Attachment-6_Quality_Assurance_Surveillance_Plan_for_NHP.docx

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Renewal of Walter Reed Army Institute of Research (WRAIR) Non-human Primates (NHP) Colony Maintenance Contract
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W81XWH-15-R-0095
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ATTACHMENT 6

QUALITY ASSURANCE SURVEILLANCE PLAN

Walter Reed Army Institute of Research (WRAIR) Non-human Primates (NHP) Colony Maintenance Contract

Contract Number: upon award

Contract Description

This requirement is a firm, fixed price, competitive Indefinite Delivery/Indefinite Quantity (IDIQ), non-personal services acquisition for husbandry, veterinary care, breeding and services to sell to approximately 320 Government owned SPF Indian origin (IO) Macaca mulatta (rhesus) NHPs, as well as purchasing services.

Contractor’s name: upon award

1. PURPOSE.

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated 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.

The following FAR clauses may apply depending on contract type:

52.246-4 Inspection of Services – Fixed-Price,

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.

Assigned KO: <upon award> Organization or Agency: <upon award> Telephone: <upon award> Email: <upon award>

b. Contract Specialist (CS) - The KS acts as an acquisition consultant and serves as liaison between the USAMRAA supported customer and the requesting program office, as well as liaison between the USAMRAA supported customer and the contractor.

Assigned CS: <upon award> Telephone: <upon award> Email: <upon award>

c. Contracting Officer’s Representative (COR) - The COR is 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. The 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.

Assigned COR: <upon award> Telephone: <upon award> Email: <upon award>

d. Other Key Government Personnel –

Name: <upon award> Title: <upon award> Telephone: <upon award> Email: <upon award>

3. CONTRACTOR REPRESENTATIVES:

The following employees of the contractor serve as the contractor’s Program Manager and Task Manager for this contract. <Communication should occur with them during QASP development. It will help if they review the draft QASP and accept the final version.>

a. Program Manager - <upon award, enter name> Telephone: <enter number> Email: <enter address>

b. Task Manager - <upon award, enter name> Telephone: <enter number> Email: <enter address>

c. Other Contractor Personnel - <upon award, enter name or delete these lines if not applicable> Title: <enter title> Telephone: <enter number> Email: <enter address>

4. PERFORMANCE STANDARDS.

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The Performance Requirements Summary Matrix, paragraph, Section 6.2 in the Performance Work Statement includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Performance Requirement
Performance Standard
Acceptable Quality Level
Method of Surveillance
Frequency
Rating
2.1.1 Monthly Financial Progress Report
Successful submission of accurate financial reports
99% timely submission of accurate reports
COR review for timeliness and accuracy
Monthly
Positive Performance rating in CPARS; exercise next option period pending availability of funds.
2.2 Transition and Shipping Services
Successful transfer of all management and functional responsibilities without any degradation in service or animal care. Successful delivery of all NHPs
99% successful transfer of NHPs and associated functions without disruption or decline in level of care. 99% successful transfer of NHPs; all NHPs in good health at time of arrival
Review Transition In /Out Plan;

COR or designated alternate will assess animal health status upon receipt at final destination At contract initiation/transition

Positive Performance rating in CPARS; exercise next option period pending availability of funds.

2.4 Quality Control and Data Management..
Perform all data management and reporting as required by the PWS and the QC Plan
Periodic Inspection: QC Plan data will be used as a checklist to confirm all required reports are on time and accurate. The COR will document the review.
COR will review from timeliness and accuracy
Monthly
Positive Performance rating in CPARS; exercise next option period pending availability of funds.
2.6 Animal Husbandry and Veterinary Care
Establish and maintain a breeding and holding colony; provide Veterinary care and monitoring to maintain appropriate health status. Veterinary care should include emergency facilities with clinical laboratory and diagnostic capabilities along with other medical equipment necessary to accurately diagnose and treat illness/injury; provide care following all SOPs and mandatory regulations.
No loss of NHPs due to Contractor negligence 99% of the time. NHPs will have access to a psychologically enriching environment 100% of the time. Veterinary care is provided 24 hrs, seven days/week, and 365 days/year. For emergency situations, a veterinarian must be available within 30 minutes.
Review Quality Control Plan, census, activities, and cull reports.

Observation and site visits.

Monthly and more frequency as required.

Positive Performance rating in CPARS; exercise next option period pending availability of funds.

2.6. 1 Animal Health Maintenance
Comply with SOPs and update as required.
99% compliance with SOP
Review SOP. Observation and site visits.
Review SOP upon request
Positive Performance rating in CPARS; exercise next option period pending availability of funds.
2.6.2 Animal Breeding
Maintain a breeding efficiency to produce at least 50 naïve IO rhesus macaques annually.
Increasing production rate (defined as the number of young weaned/ number of documented pregnancies) with a goal of ≥70%, an infant loss rate ≤8%, and an adult mortality rate ≤4%.
Review monthly reports; Observation and site visits.
Monthly
Positive Performance rating in CPARS; exercise next option period pending availability of funds.
2.7 Data Management.
Perform all data management and reporting as required by the PWS and the QC Plan
No failure to report for a second time and no more than 1 late report per quarter.
QC Plan data will be used as a checklist to confirm all required reports are on time and accurate. The COR will document the review.
Monthly
Positive Performance rating in CPARS; exercise next option period pending availability of funds.
2.8 Personnel
Provide trained personnel in compliance with OHS, training, and SOP requirements.

No employees on the job without full medical requirement compliance.

Contractor maintains evidence of employee trainings. New personnel shall be fully trained within two weeks of starting work.

100% compliance with all employees on the job with full medical requirement compliance.

80% of annuals in 12 months. 100% in 13 months every year. Certified 100%.

Training and personnel records will be reviewed for training and OHS requirements; QC Plan will be used as a checklist to insure contractor compliance.
Monthly QCP reports; Observation and site visits, training and personnel reports upon request.
Positive Performance rating in CPARS; exercise next option period pending availability of funds.
2.9 Facility
Maintain AAALAC accreditation while providing sufficient animal housing and space for veterinary care
Maintain AAALAC accreditation
Observation. Review accreditation status during scheduled site visits
At contract initiation; frequency as required.
Positive Performance rating in CPARS; exercise next option period pending availability of funds.
2.9.1 Visitation Program Policy
Maintain a written health certification program and policy concerning all visitors. visiting the breeding colony, and maintain updated records on all such individuals
99% visitors in compliance with Visitation policy
Review of visitor registry and visitation policy; review of supporting documentation to insure visitors are in good health and tested for specified illnesses.
Review upon request.

Observation Positive Performance rating in CPARS; exercise next option period pending availability of funds.

2.10Animal Delivery
Coordination and shipment of NHPs; comply with all current federal, state and local requirements for the shipment of NHPs
99% successful transfer of NHPs; all NHPs in good health at time of arrival
COR or designated alternate will assess animal health status upon receipt at final destination; or report of health status at delivery
Upon delivery direction
Positive Performance rating in CPARS; exercise next option period pending availability of funds.

11.0 AT/OPSEC

Provide iWATCH training to all personnel within 30 calendar days of contract award
Provide AT/OPSEC required training
Training report from the prime Contractor

At contract initiation Positive Performance rating in CPARS; exercise next option period pending availability of funds.

5. INCENTIVES.

The Government shall use <insert award fee, incentive fee, past performance, or other method> as incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards. Information about incentives can be found in <insert section or paragraph> of the contract.

6. METHODS OF QA 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 task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR, with assistance from the COD KS, shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

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

<Insert performance standard(s) or delete this method.>

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

<Insert performance standard(s) or delete this method.>

c. PERIODIC INSPECTION. (Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.)

<Insert performance standard(s) or delete this method.>

d. USER SURVEY. (Combines elements of validated user complaints and random sampling. Random survey is conducted to solicit user satisfaction. Appropriate for high quantity activities that have historically been satisfactory. May also generate periodic and 100% inspections.)

<Insert performance standard(s) or delete this method.>

e. VALIDATED USER/CUSTOMER COMPLAINTS. (Relies on the user of the service to identify deficiencies. Complaints are then investigated and validated. Highly applicable to services provided in quantity and where quality is highly subjective.)

<Insert performance standard(s) or delete this method.>

f. 100% INSPECTION. (Evaluates all outputs. Most applicable to small quantity, but highly important services. May be used where there are written deliverables and stringent requirements such as tasks required by law, safety, or security.)

<Insert performance standard(s) or delete this method.>

g. PERIODIC SAMPLING. (Variation of random sampling. However, sample is only taken when a deficiency is suspected. Good follow-up to MIS analysis. Sample results are applicable only for the specific work inspected. Since sample is not entirely random, it cannot be applied to total activity performance.)

<Insert performance standard(s) or delete this method.>

h. RANDOM SAMPLING. (Designed to evaluate the outputs of the award requirement by randomly selecting and inspecting a statistically significant sample. Highly recommended for large quantity repetitive activities with objective and measurable quality attributes.)

<Insert performance standard(s) or delete this method.>

i. Progress or status meetings.

<Insert performance standard(s) or delete this method.>

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

<Insert performance standard(s) or delete this method.>

k. Performance reporting. (Evaluate metrics for a specific time period. Develop metrics or use metrics found in MIS.)

<Insert performance standard(s) or delete this method.>

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.

7. RATINGS.

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

Example 1:

EXCEPTIONAL:
Performance significantly exceeds contract requirements to the Government’s benefit.
SATISFACTORY:
Performance meets contractual requirements.
UNSATISFACTORY:
Performance does not meet contractual requirements.

Example 2:

<A numerical scale with numbers 1 through 10 where 1 is poor and 10 is excellent.>

8. DOCUMENTING PERFORMANCE.

a. ACCEPTABLE PERFORMANCE.

The Government shall document positive performance. A report template is attached. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other actions.

b. UNACCEPTABLE PERFORMANCE.

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's task manager or on-site representative. A CDR template is attached to this QASP.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other actions deemed necessary by the KO.

9. FREQUENCY OF MEASUREMENT.

a. Frequency of Measurement.

During contract/order performance, the COR shall take periodic measurements, <enter how often> as specified in the AQL column of the Performance Standards Summary Matrix, and shall analyze whether the negotiated frequency of measurement is appropriate for the work being performed.

Standard language

Requirement

Acceptable Quality Level

Inspection Method

Performed By who

Frequency

2.1.1 Monthly Financial Progress Report

Successful submission of accurate financial reports
99% timely submission of accurate reports

Random Sampling

COR
Monthly
2.2 Transition and Shipping Services
Successful transfer of all management and functional responsibilities without any degradation in service or animal care. Successful delivery of all NHPs
99% successful transfer of NHPs and associated functions without disruption or decline in level of care. 99% successful transfer of NHPs; all NHPs in good health at time of arrival

100% inspection

COR
At contract initiation/transition
2.4 Quality Control and Data Management..
Perform all data management and reporting as required by the PWS and the QC Plan

99% successful reporting with no more than 1 late report per quarter and no more than 1 report redo based upon inaccurate data

COR will review from timeliness and accuracy
COR
. Monthly
2.6 Animal Husbandry and Veterinary Care
Establish and maintain a breeding and holding colony; provide Veterinary care and monitoring to maintain appropriate health status. Veterinary care should include emergency facilities with clinical laboratory and diagnostic capabilities along with other medical equipment necessary to accurately diagnose and treat illness/injury; provide care following all SOPs and mandatory regulations.
No loss of NHPs due to Contractor negligence 99% of the time. NHPs will have access to a psychologically enriching environment 100% of the time. Veterinary care is provided 24 hrs, seven days/week, 365 days/year. For emergency situations, a veterinarian must be available within 30 minutes.
Random Sampling
COR
Monthly and more frequency as required.
2.6. 1 Animal Health Maintenance
Comply with SOPs and update as required.
99% compliance with SOP
Random Sampling
COR
Review SOP upon request
2.6.2 Animal Breeding
Maintain a breeding efficiency to produce at least 50 naïve IO rhesus macaques annually.
Increasing production rate (defined as the number of young weaned/ number of documented pregnancies) with a goal of ≥70%, an infant loss rate ≤8%, and an adult mortality rate ≤4%.
Random Sampling.
COR
Monthly
2.7 Data Management.
Perform all data management and reporting as required by the PWS and the QC Plan
No failure to report for a second time and no more than 1 late report per quarter.
Random Sampling
COR
Monthly
2.8 Personnel
Provide trained personnel in compliance with OHS, training, and SOP requirements.

No employees on the job without full medical requirement compliance.

Contractor maintains evidence of employee trainings. New personnel shall be fully trained within two weeks of starting work.

100% compliance with all employees on the job with full medical requirement compliance.

80% of annuals in 12 months. 100% in 13 months every year. Certified 100%.

Random Sampling.
COR
Monthly QCP reports; Observation and site visits, training and personnel reports upon request.
2.9 Facility
Maintain AAALAC accreditation while providing sufficient animal housing and space for veterinary care
Maintain AAALAC accreditation
Random Sampling
COR
At contract initiation; frequency as required.

2.9.1 Visitation Program Policy

Maintain a written health certification program and policy concerning all visitors. visiting the breeding colony, and maintain updated records on all such individuals
99% visitors in compliance with Visitation policy.
Random Sampling
COR
Review upon request.

Observation.

2.10Animal Delivery
Coordination and shipment of NHPs; comply with all current federal, state and local requirements for the shipment of NHPs
99% successful transfer of NHPs; all NHPs in good health at time of arrival
100 % inspection
COR
Upon delivery direction

11.0 AT/OPSEC

Provide iWATCH training to all personnel within 30 calendar days of contract award
Provide AT/OPSEC required training

Random Sampling

COR

At contract initiation

b. Frequency of Performance Assessment Meetings.

The COR shall meet with the contractor <enter how often> to assess performance and shall provide a written assessment.

Prepared by: LTC Carrie Benton

Signature – Contracting Officer’s Representative

PERFORMANCE REPORT

1. CONTRACT NUMBER: <insert number>

2. Prepared by: (Name of COR) <insert name>

3. Date and time of observation:

4. Observation:

<Examples of items to include in a report are:

- Method of surveillance.

- How frequently you conducted surveillance.

- Surveillance results.

- Number of observations.>

Prepared by: <Enter COR’s name>

_____________________________________________
Signature – Contracting Officer’s RepresentativeDate

CONTRACT DISCREPANCY REPORT (CDR)

1. Contract Number: <insert number>

2. TO: (Contractor Task Manager or on-site representative) <insert name>

3. FROM: (Name of COR) <insert name>

4. Date and time observed discrepancy:

5. DISCREPANCY OR PROBLEM:

<Describe in detail. Identify any attachments.>

5. 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 not later than < # days after receipt of this

CDR. >

Prepared by: <Enter COR’s name>

_____________________________________________
Signature – Contracting Officer’s RepresentativeDate

Received by:

_____________________________________________
Signature - Contractor Task Manager or on-site representativeDate

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

File details come from the government source that posted it. Updated .