FINAL RFQ 75D301-24-Q-78214.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 73

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-24-Q-78214

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

08/09/2024

6. REQUISITION/PURCHASE

NO.

000HCNBE-2024-88425

7. ISSUED BY CODE 8219 8. ADDRESS OFFER TO (If other than Item 7) Centers for Disease Control and Prevention

Chamblee Campus Building 102, MS S102-4 4770 Buford Hwy Atlanta, GA 30341-3717

Approved as to Form and Legality: __________________________ NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in until 9:00a local time 08/29/2024

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Ashia Everett

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(404) 498-5229

C. E-MAIL ADDRESS

oiv4@cdc.gov

11. TABLE OF CONTENTS

(X) DESCRIPTION (X) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 43

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 5 X J LIST OF ATTACHMENTS 53

X D PACKAGING AND MARKING 28 PART IV - REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 29 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 30 K OTHER STATEMENTS OF OFFERORS 54

X G CONTRACT ADMINISTRATION DATA 31 L INSTRS., CONDS., AND NOTICES TO OFFERORS 60

X H SPECIAL CONTRACT REQUIREMENTS 33 M EVALUATION FACTORS FOR AWARD 65

OFFER (Must be fully completed by offeror) NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) 23. SUBMIT INVOICES TO ADDRESS SHOWN IN (4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 8219 25. PAYMENT WILL BE MADE BY CODE 434 Centers for Disease Control and Prevention Chamblee Campus Building 102, MS S102-4 4770 Buford Hwy Atlanta, GA 30341-3717

Centers for Disease Control and Prevention (FMO) PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

Ashia Everett

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

K

Subject: Automated Dried Blood Spot Platform

Solicitation Number: 75D301-24-Q-78214

ISSUANCE DATE: August 09, 2024

QUESTIONS DUE DATE/TIME: NLT Noon EST August 15, 2024

Response DUE Date/time: NLT 9:00 A.M. EST August 29, 2024

Section A – Description

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

The solicitation number for this requirement is 75D301-24-Q-78214 and is hereby issued as a Request for Proposal (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2024-05 dated May 22, 2024.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 – Analytical Laboratory Instrument Manufacturing with a Standard Size of 1,250 employees.

This is an RFP for the design and installation of an automated dried blood spot platform. The Government intends to award a single Firm-Fixed Price contract as a result of this solicitation that will include the terms and conditions that are set forth herein.

The provision at 52.212-1, Instructions to Offerors-Commercial, applies to this acquisition. FAR 52.212- 2, Evaluation-Commercial Items, is not included.

Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer or indicate if it is available online at SAM.gov. FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition; there are no addenda to the clause. FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and the additional FAR clauses cited in the clause that are applicable have been noted.

There are no additional contract requirement(s) or terms and conditions determined by the contracting officer to be necessary for this acquisition and consistent with customary commercial practices. No telephonic quotes will be processed. All responses must be received no later than the date stated above.

Contact Ashia Everett, Contracting Officer, at oiv4@cdc.gov for any questions regarding this solicitation.

Questions must be submitted in writing; no telephonic questions permitted.

https://www.acquisition.gov/far/52.212-1#FAR_52_212_1 https://www.acquisition.gov/far/52.212-2#FAR_52_212_2 https://www.acquisition.gov/far/52.212-2#FAR_52_212_2 https://www.acquisition.gov/far/52.212-3#FAR_52_212_3 https://www.acquisition.gov/far/52.212-4#FAR_52_212_4 https://www.acquisition.gov/far/52.212-5#FAR_52_212_5 mailto:oiv4@cdc.gov

Section B - Supplies Or Services and Prices/Costs

Base Period

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Title: Automated Dried Blood Spot

Platform – Design and Installation

Design & Prototype in accordance with the Work Statement below.

Period of Performance: 9/30/2024 – 5/29/2025

This is a Firm Fixed Price Line Item This is a Non-Severable Line Item

1 Job $__________ $__________

Option Period 1:

1001 Title: Automated Dried Blood Spot

Platform – Design and Installation

Build & Acceptance in accordance with the Work Statement below.

Period of Performance: 5/30/2025 – 9/29/2027

This is a Non-Severable Line Item

1 Job $__________ $__________

1002 Travel for onsite installation at CDC NSMBB location

Travel in accordance with the Work Statement below.

Period of Performance: 10/1/2025 – 9/29/2026

This is a Cost Reimbursement Only Line Item This is a Severable Line Item

1 Job $__________ $_____________

Option Period 2:

2001 Title: Automated Dried Blood Spot

Platform – Design and Installation

Maintenance in accordance with the Work Statement below.

Period of Performance: 9/30/2027 – 9/29/2028

1 Year $__________ $__________

Option Period 3:

3001 Title: Automated Dried Blood Spot

Platform – Design and Installation

Maintenance in accordance with the Work Statement below.

Period of Performance: 9/30/2028 – 9/29/2029

1 Year $__________ $__________

Base + Option Periods Total Contract Price: $___________________

Section C - Description/Specification/Work Statement

Statement of Work / Performance Work Statement Title: Automated Dried Blood Spot Platform – Design and Installation

SECTION 1 – BACKGROUND

The Newborn Screening and Molecular Biology Branch (NSMBB), within the Division of Laboratory Sciences (DLS), is part of the National Center for Environmental Health, at the Centers for Disease Control and Prevention (CDC). NSMBB is mandated by the Newborn Screening Saves Lives Reauthorization Act of 2014 to provide quality assurance (QA) and quality control (QC) materials, performance evaluation services, technical assistance and technology transfer to newborn screening programs to ensure analytic validity and utility of screening tests.

Newborn Screening has been in operation for the last 60 years in the US and aims to identify newborns who are at-risk for a panel of treatable inherited diseases. Early identification and timely treatment of these at-risk newborns result in better outcomes, preventing or reducing the severity of developmental disabilities that may have occurred if the newborn were left untreated.

For over 45 years, the Branch has operated the nation’s only quality assurance program for ensuring the accuracy of newborn screening blood spot tests conducted by State public health laboratories. The instruments used to produce these reference materials are several decades old and need replacement.

The current processes are also manual, labor intensive and would benefit from modernization of its workflow to improve efficiency and throughput.

In addition, State Newborn Screening Programs have been faced with a rapid expansion in the number of diseases to be screened, with more complex testing, and subsequently require appropriate quality assurance materials to support the accurate identification of newborns that are at risk for disease. The importance of newborn screening as a means for the detection of at-risk newborns has also led to a significant increase in advocacy from affected parent groups and members of the rare disease community, indicating that the demand for the expansion of newborn screening panels with rare diseases of interest will continue to increase for the foreseeable future.

Faced with the need to replace aging equipment, coupled with a surge in the demand for the manufacture of more disease-specific reference materials, NSMBB seeks to procure a machine that would address the current and anticipated need for the production of these reference materials so that we could be compliant with our congressional mandate.

SECTION 2 – PURPOSE/OBJECTIVE

The purpose of this acquisition is to design, validate, install, and provide instrument maintenance for an “Automated Dried Blood Spot Platform” for the Newborn Screening and Molecular Biology Branch.

The “Automated Dried Blood Spot Platform” dispenses blood onto printed filter paper, then dries and packages the blood spot cards for storage. This contract aims to modernize and improve efficiencies in

NSMBB’s work processes in support of its mission and priorities as required by the “Newborn Screening Saves Lives Reauthorization Act.

SECTION 3 – SCOPE OF WORK

Scope of Work The Contractor shall provide all personnel and services necessary to perform the tasks outlined in this performance work statement. The organization of this contract is shown down below:

SECTION 4 – TASKS TO BE PERFORMED

Task 1, 2 and 3 are Base Period activities. Task 1, 4, and 5 are Option Period 1 activities. Task 1 and 6 are Option Periods 1, 2, and 3 activities.

The contractor shall perform the following tasks:

Task 1 - Administrative Management The contractor shall be responsible for planning, organizing, coordinating, and managing all tasks.

The contractor shall work with the CDC Contracting Officer Representative (CDC COR) and CDC NSMBB Subject Matter Experts (SME) to develop general task and activity plans, progress monitoring plans, issue resolution and risk mitigation plans, and user acceptability of completed products services or deliverables.

In addition to providing specific deliverables, the contractor shall also provide ongoing evaluation of task work quality within the monthly progress reports described below. The contractor shall also communicate with CDC in providing regular status updates, identifying problems, and recommending innovative solutions or enhancements to task approach in the monthly progress reports described below.

1.1 Kickoff Meeting

The contractor shall arrange a kickoff meeting that must be held no later than 10 workdays after the initial award is made to discuss project/activity/task plans and timelines as well as to identify roles and responsibilities. During the kick-off meeting, CDC and the contractor through mutual agreement will establish a meeting schedule and determine the best mechanism and frequency of communications. The contractor shall take minutes and deliver to COR within two days of kick-off meeting.

1.2 Work Plan

The contractor shall develop a written work plan minimally including a series of specific reports and activities proposed by the contractor following the kick-off meeting, to be developed by the contractor during the course of the contract, inclusive of the contractor’s plan for ongoing monitoring and evaluation of services to assure high quality performance and customer satisfaction.

The plan must include a timeline of all essential interim deliverables leading to the contract final deliverables, as well as key staff responsible for tasks (including contractor, CDC, or other partners).

The work plan must also contain the following items:

1. Communication plan for specific task areas

2. Contractors plan for achieving high quality performance and customer satisfaction.

3. Contractor hours of operation and key points of contact.

The work plan must be a distributable document for sharing with key CDC/NSMBB Branch management/staff. The work plan is due no later than 15 workdays following the kickoff meeting. The work plan (and any schedule of interim deliverables) may be revised according to CDC acceptance of the updated work plan by the COR during the project with the restriction that these changes must not impact the overall period of performance, scope, or specifications of the contract, or otherwise impinge on the authority of the Contracting Officer. It is the responsibility of the contractor to fully understand what changes require Contracting Officer approval.

1.3 Monthly Meetings

The Contractor shall coordinate and lead meetings with CDC staff monthly to discuss updates on progress, and any specific deliverables as described in the work plan. The contractor must keep notes of relevant topics discussed, next steps, and action items from the meeting and deliver meeting notes to the COR no later than one week after the meeting.

Monthly Progress Reports

The Progress report shall be considered a deliverable of the project, for review by NSMBB Branch leadership as well as the COR and used as:

1. A tracking tool for success of this project,

2. Documentation of services as invoiced in the matching monthly invoice

3. Support for annual Contractor Performance Assessment Reporting System (CPARS) evaluation.

The contractor shall develop the monthly progress report format for review and approval by the COR.

The progress report is due no later than the 15th calendar day of each month. The progress report at a minimum must include:

1. Executive Summary highlighting the following:

a. Major accomplishments, issues, or delays in deliverables across all tasks.

b. Anticipated travel

2. Progress report by Task to include:

a. Contractor highlights for progress/update on ongoing tasks

b. Problems encountered and proposed solutions

c. New activities planned for upcoming month

d. Significant accomplishments

Task 2 – Design of the “Automated Dried Blood Spot Platform”

The Contractor shall work with CDC NSMBB SMEs in the design of the “Automated Dried Blood Spot Platform”.

During the Design Phase the Contractor shall:

1. Perform a comprehensive analysis to determine design requirements, consistent with the purpose, functionality and performance expectations of the contract.

2. Conduct market research to evaluate existing technologies and solutions capable of addressing the design needs, best practices, potential challenges and opportunities for innovation.

3. Generate design concepts based on the identified requirements

4. Discuss with CDC the feasibility of various design elements and their adoption to determine their viability within the proposed solution

5. Select the most promising design concept based on factors such as cost, complexity, and alignment of contract requirements.

6. Iteratively seek input from CDC at key milestones during the design process

7. Develop detailed design documentation, which must include schematics, drawings and specification of the proposed platform in compliance with the described technical specifications listed below “Technical Requirements and Specifications of the “Automated Dried Blood Spot Platform”.

Technical Requirements and Specifications of the “Automated Dried Blood Spot Platform.

The Newborn Screening and Molecular Biology Branch, Division of Laboratory Sciences, requires a holistic automated solution for the printing, spotting, drying and packing of dried blood spots (DBS).

The manufacturing of DBS comprises 6 processes, 4 of which must be fully automated.

Process 1: Processing and enrichment of blood to be spotted, setting the blood into containers and filling the magazines/card-feeders with cassette filter paper cards. This is a manual step performed by operators.

The overall size of the magazines/feeders must be big enough to operate at least 1 hour unattended;

however, each one shall not contain more than 300 cassettes to avoid compression. The system must have sensors that monitor the amount of cassettes remaining and notify the operator when running low on cards through a light and/or sound signal. The filter paper cards used will be in a cassette format that include filter paper on the inside and an appropriate type of paper on the outside that holds and frames the filter paper to prevent warping of the card after blood spotting. The filter paper cards will also allow for information including but not limited to lot #, bar code, and expiration date to be printed on it. The dimensions and specifications of the cassette card that the system must be configured to use can be found below in Figure 1:

Figure 1

Process 2: Printing and quality control (QC)of the printed cards. This process must be automated. The cassette feeders must automatically provide cards to be printed. The system must print information on the paper holder (See Figure 1, Part 1 above; not the filter paper) of the cassette that includes numbers/letters/bar codes and then take it through a quality control step where an optical system checks the printed portion is legible with no smear; in correct orientation and placement; and the bar code can be read by a barcode reader. In addition, it must look at any imperfections such as holes and stains . If the quality control step identifies an error, it must auto-reject and set the system to reprint that same card (i.e.

same card number) immediately after rejection to keep all cards in a sequential order. The printing on the card must be able to withstand -80 °C storage of up to 10 years. The system must allow the operators to define and input the exact content needs to be printed on each batch of the cards and make changes when needed. The CDC NSMBB SMEs will provide details on printing content, such as placement, color, font type, font size, bar code dimensions during the design of the system.

Process 3: Spotting of the cards and QC of the cards. This process must be automated. This process takes place after printing and QC checking of the card and includes the following components: reservoirs of blood, transfer tubing, pumps, dosing heads, and optical QC. The blood spotted must have the same characteristics as human blood adjusted to 50% hematocrit. The following specifications are required for the different components:

Blood reservoirs: The system must be able to accommodate three different blood reservoirs:

I. Proficiency testing (PT), daily QC and calibrators reservoir: This must contain 6 glass reservoirs, with each one able to accommodate at least 1 L of blood. Each reservoir must have one or more tubes going into it that will transfer blood onto filter paper through a pump. Each tube dead volume must be no more than 400 µL. Each blood reservoir must be temperature controlled from 4 °C to 22 °C. Temperature tolerance must be ±2 °C. The blood must be stirred continuously either with a paddle or magnetic stirring. Stirring must be rigorous but not too intense that it could lead to the blood frothing. Stirring speed must be able to be adjusted by the operator.

II. QC large volume reservoir. This must be a large capacity 6 L glass reservoir that must also be able to be cooled. Same specifications as above in item I apply in terms of tube dead volume, cooling and stirring.

III. Small volume molecular biology PT and QC. These volumes must have the capacity to accommodate 6 glass reservoirs that can range in volume from 50mL -1L. Critical requirement for this is a low volume inside the tube, with each tube having <150 µL dead volume. Magnetic stirring of each reservoir is required but cooling is not required. This must be as close to the pump/filter paper as possible to meet the low volume requirement.

Transfer tubes: As described above, depending on the program and volume spotted, each line dead volume must be either <150 µL or <400 µL.

Pumps: The system must be able to spot from 50 to 100 µL of blood with an accuracy of ±2% for the 100 µL and up to ±3% for the 50 µL spots. Most of the time, it is anticipated to spot around 55 µL on the cassette format filter paper.

Dosing heads: The positions of the dosing heads above the cards must be able to be adjusted in the X, Y and Z directions to ensure the correct placement of spots on the cards.

Optical QC: Optical QC must ensure the spots are within certain diameter tolerance (based on the volume spotted) as well as a certain distance from other spots and outside paper. If it fails, it must be rejected, and the system must reprint and ensure an additional card is immediately spotted after the failure(s). The system must be flexible to allow the operator to specify the number of spots applied to the paper, with a minimum of one and a maximum of 6. Most of the time it will be 5 or 6.

Adequate time must be allowed between cards and the movement of the cards must be slow enough to allow the blood spotted to fully absorb into the paper, forming a uniform, circular spot without splattering.

Process 4: Drying of the blood spots. This process must be automated. Following spotting and quality control of the spotted cards, the cards must be moved to a separate temperature- and humidity-controlled section to dry. The temperature of the drying section must be set between18-25°C and be set with a tolerance of ±1°C. The humidity must be ≤1.2 g/kg humidity. Time needed to dry completely shall be 2 hours ± 5 minutes. The cards cannot be stacked directly one on top of the other and must be spaced adequately to allow them to dry homogenously.

Process 5: Packaging or stacking of the blood spots. This process must be automated. After each card has been dried for two hours, it must be automatically taken for packaging or stacking of the cards.

Packaging of the cards: The majority of the programs will use this mode. Each card must be packed individually. The material of the package may be selected by the operator and be either aluminum, plastic or dessiflex (from Amcor) or similar material and packed under a dry nitrogen environment. The package must be printed and visually inspected by the system to ensure the accuracy of the printed characters. The printing on the bag must be able to withstand -80 °C storage for a minimum of 10 years. The CDC NSMBB SMEs will provide details on printing content, such as placement, and color, font type, font size, bar code dimensions during the design of the system. After inserting a filter card to an individual packing envelope, the package must be heat-sealed together and cut off. After packing, sealing, and cutting, the packed cards must be transferred to a container. At a certain frequency (e.g. every 1 out of 500 cards or following a random generated algorithm e.g. sample randomly 10 cards from a production of 5,000 cassettes), packed cassettes must be sampled and transferred to a separate bin for QC evaluation such as homogeneity testing.

Stacking of the cards: For some programs, cards will be partially spotted (e.g. 3 out of 6 spots were filled) with the rest of them to be spotted sometime in the future. Instead of packing those cards, the system must stack them in appropriate containers or magazines after drying. Stacks shall be limited to 250 cards and the system must be able to store at least 1,000 cards and allow operators access that allow them to empty filled containers/magazines and reposition them while the system is in operation.

Process 6: Storing of packed cards into the freezer. This is a manual step performed by operators.

Following packing, an operator will be sorting as needed and placing the packed cards into the freezer.

The container that cards are placed in after packing must be big enough to allow unattended operation of at least 1 hour (i.e. should be able to accommodate >1,000 packed cards). Stacked cards will be put in appropriate bags by an operator and stored in the freezer until a later date.

Additional requirements: The throughput of the automated solution must be around 1000 cards (6,000 spots) per hour when card packing takes place during process 5, and 500 cards (3,000 spots) per hour when card stacking takes place during process 5. The system must be able to operate continuously to produce at a minimum 10,000 cards. Process 2-5 must be automated in one continuous sequence without any manual intervention needed. The overall card reject rate due to equipment errors (e.g. printing process) must be < 1%. The overall catastrophic fail rate (defined as a system failure that cannot recover even after intervention leading to a failed/wasted production) must be < 0.2%.

In the case of a system failure, the system must notify the operators through a light and/or sound signal with an indication of what the error is.

The system must be able to generate reports per production including but not limited to information on number and type of cards produced, location of reprints in spotting sequence, how many failed and why, name and date of the production, and badge numbers. Data must be readily available to be exported to the existing inventory system. Details of the required export format will be provided by the CDC NSMBB SMEs during the design of the system. The system must also have safeguards where if a number of cards fail one after another (configurable), it must stop and request operator assistance. Technical assistance by phone or online from the contractor must be available 8:00am-5:00pm EST Monday through Friday.

Response time for issues must be within 24 hours. If needed, onsite service must be provided within 48 hours. Operators are only responsible for processing the blood, setting up the system initially and once in operation, filling up the magazines and collecting and storing the packed or stacked cards. The contractor shall provide steps for postproduction cleanup work and system shutdown, as well as requirements for preventive maintenance.

Photos captured after printing of the card, after spotting of blood and after printing of packaging must be visible on a screen in real time and stored on a hard drive or server. The software must allow images to be inspected during or post-production by an operator. The system must be flexible enough to allow an operator with administrative privileges to set a program that bypasses printing and associated QCs (i.e. in cases where already printed and partially spotted cards are used).

The system must be enclosed and appropriate safety locks must be in place when the system is in operation where moving parts exist that can lead to injury. The card feeders, blood containers, tubing, pumps, card stacking magazines, packing card bin and rejection bins and other equipment that the operator may need to interact with must be accessible during operation. Appropriate audit trails must exist, and operator privileges must be customized/set.

Due to space constraints, the system preferably should not exceed the following physical dimensions:

Width: 14 ft , Depth: 16 ft , Height: 7.6 ft. The system must not exceed the following physical dimensions: Width: 18 ft, Depth: 20 ft, Height: 7.6 ft. Transfer tubing and dosing heads must be removable for appropriate cleaning or exchange. The drying section must have an even airflow to ensure uniform drying of the cards. The requirement of compressed air must be at a pressure of 125 psi or lower.

The printing of the cards and the bags must be freely programmable.

High-level description of manual/automated sequence of events:

The following process is a high-level sequence of events for 1 filter paper card. The movements are detailed below in sequential fashion, however, in practice many movements will be performed in parallel.

This is for illustration purposes only. The contractor shall select the most promising design concept based on factors such as cost, complexity, and alignment of contract requirements.

Task 3 – Prototype Development of the “Automated Dried Blood Spot Platform”

During the Prototype Development Phase the Contractor shall:

1. Build a physical prototype of the Automated Platform based on the CDC approved design at contractor’s site.

2. Conduct thorough testing of the prototype to evaluate its performance, functionality and reliability. Gather feedback and iterate on the design to address any issues or improvements identified during the testing process

3. Refine the prototype based on testing results, user feedback and CDC input. This process may involve making adjustments to the design, materials, and workflow to enhance performance and usability.

4. Ensure that all components of the automated machine are well integrated and work seamlessly.

Compatibility issues must be addressed to optimize system function.

Step Module Action

START

1 Operator Start-up the system 2 Operator Perform daily maintenance procedures 3 Operator Load as needed packing foils and other supplies to the designated positions 4 Operator Load the card feeder with cards 5 Operator Load the blood containers with blood and position the tubes 6 Operator Prime the transfer tubes and dosing heads with blood 7 Card feeder Card is fed to transfer module 8 Transfer module Card is tranferred to card printing module 9 Card printer Card is printed

10 Transfer module Card is transferred to optical QC module 11 Optical QC module Optical QC module check the printing of the card

11-Rej Transfer module If QC fails, card is rejected and re-printed 12 Transfer module If QC pass, card is transferred to spotting module 13 Spotting module Blood is spotted in the card 14 Transfer module Spotted card is transferred to optical QC module

14-Rej Transfer module If QC fails, card is rejected, re-printed and re-spotted 15 Transfer module If QC pass, card is transferred to drying module 16 Drying module Card is dried in drying module for about 2 hours

17-NP Transfer module If No Packing (NP) will take place, card is transferred into a magazine.

17-NP-2 Operator Partially spotted cards in magazines are packed in bags and stored into the freezer 17-NP-3 Operator End of Sequence if no no packing is taking place.

17-P Transfer module If Packing (P) will take place, card is transferred to packing module 18 Packing printing module Foil/Bag is printed and moves forward to optical QC module 19 Optical QC module Packing printing is checked

19-Rej1 Packing module If QC fails, the system knows not to pack anything in that part of the foil/bag 19-Rej2 Packing module If QC fails, foil/bag is reprinted and rechecked

20 Packing module If QC pass, card is inserted into the foil/bag, and heat sealed 21 Packing module Foil/bag is cut to generate individual bags 22 Transfer module Bag is transferred to QC sampling module

22-QC-y QC sampling module If preset frequency selects for QC, the bag is diverted to QC bin 22-QC-n QC sampling module If QC module does not select the card for QC, send to transfer module

23 Transfer module Bag is transferred to collection bin 24 Operator Sealed bag with spotted card is placed into the freezer

5. Software components must be developed and integrated within the workflow of the platform.

6. Ensure that the prototype complies with safety and regulatory standards relevant to its intended use. Perform risk assessments and make necessary modifications to address any safety concerns.

7. Conduct user testing and gather feedback from end-users to ensure that user-specific modifications are implemented as needed.

8. Prepare comprehensive documentation, including user manuals, maintenance guides and technical specifications needed for routine maintenance, troubleshooting and user training.

9. Identify opportunities for cost optimization without compromising performance or quality

10. Develop a plan for scaling up to a working model, based on the successful prototype.

11. Finalize the design and development of the prototype based on the feedback received, testing results and necessary refinements and provide documents to CDC.

Task 4 – Build and Perform Factory Acceptance Testing to validate the performance of the “Automated Dried Blood Spot Platform” at the Factory location ---- Option Period 1

The Contractor shall build the “Automated Dried Blood Spot Platform” based on the finalized prototype and conduct the Factory Acceptance Testing (FAT), ensuring that the machine meets design specifications and functions correctly at the manufacturer’s location. During this Phase the Contractor shall:

1. Build the “Automated Dried Blood Spot Platform” according to the scale-up plan of the successful prototype.

2. Conduct FAT at the manufacturing facility before shipping the machine to CDC. This step involves testing the prototype against the mutally agreed-upon, pre-determined criteria between the contractor and CDC to ensure that it meets design specifications and include:

a. Verification of functionality and performance

b. Testing under various operating conditions

c. Validation of safety features

d. Inspection of components and materials

e. Calibration and accuracy checks

f. User interface testing

3. Deliver FAT documentation to CDC verifying the performance metrics of the Platform.

4. Send to CDC appropriate documentation and instructions for site preparation to ensure that proper infrastructure, utilities and safety measures are in place.

Task 5 – Ship, Install and Perform the Site Acceptance Testing to validate the performance of the “Automated Dried Blood Spot Platform” at the CDC location ---- Option Period 1

The Contractor shall build and install the “Automated Dried Blood Spot Platform” using several steps that include FAT and Site Acceptance Testing (SAT) to ensure that the machine meets design specification and functions correctly within its intended environment at the NSMBB labs at CDC.

During this Phase the Contractor shall:

1. Coordinate the shipping and logistics of the machine from the manufacturing facility to the

NSMBB Laboratory site at CDC, ensuring proper handling and transportation measures are in place to prevent damage during transit.

2. Install the machine at the CDC site according to the specifications and guidelines, that address physical installation, electrical connections and any other set-up procedures.

3. Conduct SAT at the CDC location to validate the performance of the “Automated Dried Blood Spot Platform” in its intended environment. These steps shall include:

a. Verification of proper installation and connection

b. Testing under site-specific conditions

c. Validation of user interface in the actual, intended operating environment

d. Functional testing with actual CDC materials

e. Safety checks and verification of emergency shutdown procedures

4. Provide training to CDC personnel on operating, maintaining and troubleshooting the platform, ensuring that the CDC end-users can effectively operate the platform.

5. Validate the performance of the machine using “real-world” conditions, which involves a period of monitoring and making adjustments to ensure optimal functionality. The Contractor shall generate and provide a report of validation and acceptance.

6. Complete, finalize and hand over all installation documentation to CDC, including any modifications made during the installation.

7. Obtain formal acceptance from CDC after successful SAT, confirming that the platform meets the specified requirements.

8. The Platform must be under warranty for a period of 12 months from the time that the SAT has been successfully completed.

a. Technical assistance by phone or online from the contractor shall be available 8:00am- 5:00pm EST Monday through Friday. Response time for issues must be within 24 hours. For issues requiring onsite repair, onsite service must be provided within 48 hours.

b. Priority repair by qualified engineer with all specialized training, necessary tools, required service instrumentation, controlled proprietary stock parts as needed.

c. Telephone support to solve the problem with trouble-shooting assistance.

Task 6 – Routine Preventative Maintenance, Repair and Technical Support ---- Option Period 1, 2 and 3

The Contractor shall provide ongoing support to address issues that may arise post-installation. This shall include troubleshooting, software updates and periodic maintenance.

Maintenance Support shall include:

1. Technical assistance by phone or online from the contractor should be available 8:00am- 5:00pm EST Monday through Friday. Response time for issues must be within 24 hours. For issues requiring onsite repair, onsite service must be provided within 48 hours.

2. Priority repair by qualified engineer with all specialized training, necessary tools, required service instrumentation, and controlled proprietary stock parts as needed.

3. Telephone support to solve the problem with trouble-shooting assistance.

4. Quarterly Conference Call with CDC to discuss service and any issues. (4 times a year)

5. Provides two (2) preventive maintenance visits per option period, including all costs for labor, travel, parts and freight, to keep the platform in good working order to avoid potential repairs.

Preventative maintenance schedule of visits shall be mutually agreed upon by the contractor and CDC.

6. Schedules repair by prior arrangement with CDC analysts at a mutually suitable time and date to avoid interruption of laboratory work. Performs regular updates to maintain functionality of the platform and ensure compatibility with CDC’s operating systems.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

N/A - No government furnished property will be issued to the contractor.

SECTION 6 – PLACE OF PERFORMANCE

Task 1 – 4 shall be performed off-site. Task 5 & 6 shall be performed at the NSMBB labs at CDC.

SECTION 7 – TRAVEL

Travel must be in accordance with / and not to exceed the Federal Travel Regulation rates. Travel must be approved in advance by the COR.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Task PWS Deliverable Description Due Date Deliver To

Task 1 – Administrative Management

1.1 Kickoff Meeting; virtual power

point presentation between Contractor and CDC teams

Within 10 workdays of Contract award.

COR and NSMBB SMEs

Task 1 – Administrative Management

1.2 Submission of Work Plan 15 days after the Kick-

off meeting.

COR and NSMBB SMEs

Task 1 – Administrative Management

1.3 Hold Meetings, at least

quarterly, to provide updates and status reports

Once each quarter COR and NSMBB SMEs

Task 1 – Administrative Management

1.4 Submit monthly progress reports No later than 15th

calendar day of each month

COR and NSMBB SMEs

Task 2 – Design of the “Automated Dried Blood Spot Platform”

2.1 Hold Meetings to seek input

from CDC staff at key milestones during the design process

Ad hoc, As needed NSMBB SMEs

Task 2 – Design of the “Automated Dried Blood Spot Platform”

2.2 Develop and deliver detailed

design documentation according to technical specifications outlined in task 2.

Documentation must include schematics, drawings and specifications of the proposed platform

Within 3 months of contract award

COR and NSMBB SMEs

Task 3 – Prototype Development of the “Automated Dried Blood Spot Platform”

3.1 Hold Meetings to seek input

from CDC at key milestones during the prototype development process

Ad hoc, As needed NSMBB SMEs

Task 3 – Prototype Development of the “Automated Dried Blood Spot Platform”

3.2 Develop and deliver detailed

documentation on prototype according to technical specifications outlined in task 7.

Documentation will include schematics, drawings and specification of the prototype platform

Within 5 months of completion and acceptance of Task 2

COR and NSMBB SMEs

Task 4 – Build and Perform Factory Acceptance Testing to validate the performance of the “Automated Dried Blood Spot Platform” at the Factory location

4.1 Conduct Factory Acceptance

Testing (FAT) of the scaled-up build of the Prototype. Deliver Documentation that indicates that the prototype meets agreed-upon design specifications as described in task 2.

Within 16 months of exercising Option period 1.

COR and NSMBB SMEs

Task 4 – Build and Perform Factory Acceptance Testing to validate the performance of the “Automated Dried Blood Spot Platform” at the Factory location

4.2 Documentation and instruction

for CDC Site Preparation to ensure that proper infrastructure, utilities and safety measures are in place for installation of new platform.

Within 16 months of exercising Option period 1.

COR and NSMBB SMEs

Task 5 – Ship, Install and Perform the Site Acceptance Testing to validate the performance of the “Automated Dried Blood Spot Platform” at the CDC location

5.1 Invoices and appropriate

documentation demonstrating shipment and receipt of Instrument packages to CDC.

Within 16 months of exercising Option period 1.

COR and NSMBB SMEs

Task 5 – Ship, Install and Perform the Site Acceptance Testing to validate the performance of the “Automated Dried Blood Spot Platform” at the CDC location

5.2 Conduct “Site Acceptance

Testing” (SAT) at the CDC location to validate the performance of the “Automated Dried Blood Spot Platform” in its intended environment.

Deliver Documentation to indicate that the platform meets agreed-upon design specifications as described in task 2 with formal acceptance from CDC.

Within 16 months of exercising Option period 1.

COR and NSMBB SMEs

Task 5 - Ship, Install and Perform the Site Acceptance Testing to validate the performance of the “Automated Dried Blood Spot Platform” at the CDC location

5.3 Provide training to CDC

personnel on operating, maintaining and troubleshooting the platform, ensuring that the CDC end-users can effectively operate the platform.

By the end of the period of performance associated with Option period 1.

Review by COR and NSMBB SMEs

Task 6 – Routine Preventative Maintenance, Repair and Technical Support

6.1 Creation of an agreed upon Preventative Maintenance Schedule. (1 per year)

Within 2 months of exercising the Option period 2.

COR and NSMBB SMEs

Task 6 – Routine Preventative Maintenance, Repair and Technical Support

6.2

Prompt confirmation of formal service request.

Between the hours of 8:00AM and 5:00 PM (24 hrs. outside this window during the week days).

Task 6 – Routine Preventative Maintenance, Repair and Technical Support

6.3 Prompt response to formal call

for service through telephone assistance, shipment of parts, and/or on-site repairs provided as necessary for remediation. (1 per service request)

Respond within 24 hours of service call placement 90% of the time

COR and NSMBB SMEs

Task 6 – Routine Preventative Maintenance, Repair and Technical Support

6.4 Service invoice/record (field

service reports) provided following all remedial and preventative maintenance (PM).

(1 per service request or PM)

Throughout award period due upon completion of service.

COR and NSMBB SMEs

Task 6 – Routine Preventative Maintenance, Repair and Technical Support

6.5

No cost software and firmware upgrades and support.

As needed throughout award period based on need and availability of updates.

COR and NSMBB SMEs

Task 6 – Routine Preventative Maintenance, Repair and Technical Support

6.6 Quarterly Conference Call with CDC to discuss service and any issues. (4 times a year)

Due once per quarter

COR and NSMBB SMEs

Task 6 – Routine Preventative Maintenance, Repair and Technical Support

6.7 Successful repair of broken elements of the Platform as covered by the agreement

As needed throughout award period.

SUBSECTION A – PERFORMANCE MATRIX

The Contractor must provide all services and deliverables under the Contract at an acceptable service and quality level to CDC and in a manner consistent with acceptable industry standards, customs, and practice.

PWS PERFORMANCE OBJECTIVE

STANDARD (and AQL) METHOD OF

SURVEILLANCE

1.1 Kickoff Meeting; virtual power point

presentation between Contractor and CDC teams

Within 10 workdays of Contract award.

Review and participation by COR and NSMBB SMEs

1.2 Submission of Work Plan Report received 15 days

after the Kick-off meeting.

Review by COR and

1.3 Hold Meetings, at least quarterly, to Meetings held at least once Review by COR and provide updates and status reports each quarter NSMBB SMEs

1.4 Submit monthly reports No later than 15th calendar

day of each month Review by COR and NSMBB SMEs

2.1 Hold Meetings to seek input from CDC

staff at key milestones during the design process

Ad hoc, As needed Review by COR and NSMBB SMEs

2.2 Develop and deliver detailed design

documentation according to technical specifications outlined in task 2.

Within 3 months of contract award, will provide documentation which include schematics, drawings and specifications of the proposed platform

Review by COR and NSMBB SMEs

3.1 Hold Meetings to seek input from CDC at

key milestones during the prototype development process

Ad hoc, As needed Review by COR and NSMBB SMEs

3.2 Develop and deliver detailed

documentation on prototype according to technical specifications, and approved design modifications, outlined in task 2.

Documentation will include schematics, drawings and specification of the prototype platform

Documentation will be received after completion and acceptance of Task 2 and within 12 months of the contract award

Review by COR and NSMBB SMEs

4.1 Conduct a scaled-up build of the

Prototype and perform Factory Acceptance Testing (FAT). Deliver Documentation that indicates that the prototype meets agreed-upon design specifications as described in task 2.

Option period 2 will be exercised upon completion of Base Year.

Documentation will be received within 12 months of exercising Option period 1.

Review by COR and NSMBB SMEs

4.2 Documentation and instruction for CDC

Site Preparation to ensure that proper infrastructure, utilities and safety measures are in place for installation of new platform.

Documentation will be received within 12 months of exercising Option period 1.

Review by COR and NSMBB SMEs

5.1 Invoices and appropriate documentation

demonstrating shipment and receipt of Instrument packages to CDC in preparation for on site installation.

Documentation will be received within 12 months of exercising Option period 1.

Review by COR and NSMBB SMEs

5.2 Build the Platform according to agreed-

upon specifications and conduct “Site Acceptance Testing” (SAT) at the CDC location successfully to validate the performance of the “Automated Dried Blood Spot Platform” in its intended environment.

Documentation will be received within 12 months of exercising Option period 1.

Review by COR and

Deliver Documentation to indicate that the platform meets agreed-upon design specifications, and approved design modifications, as described in task 2.

5.3 Provide training to CDC personnel on

operating, maintaining and troubleshooting the platform, ensuring that the CDC end-users can effectively operate the platform.

By the end of the period of performance associated with Option Period 1.

Review by COR and NSMBB SMEs

6.1 Creation of an agreed upon Preventative Maintenance Schedule. (2 per year)

Schedule will be discussed and agreed upon within 2 months of exercising Option period 2.

Review by COR and NSMBB SMEs

6.2

Prompt confirmation of formal service request.

Between the hours of 8:00AM and 5:00 PM EST (24 hrs. outside this window during the week days).

Review by COR and NSMBB SMEs

6.3 Prompt response to formal call for service

through telephone assistance, shipment of parts, and/or on-site repairs provided as necessary for remediation. (1 per service request)

Respond within 24 hours of service call placement 90% of the time

Review by COR and NSMBB SMEs

6.4 Service invoice/record (field service

reports) provided following all remedial and preventative maintenance (PM). (1 per service request or PM)

Throughout award period due upon completion of service.

Review by COR and NSMBB SMEs

6.5 No cost software and firmware upgrades

and support.

As needed throughout award period based on need and availability of updates.

Review by COR and NSMBB SMEs

6.6 Quarterly Conference Call with CDC to

discuss service and any issues. Due once per quarter Review by COR and

NSMBB SMEs

6.7 Successful repair of broken elements of

the Platform as covered by the agreement As needed throughout award period.

Review by COR and

SECTION 9 – REFERENCE MATERIALS

Not Applicable

SECTION 10 – MINIMUM VENDOR…