W81K0019Q0198 00003.pdf

0011360720

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

A. The purpose of this amendment is three-fold: 1) Add a new CLIN 0001AD and its Option Year CLINs for clarifying CMV testing, 2) Add tw o new CLINs 0001AE and 0001AF and their Option Year CLINs needed for additional required tests and 3) Update the Performance Work Statement (PWS) to refect these test changes.

B. All other solicitation terms and conditions remain the same.

See SUMMARY OF CHANGES

1. CONTRACT ID CODE PAGE OF PAGES

1 35

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 16-Dec-2019

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81K0019Q0198

X 9B. DATED (SEE ITEM 11)

24-Jul-2019

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

16-Dec-2019

CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

FT SAM HOUSTON TX 78234-0000

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81K0019Q0198

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

SUBCLIN 0001AD

This SUBCLIN has been renumbered to SUBCLIN 0001AG.

SUBCLIN 1001AD

This SUBCLIN has been renumbered to SUBCLIN 1001AG.

SUBCLIN 2001AD

This SUBCLIN has been renumbered to SUBCLIN 2001AG.

SUBCLIN 3001AD

This SUBCLIN has been renumbered to SUBCLIN 3001AG.

SUBCLIN 4001AD

This SUBCLIN has been renumbered to SUBCLIN 4001AG.

SUBCLIN 0001AD is added as follows:

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001AD 13,000 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for Babesia (pooled) for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri.

All work is to be done in accordance with the Performance Work Statement.

FOB: Destination

PSC CD: 6515

NET AMT

SUBCLIN 0001AE is added as follows:

0001AE 13,000 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for Babesia (IDS) for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri.

All work is to be done in accordance with the Performance Work Statement.

SUBCLIN 0001AF is added as follows:

0001AF 6,500 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide CMV testing on an as needed basis only for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri. All work is to be done in accordance with the Performance Work Statement.

SUBCLIN 1001AD is added as follows:

1001AD 13,000 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for Babesia (pooled) for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri.

All work is to be done in accordance with the Performance Work Statement.

SUBCLIN 1001AE is added as follows:

1001AE 13,000 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for Babesia (IDS) for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri.

All work is to be done in accordance with the Performance Work Statement.

SUBCLIN 1001AF is added as follows:

1001AF 6,500 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide CMV testing on an as needed basis only for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri. All work is to be done in accordance with the Performance Work Statement.

SUBCLIN 2001AD is added as follows:

2001AD 13,000 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for Babesia (pooled) for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri.

All work is to be done in accordance with the Performance Work Statement.

SUBCLIN 2001AE is added as follows:

2001AE 13,000 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for Babesia (IDS) for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri.

All work is to be done in accordance with the Performance Work Statement.

SUBCLIN 2001AF is added as follows:

2001AF 6,500 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide CMV testing on an as needed basis only for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri. All work is to be done in accordance with the Performance Work Statement.

SUBCLIN 3001AD is added as follows:

3001AD 13,000 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for Babesia (pooled) for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri.

All work is to be done in accordance with the Performance Work Statement.

SUBCLIN 3001AE is added as follows:

3001AE 13,000 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for Babesia (IDS) for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri.

All work is to be done in accordance with the Performance Work Statement.

SUBCLIN 3001AF is added as follows:

3001AF 6,500 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide CMV testing on an as needed basis only for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri. All work is to be done in accordance with the Performance Work Statement.

SUBCLIN 4001AD is added as follows:

4001AD 13,000 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for Babesia (pooled) for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri.

All work is to be done in accordance with the Performance Work Statement.

SUBCLIN 4001AE is added as follows:

4001AE 13,000 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for Babesia (IDS) for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri.

All work is to be done in accordance with the Performance Work Statement.

SUBCLIN 4001AF is added as follows:

4001AF 6,500 Each Blood Donor Testing

FFP

The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide CMV testing on an as needed basis only for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri. All work is to be done in accordance with the Performance Work Statement.

DELIVERIES AND PERFORMANCE

The following Delivery Schedule for SUBCLIN 0001AE has been added:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 01-MAR-2020 TO

30-SEP-2020

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

W45XTR

The following Delivery Schedule for SUBCLIN 0001AF has been added:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 01-MAR-2020 TO

30-SEP-2020

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule for SUBCLIN 0001AG has been added:

CAGE

POP 01-MAR-2020 TO

30-SEP-2020

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule for SUBCLIN 1001AE has been added:

CAGE

POP 01-OCT-2020 TO

30-SEP-2021

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule for SUBCLIN 1001AF has been added:

CAGE

POP 01-OCT-2020 TO

30-SEP-2021

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule for SUBCLIN 1001AG has been added:

CAGE

POP 01-OCT-2020 TO

30-SEP-2021

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule for SUBCLIN 2001AE has been added:

CAGE

POP 01-OCT-2021 TO

30-SEP-2022

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule for SUBCLIN 2001AF has been added:

CAGE

POP 01-OCT-2021 TO

30-SEP-2022

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule for SUBCLIN 2001AG has been added:

CAGE

POP 01-OCT-2021 TO

30-SEP-2022

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule for SUBCLIN 3001AE has been added:

CAGE

POP 01-OCT-2022 TO

30-SEP-2023

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule for SUBCLIN 3001AF has been added:

CAGE

POP 01-OCT-2022 TO

30-SEP-2023

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule for SUBCLIN 3001AG has been added:

CAGE

POP 01-OCT-2022 TO

30-SEP-2023

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule for SUBCLIN 4001AE has been added:

CAGE

POP 01-OCT-2023 TO

30-SEP-2024

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule for SUBCLIN 4001AF has been added:

CAGE

POP 01-OCT-2023 TO

30-SEP-2024

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule for SUBCLIN 4001AG has been added:

CAGE

POP 01-OCT-2023 TO

30-SEP-2024

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

INSPECTION AND ACCEPTANCE

The following Acceptance/Inspection Schedule was added for SUBCLIN 0001AD:

INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

Destination Government Destination Government

The following Acceptance/Inspection Schedule was added for SUBCLIN 0001AE:

The following Acceptance/Inspection Schedule was added for SUBCLIN 0001AF:

The following Acceptance/Inspection Schedule was added for SUBCLIN 1001AD:

The following Acceptance/Inspection Schedule was added for SUBCLIN 1001AE:

The following Acceptance/Inspection Schedule was added for SUBCLIN 1001AF:

The following Acceptance/Inspection Schedule was added for SUBCLIN 2001AD:

The following Acceptance/Inspection Schedule was added for SUBCLIN 2001AE:

The following Acceptance/Inspection Schedule was added for SUBCLIN 2001AF:

The following Acceptance/Inspection Schedule was added for SUBCLIN 3001AD:

The following Acceptance/Inspection Schedule was added for SUBCLIN 3001AE:

The following Acceptance/Inspection Schedule was added for SUBCLIN 3001AF:

The following Acceptance/Inspection Schedule was added for SUBCLIN 4001AD:

The following Acceptance/Inspection Schedule was added for SUBCLIN 4001AE:

The following Acceptance/Inspection Schedule was added for SUBCLIN 4001AF:

The following have been modified:

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT

Blood Donor Infectious Disease Testing

1. GENERAL. This is a nonpersonal services contract to provide blood donor testing services. The Government will not exercise any supervision or control over the Contractor employees performing services herein. Such employees shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

1.1 SCOPE. The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for HBsAg, Anti-HBc, Anti-HCV, Anti-HTLV I/II, Anti-HIV 1/2, STS (syphilis), ABO/Rh, ABSC, NAT pooled testing for HIV/HCV/HBV, individual donor testing for West Nile Virus, Chagas (T. cruzi), Babesia (pooled), Babesia (IDS) and individual donor testing for Zika Virus for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT

Leonard Wood, Missouri. Samples drawn from platelet donors will require the above testing and, in addition, CMV testing. CMV testing will be conducted on an as needed basis only. Any confirmatory/supplemental tests required will be free of charge and included in the cost of whole blood panel testing. The Contractor will provide for third party shipping or transport of specimens on behalf of the government, to be reimbursed at cost by the contract.

1.1.1. All tests shall be executed at the contractor's premises, OR within the Contractor's network of laboratories (affiliate or qualified subcontractor). Contractor's referrals to such affiliate's or qualified subcontractor's laboratories shall be kept to a minimum for control and uniformity purposes.

1.1.2. All testing shall be performed in accordance with the Food and Drug Administration regulations. The contractor will also provide any additional testing that is deemed by the FDA as required for the safety of the national blood supply as required by Robertson Blood Center, FT Hood, Texas, and FT Leonard Wood Blood Donor Center, FT Leonard Wood, Missouri (herein referred to as blood donor centers), will be performed IAW Code of Federal Regulation, Title 21(CFR) and applicable industrial standards.

1.2. CONTRACTOR RESPONSIBILITY.

1.2.1. The Contractor shall ensure all employees under this contract who will be interacting with government personnel (i.e., contractor representative, customer service personnel, data entry/specimen processing technician, and courier) are able to read, write, and speak English fluently, with sufficient clarity, to effectively communicate.

1.2.2. The Contractor shall ensure each laboratory possesses all legally-required license(s), certification(s), and accreditation(s) in accordance with Federal statutes and implementing regulations as well as those of the State in which the laboratory is located. The Contractor shall ensure any subcontractors performing services hereunder shall meet the same requirements as the prime contractor. Proof of the above required certification(s), accreditation(s), license(s), etc., shall be provided, as requested.

1.2.3. The Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification. The Contractor shall ensure all laboratory testing staff complies with minimum Federal, State, and local law qualifications/requirements. The Contractor shall ensure all employees comply with applicable State regulations regarding their certification or registry, or license for the State in which the Contractor's testing facility is located.

1.2.4. The contractor shall ensure all testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations.

1.2.5 The Contractor shall submit a copy of the professional certification and/or licensure of the corporate Laboratory Director and/or Medical Director to the COR within 10 working days after contract award. The Contractor shall also submit copies of all certifications/licenses for the Technical Supervisors of the Primary Contractor's laboratory.

1.2.6. CONTRACTOR PERSONNEL.

1.2.6.1. Contractor Representative. The Contractor shall designate and submit, in writing, within 10 working days after award, the name of a full-time contractor representative and alternate. The written designation shall be submitted to the contracting officer; and the COR as identified on contract. The Contractor shall also provide the telephone, pager, cell phone and facsimile numbers and email address for the designated full-time contractor representative and alternate.

1.2.6.1.1. The contractor shall ensure the contractor representative is available telephonically, or in person by appointment, as needed, for each COR within the assigned territory for troubleshooting, servicing, introducing new tests, etc. During non-duty hours, the contractor representative shall be accessible on a cell phone or pager number for COR within his/her assigned territory.

1.2.6.2 Customer Services. The Contractor shall provide customer service which shall be accessible by toll-free telephone service 24 hours per day, 7 days per week to assist Government staff in tracking test results, modifying test requests, obtaining information regarding specimen requirements, requesting emergency courier service, using, and other applicable related issues/problems that may arise in the performance of work under this contract. The Contractor shall provide toll-free number(s) as applicable to each contract.

1.2.6.3. Upon receipt of specimens, the contractor will fax an acknowledgement of receipt of specimens to the blood donor center. This receipt of specimens will list the specimen numbers received, the date and time and signature of the person receiving the shipment.

1.2.6.3.1 The Contractor will provide a combination of third party commercial shipping services and courier services to and from local commercial airports for donor specimen delivery from both of the blood donor centers to the Contractor the same date of specimen collection when at all possible. Contractor will provide all necessary instructions for shipping and supplies for transport of biologic specimens from both of the blood donor centers under this contract to the Contractor.

1.2.6.3.2 Contractor shall provide donor sample testing 7 days per week.

1.2.6.3.3. Testing on specimens submitted for this test will have a turnaround time of 12 hours upon receipt of the specimens for testing by the contractor. Results will be available within 12 hours of receipt of donor specimens. Results will be sent by e-mail to the Fort Hood, TX. Contractor will inform the blood donor centers of any delay in test results.

Contact information for the two blood donor centers under this contract is as follows:

Robertson Blood Center Fort Leonard Wood BLDG 2250, 761st Tank BN Ave Blood Donor Center Fort Hood, Texas 76544 General Leonard Wood, Missouri Office 254-285-5808 Office 573-528-0260 Fax 254-288-6405 Fax 573-596-5384

1.2.6.3.4. If the electronic reporting requirements of this contract are temporarily unavailable for use, the Contractor shall provide expedited overnight courier shipping, mailing, and/or transportation services to return printed reports of completed test results to the donor centers.

1.2.6.3.5 The Contractor shall bring any errors or discrepancies to the attention of the representatives of the blood donor centers immediately upon discovery. The names of authorized blood donor center personnel will be provided, in writing, by the Government to the Contractor and updated as necessary throughout the contract period.

1.3. PERFORMANCE QUALITY.

1.3.1. CONTRACTOR QUALITY CONTROL (QC) PROGRAM. The Contractor shall provide a copy of its existing Quality Control System. Any changes made after award of contract shall be submitted to the COR and contracting officer.

1.3.1.1. The Contractor shall maintain QC System records that are complete and reliable.

1.3.1.2. A progress meeting shall be held within 60 days after contract start date between the COR and the Contractor to discuss any issues.

1.3.1.3. The Contractor shall perform external proficiency testing surveys as required by CLIA for all regulated analytes. The Contractor shall provide the COR a listing of external proficiency surveys that the laboratory participates in accordance with CLIA. Survey results and statistical reviews for specific laboratory specialties shall be provided to COR or designee upon request.

1.3.1.4. The Contractor shall operate a quality control program as required by CLIA and FDA. Current CLIA requirements are located at the Health Care Financing Administration's website:

http://www.phppo.cdc.gov/CLIA. Upon request of the COR and the Contractor shall provide documentation of quality assurance policies, quality control results for assays, on-going calculations of quality control performance (coefficient of variation, mean and standard deviation), monthly Levy-Jennings graphs, documentation of appropriate analyzer maintenance. Upon request, the Contractor shall provide verification results for assays of non-regulated analytes, and analytes for which proficiency testing does not currently exist.

1.3.1.5. All test methods, test kits and reagents, used for blood donor testing, shall be FDA approved.

Any non-FDA approved method being performed shall have a documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

1.3.1.6. The Contractor shall ensure that Subcontracted laboratories comply with and meet all accreditations/certifications as the prime contractor.

1.3.2 The Contractor shall notify the Contracting Officer immediately, in writing, upon its loss of any required certification, accreditation, or licensure.

1.4. SAFETY REQUIREMENTS. The Contractor shall:

1.4.1. Maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

1.5. SECURITY REQUIREMENTS. 1.5.1. Physical Security.

1.5.1.1. The Contractor shall obtain all local, State and Federal government licenses, passes and permits necessary to enter the government installation to include motor vehicle registration and insurance as required.

1.5.2. Information Security. The computer system shall be processing and transferring data that is classified as Sensitive but Unclassified (SBU) and shall have the appropriate security features. Electronic transmission of identifiable patient information shall be in compliance with requirements of the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA). The following security requirements are in addition to the DoD, U.S. Army, or other government agency basic policy of initial and periodic security training, and the need for physical controls to protect hardware.

1.5.2.1. Neither the Contractor, nor any of its employees, shall disclose or cause to be disseminated any information concerning military activity operations.

1.5.2.2. Neither the Contractor, nor any of its employees, shall disclose private medical information concerning patients to third parties other than those personnel designated by the Government at each Submitting Activity to receive patient results. Results shall be handled as private medical records in accordance with Privacy Act Requirements for Medical Records Systems.

1.5.2.3. All inquiries, comments or complaints pertaining to patient information or government information, arising from any matter observed, experienced, or discovered as a result of, or in connection with, the performance of this contract shall be directed to the COR for resolution.

1.5.3. Computer Security. Computer system processing is sensitive, but unclassified information, and shall have the appropriate security features in accordance with requirements in the National Security Agency "Orange Book" (DoD 5200.28-STD, DoD Trusted Computer System Evaluation Criteria), U.S. Army's or other Government Agency basic policy of initial and periodic security training and the need for physical controls to protect hardware. The website for the Orange Book is http://www.radium.ncsc.mil/tpepilibrary/rainbow/5200.28- STD.html.

2. DEFINITIONS/ACRONYMS. 2.1. DEFINITIONS.

2.1.2. CONTRACTOR. The term as used in this contract refers to both the prime and subcontractors.

2.1.3. CONTRACTING OFFICER. A person with authority to enter into, administer, or terminate contracts, and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

2.1.4. 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.

2.1.5. CRITICAL RESULTS. Laboratory values for tests that by their nature (either below or above the reference range) are significantly abnormal and for which immediate medical attention may be required to prevent significant patient morbidity or mortality. The Contractor's laboratory shall publish a list of tests with results it deems to be in the critical range, and the special notification procedures it shall follow.

2.1.6. CURRENT PROCEDURE TERMINOLOGY (CPT). A listing of descriptive terms and identifying codes for reporting medical services and procedures performed by physicians.

2.1.7. C-2 SECURITY REQUIREMENTS. These are found in the National Security Agency "Orange Book" (DoD 5200.28-STD, DoD Trusted Computer System Evaluation Criteria). Basically, computer system processing is sensitive, but unclassified information, and shall have the appropriate security features. The following security requirements are in addition to the U.S. Army's basic policy of initial and periodic security training and the need for physical controls to protect hardware. For example:

. Discretionary Access Control; (access control lists).

. Object Reuse; (hard drives/diskettes shall be wiped clean of information before turned in to supply for transfer back to the Contractor).

. Identification and Authentication (user ID and passwords to use the system).

. Audit (the system shall have audit trail capability).

. Operational Assurance (protection from external interference or tampering).

. Accreditation (signed by a designated accreditation authority).

2.1.8. DEFECTIVE SERVICE. A unit of service which contains one or more defects, or noncompliance with specified requirements.

2.1.9. ETIOLOGIC AGENT. Infectious agents as defined by 42 CFR Part 72. See Technical Exhibit I.

2.1.10. FAMILY MEMBER PREFIX (FMP). A two-digit numeric code used as a prefix to the social security number that categorizes health care beneficiaries. See Technical Exhibit C.

2.1.11. LEGAL OBSERVATION IDENTIFIER NAMES AND CODES (LOINC). The LOINC Laboratory terms set provides a standard set of universal names and codes for identifying individual laboratory and clinical results. LOINC Codes allow users to merge clinical results from many sources into one database for patient care, clinical research, or management.

2.1.12. MEDICAL EXPENSE AND REPORTING SYSTEM (MEPRS) CODE. An ordering code (three to four alpha-numeric characters) that identify the sub-specialty within the hospital to charge expenses. As an example, code AAAA, is charged to Inpatient Internal Medicine Services.

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

2.1.14. QUALITY ASSURANCE PROGRAM (QAP). All necessary measures taken by the Government to assure that the quality of an end product or service shall meet contract requirements.

2.1.15. SHIPPING FORM. Form(s) used to initiate shipping actions.

2.1.16. SPECIMEN. A quantity of human blood, serum, tissue, excreta, patient body fluid, or environmental specimen provided for test purposes.

2.1.17. SUBCONTRACTOR. One that enters into a subcontract and assumes some of the obligations of the primary Contractor.

2.1.18. SUBMITTING ACTIVITY. Any Government activity submitting specimens under this contract.

2.1.19. TRANSFER TUBE. Any tube used to collect, transport, transship, and store samples under terms of the

PWS.

2.2. ACRONYMS.

AQL - Acceptable Quality Level ASCII - American Standard Code for Information Interchange ASCP - American Society of Clinical Pathologists CAP - College of American Pathologists CDC - Centers for Disease Control and Prevention, U.S. Public Health Service, Atlanta, GA.

CFR - Code of Federal Regulations CHCS - Composite Health Care System CLIA - Clinical Laboratory Improvement Amendments of 1988 CME - Continuing Medical Education CONUS- Continental United States CPT - Current Procedure Terminology COR - Contracting Officer Representative CSF - Cerebrospinal Fluid CV - Curriculum Vitae DES - Defense Encryption Standard DD250 - Department of Defense Form 250 (Receiving Report) DoD - Department of Defense FDA - United States Food and Drug Administration FMP - Family Member Prefix HHS - U.S. Department of Health and Human Services HIS - Hospital Information System HL7 - Health Level 7 IATA - International Air Transport Association LAN - Local Area Network LIS - Laboratory Information System LOINC - Logical Observation Identifier Names and Codes MEPRS- Medical Expense and Reporting System MIS - Management Information System ml - Milliliter MTF - Medical Treatment Facility NIDA - National Institutes of Drug Abuse OSHA - Occupational, Health, and Safety Administration OTSG - Office of the Surgeon General, U.S. Army POC - Point of Contact PRS - Performance Requirements Summary

QAP - Quality Assurance Plan QA - Quality Assurance QAP - Quality Assurance Program QNS - Quantity Not Sufficient SA - Submitting Activity PBWS - Performance Based Work Statement SSN - Social Security Number TE - Technical Exhibit VPN - Virtual Private Network

GOVERNMENT INFORMATION. 3.1. RESPONSIBILITIES. The Government will:

3.1.1. Perform specimen collection.

3.1.1.2. Provide biologic specimens that have been collected and processed per the Contractor's published pre-analytical requirements, and in accordance with standard quality procedures.

3.1.1.3. Label each sample with a unique unit number and provide the Contractor with test request, lists, or work documents with required ordering information per the contractor's requirements.

3.1.1.4. Perform donor notification IAW FDA requirements and established DoD policies.

3 .2 . GOVERNMENT-FURNISHED ITEMS.

3 .2 .1 . Specimens for testing.

CONTRACTOR RESPONSIBILITIES.

4.1. CONTRACTOR-FURNISHED ITEMS

4.1.1. COMMERCIAL CATALOG OF LABORATORY SERVICES. The Contractor shall provide a copy of its commercial catalog of laboratory services. Information shall also be provided by the Contractor to the COR. The Contractor shall provide a hard copy or electronic copy during the start-up period to each COR. Examples of the information to be provided include the following:

o Test specific specimen collection and preservation requirements for each test or analyte.

o Test specific method and interpretation for each test or analyte.

o Test specific method reference ranges, when required.

o Test specific method sensitivity, specificity, and interferences, when required.

o Test specific schedule of performance and average turnaround time for each.

o Result Code

4.1.1.1. Updated information on test methodology changes, (i.e. changes in normal ranges, methods, and reporting units, etc). In the event of any methodology change, written information/instruction shall be provided to the contracting officer and COR within 15 calendar days prior to the Contractor implementing said change.

This will allow time for changes in testing algorithms. Changes to procedures with less than 15 calendar days notice shall be made only with concurrence by the COR. The COR will notify the contracting officer in the event of noncompliance with this requirement.

4.1.2. PRODUCT INFORMATION. The Contractor shall provide product information on new test(s) offered by the Contractor. Updated information shall be provided to the contracting officer and COR once test procedure validation is complete.

4.1.3. SUPPLIES. If the contractor requires unique supplies, the Contractor shall provide an initial 6-week stock of materials or supplies to be used by the submitting facilities in each contract in preparation for shipment of specimens for testing requirements. Supplies required for the initial 6-week period shall be a part of the contract start-up period responsibilities. Government-held stock of Contractor-furnished items shall be routinely replenished by the Contractor to allow performance of all contract requirements without interruption.

Maintenance of the stock will be by request from the COR to the contractor. On a case-by-case basis, emergency supplies may be requested by each COR and shall be provided by the Contractor as required. The Contractor shall meet with the COR within 5 working days after the award of a contract to determine the quantity required for each site. The Contractor shall:

4.1.3.1. Furnish materials and supplies, necessary to meet the requirements for the provision of services established under the terms of this contract.

4.1.3.2. Furnish materials/supplies to submitting facilities to prepare specimens for shipping to the Contractor facility for processing and testing, some examples of supplies required may include, but are not limited to:

4.1.3.3. Shipping and packaging containers for submitting specimens in a manner required for efficient processing at the Contractor's facility.

4.1.3.4. As necessary, test request forms required for the Contractor.

4.1.3.5. Furnish written instructions to Government personnel for sample preparation, applying barcode labels, packing samples, preparing paperwork, and shipping or transport of containers.

4.1.4. Government facilities will utilize unique Barcode labels for identification on each sample transfer tube, or specimen container. The Contractor must be capable of accepting labels in ISBT 128 technology for samples received for testing. The Contractor shall furnish instructions on how to place the barcode labels on each transfer tube or specimen container.

4.2. FACILITIES. The Contractor shall provide and maintain the necessary facilities to perform services under the terms of this contract.

4.3. LABOR: The Contractor shall maintain necessary labor to perform the services under the terms of the contract.

5. DESCRIPTION OF WORK.

5.1. TESTING. The Contractor shall maintain and be FDA licensed for blood donor testing and provide the full range of blood donor testing currently required by the FDA. Contractor will inform of any delay in test results within the 12 hour period via telephone, e-mail or secure fax. The Contractor will provide additional FDA licensed confirmatory testing if available for donor specimens that are initially reactive as required by regulatory and service agencies. The additional confirmatory testing results shall be available within 7 calendar days to the blood donor centers. Any additional testing required by the FDA will be provided by the Contractor during the term of the contract. All blood donor laboratory testing shall be executed in accordance with standard industry practices.

Contractor must have a sample surge capacity of at least 1000 samples per day to accommodate any unforeseen mission requirements or contingency missions that would require an upsurge in blood and blood product requirement, plus other new tests added during the term of the contract. Contractor will have a plan in case of a national emergency (example 9/11), that will ensure no delay or stoppage of service.

5.1.1. The Contractor shall ensure the accurate and timely performance of laboratory testing services in biologic specimens. The quality for all services rendered hereunder shall conform to the highest standards in Blood Banking as established by accrediting and license agencies.

5.2. CONTRACTOR LABORATORY INFORMATION SYSTEM.

5.2.1 The Contractor shall provide and maintain a computerized laboratory information and management system for rapid retrieval and printing of laboratory results including elements within the Contractor's laboratory. The Contractor shall maintain the test results in accordance with appropriate regulatory/accrediting agency guidelines.

5.2.2. The Contractor's automation shall provide:

5.2.2.1. Test results reporting. Routine test results shall be sent by facsimile or electronically transmitted to the Robertson Blood Center, within 12 hours of sample receipt.

5.2.2.2. Any delays in testing due to failed runs, or instrument malfunction should be reported immediately if delay in testing beyond 12 hours will occur.

5.2.2.3. Once corrective actions have been taken or resolved and testing resumed, test results will be made available immediately upon completion of review.

5.5. HANDLING OF SPECIMEN OR REQUEST. DISCREPANCIES.

5.5.1. Specimen loss due to breakage, spillage/leakage, insufficient wet ice, misplacement, mishandling or any other Contractor-related problem(s) shall be reported immediately to the impacted blood donor center upon knowledge or detection of problem. Repeated problems with compromised specimens may be grounds for termination for cause of the contract.

5.5.2. Any specimens that have been broken, leaked, or otherwise compromised during transit shall be immediately reported to the appropriate blood donor center upon unpacking at the Contractor's laboratory.

5.5.3. All specimens shall be processed within 12 hours of receipt. Specimen discrepancies or additional specimen requirements shall be brought to the attention of Robertson Blood Center within one business day after knowledge of discrepancy.

5.6. SPECIMEN RETENTION.

5.6.1. Specimens shall be stored/retained by the Contractor for at least 7 days after the reporting of the results. In selected cases and upon request by a site; the Contractor shall store/retain specimens for up to 30 days at no additional cost. The COR may request repeat determinations or add-on tests by telephone during this 7-day or extended 30-day period.

5.7. REFERRALS TO ANOTHER LABORATORY OR INSTITUTION. The contractor shall ship specimens to other laboratories as required when referral work is sent by the Government to another institution which may be conducting joint studies or when the specimen is time sensitive. Specimen transport costs for referrals to another laboratory or institution are at no additional cost to the Government.

5.8. RESULTS REPORTING.

5.8.1. The Contractor shall provide reports of laboratory testing to Robertson Blood Center, Fort Hood, Texas.

Results are to be sent immediately upon completion of review within 12 hours of receipt of specimens.

5.8.2. Blood donor testing reports meeting CLIA requirements shall be faxed and/or electronically transmitted to Robertson Blood Center for local printing. In the Shipping/Receiving Section of each SA. As a minimum, printed reports shall include:

o The name and address of the contract laboratory where each test was performed.

o The specimen blood donor unit number assigned.

o The name of the contract Laboratory Director or Medical Director.

o A phone number to contact the contract laboratory concerning the test results.

o The specimen collection date.

o The Contractor's report date and time.

o The test name.

o The test result(s).

o The unit of measurement for quantitative tests. The normal or expected range.

o The report status (i.e. final or interim).

o Other interpretive information appropriate for the test(s).

5.8.3. Abnormal results (results outside the reference range), or incomplete testing shall be flagged as pending on the reports to differentiate them from normal results (results within the reference range). Reports will be released by the Contractor, even if all the results in each batch have not been completed within the run, with the understanding that when incomplete tests or confirmation test are completed, reports will be available to the blood donor centers. This will allow for unit release and appropriate unit quarantine. It is imperative that the results per batch be released even if some of the tests are incomplete due to mission requirements of the blood donor center, to release blood products as quickly as possible after the lot review process which is dependent upon test results. Units with incomplete testing results will be held as pending testing by the blood donor center, until such completion and release of the results and review by the lot release process.

5.8.4. In cases of malfunction of the Contractor-supplied electronic reporting method lasting more than 24 hours, the Contractor shall, without additional charge, provide express overnight shipping or courier delivery of printed reports to each COR until the automated information system is properly functioning.

5.9. MANAGEMENT REPORTS.

5.9.1. Monthly COR Reports. The Contractor shall provide monthly data summary reports of tests performed under this contract. The printed reports shall be delivered to the contracting officer and to COR as identified on the contract, by the tenth calendar day of the month after the end of each monthly reporting period.

5.9.1.1. The reported information shall include subtotals for each test and the test name, vendor's test code, test cost, number of test performed (current month), total monthly cost (per test), and number performed year to date (per test).

5.9.2. Quarterly Regional Reports. The Contractor shall provide quarterly data summary reports of tests performed for each COR as identified under this contract. The printed reports shall be delivered to the COR, and contracting officer no later than the seventh calendar day of the month after the end of each quarter. Letter issued to the contractor after award of the contract will identify the COR.

5.9.2.1. The reported information shall include subtotals by COR for each test and include test name, vendor's test code, test cost, number of test performed (current month), total monthly cost (per test), number performed year to date (per test), and cost year to date (per test) .

5.9.2.2. The reports with data required in PWS paragraph 5.9.2 shall be sorted by the COR primary method (unit numbers chronologically).

5.9.2.3. The Contractor shall provide the COR and contracting officer a Quarterly Summary Report. The recorded information shall as the minimum include:

5.9.2.3.1. Cumulative subtotals for each test ordered. Identify the test name, vendor's test code and current test cost (per unit).

5.9.2.3.2. Cumulative dollar subtotal for each test ordered. Identify the test name, vendor's test code, and current test cost (per unit).

5.9.2.3.3. Notification of when a specific test is subject to a unit price reduction based on the contractor's proposed discount schedule/terms incorporated under contract shall be provided by the Contractor to the COR. Identify the test name, vendor's test code, and revised unit cost per test.

5.9.2.3.4. Notification of the revised pricing for a given test based on price reductions will be made to the contracting officer and notification provided to COR's and other contracting officers by modification to the basic contract.

5.9.2.3.5. All reports shall be submitted in electronic spreadsheet form. Electronic supplemental narrative shall be forwarded as appropriate.

5.10. MISCELLANEOUS CONTRACTOR RESPONSIBILITIES.

5.10.1. The Contractor shall keep the contracting officer and the COR, informed of the most recent developments in clinical laboratory methods used and medical interpretation of laboratory tests through periodic newsletters, reports, data sheets, and/or Continuing Medical Education (CME) presentations. The Contractor shall provide quarterly updates.

5.10.2. The Contractor shall provide through its toll free customer service network, with minimal transfers and holding, access to knowledgeable, responsive laboratory professionals.

5.11. CONTRACT START-UP PERIOD. Immediately upon award of the contract, there will be a start-up period consisting of a maximum of 42 calendar days. The intent of this start-up period is to enhance coordination between the Government and the Contractor in order to avoid misunderstanding or mistakes on the part of both parties. The Contractor shall provide the necessary personnel required to perform training/orientation with coordination from the COR. During this period, the following shall take place:

5.11.1. The Government COR's will brief the Contractor as to where to ship their shipping/packaging materials. If needed, the Contractor will make a site visit to the donor center to instruct personnel on labeling, packing and shipping requirements.

5.11.2. The Contractor shall provide materials and supplies needed for shipment of specimens from Robertson Blood Center and from Fort Leonard Wood to Contractor to last for the initial 6-week period.

5.11.3. The Contractor shall provide each COR with processing and shipping information and their Client Services Manuel during the start-up period.

6.0 APPLICABLE REGULATIONS, MANUALS, TECHNICAL BULLETINS, PAMPHLETS, AND

SPECIFICATIONS.

REGULATION NAME

AR 340-17 Release of Information and Records (15 Dec 86).

AR 340-21 The Army Privacy Program (5 Jul 85).

AR 340-21-1 The Army Privacy Program: System Notices and Exceptions Rules (16 Dec 85).

AR 380-19 Information System Security AR 40-3 Medical, Dental, and Veterinary Care DA PAM 25-51 Privacy Requirements for Medical Records System CLIA Clinical Laboratory Improvement Amendments of 1988 DoD 5200.28-STD DoD Trusted Computer Evaluation Criteria "Orange Book".

Title 42 CFR, Part 72 Interstate Shipment…