Exhibit_3_-_Specifications.pdf

Exhibit 3 – Mandatory Specifications

SPECIFICATIONS FOR OKLAHOMA METABOLIC DISORDER

SCREENING KIT ODH #450 REV. 10/2018

Responses not complying with any of the requirements listed below will be considered non responsive and eliminated from further consideration for award.

Vendor Requirements:

1. Vendor must be registered with the Food and Drug Administration (FDA) for printing an in vitro medical diagnostic device (N 1,281,317) and must comply with FDA's "Good

Manufacturing Practices" regulations and provide documentation

2. Vendor must provide documentation1 if requested, of a satisfactory FDA inspection and authorization for printing and production of this collection kit.

3. Vendor must provide at least four physical properties of the filter paper listed below:

a. Absorption capacity

b. Homogeneity

c. Retention volume of 1/8 inch punch and

d. Absorption time for filling blood collection circles

4. Vendor must provide with the bid a Certificate of Quality Control Testing post printing of the filter paper.

5. Vendor must provide a proof of the form for examination, revision, and approval by the Public Health Laboratory prior to printing.

6. Vendor shall not print or manufacture the form until the final proof is approved by the

Public Health Laboratory Service.

7. Vendor must acknowledge compliance with all specifications listed below.

Filter paper Matrix. Specifications - before printing

1. Filter paper shall be a recent lot of S&S 903 or equivalent 100% pure cotton fiber, filter paper with no wet-strength additives or equivalent. Lot number to be printed on the filter paper attachment of page 3.

2. Basis weight should be 110 lb.+/- 5% per read (550 sheets 24 x 35 inches}.

3. Densitometer reading by Gurley method on one sheet with a 5 oz. Cylinder, 0.1 sq. orifice and 100 cc of air (Test method, modified ASTM D7266-58}.

4. pH should be 5.7 to 7.5

5. Ash% 0.2 maximum (Test method, modified ASTM D726-63}

6. Kelmn: Tappi modified useful method- UM451

7. Wet strength (ASTM D-774-67), usually around 4/5 lbs./inch sq.

8. Absorption rate: The absorption time and the diameter of blood spot produced by 100uL. Of a fresh whole blood sample (hematocrit 55 +/- 1%}. Absorption time target: 12 seconds;

range 5-30 seconds. Diameter target: 16mm; range 15-17 mm volume. Ragged edges or mottling or dried blood spot should not be observed. 1/8- inch punch of dried blood spot should equate to a blood volume of 1.54 +/- 0.17 uL.

9. Lithographic printing is not an acceptable printing process for the filter paper. A dedicated ink delivery system used only for filter paper printing is recommended.

Ink Specifications:

1. Printing ink must not interfere in analytical test procedures. Data must be available, if requested to validate the compatibility of the ink for the following tests: Phenylalanine, Amino

Acid disorders, Galactose, Galactose 1-phosphate Uridyl Transferase, Thyroxine, Thyroid

Stimulating Hormone I Cystic Fibrosis, Congenital Hyperplasia, Medium Chain Acyl CoA

Dehydrogenase, Fatty Acid oxidation disorders, Organic Acid disorders, SCID and others.

2. Circles on the filter paper must be a thin black broken line and must be same dimensions as shown on the attached sample (0.5 inches or 13 mm in diameter)

3. Page 1. Print using green ink with white headings and green check boxes and all the printing in black or green ink. See example

4. Page 2. Print on yellow paper with green ink with white headings and green check boxes and all other printing in black or green ink. Use red ink for wording on CHART COPY. See example.

5. Print serial numbers on filter paper in black ink.

6. Page 5 Collecting specimens. Use red or black ink for expiration date on filter paper.

Drawings outlined in black ink with foot having green ink showing the area for collection in green and red no designation for where not to draw sample. Use red ink in correct/ acceptable circle as well as wrong/unacceptable circles as shown on example. Use red tear drop in circle marked with one drop, on circle, one time.

7. Page 6 front and back print use red ink to print first lines of text. See example. All other printing in black ink.

Packing Specifications:

1. Forms shall be packaged in protective loose wrap in bundles of approximately 100 in numerical order.

NOTE: Shrink wrap or use of heat in packaging is not acceptable and will affect the absorption capacity of the filter paper.

2. Bundles shall be boxed in number order with bundles (forms) flat and not shipped on their side.

3. Boxes shall be numbered on the exterior with the serial number sequence.

Certificate of Post Printing Quality Control Testing of Filter Paper Matrix:

Random samples of the printed form are to be taken for quality control testing, Sampling to be based on the Military standard 105-E. Vendor must be able to provide a certificate, if requested, to verify that changes have not taken place during the printing process. Item to be tested on samples is as follows:

1. Dimensional testing, including caliper to ensure that the thickness of the filter paper hasn’t changed during the printing process. See section on filter paper specifications.

2. Text check versus the approved proof.

3. Blood absorption time for 100 uL of blood. Absorption rate: The absorption time and the diameter of blood spot produced by 100 uL. Of a fresh whole blood sample (hematocrit

55+/-1%). Absorption time target: 12 seconds, range 5-30 seconds.

4. Blood circle size for 100 uL of blood. Diameter target: 16mm, range 15-17 mm volume.

5. Circle quality: Ragged edges or mottling or dried blood spot should not be observed.

Newborn Metabolic Disorder Screening Kit Format Specifications:

See attached draft for example of the collection kit.

1. SIZE: Collection kit finished - height 5.5 x length 12.625 in

All measurements include 0.5-inch perforation on left side

Page 1 Demographic Entry Form 5.5 x 8.5-inch Printing on front

Page 2 Newborn Metabolic Disorder Screen - Chart copy (yellow) 5.5 x 9.25-inch printing on front

Page 3 Newborn Metabolic Disorder Screen - Parent information (Pastel Blue} 5.5 x 9.875-inch, printing Front and Back

Page 4 Newborn Hearing Screening - Parent information (Pastel Pink) 5.5 x 10.5-inch, Printing Front and Back

Page 5 Blood Collection Instructions and Filter Paper Cardstock back cover OUTSIDE

12.625 x 5.5

Page 6 Overlay 5.5 x 12.625-inch, printing on front and back

2. Print font: Arial or equivalent

3. Print size; Readable for average individual and fit information to designated areas of the form.

4. Print format: Minor changes in format of print fields may be allowed but must be approved in advance with a proof for approval and prior to printing.

Page 1- Print must fit in designated areas.

Page 2 - Print must fit in designated areas.

Page 3 & 4- Instructions may be re-arranged to fit into space.

Page 5 - Data must be in designated area.

See Exhibit 1 Demographic Entry Form - Layout

5. Barcode & Serial number: Each kit to be serially numbered with corresponding barcode (3 of 9 mod 43) (checksum digit) as shown in kit example.

The serial number will appear on page 1, 2, 3, 4 and the filter paper starting with the number

1976336.

a. Location of Serial number:

Page 1: Demographic- Serial number to appear top left side of sheet and perforated stub. Page 2: Chart copy- Serial number to appear top left side of sheet.

Page 3: Parent Instructions (blue), to left side of sheet Page 4: Parent copy (pink), top left side of sheet.

Page 5: Filter paper attached on right side as shown.

b. Location of Barcode:

Page 1: Demographic, to appear top left side of sheet and stub; barcode to be perforated for removal as shown.

6. Print Media & Ink

Page 1: Print in green, white, and black ink on white 20# bond, Page 2: Print front in green, white, and black ink on pastel yellow NCR 20# bond, specific areas to be in register with page 1.

Page 3: Print front and back, in black ink, on pastel blue NCR 20# bond, specific areas to be in register with page 1.

Page 4: Print front and back, in black ink. On pastel pink NCR 20# bond, specific areas to be in register with page 1. Coat face of page 4 to allow impressions.

Page 5: Print on 100# buff tag with 903 filter paper or equivalent attached to right side.

Page 6: Print on 100# buff tag.

7. In Register Printing: (pages 1, 2, 3, 4)- coated NCR

Fields required to be in register and coated

"Baby's Last Name" Page 1 with page 2, 3, 4

"Baby's First Name" Page 1 with page 2, 3, 4

Check all that apply at time of screening boxes of Page 1 must be in register with boxes on

Check all that apply Page 2

Page 1 with Page 4

All boxes on Page 1 In the Hearing Screening Results Section that are completed must be in register with Page 4

8. Designated location of boxes

In the "Specimen Information Section11

Location 1- Top right corner of form. This area of the box must be 2 inches wide and½ inch high from edge of form.

Location 2 - The top of the box is 1 ½ inches from the top edge and is 3/8 inches in height by

2 7/8inchesin length, Note: Each box to have "Do not write in this box" in small print.

See Exhibit 1 - Demographic Entry Form - Layout

9, Perforation: All pages to perforate 0.5 inches on left side and glued on left side.

Page 5 - Filter paper attachment to be perforated for removal

Page 6 - Overlay- Perforated at 3 ½ inches from the right side for easy removal

10. Fold: Page 6 -fold 1½ inches from right side to cover the circles of the filter paper.

11. Drawings: Page 6 Printed on folded panel - add drawing or facsimile of drawing. Add international Biohazard symbol on folded panel in black ink

12. Mylar Coating: Page 6-A three-inch area starting½ inch from the right side of the paper to be coated with mylar. The coated area to be in register with the front and back side of the circles of the filter paper to prevent specimen contamination by the paper stock.

13. Filter Paper Attachment: 903 filter paper attached (butts) to the right side of the page, Glue page 2, 3, & 4 on left side so all pages can be removed at the same time.

14. Circles on Filter Paper: Circle ½ inch or 13 mm in diameter printed with a broken or dotted line, Edge of circle must be printed½ inch form the right edge of the filter paper.

15. Expiration Date: Expiration date XX/XX/XX to be printed in front of the filter paper attachment of page 5 in 10 or 12 bold print.

16. Identifiers: Manufacturer's name (or identifier) and lot number of filter paper must be printed on the filter paper attachment.