DOH26-003P Exhibit B-1 Specification.pdf

PDF 4 MB Posted

Attached to
Newborn Screening Program - Screening Cards
Solicitation number
DOH26-003P
Issued by
Adams County, Asotin County, Benton County, Chelan County, Clallam County, Clark County, Columbia County, Cowlitz County, Douglas County, Ferry County, Franklin County, Garfield County, Grant County, Grays Harbor County, Island County, Jefferson County, King County, Kitsap County, Kittitas County, Klickitat County, Lewis County, Lincoln County, Mason County, Okanogan County, Pacific County, Pend Oreille County, Pierce County, San Juan County, Skagit County, Skamania County, Snohomish County, Spokane County, Stevens County, Thurston County, Wahkiakum County, Walla Walla County, Whatcom County, Whitman County, Yakima County, Asotin City, Clarkston City, Clarkston Heights-Vineland CDP, West Clarkston-Highland CDP, Benton City, Chelan City, Chelan Falls CDP, Clallam Bay CDP, Lewisville CDP, Rock Island City, Pacific Beach CDP, Whidbey Island Station CDP, Mercer Island City, Pacific City, Bainbridge Island City, Kingston CDP, Kitsap Lake CDP, Kittitas City, Klickitat CDP, Okanogan City, Anderson Island CDP, Fort Lewis CDP, Fox Island CDP, Herron Island CDP, Ketron Island CDP, North Fort Lewis CDP, Raft Island CDP, Stevenson City, Hat Island CDP, Lake Stevens City, Snohomish City, Spokane City, Spokane Valley City, Puget Island CDP, Garfield Town, Yakima City, Washington

About this file

DOH26-003P Exhibit B-1 Specification Summary

This is a bid specification document for the Washington State Department of Health Newborn Screening Program establishing technical requirements for dried clinical specimen collection cards and related materials serving Washington, Hawaii, and Idaho. The contract encompasses five distinct newborn screening kit configurations: WA NBS Kit with Hearing, WA NBS Kit without Hearing, HI NBS Kit, and ID Single/Double/Triple NBS Kits. Each kit consists of a collection card, envelope, protective flap, and brochure; hearing screening kits additionally include a hearing insert and carbon paper insert. The specification details material composition requirements including FDA-approved filter paper meeting Clinical and Laboratory Standards Institute (CLSI) standards (NBS01-A6), minimum 24-month shelf life upon receipt, and sequential barcode imprinting with a two-digit prefix and eight-digit number containing a Mod 7 check digit. Order quantities are established at minimum 40,000 kits for Washington, 25,000 kits for Idaho, and 17,000 kits for Hawaii, with special order pricing available through mutual negotiation for smaller quantities.

The specification requires contractors to perform final artwork approval coordination with DOH Newborn Screening staff prior to manufacturing and provide proofs at no additional cost. All products must be collated, shrink-wrapped in packages of fifty units, and delivered via truck with lift gate to the Washington Public Health Laboratories at 1610 NE 150th Street, Shoreline, WA 98155. Contractors must provide 14-day advance shipping notification and bear full financial responsibility for any loss or damage during shipping and delivery. Shipping costs, including all delivery, storage, and handling charges, are included in the bidder's kit price. The specification includes detailed technical drawings and dimension specifications for all card components, envelopes, and brochures for each state variation.

View the file

Other files

Show all 12

On GovTribe

Work with this file

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

Text version

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:

•One (1) Specimen Card
•One (1) Envelope
•One (1) Brochure
•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) 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

The following versions are approximate in detail.

Final verification will be required prior to printing, as part of the standard process.

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

Washington Dried Clinical Specimen Collection Newborn Screening Part 1, Page 1

Perforation Line Collection Port

8 7/8”

5”

1/2”

Washington Dried Clinical Specimen Collection Newborn Screening Part 1, Page 2

Collection Port

1/2”

Washington Dried Clinical Specimen Collection Newborn Screening Part 2, Page 1

8 9/16”

10”

Washington Dried Clinical Specimen Collection Newborn Screening Part 2, Page 2

8 9/16”

10”

Washington Dried Clinical Specimen Collection Newborn Screening Envelopes Front

9”

6”

Washington Hearing Dried Clinical Specimen Collection Card Envelopes Back

Washington Hearing Dried Clinical Specimen Collection Part 1, Page 1

Washington Hearing Dried Clinical Specimen Collection Part 1, Page 2

Collection Port Perforation Line 1 7/8”

8 1/8”

Washington Hearing Dried Clinical Specimen Collection Part 2, Front

6 7/16”

Washington Hearing Dried Clinical Specimen Collection Part 2, Back

Carbon paper faces pink card

Washington Hearing Dried Clinical Specimen Collection Part 3, Page 1

8 7/8” 1 3/4”

Washington Hearing Dried Clinical Specimen Collection Part 3, Page 2

Perforation Line

1 3/4”

Washington Hearing Dried Clinical Specimen Collection Part 4, Page 1

8 7/8” 1 3/8”

Washington Hearing Dried Clinical Specimen Collection Part 4, Page 2

10 1/4” 1 3/8”

Washington Hearing Dried Clinical Specimen Collection Card Envelopes Front

9”

6”

Washington Hearing Dried Clinical Specimen Collection Card Envelopes Back

Washington Pamphlets

5 3/8”

1/4”

Washington Pamphlets

Binder2.pdf
DOH26-003P Exhibit B Specification
DOH26-003P Exhibit B Specification ver3
Sheet1

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

Exhibit B - Bid Specification DOH26-003P - Hawaii State Newborn Screening.pdf
Exhibit B - Bid Specification DOH26-003P - Idaho Dried Clinical Specimen Collection - Single, Double, Triple.pdf
Notes:
CheckBox_1: Off
CheckBox_2: Off
CheckBox_3: Off
CheckBox_4: Off
CheckBox_5: Off
CheckBox_6: Off
CheckBox_7: Off
CheckBox_8: Off
CheckBox_9: Off
CheckBox_10: Off
CheckBox_11: Off
CheckBox_12: Off
CheckBox_13: Off
CheckBox_14: Off
CheckBox_15: Off
CheckBox_16: Off
CheckBox_17: Off
CheckBox_18: Off
CheckBox_19: Off
CheckBox_20: Off
CheckBox_21: Off
CheckBox_22: Off
CheckBox_24: Off
CheckBox_23: Off
CheckBox_25: Off
CheckBox_26: Off
CheckBox_27: Off
CheckBox_28: Off
CheckBox_29: Off
CheckBox_30: Yes
CheckBox_31: Off
CheckBox_32: Off
CheckBox_33: Off
CheckBox_34: Off
CheckBox_35: Off
CheckBox_36: Off
CheckBox_37: Off
CheckBox_38: Off
CheckBox_39: Off
CheckBox_40: Off
CheckBox_41: Off
CheckBox_42: Off
CheckBox_43: Off
CheckBox_44: Off
CheckBox_45: Off
CheckBox_46: Off
CheckBox_48: Off
CheckBox_47: Off
CheckBox_50: Off
CheckBox_49: Off
CheckBox_52: Off
CheckBox_51: Off
CheckBox_53: Off
CheckBox_54: Off
CheckBox_56: Off
CheckBox_55: Off
CheckBox_58: Off
CheckBox_57: Off
CheckBox_60: Off
CheckBox_59: Off

File details come from the government source that posted it. Updated .