PERFORMANCE_WORK_STATEMENT.pdf

PERFORMANCE WORK STATEMENT (PWS)

Part 1

General Information

1. GENERAL: This is a non-personal services contract to provide Blood Donor Testing. The

Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the

Contractor who, in turn is responsible to the Government.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Airport Expeditor Service as defined in this Performance Work

Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.1.1 Unless otherwise described in this PWS, the contractor shall use only new materials in the requirement unless otherwise stated in this PWS.

1.2 Background: Blood Donor Testing is a requirement of Food Drug Agency, Defense Health

Agency, AABB, and other regulatory agency to provide a safe blood product for transfusions.

1.3 Objectives: This service is to be used for all blood donors at each donation at Naval Hospital

Guam Blood Donor Center. This service is set forth to meet time, temperature, and testing requirements to qualify blood products for human transfusions in a clinical setting.

Scope: The scope of this service is to provide the following tests for each individual blood donation:

1. Antibody Screen

2. ABO Rh (Blood Type)

3. Syphilis

4. Hepatitis B Surface Antigen

5. Anti-Human Immunodeficiency Virus 1/2

6. Anti-Hepatitis B Core

7. Anti-Hepatitis C Virus

8. Anti-Cytomegalovirus

9. Nucleic Acid Test testing for Human Immunodeficiency Virus -1 Ribonucleic Acid, Hepatitis

C Virus Ribonucleic Acid and Hepatitis B Virus, Deoxynucleic Acid. (Pooled testing is acceptable with single testing follow up for positive pool)

10. Nucleic Acid Test for West Nile Virus (single testing)

11. Anti-Trypanosoma Cruzi (Chagas)

12. Anti-Human T-Lymphotrophic Virus I/II

13. Zika Nucleic Acid Test – Single Testing

14. Babesia NAT by IDT

15. Confirmatory

This requirement will be for 1400 individual donations and will include shipping boxes with return shipping included (of empty boxes with supplies for next shipment). Naval Hospital Guam will be responsible for providing shipping to Vendor Laboratory for Testing. It is estimated that

3-5 shipments will be sent per week with an estimated 2-3 small box shipments (platelets) and 1-2 large box shipments (whole blood drives). Results will be supplied in an electronic format that will be communicated directly to NH Guam via POC's to be determined. This may include an up loadable format or a printable paper copy of the results as required.

NOTE: Results must be available within 48 hours of shipment time.

1.4 Period of Performance: 28 November 2019 to 27 November 2020.The period of this service performance shall not exceed more than one year.

1.6 General Information

1.6.1 Quality Control (QC) (Not applicable):

1.6.1.1 Quality Control Reports: N/A

1.6.2 Quality Assurance: The contractor is responsible for maintaining any applicable state and federal licenses required to perform testing within state and federal laws. These include FDA

2830 and AABB or CAP certification.

All employees must have the ability to perform the applicable duties consistent with their license and certification, and ensure that all laboratory testing staff complies with minimum Federal, State and local law qualifications/requirements.

Testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract must meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations, the College of American Pathology (CAP) accreditation standards, or other accrediting organizations and State standards.

1.6.3 Recognized Holidays:

N/A

1.6.4 Hours of Operation: The contractor is responsible for conducting business 24/7. Each testing run may be delayed for logistical and planning processes that include other reasonable obligations of the contractor to include organ transplant testing and other lifesaving testing. These delays should not be greater than the original stated 48 hour turnaround time for result receipt.

1.6.5 Place of Performance: To be Determined

1.6.6 Type of Contract: The government will award a Firm Fixed Price Contract.

1.6.7 Security Requirements: N/A

1.6.7.1 PHYSICAL Security: N/A

1.6.7.2 Key Control: Not Applicable

1.6.7.2.1. N/A

1.6.7.2.2. N/A

1.6.7.3 Lock Combinations: Not Applicable

1.6.8 Special Qualifications: N/A

1.6.9 Post Award Conference/Periodic Progress Meetings: N/A

1.6.10 Contracting Officer Representative (COR): N/A

1.6.11 Key Personnel: The follow personnel are considered key personnel by the government:

1.6.12 Identification of Contractor Employees: Not applicable

1.6.13 Contractor Travel Not Applicable

1.6.14 Other Direct Costs Not Applicable.

1.6.15 Data Rights Not Applicable

1.6.16 Organizational Conflict of Interest (OCI): Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interest as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The

Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the

Contracting Officer and in the event the Contracting Officer unilaterally determines that any such

OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI

This requirement is not applicable to this contract.

1.6.18 Labor Standards: The contractor will ensure compliance with all US labor laws.

PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS:

2.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

2.1.2. CONTRACTING OFFICER (CO). A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the

Government. Note: The only individual who can legally bind the Government. A Contracting

Officer is the only person authorized to make changes to the terms and conditions of a contract.

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S.

Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract, and shall obtain written approval of any changes from the KO.

2.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.5. DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

2.1.6. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.7. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.8. QUALITY ASSURANCE. The Government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.9. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.10. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The

Government does not have privity of contract with the subcontractor.

2.1.12. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.13. WORK WEEK. 24/7 Monday-Monday.

2.2. ACRONYMS:

ACOR Alternate Contracting Officer's Representative

CFR Code of Federal Regulations

CONUS Continental United States (excludes Alaska, Hawaii & Guam)

COR Contracting Officer Representative

COTR Contracting Officer's Technical Representative

COTS Commercial-Off-the-Shelf

DON Department of the Navy

DD250 Department of Defense Form 250 (Receiving Report)

DD254 Department of Defense Contract Security Requirement List

DFARS Defense Federal Acquisition Regulation Supplement

DOD Department of Defense

FAR Federal Acquisition Regulation

KO Contracting Officer

NMCARS Navy Marine Corps Acquisition Regulation Supplement

OCI Organizational Conflict of Interest

OCONUS Outside Continental United States (includes Alaska, Hawaii & Guam)

PIPO Phase In/Phase Out

POC Point of Contact

PRS Performance Requirements Summary

PWS Performance Work Statement

QA Quality Assurance

QAP Quality Assurance Program

QASP Quality Assurance Surveillance Plan

QC Quality Control

QCP Quality Control Program

TE Technical Exhibit

WAWF Wide Area Work Flow

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1. Services: The U.S Government will provide a list of names for use of this service 24 hours out or an early as possible.

3.2 Facilities: Not Applicable

3.3 Utilities: Not Applicable

3.4 Equipment Not Applicable

3.5 Materials: Not Applicable

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract that are not listed under Section 3 of this PWS.

4.2 Secret Facility Clearance: Not Applicable

4.3. Materials: Not Applicable

4.4. Equipment: Not Applicable

PART 5

SPECIFIC TASKS

5. Specific Tasks:

5.1. Basic Services: The contractor shall provide testing requirements to qualify blood products for human transfusions in a clinical setting. This shall include the following:

1. Antibody Screen

2. ABO Rh (Blood Type)

3. Syphilis

4. Hepatitis B Surface Antigen

5. Anti-Human Immunodeficiency Virus 1/2

6. Anti-Hepatitis B Core

7. Anti-Hepatitis C Virus

8. Anti-Cytomegalovirus

9. Nucleic Acid Test testing for Human Immunodeficiency Virus -1 Ribonucleic Acid, Hepatitis

C Virus Ribonucleic Acid and Hepatitis B Virus, Deoxynucleic Acid. (Pooled testing is

Acceptable with single testing follow up for positive pool)

10. Nucleic Acid Test for West Nile Virus (single testing)

11. Anti-Trypanosoma Cruzi (Chagas)

12. Anti-Human T-Lymphotrophic Virus I/II

13. Zika Nucleic Acid Test testing under Roche Investigation New Drug protocol

14. Babesia NAT by IDT

15. Confirmatory

STANDARD TEST PANEL

ABO/Rh (including weak-D testing) Anti-HTLV-1/11

Red Cell Allo-Antibody Screen WNV-NAT*

Standard Test for Syphilis (STS) HIV-NAT

HBsAg HCV-NAT

Anti-HBc HBV-NAT

Anti-HCV Chagas Disease Testing

Anti-HIV-1/HIV-2 Zika-NAT*

Babesia NAT by IDT Anti-Cytomegalovirus

SELECT DONATIONS AS REQUESTED

HLA Ab (TRALI)

Anti-A Anti-B Titers.

Licensed Phenotype Screening - E,e,C,c, and Kell antigens (selective testing is scheduled 1 to 2 times per week.)

Hemoglobin S

Antibody Identification

ABO/Rh Typing discrepancy resolution

CONFIRMATORY TESTING

HBsAg Neutralization

Anti-HCV Confirmatory-second EIA methodology

Anti-HIV-I IFA

Anti-HIV-2 EIA

Bio-Rad Geenius™ HIV-1/-2 Supplemental Testing

Abbott ESA Chagas

HTL V -I/II Blot Confirmatory Testing

FTA-ABS

WNV Supplemental Testing

Zika Supplemental Testing

This will be for 1400 individual donations and will include shipping boxes with return shipping included (of empty boxes with supplies for next shipment). Naval Hospital Guam will be responsible for providing shipping to vendor’s laboratory for testing. It is estimated that 3-5 shipments will be sent per week with an estimated 2-3 small box shipments (platelets) and 1-2 large box shipments (whole blood drives). Results will be supplied in an electronic format that will be communicated directly to NH Guam via POC's to be determined. This may include an up loadable format or a printable paper copy of the results as required.

Results must be available within 48 hours of shipment time.

5.2. Task Heading. NOT APPLICABLE

5.3. Contractor Manpower Reporting (CMR) (Not applicable): The Office of the Assistant

Secretary of the Navy (Manpower & Reserve Affairs) operates and maintains a secure Navy data collection site where the Contractor shall report ALL Contractor manpower (including subcontractor manpower) required for performance of this contract. The Contractor shall completely fill in all the information in the format using the following web address https://Contractormanpower.Navy.pentagon.mil. The required information includes: (1)

Contracting Office, Contracting Officer, Contracting Officer’s Technical Representative (COTR) or also known as the Contracting Officer’s Representative (COR); (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor's name, address, phone number, e-mail address, identity of Contractor employee entering data; (5) Estimated direct labor hours (including sub-Contractors); (6)

Estimated direct labor dollars paid this reporting period (including sub-Contractors); (7) Total payments (including sub-Contractors); (8) Predominant Federal Service Code (FSC) reflecting services provided by Contractor (and separate predominant FSC for each sub-Contractor if different); (9) Estimated data collection cost; (10) Organizational title associated with the Unit

Identification Code (UIC) for the Navy Requiring Activity (the Navy Requiring Activity is responsible for providing the Contractor with its UIC for the purposes of reporting this information); (11) Locations where Contractor and sub-Contractors perform the work (specified by zip code in the United States and nearest city, country, when in an overseas location, using standardized nomenclature provided on website); (12) Presence of deployment or contingency contract language; and (13) Number of Contractor and sub-Contractor employees deployed in theater this reporting period (by country). As part of its submission, the Contractor shall provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period shall be the period of performance not to exceed 12 months ending September 30 of each

Government fiscal year and must be reported by 31 October of each calendar year or as stated in the delivery schedule of the contract.

PART 6

APPLICABLE PUBLICATIONS

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS) (Not applicable):

6.1. The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures.

PART 7

ATTACHMENT/TECHNICAL EXHIBIT LISTING

7. Attachment/Technical Exhibit List: [Not Applicable]

7.1. Technical Exhibit 1 – Performance Requirements Summary

7.2. Technical Exhibit 2 – Deliverables Schedule

TECHNICAL EXHIBIT 1

Performance Requirements Summary

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective

(The Service required—usually a shall statement)

Standard Performance Threshold (This is the maximum error rate. It could possibly be “Zero deviation from standard”)

Method of

Surveillance

PRS # 1.

The contractor shall provide results in under 60 hours from shipment.

100% of results are transferred before

48 hours from shipment time. (exempt from shipment errors outside of their control)

There will be zero deviations from the standard

100% inspection

PRS # 2

The contractor shall provide results for all listed tests required.

100% results of samples sent are required. (results may include indeterminate results for specific tests)

There will be zero deviations from the standard

100% inspection

The following listing provides various types of Surveillance as examples to select from and should not be included on the final document:

Customer Feedback: This will be the preferred method of surveillance

Random Sampling: Appropriate for frequently recurring tasks. Evaluate randomly selected samples of the lot to determine the acceptability of the entire lot.

Random Inspection Guide, Method of surveillance, Lot size, Sample size, Performance requirement, Sampling procedure, Inspection procedure

100 Percent Inspection: Appropriate for tasks that occur infrequently. Inspect and evaluate performance each time task is performed

Periodic Surveillance: Evaluation of samples selected on other than 100% or statistically random basis. (i.e., monthly, quarterly, semi-annually etc.)

Validated Customer Complaint: Complaints must be validated.

NOTE: YOU MAY ALSO IDENTIFY ANY SURVEILLANCE METHOD USED IN THE

COMMERCIAL MARKET TO SURVEY THE REQUIRED SERVICE. (THIS WILL BE

DISCOVERED WHEN MARKET RESEARCH IS CONDUCTED).

TECHNICAL EXHIBIT 2

DELIVERABLES SCHEDULE

[Not Applicable]

(This technical exhibit lists any reports or documentation that is required as a deliverable to include the frequency, # of copies, medium/format and who/where it is to be submitted. A deliverable is anything that can be physically delivered but may include non-physical things such as meeting minutes. Note: All PWS deliverables should be included in this exhibit.)

Deliverable Frequency # of Copies Medium/Format Submit To

[Insert the deliverable, i.e., the DoD Business

Process and

Agency Operating

Models Report and the PWS paragraph number, i.e., PWS paragraph 5.5.]

[Insert how often it is to be provided, i.e., by the 5th of every month, within 30 days of contract award, etc.]

[Insert the number of copies, i.e., 1 original and 2 copies, how often it is to be provided, i.e., by the 5th of every month, within 30 days of contract award, etc.]

[Insert the medium/format that the deliverable is to be provided in, i.e., paper (hard copy), CD in MS Word, DVD, Briefing

Slides on CD, Excel Spreadsheet, etc.]

[Insert where the deliverable is to be delivered, i.e., Name of Activity, ATTN: POC, and

Address.]

[Continue to insert the deliverables in accordance with the example provided above.]

[Same as above.] [Same as above.] [Same as above.] [Same as above.]

[Same as above.] [Same as above.] [Same as above.] [Same as above.] [Same as above.]

[Same as above.] [Same as above.] [Same as above.] [Same as above.] [Same as above.]