Attachment 2 - Performance Work Statement - PR 49849.pdf

PERFORMANCE-BASED WORK STATEMENT

Title: Production and Distribution of Proficiency Testing samples

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 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 contract are to obtain spiked samples in biological matrices necessary for accomplishing ERB’s mission to maintain a proficiency testing program for toxic chemicals of interest in order to support the measurement of exposures to chemical threat agents. This requirement includes planning, producing, and distributing proficiency testing 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 proficiency testing samples from an ISO 17034 provider to support proficiency testing activities for toxic chemicals of interest. The contractor shall produce a homogeneous lot for each proficiency testing event that meets the criteria listed below. The contractor shall provide ten samples per paid participant per event with three proficiency testing events per award year for each method identified in the Description of Methods table below. The contractor shall label and barcode each sample with a unique ten-digit, sample ID with a format provided by ERB. Since these will be used for assessment, the nominal concentration shall not be on any label or paperwork sent to the participating laboratories. Proficiency testing events will occur on a schedule provided by ERB, with sample delivery to occur on the week preceding the scheduled event. Spiking concentrations for each sample in each event will be provided by ERB upon contract award. These PT samples shall be made available for purchase, at rates provided in section B, by LRN-C laboratories that participate in proficiency testing for this method at the same price attributed to each task listed below. 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 Methods (event groups distinguished by color)

Method Method

Code

Sample

Matrix

Spiked Analytes Events Expected

Participants

Cyanide in Whole

Blood

CN Human

Whole Blood potassium cyanide Jan, Apr, Sep 45

Nitrogen Mustard

Metabolites in Urine

NMM Human Urine N-Methyldiethanolamine

(MDEA),

N-ethyldiethanolamine

(EDEA)

Jan, Apr, Sep 11

Nerve Agent

Metabolites in Serum

NAx-S Human

Serum

GB Acid, GD Acid, GF

Acid, rVX Acid, VX Acid

Jan, Apr, Sep 45

Nerve Agent

Metabolites in Urine

NAx-U Human Urine GB Acid, GD Acid, GF

Acid, rVX Acid, VX Acid

Jan, Apr, Sep 45

HNPAA in Urine HNPAA Human Urine 4-Hydroxy 3-

Nitrophenylacetic Acid

(HNPAA)

Feb, May, Oct 27

Sulfur Mustard

Metabolites in Serum

SBMSE-S Human

Serum

1,1'-sulfonylbis[2-

(methylthio)ethane

(SBMTE)

Feb, May, Oct 14

Sulfur Mustard

Metabolites in Urine

SBMSE-U Human Urine 1,1'-sulfonylbis[2-

(methylthio)ethane

(SBMTE)

Feb, May, Oct 14

Abrine/Ricinine in

Urine

AbRc Human Urine abrine, ricinine Mar, Aug, Nov 44

Tetramine in Urine TET Human Urine tetramine Mar, Aug, Nov 45

Volatile Organic

Compounds in Serum

VOC Bovine

Serum m- xylene, p-xylene, o-xylene, styrene, tetrachloroethylene, toluene, 1,2-dichloroethane, benzene, carbon tetrachloride, chloroform, ethylbenzene

Mar, Jul, Oct 44

Task List for Proficiency Testing Program

Tasks Quantity Required Deliverable Description Date of Delivery

1 10 samples per event delivered to CDC

Additional samples shall be sent to participating laboratories upon payment from participating laboratory

Preparation of samples for the Cyanide in Whole Blood proficiency testing events as described in the Description of

Methods table according to ISO 17034 standards. Each of the analytes listed for this method shall be spiked into the pooled sample matrix at the concentration provided by ERB, within the range of 25 to 2500 ng/mL. Each sample shall contain at least 0.5 mL of spiked matrix. Each sample shall be stored in a 1.5 mL cryovial (or equivalent container) and stored at -

80°C until shipment. Each container shall be labeled to provide the Method, Event ID, Sample Matrix, and unique

Sample ID with barcode. These samples shall be made available for purchase to LRN-C laboratories that participate in proficiency testing for this method. Samples in whole blood shall be frozen once and remain frozen until used by the recipient laboratory.

No later than the week preceding the events in January, April, and

September

2 10 samples per event laboratories upon payment from participating laboratory

Preparation of samples for the Nitrogen Mustard Metabolites in Urine proficiency testing events as described in the

Description of Methods table according to ISO 17034 standards. Each of the analytes listed for this method shall be spiked into the pooled sample matrix at the concentration provided by ERB, within the range of 1 to 500 ng/mL. Each sample shall contain at least 1.5 mL of spiked matrix. Each sample shall be stored in a 5 mL cryovial (or equivalent container) and stored at -80°C until shipment. Each container shall be labeled to provide the Method, Event ID, Sample

Matrix, and unique Sample ID with barcode. These samples shall be made available for purchase to LRN-C laboratories that participate in proficiency testing for this method.

No later than the week preceding the events in January, April, and

September

3 10 samples per event laboratories upon payment from participating laboratory

Preparation of samples for the Nerve Agent Metabolites in

Serum proficiency testing events as described in the

Description of Methods table according to ISO 17034 standards. Each of the analytes listed for this method shall be spiked into the pooled sample matrix at the concentration provided by ERB, within the range of 5 to 200 ng/mL. Each sample shall contain at least 1.5 mL of spiked matrix. Each sample shall be stored in a 5 mL cryovial (or equivalent container) and stored at -80°C until shipment. Each container shall be labeled to provide the Method, Event ID, Sample

Matrix, and unique Sample ID with barcode. These samples shall be made available for purchase to LRN-C laboratories that participate in proficiency testing for this method.

No later than the week preceding the events in January, April, and

September

4 10 samples per event

Preparation of samples for the Nerve Agent Metabolites in

Urine proficiency testing events as described in the

Description of Methods table according to ISO 17034 standards. Each of the analytes listed for this method shall be spiked into the pooled sample matrix at the concentration

No later than the week preceding the events in January, April, and

September laboratories upon payment from participating laboratory provided by ERB, within the range of 5 to 200 ng/mL. Each sample shall contain at least 1.5 mL of spiked matrix. Each sample shall be stored in a 5 mL cryovial (or equivalent container) and stored at -80°C until shipment. Each container shall be labeled to provide the Method, Event ID, Sample

Matrix, and unique Sample ID with barcode. These samples shall be made available for purchase to LRN-C laboratories that participate in proficiency testing for this method.

5 10 samples per event laboratories upon payment from participating laboratory

Preparation of samples for the HNPAA in Urine proficiency testing events as described in the Description of Methods table according to ISO 17034 standards. Each of the analytes listed for this method shall be spiked into the pooled sample matrix at the concentration provided by ERB, within the range of 5 to 1000 ng/mL. Each sample shall contain at least

1.5 mL of spiked matrix. Each sample shall be stored in a 5 mL cryovial (or equivalent container) and stored at -80°C until shipment. Each container shall be labeled to provide the

Method, Event ID, Sample Matrix, and unique Sample ID with barcode. These samples shall be made available for purchase to LRN-C laboratories that participate in proficiency testing for this method.

No later than the week preceding the events in February, May, and October

6 10 samples per event laboratories upon payment from participating laboratory

Preparation of samples for the Sulfur Mustard Metabolites in

Serum proficiency testing events as described in the

Description of Methods table according to ISO 17034 standards. Each of the analytes listed for this method shall be spiked into the pooled sample matrix at the concentration provided by ERB, within the range of 0.1 to 100 ng/mL. Each sample shall contain at least 1.5 mL of spiked matrix. Each sample shall be stored in a 5 mL cryovial (or equivalent container) and stored at -80°C until shipment. Each container shall be labeled to provide the Method, Event ID, Sample

Matrix, and unique Sample ID with barcode. These samples shall be made available for purchase to LRN-C laboratories that participate in proficiency testing for this method.

No later than the week preceding the events in February, May, and October

7 10 samples per event laboratories upon payment from participating laboratory

Preparation of samples for the Sulfur Mustard Metabolites in

Urine proficiency testing events as described in the

Description of Methods table according to ISO 17034 standards. Each of the analytes listed for this method shall be spiked into the pooled sample matrix at the concentration provided by ERB, within the range of 0.1 to 100 ng/mL. Each sample shall contain at least 1.5 mL of spiked matrix. Each sample shall be stored in a 5 mL cryovial (or equivalent container) and stored at -80°C until shipment. Each container shall be labeled to provide the Method, Event ID, Sample

Matrix, and unique Sample ID with barcode. These samples shall be made available for purchase to LRN-C laboratories that participate in proficiency testing for this method.

No later than the week preceding the events in February, May, and October

8 10 samples per event laboratories upon payment from participating laboratory

Preparation of samples for the Abrine/Ricinine in Urine proficiency testing events as described in the Description of

Methods table according to ISO 17034 standards. Each of the analytes listed for this method shall be spiked into the pooled sample matrix at the concentration provided by ERB, within the range of 0.3 to 500 ng/mL. Each sample shall contain at least 1.5 mL of spiked matrix. Each sample shall be stored in a 5 mL cryovial (or equivalent container) and stored at -80°C until shipment. Each container shall be labeled to provide the

Method, Event ID, Sample Matrix, and unique Sample ID with barcode. These samples shall be made available for purchase to LRN-C laboratories that participate in proficiency testing for this method.

No later than the week preceding the events in March, August, and

November

9 10 samples per event laboratories upon payment from participating laboratory

Preparation of samples for the Tetramine in Urine proficiency testing events as described in the Description of Methods table according to ISO 17034 standards. Each of the analytes listed for this method shall be spiked into the pooled sample matrix at the concentration provided by ERB, within the range of 5 to 500 ng/mL. Each sample shall contain at least

2.5 mL of spiked matrix. Each sample shall be stored in a 5 mL cryovial (or equivalent container) and stored at -80°C until shipment. Each container shall be labeled to provide the

Method, Event ID, Sample Matrix, and unique Sample ID with barcode. These samples shall be made available for purchase to LRN-C laboratories that participate in proficiency testing for this method.

No later than the week preceding the events in March, August, and

November

10 10 samples per event laboratories upon payment from participating laboratory

Preparation of samples for the Volatile Organic Compounds in Serum proficiency testing events as described in the

Description of Methods table according to ISO 17034 standards. Each of the analytes listed for this method shall be spiked into the pooled sample matrix at the concentration provided by ERB, within the range of 100 to 10,00 ng/mL.

Each sample shall contain at least 2.5 mL of spiked matrix.

Each sample shall be stored in a flame-sealed glass ampoule

(or equivalent container) and stored at -80°C until shipment.

Each container shall be labeled to provide the Method, Event

ID, Sample Matrix, and unique Sample ID with barcode.

These samples shall be made available for purchase to LRN-

C laboratories that participate in proficiency testing for this method.

No later than the week preceding the events in March, July, and October

11 One completed template per event delivered to

CDC

At the conclusion of each shipping event, a completed spreadsheet template shall be provided to ERB with the

Sample IDs, nominal concentration level, and recipient laboratory for each sample in a template provided by ERB.

After each shipping event

IV. 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

CN PT

Samples

Receipt of 10 samples per event delivered by

CDC

Additional samples made available for purchase to participating laboratories

100% of samples are shipped to participants that have purchased the product during the week prior to the event

AND

90% of samples are within

±30% of the nominal concentration level as established by the network reported results

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

NMM PT

Samples

Receipt of 10 samples per event made available for purchase to participating laboratories

100% of samples are shipped to participants that have purchased the product during the week prior to the event

AND

90% of samples are within

±20% of the nominal concentration level as established by the network reported results

No deviations from the standard allowed

Government performance will be documented in past performance reports

(CPARS), or contract termination

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

NAx-S PT

Samples

Receipt of 10 samples per event made available for purchase to participating laboratories

100% of samples are shipped to participants that have purchased the product during the week prior to the event

AND

90% of samples are within

±20% of the nominal concentration level as established by the network reported results

No deviations from standard allowed

Government performance will be documented in past performance reports

(CPARS), or contract termination

NAx-U PT

Samples

Receipt of 10 samples per event made available for purchase to participating laboratories

100% of samples are shipped to participants that have purchased the product during the week prior to the event

AND

90% of samples are within

±20% of the nominal concentration level as established by the network reported results

No deviations from the standard allowed

Government performance will be documented in past performance reports

(CPARS), or contract termination

HNPAA

PT

Samples

Receipt of 10 samples per event made available for purchase to participating laboratories

100% of samples are shipped to participants that have purchased the product during the week prior to the event

AND

90% of samples are within

±20% of the nominal concentration level as established by the network reported results

No deviations from the standard allowed

Government performance will be documented in past performance reports

(CPARS), or contract termination

SBMSE-S

PT

Samples

Receipt of 10 samples per event

100% of samples are shipped to participants that have purchased the

No deviations from the

Government performance will be documented in past

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 made available for purchase to participating laboratories product during the week prior to the event

AND

90% of samples are within

±20% of the nominal concentration level as established by the network reported results standard allowed performance reports

(CPARS), or contract termination

SBMSE-U

PT

Samples

Receipt of 10 samples per event made available for purchase to participating laboratories

100% of samples are shipped to participants that have purchased the product during the week prior to the event

AND

90% of samples are within

±20% of the nominal concentration level as established by the network reported results

No deviations from the standard allowed

Government performance will be documented in past performance reports

(CPARS), or contract termination

AbRc PT

Samples

Receipt of 10 samples per event made available for purchase to participating laboratories

100% of samples are shipped to participants that have purchased the product during the week prior to the event

AND

90% of samples are within

±20% of the nominal concentration level as established by the network reported results

No deviations from the standard allowed

Government performance will be documented in past performance reports

(CPARS), or contract termination

TET PT

Samples

Receipt of 10 samples per event

100% of samples are shipped to participants that have purchased the product during the week prior to the event

AND

No deviations from the standard allowed

Government performance will be documented in past performance reports

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

Additional samples made available for purchase to participating laboratories

90% of samples are within

±20% of the nominal concentration level as established by the network reported results

(CPARS), or contract termination

VOC PT

Samples

Receipt of 10 samples per event made available for purchase to participating laboratories

100% of samples are shipped to participants that have purchased the product during the week prior to the event

AND

90% of samples are within

±20% of the nominal concentration level as established by the network reported results

No deviations from the standard allowed

Government performance will be documented in past performance reports

(CPARS), or contract termination

Completed

Sample

Reporting

Templates

Receipt of 1 completed sample reporting template per event delivered by

CDC

100% of completed sample reporting templates are sent to CDC within 2 days of sample shipment for each event

No deviations from the standard allowed

Government performance will be documented in past performance reports

(CPARS), or contract termination

V. Items from CDC appropriate for preparation of quotes:

Example Spiking Scheme for one OPNA-S PT event to be provided by ERB:

GBA GDA GFA RVXA VXA

Event ID Spiking Level (ng/ml) (ng/ml) (ng/ml) (ng/ml) (ng/ml)

NS202001 PT level 1 0 0 0 0 0

NS202001 PT level 2 0 0 0 0 0

NS202001 PT level 3 10 160 100 80 70

NS202001 PT level 4 20 10 160 100 80

NS202001 PT level 5 30 20 10 160 100

NS202001 PT level 6 50 30 20 10 160

NS202001 PT level 7 70 50 30 20 10

NS202001 PT level 8 80 70 50 30 20

NS202001 PT level 9 100 80 70 50 30

NS202001 PT level 10 160 100 80 70 50

VI. Items from CDC appropriate for task completion:

ERB will provide the contractor with a list of participating laboratories for each 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. CDC will also provide a calendar to the contractor with established event dates for the award period.

If any native analyte is not commercially available, CDC can provide an adequate quantity of synthesized native material through a Material Transfer Agreement upon award of the contract. Any remaining material provided by CDC will be returned to CDC upon the completion of the contract. Synthesis of any analyte is not required by this contract.

VII. 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.