ATTACHMENT__2_-_QUALITY_ASSURANCE_SURVEILLANCE_PLAN.pdf

ATTACHMENT #2 SOLICITATION #W81XWH-19-Q-0183

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

FOR

DEVELOPMENT OF NOVEL MONOCLONAL ANTIBODIES AND LONGITUDINAL STUDY

OF IMMUNE RESPONSES USING SERUM AND PBMC'S OF INFECTIOUS DISEASE

SURVIVORS

FOR

UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES

(USAMRIID)

1. PURPOSE

The Quality Assurance Surveillance Plan (QASP) is a government-developed document used to determine if the contractor's performance meets the performance standards contained in the contract. The QASP establishes procedures on how this assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process:

1.1. Delivery of all items IAW the delivery schedule outlined in the PWS will be monitored, as well as

Contractor technical performance on all assigned tasks.

1.2. Monitoring will take place on a monthly and/or quarterly basis.

1.3. All surveillance activities will be conducted by the COR or his/her designated appointee.

1.4. Surveillance results will be documented in memorandum format or by using the attached document templates. All deviations will be shared with the Contractor and the Contractor shall provide a written corrective action plan to the COR within 7 calendar days of notice.

1.5. The contractor is responsible for implementing and delivering performance that meets contract standards using its Quality Control Plan. The QASP provides the structure for the government's surveillance of the contractor's performance to assure that it meets contract standards. It is the government's responsibility to be objective, fair and consistent in evaluating contractor performance.

1.6. The QASP is a living document and not intended to duplicate the contractor’s quality control plan.

Flexibility in the QASP is required to allow for an increase or decrease in the level of surveillance necessary based on contractor performance.

1.7. The government may provide a copy of the QASP to the contractor to facilitate open communication.

In addition, the QASP should recognize that unforeseen or uncontrollable circumstances might occur that are outside the control of the contractor.

Bottom line, the QASP should ensure early identification and resolution of performance issues to minimize impact on mission performance.

2. AUTHORITY

2.1. Authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation, Inspection of Services clauses, which provide for inspection, acceptance and documentation of the service called for in the contract or order. This acceptance is to be executed by the contracting officer or a duly authorized representative.

3. ROLES AND RESPONSIBILITIES

3.1. The following personnel shall oversee and coordinate contract surveillance activities.

3.1.1. 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 ensure that the contractor receives impartial, fair, and equitable treatment under this contract. Determine and document the final assessment of the contractor's performance in the governments past performance tracking system.

Assigned KO: Mr. Philip H. Huff

Organization or Agency: U.S. Army Medical Research Acquisition Activity (USAMRAA)

Telephone: 301-619-2940

Email: philip.h.huff.civ@mail.mil

3.1.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The COR is responsible for providing continuous technical oversight of the contractor's performance. The

COR uses the QASP to conduct the oversight/surveillance process. The COR shall keep a Quality

Assurance file that accurately documents the contractor's actual performance. The purpose is to ensure that the contractor meets the performance standards contained in the contract. The COR is responsible for reporting early identification of performance problems to the KO. The COR is required to provide an annual performance assessment to the KO which will be used in documenting past performance. The

QASP is the primary tool for documenting contractor performance. The COR is not empowered to many any contractual commitments or to authorize any contractual change on the Government's behalf.

Primary COR: Dr. John M. Dye

Organization or Agency: U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)

Telephone: 301-619-8782

Email: john.m.dye1.civ@mail.mil

3.1.3. CONTRACTOR REPRESENTATIVES:

The following contractor employee(s) will serve as primary points of contact for the Government.

Title: TBD

Telephone: TBD

Email: TBD

4. PERFORMANCE STANDARDS AND METHODS OF SURVEILLANCE

4.1. PERFORMANCE STANDARDS

4.1.1 The goal of the QASP is to ensure that contractor performance is effectively monitored and documented. The COR's contribution is their professional relationships with the KO, PM and the contractor, which enables positive, open and timely communications. The foundation of this relationship is built upon objective, fair, and consistent COR evaluations of contractor performance against contract requirements. The COR uses the methods contained in this QASP to ensure the contractor is in compliance with contract requirements. The COR function is responsible for a wide range of surveillance requirements that effectively measure and evaluate the contractor's performance.

mailto:philip.h.huff.civ@mail.mil mailto:john.m.dye1.civ@mail.mil

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

4.1.3. The Performance Requirements Summary Matrix includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Table #1 – Performance Requirements Summary Matrix

PERFORMANCE

REQUIREMENT

PWS

PARA.

REF.

PERFORMANCE STANDARD

ACCEPTABLE

QUALITY

LEVEL (AQL)

METHOD OF

SURVEILLANCE

Identify a cohort of survivors 1.4.1.

Identify a Cohort of Survivors of MVD (Uganda) and VEE

(Panama) and perform initial whole blood collection. Blood samples will be delivered to the in-country host laboratory expeditiously following each collection.

100% Complete

100% Observation and Random

Sampling

Develop a database 1.4.2.

Develop a Database to track survivors over time, and assess their immune status.

100% Complete

100% Observation and Random

Sampling

Perform a Follow-

Up 1.4.3.

Every six (±2) months perform follow-up collection of survivor’s sera and lymphocyte samples (whole blood), as in 1.4.1.

100% Complete

100% Observation and Random

Sampling

Blood Processing

Analysis

1.4.4.

Assist USAMRIID and/or host country personnel in blood processing and analysis as needed.

100% Complete

100% Observation and Random

Sampling

Ship Blood and

Blood Products 1.4.5.

Ship blood products to laboratories at USAMRIID, or to collaborators, as needed.

100% Complete

100% Observation and Random

Sampling

4.2. METHODS OF SURVEILLANCE

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

4.2.2. 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.

4.2.2.1. DIRECT OBSERVATION. Can be performed periodically or through 100% surveillance.

4.2.2.2. 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.

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

4.2.2.4. 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.

4.2.2.5. VALIDATED USER/CUSTOMER COMPLAINT. 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.

4.2.2.6. 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.

4.2.2.7. PERIODIC SAMPLING. Variation of random sampling. However, sample is only taken when a deficiency is suspected. 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.

4.2.2.8. 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.

4.3. RATINGS

4.3.1. 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:

Table #2 – Assessment Ratings

Rating Criteria

Exceptional

“GO”

Performance meets contractual standards and exceeds many to the Government’s benefit. The element being assessed was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective.

Very Good

“GO”

Performance meets contractual standards and exceeds some to the Government’s benefit. The element being assessed was accomplished with some minor problems for which corrective actions taken by the contractor were effective.

Satisfactory

“GO”

Performance meets contractual standards. The element being assessed contains some minor problems for which corrective actions taken by the contractor appear or were satisfactory.

Marginal

“NO GO”

Performance does not meet some contractual standards. The element being assessed reflects a serious problem for which the contractor has not yet identified effective corrective actions.

Unsatisfactory

“NO GO”

Performance does not meet most contractual standards and recovery is not likely in a timely manner. The element being assessed contains a serious problem(s) for which the contractor’s corrective actions appear or were ineffective.

4.3.2. 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.

4.3.3. 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.

4.3.3.1. When 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.

4.3.3.2. 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.

4.3.3.3. 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.

Table 3. Corrective Action Requests

CAR

Level

Initiator Examples of Circumstances (Not all inclusive)

I COR a. The issue is not considered to be systemic, significant or recurring.

b. The issue can be corrected in an expedited manner.

c. Corrective action plan provided on the CAR form.

II AMLO a. Escalation of Level I CAR issues when corrective actions are in-effective.

b. Systemic issues exist, adversely affecting quality performance and supporting processes.

c. Issue affects cost, schedule or performance.

d. Issue is significant, repetitive or recurring.

e. Issue involves safety and/or security considerations.

f. Issue is minor non-compliance with applicable policies or regulations.

g. Requires root cause analysis and corrective action plan.

III Contracting

Officer

a. Escalation of Level II CAR issues when corrective actions are in-effective.

b. Issue is major non-compliance with applicable policies or regulations.

c. Serious contractual non-compliances.

d. Requires comprehensive root cause analysis and corrective action plan.

4.4. FREQUENCY OF MEASUREMENT

4.4.1. During contract/order performance, the COR shall take periodic measurements 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.

4.4.2. The COR shall meet with the contractor monthly and/or quarterly to assess performance and shall provide a written assessment. This report will serve as the written assessment of the review upon endorsement by the COR.

5. REPORTS

5.1. The following documents will be used to measure performance, report deficiencies, and describe corrective actions under this contract.

5.1.1. PERFORMANCE ASSESSMENT REPORT (PAR)

PERFORMANCE ASSESSMENT REPORT (PAR)

(If more space is needed, use reverse and identify by number)

1. CONTRACT/TASK ORDER

NUMBER

2. CONTRACTOR 3. TYPE OF SERVICES

4. QUALITY ASSURANCE PERSONNEL (QAP) SIGNATURE AND

DATE

5. QAP PHONE 6. SUSPENSE

DATE

I. PERFORMANCE

7. DEFICIENCY (CHECK ALL BOXES THAT APPLY)

NEW

REPEAT

NO DEFICIENCY NOTED

8. SERVICES SUMMARY or SOW PARAGRAPH

ITEM REVIEWED

9. BRIEF DESCRIPTION OF DEFICIENCY (IF

DEFICIENCY BOX WAS CHECKED)

10. DETAILED PERFORMANCE ASSESSMENT

II. CONTRACTOR VALIDATION

11. CONTRACTOR REPRESENTATIVE CONCUR

NON-CONCUR

12. CORRECTIVE ACTION ESTIMATED

COMPLETION DATE

13. CONTRACTOR REPRESENTATIVE CORRECTIVE ACTION AND PREVENTION OF RECURRENCE OR

REASON FOR NON-CONCURRENCE OF QAP CITED DEFICIENCY

III. ACTION CORRECTED

14. CONCUR NON-CONCUR QAP SIGNATURE AND DATE

15. QAP REMARKS (REQUIRED)

16. CONTRACTOR REPRESENTATIVE REMARKS

5.1.2. CUSTOMER COMPLAINT RECORD (CCR)

CUSTOMER COMPLAINT RECORD

DATE/TIME OF

COMPLAINT

SOURCE OF COMPLAINT

ORGANIZATION

BUILDING

NUMBER

INDIVIDUAL

PHONE

NUMBER

NATURE OF COMPLAINT

CONTRACT REFERENCE

VALIDATION

DATE/TIME CONTRACTOR INFORMED OF COMPLAINT

ACTION TAKEN BY CONTRACTOR

RECEIVED/VALIDATED BY

5.1.3. CORRECTIVE ACTION REPORT

CORRECTIVE ACTION REPORT (CAR)

(If more space is needed, use reverse and identify by number)

1. CONTRACTOR 2. CONTRACT NUMBER 3. TYPE OF SERVICES

4. FUNCTIONAL AREA 5. SUSPENSE DATE 6. CONTROL NUMBER

7. DEFICIENCY MAJOR MINOR FINDING:

FINDING IMPACT:

Please respond with a written corrective action plan that details the corrective action of the cited deficiency, the cause of the deficiency, and actions taken to prevent recurrence by Suspense Date in Block 5.

8. QUALITY ASSURANCE PERSONNEL (COR)

TYPED NAME AND GRADE SIGNATURE AND DATE

9. ISSUING AUTHORITY

TYPED NAME AND GRADE SIGNATURE AND DATE

10. COR RESPONSE TO CONTRACTOR CORRECTIVE ACTION AND ACTION TAKEN TO PREVENT

RECURRENCE:

11. COR DETERMINATION ACCEPTED REJECTED

12. CLOSE DATE