Attachment 13 - Task Order 1 QASP- Science Research Support Services (SRRS).pdf

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

FOR

SCIENCE RESEARCH SUPPORT SERVICES (SRSS)

TASK ORDER 1

1. PURPOSE:

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated non-personal services contract. This QASP provides a matrix that delineates the acceptable standards of performance for contracted events and deliverables, and explains the following:

a. What will be monitored

b. Monitoring modes and strategies

c. Responsibilities and Government and contractor

d. How monitoring efforts and results will be documented

Also included in this document is information about the relationship of the QASP to the solicitation;

information about potential revisions to the QASP; the role and responsibilities of the Government in implementing the specifications of the QASP; as well as the contractor’s roles and responsibilities and the quality requirements.

This QASP does not detail the strategies the contractor should use to accomplish the work; rather, it describes the core areas of contractor responsibility with regards to the quality management and deliverable of services and products required to meet the terms of the contract. The Government recognizes that unforeseen and uncontrollable situations may occur that could potentially compromise contractor quality initiatives, and as such, it aims to remain objective, fair, and consistent in evaluating contractor performance on each contract.

The QASP is considered a "living document" and the Government reserves the rights to review and revise it on a regular basis to advance the quality of contracted products and services. Contractor input will be instrumental in reshaping the QASP, and in the event changes are required, the

Government shall consider implementing contractor input that reflects the least risks to the government. Updates to the QASP will help to ensure that the document remains a meaningful, useful, and enforceable instrument for furthering the quality of contractor performance. Copies of the original QASP, with respective revisions, will be provided to the contractor as well as to Government officials implementing surveillance activities.

2. QASP RELATION TO THE SOLICITATION:

QASPs appear in every solicitation and contract to apprise potential and awarded offerers of the

Government’s expectations for quality. The Government retains 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 or Federal compliance. Proposals that demonstrate adherence to QASP performance standards are, primarily, those considered for an award.

3. REVISIONS TO THE QASP IN RELATION TO CONTRACTOR PERFORMANCE

PATTERNS:

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 for respective contracts shall be made as per bilateral input from the contractor and the COR.

The contractor will assume responsibility for all tasks and deliverables in the PWS under the contract to which this QASP is applied. As the performance period progresses, the levels of surveillance may be altered 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.

4. GOVERNMENT ROLES AND RESPONSIBILITIES:

The following personnel shall oversee and coordinate surveillance activities:

a. Contracting Officer (KO)—The KO shall (a) ensure performance of all necessary business actions for effective contracting; (b) ensure compliance with the contract terms; (c) shall safeguard the interests of the United States Government in the contractual relationship; and (d) assure that the contractor receives impartial, fair, and equitable treatment under this contract.

Ultimately, the KO is responsible for making final determinations about the adequacy of the contractor's performance. As such, the contractor shall refer all requests for contractual changes pertaining to contract price, terms, or conditions to the KO for action.

Assigned KO: ______________________________________________________

Organization or Agency: US Army Medical Research Acquisition Activity

Telephone: ________________________________________________________

E-mail: ___________________________________________________________

b. Contracting Officer's Representative (COR)—The COR will be located at the Walter Reed Army

Institute of Research (WRAIR), Preventive Medicine Branch at 503 Robert Grant Ave, Silver

Spring, MD. The COR will support (a) the technical administration of the contract on behalf of the Government, in coordination with the KO, and in collaboration with the contractor. It is the responsibility of the COR to implement and assure proper Government surveillance of the contractor's performance, and to operationalize the surveillance methods to reflect the stated frequency and performance standard. The COR is required to keep a quality assurance file per contractor, with documentation of contractor performance surveillance activities, and communication respective to such activities. Additionally, the COR is responsible for providing such documentation to the KO upon request and at the end of each contract. A COR may not sanction contractual commitments or changes on the Government's behalf; this is the responsibility of the KO.

Assigned COR

Telephone:

E-mail:

5. CONTRACTOR ROLES AND RESPONSIBILITIES:

The contractor is responsible for delivering services in accordance with those specified in the contract, and in relation to the standards specified in the QASP. The contractor shall assign a single off-site point-of-contact (e.g., contract manager) to act as a central recipient of communication from the Government.

Contract Manager Name: _______________________________________

Function at Contractor Organization: ______________________________

Telephone: __________________________________________________

E-mail: ______________________________________________________

6. CONTRACT QUALITY REQUIREMENTS:

a. Contract quality requirements are the technical requirements in the contract that reflect the contents of the QASP matrix, and relates specifically to the quality of respective services and products generated by the contract. They also relate to contract clauses prescribing inspection and other quality controls that the contractor is obligated to fulfill to assure that its performance 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 contractual requirements.

The contractor’s failure to meet or exceed the described standards of contract quality requirements (as specified in the QASP) is defined as "nonconformance." Section b (below) provides the definitions for three key degrees of nonconformance, including the potential risks to the Government. The contractor will be held responsible for identified nonconformance, and depending on the degree of nonconformance, the government may require the work to be re-performed.

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

i. "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.

ii. "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.

iii. "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.

iv. "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.

v. "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 of noncompliance:

i. 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 and shall forward the documentation to the KO by means of a Contract Discrepancy Report

(CDR), who will undertake business related actions to remedy the contractor’s noncompliance. A sample of the CDR report template is provided in Appendix B.

d. Remedial Action by the Contracting Officer:

i. To initiate remedial actions to assuage the effects of potential noncompliance, the KO shall conduct the following duties;

o Notify the contractor in writing of the nonconforming service;

o By contract or otherwise, perform the replacement or correction, charge to the

Contractor any increased cost, or make an equitable reduction in any fixed fee paid or payable under the contract;

o Require delivery of any undelivered articles and shall have the right to make an equitable reduction in any fixed fee paid or payable under the contract; or o Terminate the contract for default.

ii. The KO will determine the penalty for nonconformance based upon his or her judgment and the severity of the nonconformance.

7. METHODS OF QUALITY ASSURANCE SURVEILLANCE:

The Government utilizes various methods to monitor contractor performance, many of which are presented in the performance requirements summary matrix in section 9.. The COR shall use those surveillance methods to administer the QASP on the Contract. Regardless of the surveillance method, the COR shall always contact the contractor's point of contact (noted in Section 5) to inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor's performance relative to the contract's quality requirements.

The Contractor should review, carefully, the contents of the performance requirements summary matrix to determine the areas of surveillance on the current project. Key types of surveillance methods that the Government implements include direct observation, Evaluation of Contractor

Outputs through, and periodic inspection; a description of each is provided below.

a. Direct Observation:

The Government may choose to conduct direct observations by periodically visiting, for the purposes of observing quality, the implementation of contractor work within “normal” working conditions. In such cases, the Government will utilize best industry practices in

“observation”, as a research method, to survey contractor work quality. The Government reserves the rights to conduct direct observations as needed and without notification, especially within the context of laboratory settings overseen by its staff.

b. General Evaluation of Contractor Outputs:

The Government considers both activities and products as contractor outputs and may utilize information resulting from such outputs to examine contractor quality. For example, the

Government may evaluate contractor outputs through monthly, quarterly, or annual reports that the contractor submits to the Government as deliverables, or through any other task-based deliverable or activities on the contract. The contractor’s delivery of actual products generated by the contract (e.g., reports) or its operationalization of each major task (e.g., the efficiency in which the contractor implements each required task) are all subject to surveillance by the

Government, and are considered important data elements that the Government may use to determine contractor quality.

c. Periodic Inspection:

Periodically, the government may choose to, comprehensively, evaluate only selected outputs

(e.g., products generated under only one key task) and closely inspect such products to determine the degree of quality and adherence to the QASP. Periodic inspections could also include the following:

i. Analysis of contractor's progress and progress reports over time (i.e., Evaluate cost, schedule, etc.)

ii. Performance reporting—evaluation of the contractor’s assessment of their performance through performance reporting. See Appendix A for a sample performance reporting template.

iii. Customer Feedback—examination of third party feedback about contractor performance.

In some cases, and depending on the context, the Government may choose to inspect specific locations, sites, or settings, that the contractor is commissioned to create or manage.

Surveillance results may be used as the basis for actions (e.g., fixed fee deductions) against the contractor. In such cases, the Inspection of Research and Development-Cost Reimbursement clause

(52.246-8) in the Contract becomes the basis for the KO's actions.

8. FREQUENCY OF MEASUREMENT:

The Government, through the KO and COR, will monitor the contractor’s performance under this contract whenever necessary. The Government’s Quality Assurance Surveillance Plan follows:

a. Random observation of contractor personnel during performance of tasks noting knowledge and competence with which the tasks are performed; and

b. Scheduled review of contractor products, as specified in the table of deliverables.

c. For projects involving contractor presence on government property, the Government will review Managerial reports to insure proper reporting of the contractor’s time and listing of daily or weekly tasks performed and status of each.

9. PERFORMANCE STANDARDS:

The Government’s Performance standards define its desired standards for excellence on the contract.

The Government performs surveillance to determine if the contractor exceeds, meets or fails to meet these standards, or whenever an unfavorable trend in Contractor performance is detected. Any contractor efforts to mitigate risks to the government may be considered in the KO’s determination about remedial actions or consequences for contractor noncompliance.

The Performance Requirements Summary matrix, shown in Table 1 below and also in the

Performance Work Statement (PWS) for this contract in section 5, includes performance standards.

The Government shall use these standards to determine contractor performance and shall compare contractor performance to its Acceptable Quality Level (AQL). This contract requires between 95% to 100% contractor quality performance per specified standard.

No. PWS

Reference

Requirement Inspec tion

Metho d

Surveillance

Method/

Performed by

Acceptable

Quality Level

(AQL)

Incentives

1 Base IDIQ

PWS

Section 6.4.7

Management Plan 100% inspec tion

General

Evaluation of

Contractor

Outputs by

COR

Compliance with TOMP

Past

Performance

2 Task Order Section 8.0

Monthly task status report is complete, accurate, and timely.

Contractor shall submit monthly performance reports addressing project performance in a format provided by the Government, to the COR.

100% inspec tion

General

Evaluation of

Contractor

Outputs by

COR

Monthly report is delivered on time 90% of the time and has less than 3 errors/report detected by the government.

Submissions will be received by the COR No later than the

2nd working day of the month.

Past

Performance

3 Task Order

PWS

Section 4.0

(1) Ensure shipment of biologics as required are shipped to all applicable country standards and policies (2.)

Ensure safe transport and shipment of biologics

100% inspec tion

General

Evaluation of

Contractor

Outputs by

COR

No deviations are allowed

Past

Performance

4 Base IDIQ

PWS

Section 6.3.2

Contractor will not conduct any research or surveillance activities that do not have approved Human Subjects protocol and business agreements when required.

100% inspec tion

General

Evaluation of

Contractor

Outputs by

COR

No deviations are allowed

Past

Performance

5 Base IDIQ

PWS

Section 6.3.3

Contractor shall conduct clinical surveillance activities with safety as a primary objective.

100% inspec tion

General

Evaluation of

Contractor

Outputs by

Contractor shall cause no adverse safety events in the laboratory.

Past

Performance

COR

6 Task Order

PWS 3.3.3,

3.3.5, 3.3.8

Contractor shall document all research activities in accordance with policies, SOPs and processes.

Dema nd

Inspec tion

General

Evaluation of

Contractor

Outputs by

COR

Support will be in accordance with established guidelines 90% of the time.

Past

Performance

7 Task Order

PWS

Section

2.1.2. & 3.3.3.

Contractor will establish, document, and monitor Human

Use compliance. Any compliance issues will be documented in writing to the COR within 1 day of discovery.

Dema nd

Inspec tion

General

Evaluation of

Contractor

Outputs by

COR

99% of activities will be documented

Past

Performance

8 Task Order

PWS

Section 6.1

Travel:

(1) support travel needs of employees as defined by USAMRU-

G mission

(2) ensure compliance with all applicable policies and regulations.

(3) plan and request travel within timeline guidance provided

Rando m sampli ng

Periodic

Inspection by COR

Travel requirements will be met

95% of the time

Past

Performance

9 Task Order

PWS

Section 6.0

Contractor will provide COR with actual costs for approved expenditures.

Rando m sampli ng

Periodic

Inspection by COR

No deviations are allowed

Past

Performance

10 Task Order

PWS

Section 7.0

Contractor will submit invoices & provide adequate substantiating documentation with each monthly invoice..

100% inspec tion

General

Evaluation of

Contractor

Outputs by

COR

99% of invoices will be submitted monthly.

Past

Performance

11 Task Order

PWS

Section 6.4

Subcontractors must be pre-approved prior to the start of performance.

Subcontractor

Expenditures shall be included in the monthly status report.

- subcontractors follow all applicable regulations or policies governing the particular scope of work

Dema nd

Inspec tion

General

Evaluation of

Contractor

Outputs by

COR

Submissions will be received by the

Government

NLT the 5th

Day of the month. No deviations are allowed

12 Base IDIQ

PWS

Section 16.16

PII and PHI will be maintained in accordance with

Government requirements

Rando m

Sampl ing

Periodic

Inspection by COR

No deviations are allowed

Past

Performance

13 Base IDIQ

PWS

Section 12.0

Contractor maintains inventory and status of issued GFE/GFI.

Dema nd

Inspec tion

General

Evaluation of

Contractor

Outputs by

COR

Inventory is available within

1 business day of government request 90% of the time; status must be

Past

Performance

14 Task Order

PWS

Section 2.1.2

Support management of: Business agreement(s); Human or animal-use protocol(s); Project / protocol relevant

SOPs / SSPs) and RAs; Data and its analysis

100%

Inspec tion

General

Evaluation of

Contractor

Outputs by

COR

Contractor will provide these functions 98% of the time.

Past

Performance

15 Task Order

PWS

Section 3.3.3

Develop / submit complete (all required documents) pre-proposals / proposals to COR, or their designee, on time based on deadlines provided.

100%

Inspec tion

General

Evaluation of

Contractor

Outputs by

COR

Contractor will provide these functions 98% of the time.

Past

Performance

16 Task Order

PWS

Section 4.3 & 8.2

Performs inventories of specimen and samples in the frequency designated in the PWS (10% monthly and 100% annually) within the parameters identified.

100%

Inspec tion

General

Evaluation of

Contractor

Outputs by

COR

Contractor will provide these functions 98% of the time.

Past

Performance

17 Task Order

PWS

Section 8.2

Provides monthly inventories of supplies on time.

Rando m

Sampl ing

Periodic

Inspection by COR

Contractor will provide these functions 98% of the time.

Past

Performance

18 Task Order

PWS

Section 3.3.3

Provide proposals / project i.e. milestones timeline, deliverables, and cost estimates.

Dema nd

Inspec tion

General

Evaluation of

Contractor

Outputs by

COR

Support will be in accordance with established guidelines 90% of the time.

Past

Performance

19 Task Order

PWS

Section 2.1.2 and Section 8.0

Develop/submit +/-present, knowledge products (abstract, poster, etc.) at military relevant / appropriate scientific venues; Deliver knowledge products in compliance with

Dema nd

Inspec tion

General

Evaluation of

Contractor

Outputs by

COR

At least one submission per mutually agreed upon appropriate opportunity agreements

Appendix A. Performance Report Template

1. REPORT DATE:

2. CONTRACT NUMBER:

3. DESCRIPTION OF SURVEILLANCE TYPE(S) AND METHOD(S)

A.

B.

C.

4. SUMMARY OF SURVEILLANCE FREQUENCY

5. RESULTS OF SURVEILLANCE

A.

B.

C.

6. PREPARED BY: Contracting Officer’s Representative

7. SIGNATURE - Contracting Officer's Representative Date

Appendix B. Contract Discrepancy Report (CDR) Template

1. REPORT DATE

2. CONTRACT NUMBER:

3. TO: < KO >

4. FROM: < COR>

5. DESCRIPTION OF DISCREPANCY OR PROBLEM:

< Describe in detail. Identify any attachments >

6. REMEDIAL/CORRECTIVE ACTION PLAN:

A written corrective action plan < is / is not > required.

< If a written corrective action plan is required include the following. >

The written Corrective Action Plan will be provided to the undersigned no later than < # days after receipt of this CDR. >

7. PREPARED BY: COR NAME

8. COR SIGNATURE: _____________________________________________Date

9. RECEIVED BY: KO NAME

10. KO SIGNATURE: ______________________________________________ Date

11. RECEIVED BY: CONTRACTOR REP. NAME

12. CONTRACTOR REP SIGATURE: ________________________________Date

Note: The COR may initiate a CDR at any time, including (a) whenever the number of monthly recorded defects for a performance standard exceeds the allowable number of defects; (b) any time unacceptable performance is determined critical in nature and requires formal corrective action; and (c) whenever an unfavorable trend is detected in contractor performance.