W9114F-17-T-0002_Amendment_0002.pdf

W40M EUR REGIONAL CONTRACT OFC

CONTRACTING OFFICE KO

POC: HENNING MAYER-GOLDSTEIN

CMR 402

APO AE 09180

0010936641-0001

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 to change the closure date and time from 26 Oct 2016 at 04:00 PM local Germany time to 8 Nov 2016 at 04:00 PM local Germany time and make the follow ing changes.

b. Removed verbiage about confirmation tests from PWS paragraphs 1.2.6.3.2 and 5.6.3.

c. Deleted Technical Subfactors 2 and 4 and renumbered the remaining Subfactors accordingly.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 22

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

16C. DATE SIGNED

BY 04-Nov-2016

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 W9114F-17-T-0002

X 9B. DATED (SEE ITEM 11)

12-Oct-2016

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 X is extended, 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

04-Nov-2016

CODE

W40M EUR REGIONAL CONTRACT OFC

CONTRACTING OFFICE KO

CMR 402

APO, 09180

UNITED STATES OF AMERICA (THE)

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

4. REQUISITION/PURCHASE REQ. NO.

CODE W9114F

FACILITY CODECODE

EMAIL:TEL:

W9114F-17-T-0002

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 26-Oct-2016 04:00 PM to 08-Nov-2016 04:00 PM.

The following have been modified:

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

FOR

ZIKA VIRUS TESTING / REFERENCE LABORATORY TESTING

1. GENERAL. This is a non-personal services contract to provide blood donor testing for the Zika Virus 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 is a result of guidance from USAMRMC requiring all DoD Blood Donor Centers (BDC) to participate in an Investigational Drug (IND) study using FDA approved protocol testing for the Zika Virus. The approved IND test kit is currently unlicensed but is allowed for use under an emergency use authorization (EUA) from the Food and Drug Administration (FDA). The IND testing is only offered by select blood donor testing centers.

1.1. SCOPE. The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide blood donor Zika testing services in support of the U.S. Army. Use of this contract will be limited to those agencies identified. No other federal agencies will be considered at this time.

1.1.1. The Zika test shall be executed at the Contractor’s premises, or within the Contractor's network of laboratories (affiliate or qualified subcontractor). Contractor referrals to a secondary (subcontractor) laboratory shall be kept to a minimum for control and uniformity purposes. Contractor shall have a plan to ensure no delay or stoppage of service in case of a national emergency.

1.1.2. 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 under FDA Investigational New Drug (IND) protocol (shall be performed in accordance with 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 to the BDCs in accordance with the FDA regulations.

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 troubleshooting, servicing, introducing new tests, etc. During non-duty hours, the contractor representative shall be accessible on a cell phone or pager.

1.2.6.1.2. 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.

1.2.6.2. 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, 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).

1.2.6.3. The contractor shall provide testing service 7 days a week.

1.2.6.3.1. The Contractor shall provide all necessary instructions for shipping and supplies for biologic specimens to be transported from the blood donor centers submitting test requests under this contract to the Contractor.

1.2.6.3.2. The primary result reporting shall be by email or electronic upload into the Enterprise Blood Management System (EBMS) to the representatives of the blood donor centers. Results must be e-mailed or uploaded in EBMS 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.

Original hard copy results must be sent to the representatives of the blood donor centers by courier or mail.

Facsimile shall be utilized as a back-up to e-mail. A list of email addresses will be provided by the representatives of the blood donor centers within 10 working days after award to the Contractor to provide results electronically through email. Original test results shall be mailed to the following addresses:

Landstuhl Regional Medical Center BLDG 3738, Room 005 Armed Services Blood Bank Services

66849 Landstuhl

1.2.6.3.3. 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 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.

1.3. PERFORMANCE QUALITY.

1.3.1. 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.

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

1.3.1.2. A progress meeting shall be held by telephone within 60 calendar 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 FDA; Current CLIA requirements are located at the Centers for Disease Control and Prevention (CDC) website: http://wwwn.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.

1.3.1.5. 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 and testing methods, standard operating procedures must be validated prior to implementation and use by the Contractor providing blood donor testing in accordance with FDA requirements.

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. 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.

1.3.3 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. 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: http://jko.jten.mil

1.5.1.2. 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.

1.5.2. 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 DA Pam 25-51, 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.

1.6. SHARP.

1.6.1 The contractor shall comply with OTSG/MEDCOM Policy Memo 16-033, OTSG/MEDCOM Policy Memo 16-033, Sexual Harassment/Assault Response and Prevention (SHARP) Program, 29 March 2016. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

1.6.2 The contractor shall require all Contract Service Providers (CSP) with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

1.6.3 The contractor shall require all CSPs with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

2. DEFINITIONS/ACRONYMS.

2.1. DEFINITIONS.

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 unit of service which contains one or more defects, or noncompliance with specified requirements.

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

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

2.1.8. 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.

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

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

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

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

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

PWS .

2.2. ACRONYMS.

ACOR - Alternate Contracting Officer’s Representative

AQL - Acceptable Quality Level ASCII - American Standard Code for Information Interchange ASCP - American Society of Clinical Pathologists BDC - Blood Donor Center CAP - College of American Pathologists CDC - Centers for Disease Control and Prevention (CDC) CFR - Code of Federal Regulations CLIA - Clinical Laboratory Improvement Amendments of 1988 CME - Continuing Medical Education CONUS - Continental United States COR - Contracting Officer Representative CV - Curriculum Vitae DES - Defense Encryption Standard DD250 - Department of Defense Form 250 (Receiving Report) DoD - Department of Defense 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 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 ml - Milliliter MTF - Medical Treatment Facility NAT - Nucleic Acid Test OSHA - Occupational, Health, and Safety Administration 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 SHARP - Sexual Harassment/Assault Response & Prevention SSN - Social Security Number UIC - Unit Identification Code VPN - Virtual Private Network

3. 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 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. The contractor shall ensure all service providers receive Sexual Harassment/Assault Response and Prevention (SHARP) training not later than 60 calendar days after contractor personnel begin performance under this contract. Training can be obtained either online or in person. Contractor personnel can attend SHARP training provided by MEDCOM on an every other month basis by contacting (210) 221-6118 for class date/time and availability. If the employee has an AKO account, they can access online the Team Bound Self Study course through Army Learning Management System (ALMS) at http://www.atsc.army.mil/tadlp/delivery/alms.asp.

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 each 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.

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 the FDA. Approximately 3000 units of whole blood products units annually from the blood donor center will require the Zika virus donor testing and repeat testing, on a platform approved under FDA Investigational New Drug (IND) protocol. 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. 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 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 in biologic specimens provided by CORs. 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 have a plan, in case of a national emergency (example 9/11), that shall ensure no delay or stoppage of service.

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 and or electronically transmitted to each to the submitting facility, 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 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.

5.3.2. 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.

5.3.3. 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.

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.

5.6.2. Blood donor testing reports meeting CLIA requirements shall be faxed and/or electronically transmitted to each submitting facility for local printing. As a minimum, printed reports shall include:

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

The specimen blood donor unit number assigned by the COR.

The name of the contract Laboratory Director or Medical Director.

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

The specimen collection date.

The Contractor’s report date and time.

The test name.

The test result(s).

The unit of measurement for quantitative tests.

The normal or expected range.

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

Other interpretive information appropriate for the test(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. Units with incomplete testing results will be quarantined by the submitting facility, until such completion and release of the results and review by the lot release process.

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 each 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 for each COR under this contract. 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 5.7.1.1. 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 for each COR as identified under this contract. 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.

5.8.3. Sexual Assault Reporting. The contractor will immediately (within 24 hours) report an incident of sexual assault to the COR.

5.8.4. Sexual Harassment Reporting. The contractor will immediately (within 24 hours) report an incident of sexual harassment to the COR.

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 REGULATIONS, MANUALS, TECHNICAL BULLETINS, PAMPHLETS, AND

SPECIFICATIONS. The following regulations are Mandatory. Electronic or scanned copies of all applicable regulations will be made available to the contractor after award, but prior to performance of the contract.

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, 10 April 2012 AR 200-1 Hazardous Material Management Files, 13 December 2007 AR 340-21 The Army Privacy Program, 5 July 1985 AR 380-5 Department of the Army Information Security Program, 29 Sep 2000 AR 600-20 Army Command Policy, 6 November 2014 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 Guide to Record Keeping in the Army, 11 August 2008 DA PAM 385-61 Toxic Chemical Agent Safety Standards, 13 November 2012 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

7. Accounting for Contract Services.

7.1. CONTRACTOR MANPOWER REPORTING. The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the contractor will report ALL contractor manpower (including subcontractor manpower) required for performance of this contract. The contractor is required to completely fill in all the information in the format using the following web address https://cmra.army.mil/.

The required information includes:

(1) Contracting Office, Contracting Officer, Contracting Officer's Technical Representative;

(2) Contract number;

(3) Beginning and ending dates covered by reporting period;

(4) Contractor name, address, phone number, e-mail address, identity of contractor employee entering data;

(5) Estimated direct labor hours (including sub-contractors);

(6) Estimated direct labor dollars paid this reporting period (including sub- contractors);

(7) Total payments (including sub-contractors);

(8) Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant FSC for each sub-contractor if different); Q301

(9) Estimated data collection cost;

(10) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible fair-providing the contractor with its UIC for the purposes of reporting this information); W1HHAA

(11) Locations where contractor and sub-contractors perform the work (specified by zip code in the United States and nearest city, country, when in an overseas location, using standardized nomenclature provided on website);

(12) Presence of deployment or contingency contract language; and

(13) Number of contractor/and sub-contractor employees deployed in theater this reporting period (by country). As part of its submission, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement.

7.2. Reporting period will be the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. The contractor shall notify the Contracting Officer's Representative (COR) by the 5th working day of November whether or not they have completed this report. If the COR is unavailable, the contractor will notify the Contracting Officer.

8. Exclusion from Participation in Federal Health Care Programs (October 2015)

8.1. 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.”

8.2. 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.

8.3. 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.

8.4. 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. The Government will notify the Contractor in the event any contractor personnel working in the MTF appear on either of the Lists.

8.5. Should any person providing items or services under the contract appear on either of the Lists at any time during contract performance, the Contractor shall

(a) in cases where the Contractor identified the person, notify the Contracting Officer, and

(b) promptly remove that person from the contract.

8.6. Violation of any aspect of the above paragraphs shall be considered a material breach of the contract and may result in termination of the contract.

8.7. The Contractor is further advised that, in accordance with Civil Monetary Penalties Law [CMP] (codified at 42 USC § 1320a-7a):

a. There are steep civil monetary penalties associated with billing the Government for providing items or services by a person on either of the Lists, and with failing to return to the Government any overpayments received for provision of such items or services.

b. Billing under the contract for provision of items or services by a person on either List may also result in exclusion of the person that employs or contracts with such person.

8.8. HHS OIG has issued a Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs with additional information on the CMP. The Special Advisory Bulletin may be found at http://oig.hhs.gov/exclusions/files/sab-05092013.pdf.

9. Non-Defense Health Agency (Non-DHA) Health Insurance Portability and Accountability Act (HIPAA) Business Associate Agreement (BAA) (7 July 2014)

Introduction

In accordance with 45 CFR 164.502(e)(2) and 164.504(e) and paragraph C.3.4.1.3 of DoD 6025.18-R, “DoD Health Information Privacy Regulation,” January 24, 2003, this document serves as a BAA between the signatory parties for purposes of the HIPAA and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA Issuances (both defined below). The parties are a DoD Military Health System (MHS) component, acting as a HIPAA covered entity, and a DoD contractor, acting as a HIPAA business associate. The HIPAA Rules require BAAs between covered entities and business associates. Implementing this BAA requirement, the applicable DoD HIPAA Issuance (DoD 6025.18-R, paragraph C3.4.1.3) provides that requirements applicable to business associates must be incorporated (or incorporated by reference) into the contract or agreement between the parties.

(a) Catchall Definition. Except as provided otherwise in this BAA, the following terms used in this BAA shall have the same meaning as those terms in the DoD HIPAA Rules: Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices (NoPP), Protected Health Information (PHI), Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.

—Breach means actual or possible loss of control, unauthorized disclosure of or unauthorized access to PHI or other PII (which may include, but is not limited to PHI), where persons other than authorized users gain access or potential access to such information for any purpose other than authorized purposes, where one or more individuals will be adversely affected. The foregoing definition is based on the definition of breach in DoD Privacy Act Issuances as defined herein.

—Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean [insert name of Business Associate signatory to this BAA].

—Agreement means this BAA together with the documents and/or other arrangements under which the Business Associate signatory performs services involving access to PHI on behalf of the MHS component signatory to this

BAA.

—Covered Entity shall generally have the same meaning as the term “covered entity” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean [insert name of MHS component signatory to this BAA].

—DHA Privacy Office means the DHA Privacy and Civil Liberties Office. The DHA Privacy Office Director is the HIPAA Privacy and Security Officer for DHA, including the National Capital Region Medical Directorate

(NCRMD).

—DoD HIPAA Issuances means the DoD issuances implementing the HIPAA Rules in the DoD Military Health System (MHS). These issuances are DoD 6025.18-R (2003), DoDI 6025.18 (2009), and DoD 8580.02-R (2007).

—DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDD 5400.11 (2007) and DoD 5400.11-R (2007).

—HHS Breach means a breach that satisfies the HIPAA Breach Rule definition of breach in 45 CFR 164.402.

—HIPAA Rules means, collectively, the HIPAA Privacy, Security, Breach and Enforcement Rules, issued by the U.S. Department of Health and Human Services (HHS) and codified at 45 CFR Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C-D (Enforcement), as amended by the 2013 modifications to those Rules, implementing the “HITECH Act” provisions of Pub. L. 111-5. See 78 FR 5566- 5702 (Jan. 25, 2013) (with corrections at 78 FR 32464 (June 7, 2013)). Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this BAA and are not included in the term HIPAA Rules.

—Service-Level Privacy Office means one or more offices within the military services (Army, Navy, or Air Force) with oversight authority over Privacy Act and HIPAA privacy compliance.

I. Obligations and Activities of Business Associate

(a) The Business Associate shall not use or disclose PHI other than as permitted or required by the Agreement or as required by law.

(b) The Business Associate shall use appropriate safeguards, and comply with the DoD HIPAA Rules with respect to electronic PHI, to prevent use or disclosure of PHI other than as provided for by the Agreement.

(c) The Business Associate shall report to Covered Entity any Breach of which it becomes aware, and shall proceed with breach response steps as required by Part V of this BAA. With respect to electronic PHI, the Business Associate shall also respond to any security incident of which it becomes aware in accordance with any Information Assurance provisions of the Agreement.