophane packaging must not interfere with the ability to scan the barcode of the first specimen in the cellophane bundle.

e. All devices in 100 device packages to be stacked face side up. Within each package of 100 forms, no less than 50 forms should be rotated 180º to maintain levelness of packaged unit.

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f. Unit Packages of 100 forms are to be packaged in cartons in sequence with clearly marked numbers on the outside of each carton showing the range of serial numbers of the contents. These cartons should be numbered in numerical sequence.

g. Purchase order/Contract number is required on all packages delivered.

h. Required Pallet size: 48” x 36” with the 36” side being the front.

i. Arrangement of Boxes on Pallet: Cases to have labels facing forward (outward) with 3 across the front, one on each side (middle), and 3 across the back to form a layer, 2 layers per pallet.

j. Verify, prior to shipping, with DSHS Laboratory contact, D’Andra Luna, 512-945- 7841 or dandra.luna@dshs.texas.gov to confirm that the laboratory is ready to receive shipment. Provide number and size of pallets to be shipped for each kit type (Item 1, NBS 3 and Item 2, NBS 4).

k. Delivery Schedule

i. Item 1. Medicaid – NBS 3 devices

1. Department requests delivery of 211,200 devices by February 1, 2027.

2. Department requests delivery of 211,200 devices by July 1, 2027.

ii. Item 2. Paid – NBS 4 Forms

1. Department requests delivery of 177,000 devices by February 1, 2027.

2. Department requests delivery of 177,000 devices by July 1, 2027.

7.1.1 Delivery Address

HHS, at its sole discretion, with a 30 days’ advance written notice, reserves the right to change, consolidate, delete or add delivery locations.

a) Location(s) for Delivery

HHS Warehouse

Texas Department of State Health Services

Attention: Lab Stock

1111 W. North Loop, Austin, Texas 78756-2154

b) Changes to delivery location(s) include, but are not limited to: new office space within the facility; office closure; consolidation of multiple offices increasing or decreasing square footage; expansion of an office into multiple offices; and relocation of office.

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7.1.2 Performance Schedule

Contractor shall perform contracted services, including any minor adjustment call-back services, Monday through Friday between the hours of 8 a.m. and 5 p.m. (Central Time). Contractor shall not interfere with normal flow of HHS Agency business at the service location.

7.1.3 Services Outside Regular Business Hours

Services performed outside of the regular service hours without prior approval, will be at Contractor’s own risk and will be billed at the established Regular Business Hours service rate stated in Exhibit C – Pricing Sheet

Emergencies: The HHS Agency reserves the right to declare any necessary work within the Scope of Services to be an emergency during regular service hours or outside regular service hours and will request emergency services in writing. Contractor shall respond on-site to a request for emergency services within one (1) hour of notification and continue work until the services requested are complete to the satisfaction of the HHS Agency.

7.1.4 State Holidays

The state holidays observed are maintained by the State Auditor’s Office and may be accessed at: https://hr.sao.texas.gov/Holidays. HHS Agency does not require services to be performed on the “All agencies closed” holidays and any exception will be provided in writing to the Contractor. HHS Agency requires services to be performed for “Optional Holidays” or “Skeleton Crew Required” holidays.

To fulfill the required services, as applicable, the Contractor may perform the services on a holiday observed by HHS at NO additional expense to the HHS Agency.

Authorized services performed by Contractor on a state holiday will be invoiced at the Contract rate for Outside Regular Hours.

7.1.5 Minimum Experience and Qualifications

These minimum requirements apply to the Contractor and Contractor’s personnel and any Subcontractor and Subcontractor’s personnel.

Bidder shall submit documentation of experience and qualifications with Response, if requested in Exhibit C– Pricing Sheet.

a) The Bidder shall have relevant experience required for the performance of the services as outlined in this IFB. The minimum experience required is two (2) years.

b) All Contractor or Subcontractor personnel assigned to perform the services must be at least 18 years of age.

c) The Bidder must provide a minimum of three (3) verifiable references for current or previous contracts of the same size and for similar or same services within the last two

(2) years in Exhibit D – Bidder Reference Form and return with Response.

https://hr.sao.texas.gov/Holidays

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7.1.6 Contractor Responsibilities

The Contractor(s) is solely responsible for the performance of all services and…