Exhibit D Draft Statement of Work.pdf

EXHIBIT D

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DRAFT STATEMENT OF WORK

To Original Contract Number

These provisions are to be read and interpreted in conjunction with the provisions of the contract specified above.

I. Entity Name: TBD

Term: 10 years

II. Project Description

This project serves to ensure the Colorado Department of Public Health and Environment (CDPHE)

Newborn Screening (NBS) Laboratory is equipped to carry out the statutory mandate to screen all

Colorado newborns for specific genetic and metabolic disorders. CDPHE also contracts with the State of Wyoming to screen all Wyoming newborns. The US National Library of Medicine states

“Newborn screening is the practice of testing all babies in their first days of life for certain disorders and conditions that can hinder their normal development. The conditions included in newborn screening can cause serious health problems starting in infancy or childhood. Early detection and treatment can help prevent intellectual and physical disabilities and life-threatening illnesses.”

Newborn screenings require specific supplies and equipment such as screening assays, or reagents and laboratory equipment/firmware and software to run the analyses. Additionally, services such as technical support for staff training and preventative equipment maintenance and repair ensures equipment remains in working order.

III. Definitions

1. CDPHE: Colorado Dept. of Public Health and Environment

2. Gateway computer- Regulates traffic between two dissimilar networks.

3. Immunoassay (GSP) – An immunoassay is a test that relies on biochemistry to measure the presence and/or concentration of an analyte. The analyte can be large proteins, antibodies that a person has produced as a result of an infection or small molecules.

4. Isoelectric Focusing - An electrophoretic technique for separating proteins by causing them to migrate under the influence of an electric field through a medium (such as a gel) having a pH gradient to locations with pH values corresponding to their isoelectric points.

5. MSMS - or Tandem mass spectrometry is a technique in instrumental analysis where two or more mass analyzers are coupled together using an additional reaction step to increase their abilities to analyze chemical samples. Mass spectrometry is an analytical technique that measures the mass-to-charge ratio of ions. The results are typically presented as a mass spectrum, a plot of intensity as a function of the mass-to-charge ratio.

EXHIBIT C

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6. Fluorimeter – A device used to measure parameters of visible spectrum fluorescence. These parameters are used to identify the presence and the amount of specific molecules in a medium.

7. NBS – Newborn Screening.

8. Punching – Refers to punching dry blood spot samples into microtitration plates.

9. Reagents - A substance or mixture used in chemical analysis or other reactions.

IV. Work Plan

Goal #1:

To have a vendor provide instrumentation, equipment, reagents and/or service to maintain newborn screening bloodspot testing for all of Colorado and Wyoming. These items and services will meet the testing needs for the designated disorders, sample volume and hours of operation of the Colorado

Newborn Screening Program.

Objective #1:

Installation and maintenance of testing instruments, equipment and supplies for the duration of the contract that operates 6 days a week with the capacity of 140,000 samples annually.

Primary Activity #1

1. The Contractor shall provide instruments, software, reagents, kits and other supplies necessary to run the following newborn screening workflows:

a. Cystic fibrosis initial screening (75,000 samples annually)

b. Endocrine disorders initial screening (140,000 samples annually)

c. Endocrine disorders second tier screening (30,000 sample annually)

d. Galactosemia disorder (75,000 samples annually)

e. Genetic metabolic and X-ALD disorders (75,000 samples annually)

f. Hemoglobinopathies initial screening (75,000 samples annually)

g. Hemoglobinopathies second tier screening (15,000 samples annually)

h. Lysosomal storage disorders (75,000 samples annually)

Sub- Activity #1

1. The contractor shall provide a minimum of two (2) instruments to provide backup for instrument failure.

2. The Contractor shall provide a computer to function as a gateway allowing the instruments to communicate with CDPHE’s network.

3. The Contractor shall provide a minimum of fifteen (15) licenses to operate instrument software.

4. The Contractor shall provide reagents and supplies to operate the instrument to determine abnormal results.

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5. The Contractor shall provide a packing list that itemizes each delivery.

Primary Activity #2

The Contractor shall provide technical support for all instruments, software, kits, reagents and other supplies.

Sub- Activity #2

1. The Contractor shall provide technical support between the hours of 8:00AM – 5:00PM EST

Monday through Friday, with the exception of the eight (8) Contractor observed holidays.

2. The Contractor shall provide technical support via telephone or email.

3. The Contractor shall utilize remote internet connections to the instrument computers to help diagnose and resolve issues.

4. Technical Support shall include phone and email support.

5. The Contractor shall provide Field Service Engineers for on-site service of an instrument no later than two (2) business days following notification to address a failure or when technical support cannot resolve an issue.

Primary Activity #3

The Contractor shall provide instrument service to include:

A. Installation

B. Preventative maintenance on all instruments to maintain warranty.

C. Repair

Sub- Activity #3

1. The Contractor shall arrange for a mutually agreed upon delivery date and location.

2. The Contractor shall provide all physical space and service requirements for instruments n later than three (3) months prior to delivery.

3. CDPHE will provide required physical space and services needed for installation such as power, water, drain, air, bottled gases, permits, licenses, approvals.

4. CDPHE will provide assistance in uncrating and transporting the instrument to its location for use.

5. The Contractor’s service engineer shall install instruments. During installation, instruments shall be tested by the Contractor to ensure the instrument is performing within specifications.

6. The Contractor shall provide an installation quality report upon completion of the install.

7. The Contractor shall conduct preventative maintenance on-site at a minimum of two (2) times per year.

8. The Contractor shall schedule on-site preventative maintenance visits a minimum of two (2) calendar weeks prior to the visit to ensure the instrument’s availability.

9. The Contractor shall provide remote diagnostics to help determine instrument issues requiring service.

10. The Contractor shall provide on-site service.

11. CDPHE will return instruments to the Contractor for service when service cannot be completed on-site with shipping charges prepaid by the Contractor. A replacement instrument shall be installed prior to the return of the malfunctioning instrument.

Primary Activity #4

1. The Contractor shall provide training on the use of:

a. Instrument

i. Familiarity

ii. Operation

iii. Maintenance procedures

b. Software

i. Instrument specific software

ii. Gateway software

iii. Updates to instrument software

iv. Test software for validations

c. Kits

d. Reagents

Sub- Activity #4

1. The Contractor shall provide training presented by Contractor’s field service or technical support team on the following topics:

a. Installation of new instruments

b. Updates to software

c. Updates to reagents or kits

d. New reagent or kits

e. Updated maintenance procedures.

2. The Contractor shall provide an agenda no later than 5 business days prior to the course.

3. The Contractor shall document each training to include training date(s), topic, name and title of Contractor personnel facilitating the training, CDPHE personnel in attendance and agenda.

4. The Contractor shall provide, at no cost, a maximum of two (2) products necessary for

CDPHE to conduct validation studies following training on a new instrument, reagent or kit.

5. CDPHE will conduct validation studies no later than eight (26) weeks following the conclusion of training on a new instrument, reagent or kit.

Standards and

Requirements

1. The content of electronic documents located on CDPHE and non-CDPHE websites and information contained on CDPHE and non-CDPHE websites may be updated periodically during the contract term. The contractor shall monitor documents and website content for updates and comply with all updates.

2. The Contractor shall provide instruments and products to the specifications as required by

CDPHE.

3. The Contractor shall pack product for shipment in a manner that will maintain the integrity of the product for a minimum of ten (10) hours following delivery.

4. CDPHE will notify the Contractor by email no later than ten (10) business days after receipt of product for any damaged or degraded product or deficiency in fulfillment of order.

5. CDPHE will provide written notification by email prior to the return of products. Returns will be made no later than thirty (30) business days of receipt of Contractor provided return authorization number and invoice.

6. CDPHE will keep the instruments in its sole possession and control.

7. CDPHE will not move instruments from the location of original installation without the prior written consent of Contractor.

8. CDPHE will notify Contractor of any accident allegedly resulting from the use or operation of the instruments.

9. CDPHE will not alter or modify an instrument without the Contractor’s prior written consent.

10. The Contractor’s instrument software residing on CDPHE’s network shall be compatible with

CDPHE’s system and requirements.

11. The Contractor’s instruments shall be compatible with other vendor operating software.

12. The Contractor’s instruments shall be compatible with other vendor Laboratory Information

Management Systems (LIMS).

13. The Contractor shall maintain all ownership rights and responsibilities to provided instruments.

14. CDPHE will not remove identification tags, decals or plates affixed to instruments by the

Contractor or allow them to be concealed.

15. CDPHE will notify Contractor of malfunctioning instrument by phone or e-mail no later than 3 business days following of discovery of malfunction.

16. The Contractor shall replace at no cost consumable products and reagents utilized in conjunction with a malfunctioning instrument.

17. The Contractor shall ship all reagents and supplies in a timely manner that meets the requirements of maintaining the function and expiration date of the reagents and supplies.

18. The Contractor shall maintain inventory of supplies and reagents to meet expected testing needs.

19. The Contractor shall provide replacement reagents and supplies due to damage and test failure resulting from the Contractor’s shipping or instrumentation failure.

Expected Results of Activity(s)

1. Supplies, equipment, reagents and instruments/software to conduct all newborn screenings

2. Staff trained to all instruments, supplies, kits, and reagents

3. Instruments and software that meet the needs of the laboratory

Measurement of

Expected Results

1. Quantity of ordered supplies delivered

2. Quantity of ordered instruments installed

3. Number of staff trainings relative to product changes or updates

4. Number of times validation is successfully completed

5. Number of times an instrument or software is not functioning correctly

Deliverables

Description Completion Date

1. The Contractor shall submit an Installation

Quality Report for each instrument installed via email to the Newborn Screening

Laboratory Manager.

No later than (5) business days following the installation.

2. The Contractor shall submit documentation of training provided to include date(s), topic of training, name and title of Contractor personnel facilitating the training, CDPHE personnel in attendance and agenda via email to the Newborn Screening Laboratory

Manager.

No later than (5) business days following the installation.

3. The Contractor shall submit Preventative

Maintenance Service logs via email to the

Newborn Screening Laboratory Manager.

No later than (5) business days following the installation.

4. The Contractor shall submit Service logs for instrument diagnostics and repair via email to the Newborn Screening Laboratory

Manager.

No later than the last business day of each month.

5. The Contractor shall ship all reagents to maintain the standards required for testing under CLIA. Reagents quantity shall correspond to requested order. Reagents part numbers, expiration dates, material data sheets and overall quality will correspond to the Colorado Newborn Screening

Laboratory’s validated methods once established.

No later than five (5) upon receipt of reagents and supplies at the Colorado

State Laboratory.

V. Monitoring

CDPHE’s monitoring of this contract for compliance with performance requirements will be conducted throughout the contract period by the lab contract monitoring team. Methods used will include a review of documentation determined by CDPHE to be reflective of performance to include progress reports and other fiscal and programmatic documentation as applicable. The Contractor’s performance will be evaluated at set intervals and communicated to the Contractor. A Final

Contractor Performance Evaluation will be conducted at the end of the life of the contract.

VI. Resolution of Non-Compliance

The Contractor will be notified in writing within 10 calendar days of discovery of a compliance issue.

Within 30 calendar days of discovery, the Contractor and the State will collaborate, when appropriate, to determine the action(s) necessary to rectify the compliance issue and determine when the action(s) must be completed. The action(s) and time line for completion will be documented in writing and agreed to by both parties. If extenuating circumstances arise that requires an extension to the time line, the Contractor must email a request to the lab contract monitoring team and receive approval for a new due date. The State will oversee the completion/implementation of the action(s) to ensure time lines are met and the issue(s) is resolved. If the Contractor demonstrates inaction or disregard for the agreed upon compliance resolution plan, the State may exercise its rights under the provisions of this contract.