Attachment_3_QASP.doc

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Attached to
Genome Sequencing Analysis Federal contract opportunity
Solicitation number
W81XWH17T0135
Issued by
Department of the Army Medical Command

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Attachment 3 QASP

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W81XWH17T0135_0002.pdf PDF
Q_and_A_W81XWH-17-T-0135_GOV_Response.pdf PDF
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W81XWH17T0135_Draft.pdf PDF

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Quality Assurance Surveillance Plan (qasp)

NOvember 30 2016

1. PURPOSE:

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated non-personal services contract. This QASP explains the following:

· What will be monitored?

· How monitoring will take place.

· Who will conduct the monitoring?

· How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

a. QASP RELATION TO THE SOLICITATION:

QASPs shall be developed and appear in every solicitation, as well as the resultant service contract. The Government will retain the right to change the surveillance methods and Quality Assurance (QA) procedures, or to increase or decrease the degree of surveillance efforts at any time necessary to assure contract compliance

b. REVISIONS TO THE QASP:

The QASP is a tool for use in Government administration of the Performance Work Statement/Statement of Work (PWS/SOW) and remains subject to revision at any time by the Government throughout the contract performance period. Revisions to this surveillance plan are the responsibility of the Contracting Officer’s Representative (COR). Changes to the QASP shall be made bilaterally.

The contractor will assume responsibility for all tasks and deliverables in the PWS under this award. As the performance period progresses, the levels of surveillance may be altered for service areas in cases where performance is either consistently excellent or consistently unsatisfactory. If observations reveal consistently good performance, then the amount of surveillance may be reduced. If observations reveal consistent deficiencies, increased surveillance may be implemented.

2. Government Roles and Responsibilities:

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (KO) - The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

b. Contracting Officer’s Representative (COR) – The COR will be located at US Army Institute of Surgical Research, Fort Sam Houston, TX. The COR will be responsible for technical administration of the contract, and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. A COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

3. Contractor Roles and responsibilities:

The contractor is responsible for delivering services in accordance with the Contract. The contractor shall appoint a single off-site point-of-contact to act as a central recipient of communication from the Government.

4. Contract Quality Requirements:

a. Contract quality requirements are the technical requirements in the contract relating to the quality of the service and those contract clauses prescribing inspection, and other quality controls incumbent on the contractor, to assure that the service conforms to the contractual requirements. Government contract quality assurance shall be performed at such times and places as may be necessary to determine that the services conform to the contract requirements. Failure to meet or exceed the contract quality requirements is defined as a “nonconformance” on the part of the contractor. The contractor shall be held responsible for any identified nonconformance, and the government may require the work to be re-performed.

b. The Government’s contract quality assurance is defined as follows:

1. “Acceptance” means the act of an authorized representative of the Government by which the Government, for itself or as agent of another, assumes ownership of existing identified supplies tendered or approves specific services rendered as partial or complete performance of the contract.

2. “Conditional acceptance” means acceptance of supplies or services that do not conform to contract quality requirements, or are otherwise incomplete, that the contractor is required to correct or otherwise complete by a specified date.

3. “Minor nonconformance” means a nonconformance that is not likely to materially reduce the usability of the supplies or services for their intended purpose, or is a departure from established standards having little bearing on the effective use or operation of the supplies or services.

4. “Major nonconformance” means a nonconformance, other than critical, that is likely to result in failure of the supplies or services, or to materially reduce the usability of the supplies or services for their intended purpose.

5. “Critical nonconformance” means a nonconformance that is likely to result in hazardous or unsafe conditions for individuals using, maintaining, or depending upon the supplies or services; or is likely to prevent performance of a vital agency mission.

c. Documentation:

1. Thorough documentation of unperformed or nonconformance is essential for tracking contractor performance throughout the period of performance. The COR will document deficient work by compiling facts describing the inspection methods and results. The COR will develop documentation to substantiate nonconformance with the Contract.

2. Remedial Action by the Contracting Officer:

(i) Shall notify the contractor in writing of the nonconforming service;

(ii) Shall request that the contractor perform the service, at no cost to the Government; and

(iii) May accept consideration if offered. For guidance on solicitation of a refund, see Subpart 242.71. In accordance with FAR 52.246-4: Inspection of Services-Fixed-Price, the Government may require the contractor to re-perform any services that do not conform to contract requirements. If the defects cannot be corrected by re-performance, the KO may either require the contractor to take the necessary action to ensure that future performance conforms to the requirements, or the KO may reduce the Contract price to reflect the reduced value of the services performed. At an extreme decision point, penalties may include a decision not to exercise contract options. The KO will determine the penalty for nonconformance based upon his or her judgment and the severity of the nonconformance.

5. Methods of Quality Assurance Surveillance:

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

Regardless of the surveillance method, the COR shall always contact the contractor's point of contact inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor’s performance in meeting the contract’s quality requirements.

· DIRECT OBSERVATION: (Can be performed periodically or through 100% surveillance.)

· MANAGEMENT INFORMATION SYSTEMS: (Evaluates outputs through the use of management information reports. Best used for general surveillance and may need to be supplemented by periodic inspections.)

· PERIODIC INSPECTION: Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled as required.

· Analysis of contractor's progress reports. (Evaluate cost, schedule, etc.)

· Performance reporting.

· Customer Feedback

Surveillance results may be used as the basis for actions (to include payment deductions) against the contractor. In such cases, the Inspection of Services clause in the Contract becomes the basis for the KO’s actions.

6. Frequency of Measurement: During contract performance, the COR shall periodically analyze whether the frequency of measurement is appropriate for the work being performed.

Required Service / Deliverable

Performance Standard
Acceptable Quality Level

(AQL)

Monitoring Method

Metagenomics Study
with 95% accuracy
with 95% accuracy
Periodic Review
DNA Library Preparation
with 95% accuracy
with 95% accuracy
Periodic Review
Whole-metagenome sequencing
with 95% accuracy
with 95% accuracy
Periodic Review
DNA Bioinformatics Analysis
with 95% accuracy
with 95% accuracy
Periodic Review
Metatranscriptomics Study
with 95% accuracy
with 95% accuracy
Periodic Review
cDNA Library Preparation
with 95% accuracy
with 95% accuracy
Periodic Review
RNA-Sequencing of microbiome metatranscriptome
with 95% accuracy
with 95% accuracy
Periodic Review
RNA Bioinformatics Analysis
with 95% accuracy
with 95% accuracy
Periodic Review
Provide output sequenced reads of metagenomic sequencing
Within first year of contract
Within first year of contract
Direct Observation
Conduct assembly, annotation, and computational analysis of metagenomics sequenced read files.
Within first year of contract
Within first year of contract
Direct Observation
Provide ISR investigators with finalized, polished, publication ready results and figures.
Within first year of contract
Within first year of contract
Direct Observation
Provide output of transcript reads of RNA-sequencing
Within second year of contract
Within second year of contract
Direct Observation
Conduct assembly, annotation, and computational analysis of the metatranscriptome sequenced read files.
Within second year of contract
Within second year of contract
Direct Observation
Provide ISR investigators with finalized, polished, publication ready results and figures.
Within second year of contract
Within second year of contract
Direct Observation

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