A03_Attachment_2_Specimen_Shipping_QASP_8.8.18.docx

ATTACHMENT 4: QUALITY ASSURANCE SURVEILLANCE PLAN (DRAFT)

Walter Reed Army Institute of Research (WRAIR), Human Immunodeficiency Virus (HIV) Diagnostics and Reference Laboratory (HDRL), Specimen Shipping and Supply Management for CONUS MEPS and OCONUS Sites

1 Vision

The efforts described herein support the vision of WRAIR and HDRL, by supporting the clinical testing mission in support of U.S Military Entrance Processing Command as well as other U.S. Army and DoD entities.

The Department of Laboratory Diagnostics and Monitoring (DLDM) is a world class leader in the development of diagnostic countermeasures for HIV, Sexually Transmitted Infections (STIs), Bloodborne Infections (BBIs), Leishmania, and prevalent and emerging pathogens of US Military, US National, and Global Health interest, as well as the critical monitoring parameters utilized by the US Military, National, and Global Health Care Providers for clinical and therapeutic management of a wide variety of infectious diseases. This mission is currently executed through five laboratory sections: (1) HDRL, (2) Leishmania Diagnostic Laboratory (LDL), (3) the Technology Assessment Laboratory (TAL), (4) Clinical Evaluation Unit, and (5) the Specimen Processing Laboratory and Bio-Repository (SPL/Bio).

2 Mission

The purpose of this requirement is to support the HDRL’s clinical test mission in support of U.S Military DoD soldiers and their beneficiaries (approximately 9.4 million), as well as other U.S. National interests worldwide. The Contractor shall provide medical consumables, logistical shipping support, and real-time on line shipping tracking to meet this requirement.

DLDM is a world class leader in the development of diagnostic countermeasures for HIV, Sexually Transmitted Infections (STIs), Bloodborne Infections (BBIs), Leishmania, and prevalent and emerging pathogens of US Military, US National, and Global Health interest, as well as the critical monitoring parameters utilized by the US Military, National, and Global Health Care Providers for clinical and therapeutic management of a wide variety of infectious diseases. This mission is currently executed through five laboratory sections: (1) HIV Diagnostics and Reference Laboratory (HDRL), (2) Leishmania Diagnostic Laboratory (LDL), (3) the Technology Assessment Laboratory (TAL), (4) Clinical Evaluation Unit, and (5) the Specimen Processing Laboratory and BioRepository (SPL/Bio).

3 Purpose

3.1. This 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:

3.1.1. What will be monitored

3.1.2. How monitoring will take place

3.1.3. Who will conduct the monitoring

3.1.4. How monitoring efforts and results will be documented

3.2. 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.

3.3. The QASP is not part of the contract nor is it intended to duplicate the contractor's quality control plan. This QASP is a living document. Flexibility in the QASP is required to allow for an increase or decrease in the level of surveillance necessary based on contractor performance.

3.4. 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.

4 Authority

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.

5 Roles and Responsibilities

The following personnel shall oversee and coordinate surveillance activities.

5.1 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: This section is to be completed at time of award

Organization or Agency: To be completed at time of award

Telephone:

Email:

5.2 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.

Assigned COR: This section is to be completed at time of award

Organization or Agency:

Telephone:

Email:

5.3 Other Key Government Personnel

This may include performance monitors, inspectors, technical experts, or others who provide information that helps the COR monitor contractor performance.

The designated technical quality assurance personnel are:

Name: This section is to be completed at time of award

Telephone:

Email:

5.4 Contractor Representatives

The following employees of the contractor serve as the contractor's Program Manager and Task Manager for this contract. (This section is to be completed at time of award)

5.4.1. Program Manager

Name:

Telephone:

Email:

5.4.2. Task Manager – This section is to be completed at time of award

5.4.3. Other Key Contract Personnel – This section is to be completed at time of award

6 Performance Requirements and Method of Surveillance

This section describes the special requirements for this effort. The following sub-sections provide details of various considerations on this effort.

6.1 Contract Surveillance

The goal of the QASP is to ensure that contractor performance is effectively monitored and documented. The COR's contribution is their professional, non-adversarial 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. Additionally, this QASP is based on the premise that the contractor, not the government, is responsible for management and QC/QA actions to successfully meet the terms of the contract.

6.2 Surveillance Matrix

6.2.1. The Surveillance Matrix Table 1 is the list of performance objectives and standards that must be performed by the contractor. This matrix details the method of surveillance the COR will use to validate and inspect these performance elements. Inspection of each element will be documented in the COR file.

6.2.3. Performance objectives define the desired outcomes. Performance Standards define the level of service required under the contract to successfully meet the performance objective. The inspection methodology defines how, when, and what will be assessed in measuring performance. The Government performs surveillance, using this QASP, to determine the quality of the contractor's performance as it relates to the performance element standards. The matrix should be used to form the foundation of the COR's inspection checklist. In evaluating the quality of contractor’s performance, the following performance ratings may be used.

Performance Rating Criteria

Table 1 - Surveillance Matrix

the testing facility no later than 8:00 A.M. the day after Shipment from CONUS sites.

Specimens will arrive at the testing facility no later than 8:00 A.M NLT 95% of the time

domestic specimen shipments are to be at ambient temperature, 18-30° Celsius 99% of the time

OCONUS specimen shipments and day before holiday shipments are to be maintained at a temperature range of 2-8 ° Celsius 99% of the time

and 2 site staff or members at each site at no additional cost to the Government. Vendor will also provide additional on line training for end users as needed

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. If date was not entered in Block 5, the contractor is not required to provide a response.

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

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

PERFORMANCE ASSESSMENT REPORT (PAR)

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

4. QUALITY ASSURANCE PERSONNEL (COR) SIGNATURE AND DATE

I. PERFORMANCE

7. |_| DEFICIENCY (CHECK ALL BOXES THAT APPLY)

|_| NEW

|_| REPEAT

|_| NO DEFICIENCY NOTED

8. SERVICES SUMMARY or PWS PARAGRAPH ITEM REVIEWED

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 COR CITED DEFICIENCY

III. ACTION CORRECTED

14. |_| CONCUR |_| NON-CONCUR COR SIGNATURE AND DATE

15. COR REMARKS (REQUIRED)

16. CONTRACTOR REPRESENTATIVE REMARKS