Exhibit B - Bid Specification for DOH26-003P # Item Description Yes No Notes 1 WA NBS Kit w/ Hearing A kit consists of:

• Collection Card (1)

• Protection flap (1)

• Envelope (1)

• Brochure, multipage (1)

• Hearing insert (1)

• Carbon paper insert (1)

[ ] Yes [ ] No (fail)

WA NBS Kit without Hearing A kit consists of:

• Collection Card (1)

• Envelope (1)

• Brochure, multipage (1)

• Protection flap (1)

[ ] Yes [ ] No (fail)

HI NBS Kit A kit consists of:

• Collection Card (1)

• Envelope (1)

• Protection flap (1)

[ ] Yes [ ] No (fail)

ID Single NBS Kit A kit consists of:

• Collection Card (1)

• Envelope (1)

• Protection flap (1)

[ ] Yes [ ] No (fail)

ID Double NBS Kit A kit consists of:

• Collection Card (2)

• Envelope (2)

• Protection flap (2)

[ ] Yes [ ] No (fail)

ID Triple NBS Kit A kit consists of:

• Collection Card (3)

• Envelope (3)

• Protection flap (3)

[ ] Yes [ ] No (fail)

4 Photos DOH has uploaded photos of both collection cards, the associated envelope, and the brochure.

[ ] Yes [ ] No (fail)

Filter Paper Filter paper used in printing the cards shall contain only filter paper from the same lot number.

[ ] Yes [ ] No (fail)

Filter Paper FDA approved. Filter paper must also meet the approved standards in the Clinical and Laboratory Standards Institute (CLSI) document "Blood Collection on Filter Paper for Newborn Screening Programs;

Approved Standard-Sixth Edition.11

(NBS01-A6}

[ ] Yes [ ] No (fail)

Shelf-life Contractor warrants the filter paper used to produce the card kit is fresh (new and unused) and has at least 24 months of shelf-life remaining when received by the Department of Health.

[ ] Yes [ ] No (fail)

Bar Code Imprint a two digit prefix and eight-digit bar code with the eighth character being a Mod 7 check digit for all Dried Clinical Specimen Collection Cards.

[ ] Yes [ ] No (fail)

Bar Code The starting barcode pre-fix and number is TBD and all cards shall be sequential and unique (no duplicate numbers).

[ ] Yes [ ] No (fail)

General System Requirements The required technical features of the good or service include:

Bar Code and Form Number Individual cards: Bar code when scanned should read the prefix and 8 digit card numbers.

Packs of cards/boxes of cards: Barcode should include info of first and last pre-fix/number of the range.

[ ] Yes [ ] No (fail)

Artwork Vendor shall work directly with a representative of the DOH Newborn Screening staff for final artwork approval PRIOR to manufacturing product.

[ ] Yes [ ] No (fail)

Artwork Over the life of this contract, the artwork will change to meet additional DOH needs and/or to make he card work with emerging technology and systems.

[ ] Yes [ ] No (fail)

Artwork Vendor shall provide proofs of all artwork at no additional cost.

[ ] Yes [ ] No (fail)

Artwork Artwork will be supplied by Newborn Screening office.

[ ] Yes [ ] No (fail)

Envelope WA, HI, ID Envelope Specification:

6"x9", 24# Western Sulphite

• Open side Booklet, Regular Gum Seal

• Printed black ink face only

• Blue Security Tint Printed on Inside

• Includes the NBS Logo and "Newborn Screening/Dried Clinical Specimens" text at bottom left.

[ ] Yes [ ] No (fail)

Brochure Brochure This is booklet features 4 full size (8.5 x 11) pages printed in color front and back, folded in half. Two staples at the seams.

Vendor shall provide proofs of all artwork at no additional cost.

[ ] Yes [ ] No (fail)

Orders To bring down the per unit costs, DOH agrees to place orders in multiples of 40,000 kits or greater for WA; 25,000 kits for ID; 17,000 kits for HI

[ ] Yes [ ] No (fail)

Special Orders In the event DOH needs to place an order less than 40,000 kit guarantee, pricing will be by mutual negotiation between DOH and the Contractor.

[ ] Yes [ ] No (fail)

Packaging For both the Newborn Kit and the Newborn Hearing Kit, the Contractor shall ensure that each kit is: Collated and shrink-wrapped, Packaged in quantities of fifty

(50) units per package and comprised of the following components:

All packaging and assembly shall be performed in accordance with applicable quality standards and specifications provided by the Client.

[ ] Yes [ ] No (fail) Specific Requirements (add new section to detail specific requirements of a system)

Packaging For ID kits, the Contractor shall ensure that each kit is: Collated and shrink-wrapped, Packaged in quantities of fifty (50) units per package and comprised of the following components:

•One (1) Specimen Card •One (1) Envelope •One (1) Protective flap All packaging and assembly shall be performed in accordance with applicable quality standards and specifications provided by the Client.

[ ] Yes [ ] No (fail)

Packaging For HI kits, the Contractor shall ensure that each kit is: Collated and shrink-wrapped, Packaged in quantities of fifty (50) units per package and comprised of the following components:

•One (1) Specimen Card •One (1) Envelope •One (1) Protective flap All packaging and assembly shall be performed in accordance with applicable quality standards and specifications provided by the Client.

[ ] Yes [ ] No (fail)

Packaging Any Quality Control cards that are pulled from the package by vendor, should be noted on/in the package with each barcode number that was removed.

[ ] Yes [ ] No (fail)

Shipping Provide shipping notification for all shipments a minimum of 14 days prior to shipment.

[ ] Yes [ ] No (fail)

Shipping All shipments must be delivered to the WA Public Health laboratories (Newborn Screening warehouse), 1610 NE 150th Street, Shoreline, WA 98155.

[ ] Yes [ ] No (fail)

Shipping Delivery at this location requires the CONTRACTOR to deliver using a truck with a lift gate.

[ ] Yes [ ] No (fail)

Shipping Shipping is included in Bidder/Contractor's "Kit" price provided by the Bidder/Contractor on Cost Proposal Price Sheet (Section 2c, Table) which shall include all delivery, storage, and handling charges to the Newborn Screening laboratory located at 1610 NE 150th Street, Shoreline, WA 98155.

[ ] Yes [ ] No (fail)

Shipping The Contractor shall bear full financial responsibility for any loss or damage to goods incurred during shipping, transit, or delivery. All such costs shall be the sole obligation of the Contractor and shall not be reimbursed by the Client under any circumstances.

[ ] Yes [ ] No (fail)

Washington State Department of Health, Newborn Screening - Exhibit B – Bid Specification DOH26-003P

Hawaii Dried Clinical Specimen Collection Part 1, Page 1

Perforation line

Add an additional box labeled "Collected By:" to the layout Collection port

8 7/8”

5”

1/2” 1 7/16”

Hawaii Dried Clinical Specimen Collection Part 1, Page 2

Collection port

8 1/4”

1/2”

Hawaii Dried Clinical Specimen Collection Part 2, Page 1

Perforation Line

8 13/16”

1 7/16”

Hawaii Dried Clinical Specimen Collection Part 2, Page 2

10 3/16” 1 7/16”

Hawaii Dried Clinical Specimen Collection – Envelope Front

9”

6”

Hawaii Dried Clinical Specimen Collection – Envelope Back

Idaho Dried Clinical Specimen Collection - Single Part 1,Page 1

Perforation Line

8 3/4”

5”

Idaho Dried Clinical Specimen Collection - Single Part 1,Page 2

Collection port

1 7/8”

Idaho Dried Clinical Specimen Collection - Single Part 2,Page 1

Idaho Dried Clinical Specimen Collection - Single Part 2,Page 2

8 3/4” 1 1/2”

Idaho Dried Clinical Specimen Collection – Double Part 1,Page 1

Idaho Dried Clinical Specimen Collection – Triple Part 1,Page 1

4”

4”

4”

Exhibit B - Bid Specification DOH26-003P - Washington Dried Clinical Specimen Collection Newborn Screening