Attachment 2 - Performance Work Statement - PR 49898.pdf

PERFORMANCE-BASED WORK STATEMENT

Title: Production, Distribution, and Storage of Abrine and Ricinine Reference Materials

I. Background including public health impact:

The Emergency Response Branch (ERB) of the Centers for Disease Control and

Prevention/National Center for Environmental Health/Division of Laboratory Sciences

(CDC/NCEH/DLS) is responsible for improving the detection, diagnosis, treatment, and prevention of disease from exposure to synthetic and naturally occurring chemical threat agents in order to protect the public health in the event of a chemical emergency. To achieve this end goal, ERB must develop effective and valid clinical methods for measuring chemicals and their metabolites in biological fluids, assure the quality of these methods, transfer these methods to other public health organizations including members of the Laboratory Response Network for

Chemical Threats (LRN-C), and apply these methods to incidents of suspected exposure.

ERB has been tasked with providing ongoing laboratory improvement support for the LRN-C.

To fulfill this request, ERB has identified a need for the development of reference materials for proficiency testing, calibration, and quality control programs for the detection of biomarkers for exposure chemical threat agents.

II. Project Objective:

The objectives of this task are to obtain spiked samples in biological matrices necessary for accomplishing ERB’s mission to maintain testing capabilities for toxic chemicals of interest in order to support the measurement of exposures to chemical threat agents. The proposed work will include a variety of tasks that will require planning, producing, and distributing reference materials in support of ERB’s chemical emergency preparedness and response goals.

III. Description of work (organized by Task):

The primary purpose of this project is to obtain reference materials from an ISO 17034 provider to support response activities for toxic chemicals of interest. The contractor shall produce a sizeable, homogeneous lot of a material that meets the criteria listed below. This contractor shall be make this materials available for purchase by LRN-C laboratories that participate in proficiency testing for this method at the same price-per-unit attributed to each item in the pricing table. This objective supports ERB’s mission and requires a flexible and multi-faceted approach including the key tasks provided in the Task List below.

Description of Method

Method Material Name Sample Matrix Spiked Analytes Expected Participants

Abrine/Ricinine in Urine AbRc8 Human Urine abrine, ricinine 45

Task List

Task Deliverable Description Date of Delivery

2 Preparation of the Internal Standard Pack (ISP) for the Abrine/Ricinine in Urine method as described in the Description of Method table according to ISO 17034 standards. Each ISP shall contain ten vials of internal standard in water or other agreed-upon solvent. Each internal standard vial shall contain at least 1.2 mL of spiked solvent containing both (abrine-13C5 D3) and (ricinine-ring-13C5, cyano-13C) at the concentrations described below. Each sample shall be stored in a 2 mL cryovial (or equivalent container) and stored at -80°C until shipment. Each container shall be labeled to provide the internal standard name, matrix, and concentration(s).

Internal

Standard

Name

Abrine

(13C5 D3) Concentration

(ng/mL)

Ricinine

(ring-13C5, cyano-13C) Concentration

(ng/mL)

ABRC8-IS 4125 2750

The final batch shall contain at least 71 ISPs, or 710 internal standard vials. CDC requires 6

ISPs. The remaining ISPs shall be made available for purchase by LRN-C laboratories that participate in proficiency testing for this method. It is anticipated that approximately 53 ISPs will be purchased by LRN-C laboratories within the first year of the contract, and approximately

12 ISPs will remain in reserve beyond the first year as described in Task 4.

Quality/Evaluation Criteria: The homogeneity of the batch shall be established by liquid chromatography-mass spectrometry (LC-MS) by testing no less than 1% of the internal standard vials in the batch. The final batch must meet the following criteria for all analytes. A summary of the homogeneity data shall be sent to CDC for review.

Standard Name Native Analyte Concentration (ng/mL) %RSD

ABRC8-IS less than ABRC8-S1 ±15%

Documentation: Certificate of analysis and safety data sheet documentation shall be completed for this material and a hardcopy shall be provided to all recipients with the shipment of materials. The certificate of analysis must include the following information regarding the analyte composition, target analyte concentration, analyte purity, solvent composition, sample volume, storage conditions, handling instructions, and retest/retire date, which shall be assigned as the five years from the date of manufacture.

Within 90 Days of Award

3 Preparation of the Quality Control Pack (QCP) for the Abrine/Ricinine in Urine method as described in the Description of Method table according to ISO 17034 standards. Each CP shall contain thirty vials each of three quality control levels in human urine. Each calibration standard shall contain at least 1.2 mL of spiked matrix containing both abrine and ricinine at the concentrations described below. Each sample shall be stored in a 2 mL cryovial (or equivalent container) and stored at -80°C until shipment. Each container shall be labeled to provide the QC

Task Deliverable Description Date of Delivery level name, matrix, and quality control level name. The concentration level shall not be provided on the label.

QC Level Name Abrine Concentration (ng/mL) Ricinine Concentration (ng/mL)

ABRC8-QL 15 2

ABRC8-QM 75 20

ABRC8-QH 350 85

The final batch shall contain at least 165 QCPs, or 4950 quality control vials per standard level.

CDC requires 8 QCPs. The remaining QCPs shall be made available for purchase by LRN-C laboratories that participate in proficiency testing for this method. It is anticipated that approximately 129 QCPs will be purchased by LRN-C laboratories within the first year of the contract, and approximately 28 QCPs will remain in reserve beyond the first year as described in Task 4.

Quality/Evaluation Criteria: The accuracy and homogeneity of the batch shall be established by liquid chromatography-mass spectrometry (LC-MS) by testing no less than 1% of the quality control level vials in the batch. The final batch shall meet the following criteria for all analytes.

A summary of the accuracy and homogeneity data shall be sent to CDC for review.

Standard Name Accuracy %RSD

ABRC8-QL ±20% ±20%

ABRC8-QM ±20% ±10%

ABRC8-QH ±20% ±10%

Documentation: Certificate of analysis and safety data sheet documentation shall be completed for this material and a hardcopy shall be provided to all recipients with the shipment of materials. The certificate of analysis shall include the following information regarding the analyte composition, target analyte concentration, analyte purity, solvent composition, sample volume, storage conditions, handling instructions, and retest/retire date, which will be assigned as the final date of the period of performance on this award.

4 Reservation of ABRC8 Materials: This contractor shall be make this materials available for purchase by LRN-C laboratories that participate in proficiency testing for this method at the same price-per-pack attributed to each item in the pricing table.

Storage of ABRC8 Materials: Any materials not purchased within the first year of the contract will be stored by the contractor and made exclusively available for purchase by CDC-approved laboratories for the remainder of the contract.

V. Performance Matrix:

The Performance Matrix is the portion of the performance-based SOW that explains to the contractor what the Government’s expectations are, and how (and how often) deliverables or services will be monitored and evaluated. It also spells out any incentives that would encourage the contractor to exceed the performance standards. It also imposes negative incentives when the outputs/outcomes are below the performance standards.

Desired Outcomes

Required Services SLA Performance Standard

(completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable Quality Level

(AQL)

Monitoring Method (Quality Assurance

Surveillance Plan/QASP)

Incentives/ Disincentives

ABRC8-CP

6 Calibration Packs

(CPs) delivered to

CDC

Additional CPs should be sent to participating laboratories upon payment from participating laboratory

Accuracy for each analyte in each calibrator must fall within: ±20% for S1, ±15% for S2, and ±10% for S3 through S7.

The %RSD across the batch for each analyte in each calibrator must fall within: ±20% for S1, ±15% for S2, and ±10% for S3 through S7.

No deviations from the standard allowed

Government inspection and acceptance

A positive or negative performance will be documented in past performance reports

(CPARS), or contract termination

ABRC8-ISP

6 Internal Standard

Packs (ISPs) delivered to CDC

Additional ISPs participating laboratories upon payment from participating laboratory

The %RSD across the batch for each analyte must fall within ±15%

No deviations from the standard allowed

Government inspection and acceptance

A positive or negative performance will be documented in past performance reports

(CPARS), or contract termination

ABRC8-

QCP

8 Quality Control

Packs (QCPs) delivered to CDC

Additional QCPs participating laboratories upon payment from participating laboratory

Accuracy for each analyte in each quality control must fall within: ±20%.

The %RSD across the batch for each analyte in each calibrator must fall within: ±20% for QL, and

±10% for QM and QH.

No deviations from the standard allowed

Government inspection and acceptance

A positive or negative performance will be documented in past performance reports

(CPARS), or contract termination

Desired Outcomes

Required Services SLA Performance Standard

(completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable Quality Level

(AQL)

Monitoring Method (Quality Assurance

Surveillance Plan/QASP)

Incentives/ Disincentives

Reservation and Storage of ABRC8 materials for the lifetime of the contract

Remaining ABRC8 materials should be made exclusively available for purchase by participating laboratories at the ascribed for the lifetime of the contract

AND

Remaining ABRC8 materials should be stored at -80 °C for the lifetime of the contract

100% of remaining

ABRC8 materials should be reserved and stored appropriately for the lifetime of the contract

No deviations from the standard allowed

Government inspection

A positive or negative performance will be documented in past performance reports

(CPARS), or contract termination

VI. Items from CDC appropriate for preparation of quotes:

N/A

VII. Items from CDC appropriate for task completion:

ERB will provide the contractor with a list of participating laboratories for the Abrine/Ricinine in

Urine method along with contact information for each participating laboratory. CDC will also provide ordering information to each of the participating laboratories once the contract has been awarded. If needed, LC-MS parameters for detecting both abrine and ricinine in urine may be found in the following reference: J Anal Toxicol. 2013 May ; 37(4): 237–240.

doi:10.1093/jat/bkt010.

CDC can provide an adequate quantity of isotopically-labeled abrine through a Material Transfer

Agreement upon award of the contract. Any remaining material provided by CDC will be returned to CDC upon final approval of tasks 1-3 by CDC. Synthesis of any analyte is not required by this contract.

VIII. Period of Performance:

The performance period is for five years from date of award, and the overall end date is 9/30/2025.

IX. Place of Performance:

It is estimated that approximately 0% of the contract will be performed on-site at CDC facilities and 100% will be performed off-site at the contractor’s facilities. No travel is anticipated for this requirement.