W9114F23Q0035_Amendment_0001.pdf

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

POC: HENNING MAYER-GOLDSTEIN

CMR 402

APO AE 09180

0011912247

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

The purpose of this modification is to do the follow ing:

a. Amend verbiage w ithin PWS Paragraph 5.1.2.1.

b. Incorporate PWS Paragraph 5.1.2.1.1.

c. Amend verbiage of PWS Paragraph 5.1.2.2.

d. Publicize the Questions received from Industry along w ith the appropriate Answ ers from the Government. See 'Summary of Changes' for details.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 23

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

16C. DATE SIGNED

BY 12-Apr-2023

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 W9114F23Q0035

X 9B. DATED (SEE ITEM 11)

28-Mar-2023

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

12-Apr-2023

CODE

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

CMR 402

APO AE 09180

W9114F 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W9114F

FACILITY CODECODE

EMAIL:TEL:

W9114F23Q0035

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been added by full text:

QUESTIONS AND ANSWERS (Q&A)

Question 1: Our company has some questions regarding the requested STANDARD TEST PANEL and

CONFIRMATORY TESTING in the PWS (Paragraphs 5.1.2.1. and 5.1.2.2.). Please clarify the following:

a. The RFQ lists Nucleic Acid Multiplex (HIV, HCV, HBV) testing as part of the STANDARD TEST PANEL. Our company can also provide Standard Nucleic Acid Test Panel (HIV/HCV/HBV NAT Ultrio) (pooled). Please clarify if this would also be acceptable.

b. The RFQ lists CMV testing to be part of the STANDARD TEST PANEL. CMV testing is usually required only once for 1st-time donors, but not for recurring donors. Please clarify if CMV testing will be required on each sample?

c. The RFQ lists FTA ABS testing as part of the CONFIRMATORY TESTING. Our company can only perform Confirmatory Treponema Pallidum, (Syphilis Supplemental)CAPTIA Syphilis (T. pallidum) - G. Please clarify if this would also be acceptable.

d. The RFQ lists HIV NAT (Individualized Testing) testing as part of the CONFIRMATORY TESTING. Our company implemented the BioRad Geenius HIV 1/2 Confirmatory Assay which will replace the current HIV-1 Western Blot and HIV-2 EIA assays. Please clarify if this would also be acceptable.

e. The RFQ lists WNV NAT (Individualized Testing) testing as part of the CONFIRMATORY TESTING. Our company can only perform WNV (IDT) but do not offer any other WNV confirmatory. Please clarify if this would also be acceptable.

f. The RFQ lists HBsAg Neutralization (Individualized Testing) testing as part of the CONFIRMATORY TESTING. Our company no longer performs HBs Neutralization, only HB Confirmatory. Please clarify if this would also be acceptable.

Answer 1: a. Either test is acceptable.

If a mini-pool is used, a positive would require the individual donor samples in the pool to be tested, either with a “Multiplex” (combination) assay for HIV, HCV, and HBV, or else with the individual NAT tests for these three viruses.

b. The Government will only be testing Platelet products and O NEG Leuko-reduced whole blood (WB). We estimate 600 CMV tests per year.

c. CAPTIA-G is acceptable.

Initial Screening with Non-Treponemal Based Assay (e.g., FDA cleared Venereal Disease Research Laboratory (VDRL), Rapid Plasma Reagin (RPR), Automated Reagin Test (ART)) must be confirmed with a Treponemal assay (e.g. EIA, FTA-ABS, MHA-TPA, or TP-PA).

Initial screening with a Treponemal assay must be confirmed with a different Treponemal assay.

d. BioRad Geenius HIV 1/2 Confirmatory Assay is approved for donor testing based on the acceptability criteria published by the FDA. A complete list of acceptable methodologies for donor screening can be found at: https://www.fda.gov/vaccines-blood-biologics/complete-list-donor-screening-assays-infectious-agents-and-hiv-diagnostic-assays

e. No additional WNV testing is required if WNV (IDT) is performed initially on all samples. If WNV is tested on pooled samples a positive pool would need to be followed by WNV (IDT).

f. Approved confirmatory tests for HBsAG are HBs Neutralization (Abbot Prism ChLIA) and HB Confirmatory (Genetic Systems EIA).

Question 2: There is no quantity associated with the confirmatory testing. Would you please provide me with an estimated quantity per year? Or do you only need the price for each test?

Answer 2: The Government is estimating an annual total quantity of 30 confirmatory tests. These conformity tests as well as the estimate annual total quantity of 600 CMV tests need to be taken into consideration for your quoted price which is for reportable tests only (patient results).

Question 3: Our company is a Small business Set-Aside located in the United States but writing to show interest in the above solicitation and would like to ask if this solicitation is for Small business Set- Aside and if we are also allowed to partner/subcontractors with local Blood testing center located in Germany.

Answer 3: The Government allows subcontracting for this requirement with limitations and restrictions as described in the following clauses:

52.203-6 Alt I, Restrictions On Subcontractor Sales To The Government -- Alternate I

52.209-6, Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment

52.244-6, Subcontracts for Commercial Products and Commercial Services

The solicitation is unrestricted (full and open competition) which means that there are no limitations on competition.

Please note that the Government will only accept a single location for all tests to be shipped to.

(End of Q&A)

The following have been modified:

PWS

PERFORMANCE WORK STATEMENT (PWS)

FOR

BLOOD DONOR TESTING

1. GENERAL. This is a non-personal services requirement, in accordance with Federal Acquisition Regulations (FAR) Part 37, to provide blood donor testing for the Armed Services Blood Bank Center - Europe (ASBBC-E).

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. This testing requirement fulfills guidance from the United States Food & Drug Administration (FDA) requiring all DoD Blood Donor Centers (BDCs) to test samples from individual human donors, including donors of whole blood and blood components, and other living donors for blood type, occurrence of blood antibodies and infectious diseases.

1.1. SCOPE. The Contractor shall provide all required facilities, personnel, services, materials, equipment, and supplies required to meet the requirements outlined in this Performance Work Statement. All testing shall be in accordance with the Food and Drug Administration (FDA) regulations for the manufacturing of transfusable blood products and for blood bank reference lab testing. The standard test shall be a platform approved by the FDA (shall be performed in accordance with Unites States Code of Federal Regulation, Title 21 (CFR) and applicable industrial standards). Donor blood testing services will support the Armed Services Blood Bank Center - Europe (ASBBC-E) located at Landstuhl Regional Medical Center, Landstuhl (LRMC), Germany.

1.2. REQUIREMENTS. The Contactor shall provide the full range of donor blood diagnostic testing capabilities to execute required tests annotated in PWS paragraph 5. entitled “Description of Work”. Whole blood and platelet/plasma apheresis products from the ASBBC-E will require the routine individual donor blood testing panel and repeat testing, as well as confirmation testing. The Contractor shall provide any confirmatory testing and additional tests required by the FDA. All donor blood laboratory testing shall be executed in accordance with standard industry practices. All tests shall be executed at the Contractor's premises, or within the Contractor's network of laboratories (affiliate or qualified subcontractor). Contractor shall provide a Contingency Plan that describes in detail, how the Contractor intents to perform when an emergency/natural disaster is declared and there is a surge in units to be tested, to avoid any delay or stoppage of service.

1.3. NON-PERSONAL SERVICES. The Government shall neither supervise Contractor employees nor control the method by which the Contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual Contractor employees. It shall be the responsibility of the Contractor to manage its employees and to guard against any actions that are of the nature of personal services, or give the perception of personal services. If the Contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the Contractor's responsibility to notify the Procuring Contracting Officer (PCO) immediately. [FAR Part 37]

1.4. CONTRACTOR RESPONSIBILITY.

1.4.1. 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.

1.4.2. 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 to the BDC in accordance with the FDA regulations.

1.4.3. 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.

1.4.4. 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 (USA).

1.4.5. The Contractor shall submit a copy of the professional certification and/or licensure of the corporate Laboratory Director and/or Medical Director to the Contracting officer’s Representative (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.

1.5. CONTRACTOR PERSONNEL.

1.5.1. 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.

1.5.1.1. The Contractor shall ensure the Contractor Representative is available telephonically, or in person by appointment, as needed, for troubleshooting, servicing, introducing new tests, etc. During non-duty hours, the Contractor Representative shall be accessible on a cell phone or pager.

1.5.1.2. The Contractor shall ensure the Contractor Representative is available telephonically, or in person by appointment, to meet, as necessary, with the COR, as identified on contract, to discuss immediate administrative, technical issues, and problem areas the customers may be experiencing in the field. During non-duty hours, the Contractor Representative shall be accessible on a cell phone or pager number.

1.5.2. 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, and other applicable related issues/problems that may arise in the performance of work under this contract. The Contractor shall provide toll-free international number(s).

1.5.2.1. The Contractor shall provide testing service 7 days a week.

1.5.2.2. The Contractor shall provide all necessary instructions for shipping and supplies for biologic specimens to be transported from the ASBBC-E to the Contractor. Offeror shall assume no SOFA/DoD rights or privileges applicable to the transportaion or testing of specimens.

1.5.2.3. The primary result reporting shall be by email or shared electronic file to the representatives of the ASBBC- E. Results shall be e-mailed or uploaded upon completion of the testing and verification of results for accuracy within a 24 hour period following receipt of the specimens. Contractor shall inform the COR of any delay in test results within the 24-hour period via e-mail. Repeat positive results for initially reactive and failed run sample shall be available within 48 hours of receipt of donor specimens.

1.5.2.3.1. A list of email addresses will be provided by the ASBBC-E within 10 working days after award to the Contractor to provide results electronically through email.

1.5.2.5. The Contractor shall bring any errors or discrepancies to the attention of the representatives of the ASBBC- E immediately upon discovery. The names of authorized representatives of blood donor center personnel will be provided, in writing, by the Government within 10 working days after award of the contract, to the Contractor and updated as necessary throughout the contract period.

1.6. PERFORMANCE QUALITY.

1.6.1. CONTRACTOR QUALITY CONTROL (QC) PROGRAM. The Contractor shall provide a copy of its existing Quality Control System within 10 working days after award of the contract. Any changes made after award of contract shall be submitted to the COR and to the Contracting Officer for Government’s review and approval prior to implementation.

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

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

1.6.1.3. 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

1.6.1.4. The Contractor shall operate a quality control program as required by FDA; current CLIA requirements are located at the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/clia/. Upon request of the COR , 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, and 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.

1.6.1.5. All test methods shall be FDA approved for blood donor testing. 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. All instrumentation, testing methods, and standard operating procedures shall be validated prior to implementation and use by the Contractor providing blood donor testing in accordance with FDA requirements.

1.6.1.6. The Contractor shall ensure that subcontracted laboratories comply with and meet all accreditations/certifications as the prime Contractor.

1.6.2. Government Performance Requirements Summary (PRS). The Government will monitor the Contractor’s performance under this contract, in part using specimen pick times, result turn-around times, percentage of discrepant results and by selected inspections or audits of the Contractor’s own written instructions and procedures.

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

1.7. SAFETY REQUIREMENTS. The Contractor shall:

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

1.8. SECURITY REQUIREMENTS.

1.8.1. Physical Security.

1.8.1.1. All Contractor Employees, to include subcontractor employees, requiring access Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable.

The Contractor shall submit certificates of completion for each affected Contractor Employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 7 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: https://jko.jten.mil/

1.8.1.2. 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.

1.8.2. 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) (USA). 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.

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

1.8.2.2. 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 DA Pam 25-51, Privacy Act Requirements for Medical Records Systems.

1.8.2.3. 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.

2. DEFINITIONS/ACRONYMS.

2.1. DEFINITIONS.

CONTRACT ADMINISTRATOR. The official Government representative delegated authority by the Contracting Officer to administer a contract. This individual is normally a member of the appropriate Contracting/Procurement career field and advises on all technical contractual matters.

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

2.1.2. 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.

2.1.3. 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.

2.1.4. 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).

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

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

2.1.7. GOVERNMENT-FURNISHED PROPERTY (GFP) OR GOVERNMENT PROPERTY (GP). Property in the possession of, or directly acquired by, the Government and subsequently made available to the Contractor.

2.1.8. 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 quote.

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

2.1.10. ETIOLOGIC AGENT. Infectious agents as defined by 42 CFR Part 72.

2.1.11. QUALITY ASSURANCE. The Government procedures to verify that services being performed by the Contractor are acceptable in accordance with established standards and requirements of this contract.

2.1.12. QUALITY ASSURANCE SPECIALIST. An official Government representative concerned with matters pertaining to the contract administration process and quality assurance/quality control. Acts as technical advisor to the Contracting Officer in these areas.

2.1.13. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). 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.

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

2.1.15. 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.

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

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

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

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

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

PWS.

2.2. ACRONYMS.

AABB - American Association of Blood Banks (USA)

ACOR - Alternate Contracting Officer’s Representative ASBBC-E - Armed Services Blood Bank Center – Europe ASCII - American Standard Code for Information Interchange ASCP - American Society of Clinical Pathologists (USA) AQL - Acceptable Quality Level BDC - Blood Donor Center CAP - College of American Pathologists CDC - Centers for Disease Control and Prevention (CDC) (USA) CFR - Code of Federal Regulations (USA) CLIA - Clinical Laboratory Improvement Amendments of 1988 (USA) COR - Contracting Officer Representative DES - Defense Encryption Standard DD250 - Department of Defense Form 250 (Receiving Report) DoD - Department of Defense DoDD - Department of Defense Directive EIA - Enzyme Immunoassay FDA - United States Food and Drug Administration FSC - Federal Service Code HHS - U.S. Department of Health and Human Services HIPAA - Health Insurance Portability & Accountability Act (USA) HL7 - Health Level 7 HTLV 1&2 - Human T-Lymphotropic Viruses Types I&II IATA - International Air Transport Association IAW - In Accordance With LAN - Local Area Network MIS - Management Information System NAT - Nucleic Acid Test OSHA - Occupational, Health, and Safety Administration (USA) OTSG - Office of the Surgeon General, U.S. Army POC - Point of Contact PRS - Performance Requirements Summary PWS - Performance Work Statement QASP - Quality Assurance Surveillance Plan QA - Quality Assurance QC - Quality Control QNS - Quantity Not Sufficient SBU - Sensitive But Unclassified SAPR - Sexual Assault and Response Program SSN - Social Security Number UIC - Unit Identification Code VPN - Virtual Private Network

3. GOVERNMNET RESPONSIBILITES.

3.1. 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 requests, lists, or work documents with required ordering information per the Contractor’s requirements.

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

3.2. GOVERNMENT-FURNISHED ITEMS.

3.2.1. Specimens for testing.

3.3. GOVERNMENT UNIQUE TRAINING

4. CONTRACTOR RESPONSIBILITIES.

4.1. CONTRACTOR-FURNISHED ITEMS

4.1.1. COMMERCIAL CLIENT SERVICES MANUAL. The Contractor shall provide a hard copy (electronic copy optional) of its Client Services Manual to the COR at the BDC during the start-up period. Examples of the information to be provided include the following:

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

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

Test-specific method reference ranges, when required.

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

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

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 – if needed. 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 Contracting Officer and COR once test procedure validation is complete.

4.1.3. MATERIALS/CONSUMABLES. The Contractor shall provide all necessary shipping supplies for biologic specimens to be transported from the ASBBC-E in Landstuhl, Germany, to the Contractor's laboratory.

4.1.3.1. The Contractor shall routinely replenish Government-held stock of Contractor-furnished items to allow performance of all contract requirements without interruption. The Contractor is responsible for the maintenance of the stock.

4.1.3.2. The Contractor shall provide, emergency supplies if requested by the COR(s) on a case-by-case basis, as required.

4.1.3.3. The Contractor shall furnish materials, supplies, equipment, and reagents necessary to meet the requirements for the provision of services established by this contract.

4.1.3.4. The Contractor shall furnish shipping and packaging containers to the ASBBC-E to prepare specimens for shipping to the Contractor Facility for processing, testing, reporting and storage. Some examples of supplies required may include: packing material capable of maintaining temperature requirements for specimens until they reach the Contractor's laboratory under the terms of this contract.

4.1.3.5. The Contractor shall furnish required labels and packaging materials for shipping specimens via courier that are potentially infectious, in accordance with appropriate requirements as stipulated by the Food and Drug

Administration Code of Federal Regulation regarding blood and blood products. Offeror shall assume no SOFA/DoD rights or privileges applicable to the transportaion or testing of specimens.

4.1.3.6. The Contractor shall furnish electronic test request forms, with the appropriate Shipping Section and account information for the tests offered.

4.1.3.7. The Contractor shall furnish electronic test request forms for confirmation or additional testing, if required.

4.1.3.8. The Contractor shall furnish instructions on how to place the barcode labels on each specimen tube as required by the Contractors' barcode reading requirements for its instrumentation.

4.1.3.9. The Contractor shall furnish written instructions to Government personnel for sample preparation, applying barcode labels, packing samples, preparing paperwork, and shipping or transport of containers. ASBBC-E will use barcode labels for identification of each specimen that will uniquely identify the unit number of the individual donor blood testing specimen.

4.1.3.10. The Contractor shall provide an initial two-week stock of shipping materials for testing requirements as part of the phase-in period.

4.1.4. CUSTOMER SERVICE. The Contractor Customer Service shall be accessible by toll-free telephone service 24 hours per day, 7 days per week (Monday through Sunday) to assist Government staff in tracking test results, modifying test requests, obtaining information regarding specimen requirements, and other related issues that may arise.

5. DESCRIPTION OF WORK.

5.1. TESTING. The Contractor shall be FDA licensed for blood donor testing and provide the full range of blood donor testing currently required by, and on a platform approved by, the FDA. Contractor shall inform of any delay in test results within the 24 hour period via telephone, e-mail or fax. Repeat positive results for initially reactive and failed run sample shall be available within 48 hours of receipt of donor specimens. The Contractor shall provide any additional testing required by the FDA during the term of the contract. All blood donor laboratory testing shall be executed in accordance with standard industry practices. Contractor shall have a sample surge capacity of at least 1,000 samples per day to accommodate any unforeseen mission requirements or contingency missions that would require an upsurge in blood and blood product requirement.

5.1.1. The Contractor shall ensure the accurate and timely performance of laboratory testing services for biologic specimens provided by the ASBBC-E. The quality for all services rendered hereunder shall conform to the highest standards in the clinical pathology and clinical reference laboratory professions as established by accrediting and licensing agencies. Contractor shall provide a Contingency Plan that describes in detail, how the Contractor intents to perform when an emergency/natural disaster is declared and there is a surge in units to be tested, to avoid any delay or stoppage of service.

5.1.2. INDIVIDUAL DONOR TESTING.

5.1.2.1. STANDARD TEST PANEL. The Contractor shall perform the Standard Test Panel in compliance with the FDA regulations for the manufacturing of transfusable blood products on all samples as follows: ABO/Rh, Antibody Screen, STS, HBcAb, HBsAg, HCV, HIV 1/2, HTLV I/II, NAT (HIV, HCV, HBV), WNV NAT, Chagas (T. cruzi), and Babesia (Individualized Testing).

5.1.2.1.1 CMV testing will be ordered with the standard test panel on a case-by-case basis. This only applies to specific samples identified by the Armed Services Blood Bank Center - Europe.

5.1.2.2. CONFIRMATORY TESTING. The Contractor shall perform additional confirmatory testing when needed in compliance with the FDA regulations for the manufacturing of transfusable blood products. Confirmatory or further testing is required for repeat reactive results on the following tests from the standard test panel: STS, HBsAg, HCV, HIV 1/2, HTLV I/II, NAT (HIV, HCV, HBV), WNV NAT, Chagas (T.cruzi).

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 electronically uploaded to a shared file system or emailed to the ASBBC-E, within 24 hours from receipt of samples.

5.2.2.2. Any delays in testing due to failed runs, or instrument malfunctions should be reported immediately if delay in testing beyond 24 hours will occur.

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

5.3. HANDLING OF SPECIMEN OR REQUEST DISCREPANCIES.

5.3.1. Specimen loss due to breakage, spillage/leakage, insufficient dry ice, misplacement, mishandling or any other Contractor-related problem(s) shall be reported immediately to ASBBC-E upon knowledge or detection of problem.

Repeated problems with compromised specimens may be grounds for termination for cause of the contract.

5.3.2. Any specimens that have been broken, leaked, or otherwise compromised during transit shall be immediately reported to ASBBC-E upon unpacking at the Contractor’s laboratory.

5.3.3. All specimens shall be processed within 24 hours of receipt. Specimen discrepancies or additional specimen requirements shall be brought to the attention of the submitting facility within the 24-hour period.

5.4. SPECIMEN RETENTION.

5.4.1. 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.

5.5. 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 expense for referrals to another laboratory or institution are at no additional cost to the Government. Offeror shall assume no SOFA/DoD rights or privileges applicable to the transportaion or testing of specimens.

5.6. RESULTS REPORTING.

5.6.1. The Contractor shall provide reports of donor testing to the submitting facility within a 24 hour turn-around time from receipt. The Contractor shall report results by giving the ASBBC-E access to the Contractor's web-based laboratory information system, by upload to a shared file system or by electronic mail to the ASBBC-E. A list of email addresses will be provided by the COR(s) to the Contractor to provide results via email. In the event that the results cannot be reported electronically, the Contractor shall contact the ASBBC-E to determine a course of action.

5.6.1.1. Standard Test Panel Results. The Contractor shall provide initial test results from the Standard Test Panel, within 24 hours after receipt of the specimens.

5.6.1.2. Confirmatory Testing Results. If confirmatory testing is necessary, the Contractor shall provide additional confirmatory test results within 48 hours of receipt of specimen, based upon the requirements established by the specific testing procedure.

5.6.2. Blood donor testing reports meeting CLIA requirements shall be transmitted to the ASBBC-E for local printing. The file shall be configured to upload to the ASBBC-E’s Enterprise Blood Management System (BECS) via API upload. As a minimum, printed reports shall include:

The specimen donor unit number assigned by the ASBBC-E.

The test name.

The test result(s).

5.6.3. Abnormal results (results outside the reference range), or incomplete testing shall be flagged by some indication on the reports to differentiate them from normal results (results within the reference range). Reports shall be released by the Contractor, even if all of the results in each batch have not been completed within the run, with the understanding that when incomplete tests are completed, reports shall be made available to the submitting facility. 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 submitting facility to release blood products as quickly as possible after the lot review process which is dependent upon test results.

5.6.4. 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 the COR until the automated information system is properly functioning.

5.7. MANAGEMENT REPORTS.

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

5.7.1.1. The reported information shall include subtotals for each test and the test name, vendor's test code, test cost, number of tests performed (current month), total monthly cost (per test), number performed year to date (per test), and cost year to date (per test). The Contractor shall also provide notice of when a selected test is subject to a unit price reduction based on the discount terms incorporated under contract. The test name, vendor’s test code, the revised unit cost per test, and effective date shall be annotated.

5.7.1.2. The reports with data required in PWS paragraph 5.1.2.1. shall report using the primary method. Results may be sorted by three additional methods:

5.7.1.2.1. Results listed chronologically by unit number is the primary reporting method.

5.7.1.2.2. Test names listed alphabetically.

5.7.1.2.3. Test names listed in order of year-to-date test frequency (highest to lowest).

5.7.1.2.4. Test names listed in order of year-to-date total test cost (highest to lowest).

5.7.2. Quarterly Regional Reports. The Contractor shall provide quarterly data summary reports of tests performed to the COR. The printed reports shall be delivered to the COR, and contracting officer no later than the tenth 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.

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

5.7.2.2. The reports with data required in PWS paragraph 5.7.2.1. shall be sorted by the COR using the primary method (unit numbers chronologically) and may be reported by the additional three methods outlined at paragraphs PWS paragraph 5.7.1.2.2. through 5.7.1.2.4.

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

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

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

5.7.2.3.3. 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 and the contracting officer. Identify the test name, vendor's test code, and revised unit cost per test.

5.7.2.3.4. Notification of the revised pricing for a given test based on price reductions shall be made to the contracting officer and notification provided to CORs and other contracting officers by modification to the basic contract.

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

5.8. MISCELLANEOUS CONTRACTOR RESPONSIBILITIES.

5.8.1. 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.

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

5.9. CONTRACT START-UP PERIOD. Immediately upon award, there will be a start-up period consisting of a maximum of 30 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:

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

5.9.2. The Contractor shall provide materials and supplies needed for shipment of specimens from COR to Contractor to last for the initial 6-week period.

5.9.3. The Contractor shall provide each COR with processing and shipping information and their commercial client services manual during the start-up period.

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS): The following publications, manuals, regulations, etc. are mentioned in this PWS and are listed below.

AR 25-22 The Army Privacy and Civil Liberties Program, 30 September 2022

AR 40-3 Medical, Dental, and Veterinary Care, Chapter 5, Army Blood Programs, 23 April

AR 40-7 Use of U.S. Food And Drug Administration-Regulated Investigational Products in Humans Including Schedule I Controlled Substances, 19 October 2009

AR 40-66 Medical Record Administration and Health Care Documentation, 17 June 2008 AR 190-17 Biological Select Agents and Toxins Security Program, 5 March 2019 AR 200-1 Environmental Protection and Enhancement, 13 December 2007 AR 380-5 Army Information Security Program, 25 March 2022 AR 600-20 Army Command Policy, 24 July 2020 ARMY DIR 2016-24 Department of Defense Biological Select Agent and Toxins Biosafety Program, 25 July

OPNAVINST 6530.4B Department of the Navy Blood Program, 13 August 2007 DA PAM 25-403 Army Guide to Recordkeeping, 10 November 2022 DA PAM 385-61 Toxic Chemical Agent Safety Standards, 1 November 2018 DA PAM 385-69 Safety Standards for Microbiological and Biomedical Laboratories, 6 May 2009 CLIA Clinical Laboratory Improvement Amendments of 1988 Title 29 CFR, Part 1910 Occupational Safety and Health Standards DoDD 6495.01 Sexual Assault and Response (SAPR) Program

*All pertinent DHA Publications, including most up to date versions, are located at health.mil.

7. EXCLUSION FROM PARTICIPATION IN FEDERAL HEALTH CARE PROGRAMS (OCTOBER 2015)

7.1. The Contractor shall not employ or contract with any individual or entity (hereinafter collectively referred to as “person”) to provide items or services that will be included in invoices submitted to the Government under this contract if such person is listed on the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) List of Excluded Individuals and Entities (LEIE) or the TRICARE Sanctioned Provider List. The Government is legally prohibited from paying for provision of items or services by such persons. The prohibition extends to services beyond direct patient care, such as services of persons in executive or leadership roles and administrative and management services, whether or not such services are billed separately. The LEIE may be found at http://oig.hhs.gov/fraud/exclusions.asp, and the TRICARE Sanctioned Provider list at http://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And-Safety-of- Healthcare/Program-Integrity/Sanctioned-Providers. The LEIE and TRICARE Sanctioned Provider List are hereinafter collectively referred to as “the Lists.”

7.2. Prior to start of contract performance, the Contractor shall

(a) query the Lists to determine whether the name of any person the Contractor employs or contracts with to provide services or items for which payment may be made under this contract appears on the Lists, and

(b) certify to the Contracting Officer that the Contractor has queried the Lists and no such names appear on either of the Lists.

7.3. During performance of the contract, and prior to persons other than those whose names were queried in accordance with paragraph 2, above, (hereinafter “new persons”) providing services or items under the contract, the Contractor shall

(a) query the Lists as in paragraph 2, and

(b) certify to the Contracting Officer that the names of such new persons do not appear on either of the Lists.

7.4. The Contractor is advised that during performance of the contract, MTF personnel will perform a recurrent recheck of the names of Contractor personnel working in the MTF against the Lists, as specified in OTSG/MEDCOM Policy Memo 15-037.