Attachment 2 MRDA GEIS QASP Final 6 Apr 21.pdf

QUALITY ASSURANCE AND SURVEILLANCE PLAN

For US Army Medical Research Directorate – Africa (USAMRD-A) Non-Personal Support Services for Africa’s Infectious Disease Surveillance Program in Sub-Saharan Africa

Contract Number: < upon award, enter contract number> Contract Description: < enter contract description >

Contractor’s name: < upon award, enter contractor name > (hereafter referred to as the contractor).

CONTENTS PAGE

PURPOSE 1

GOVERNMENT ROLES AND RESPONSIBILITIES 1

CONTRACTOR ROLES AND RESPONSIBLITIES 2

CONTRACTOR QUALITY REQUIREMENTS 2

METHODS OF QUALITY ASSURANCE SURVEILLANCE 3

FREQUENCY OF MEASUREMENTS 4

PERFORMANCE REPORT 8

CONTRACTOR DEFICIENCY REPORT (CDR) 9

1. PURPOSE:

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated Emerging Infectious Disease Program Overseas Support 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.

Assigned KO: Jennifer Jackson Organization or Agency: USAMRAA Telephone: (301) 619-2054 Email: jennifer.c.jackson18.civ@mail.mil

b. Contract Specialist (CS) - The CS acts as an acquisition consultant and serves as liaison between the contract office and USAMRD-A.

mailto:jennifer.c.jackson18.civ@mail.mil

Assigned: CS: John (Jack) Fitzsimmons Organization or Agency: USAMRAA Telephone: (301) 619-8435 Email: john.l.fitzsimmons8.civ@mail.mil

c. Contracting Officer’s Representative (COR) – The COR will be located at AFRIMS, Bangkok. 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.

Assigned COR: TBD Telephone: TBD Email: TBD

Other Key Government Personnel:

Title: TBD Telephone: TBD Email: TBD

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.

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. You may delete the stated roles or change the naming convention if applicable. >

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

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

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

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.

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

o Performance reporting.

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.

Table 1: Required Performance Metrics for Contractor Performance

Performance Requirement Reference

Task/Activity Standard AQL Surveillance Methods

Incentives

6.2.2 & 10 Enroll patients, collect samples, and perform primary testing at all clinical sites.

Human biological samples and documentation of compliance with IRB protocols at each site.

100% Compliance Summary of enrollment per site, per protocol to be provided to the COR weekly with monthly roll up reports.

Electronic or in person audits to be conducted by PIs, Regulatory Affairs, and/or COR. Each protocol and site will be audited in person a minimum of annually; if conducted by personnel other than the COR, a report of findings will be submitted within 5d of audit completion.

Compliance with the task requirements will result in at minimum Satisfactory rating based on timeliness and quality.

Non-compliance will result in an unsatisfactory rating.

6.2.2 Clinical or vector

samples suitable for genetic characterization of etiologic agents of

AMR, FVBI, RI,

and EI by validated detection assays and test methods.

Human biological samples.

100% Accountability

Samples to be provided to laboratories within 14 days of collection IAW all applicable regulatory and safety laws and guidelines, as well as technical Standard Operating Procedures

Compliance with the task requirements will result in at minimum Satisfactory rating based on timeliness and quality.

Non-compliance will result in an unsatisfactory rating.

6.2.5 Contractor, with

input from the Principal Investigator if required, is to develop and implement or ensure completion of USAMRD-A-provided task-relevant training for all contract employees

The Contractor shall ensure that support personnel receive appropriate training to maintain their skills and certifications necessary to provide the required services throughout

WRAIR.

Training courses

When appropriate, accredited training programs providing certifications will be used. 95% of personnel attending accredited programs will achieve certification.

Training must be coordinated in advance with the

Training documentation to be maintained by the contractor and submitted electronically to COR in monthly operational support plan reports for review. Review of training records by COR or designee, as required. Includes training required by WRAIR for

Compliance with the task requirements will result in at minimum Satisfactory rating based on timeliness and quality.

Non-compliance will result in an unsatisfactory rating.

for support personnel may be offered at the WRAIR site with the approval of the COR.

Contractor must provide a written training plan and documentation each personnel have been trained

COR and then approved by the COR prior to the Contractor incurring the cost.

Training costs must be within the budget.

Professional employees must maintain valid licenses and certifications.

investigators.

Review of licenses and professional certifications by COR or designee.

6.5 Raw and analyzed

data from all clinical samples.

Data reports and transfer of analyses on all clinical samples.

100% Compliance with CDRL technical data deliverable.

Summary of progress and preliminary data to be provided in monthly technical reports to GEIS (funding agency), with contractor copied. Annual technical report.

Electronic requests for data and miscellaneous reports met when and within the allowable timeframe at least 75% of the time.

Compliance with the task requirements will result in at minimum Satisfactory rating based on timeliness and quality.

Non-compliance will result in an unsatisfactory rating.

6.6 Procurement and

medical logistics.

Obtaining supplies and equipment in a cost effective and timely manner and within agreed upon estimate.

Ensuring maintenance of equipment and tools that are contractor-acquired, USG-owned.

Contractor will have a procurement plan/process and communicate that to the COR, KO, and Customer (laboratory investigators and managers).

Supplies and equipment are ordered or put out for bid within 30d of laboratory requisition.

Supply orders are completed in total within 60d of laboratory requisition.

Equipment orders are completed within 120d of laboratory requisition.

Monthly administrative report, procurement section that minimally includes: number of laboratory requisitions received, number of laboratory requisitions processed, number of completed orders, %/dollar amount of items requested that are pending receipt or canceled. COR reviews receiving reports, invoices, and Customer feedback.

Compliance with the task requirements will result in at minimum Satisfactory rating based on timeliness and quality.

Non-compliance will result in an

Supplies and Supplies and equipment meet all required specifications to fulfill research mission within regulatory requirements.

12.1 Contractor Travel The Contractor

shall arrange for travel of support personnel at the request of the COR when it is necessary to surveillance or research activities. Travel is to include within and outside the continental United States.

The Contractor must provide for all necessary travel documents, immunizations, and safety plans that may be required for some destinations.

Contractor must provide an invoice for all travel expenses, and if requested copies of receipts 100% of the time.

Travel will be arranged in accordance with requests and specifications of the COR 100% of the time. Travel arrangements will ensure that personnel are at the Conference location and able to fully participate as needed. Travel costs will not exceed previously agreed amounts.

100% observance.

COR approval of all travel prior to departure, and subsequent review of invoices for travel costs to ensure that amounts are within budget. Summary of completed travel in monthly administration report.

Compliance with the task requirements will result in at minimum Satisfactory rating based on timeliness and quality.

Non-compliance will result in an

PERFORMANCE REPORT

Contract Number: <insert number>

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

Date and time of observation: <insert date>

Observation:

<Examples of items to include in a report are:

- Method of surveillance.

- How frequently you conducted surveillance.

- Surveillance results (Exceeds, Meets, Does Not Meet).

- Number of observations.>

Prepared by: <Enter COR’s name>

COR’s Signature Date

CONTRACT DEFICIENCY REPORT (CDR)

< 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.>

Contract Number: <insert number>

Contractor Project Manager: <insert name>

From: <insert name of COR>

Date and time observed discrepancy:

Contract Discrepancy:

<Describe in detail. Identify any attachments.>

Corrective action plan:

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

< If a written corrective action plan is required include the following. > The contractor shall provide the COR with the Corrective Action Plan not later than < # days after receipt of this CDR. >

Prepared by: <Enter COR’s name>

COR’s Signature Date

Received by: <Enter contractor project manager’s name>

Contractor Project Manager’s Signature Date