Blood Donor Infectious Disease Testing PWS.docx

PERFORMANCE WORK STATEMENT

Blood Donor Infectious Disease Testing General Leonard Wood Army Community Hospital (GLWACH) Fort Leonard Wood, Missouri

PART 1 GENERAL INFORMATION

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

1.1 Description of Services. The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for HBsAg, Anti-HBc, Anti-HCV, Anti-HTLV I/II, Anti-HIV 1/2, STS (syphilis), ABO/Rh, ABSC, NAT pooled testing for HIV/HCV/HBV, individual donor testing for West Nile Virus, Chagas (T. cruzi), Babesia (pooled), Babesia (IDS) for specimens submitted by Ft. Leonard Wood, Blood Donor Center, Ft. Leonard Wood, Missouri. Samples drawn from platelet donors will require the above testing and, in addition, CMV testing. CMV testing and HLA Antibody testing will be conducted on an as needed basis only. Any confirmatory/supplemental tests required will be free of charge and included in the cost of whole blood panel testing. The Contractor will provide for third party shipping or transport of specimens on behalf of the government, to be reimbursed at cost by the contract.

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

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

1.2 CONTRACTOR RESPONSIBILITY

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

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

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

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

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

1.2.6 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.

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

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

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

1.2.9 The Contractor will provide a combination of third party commercial shipping services and courier services to and from local commercial airports for donor specimen delivery from the blood donor center to the Contractor’s testing facility the same date of specimen collection when at all possible. Contractor will provide all necessary instructions for shipping and supplies for transport of biologic specimens from the blood donor center to the Contractor’s testing facility.

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

1.2.11 Testing on specimens submitted for this test will have a turnaround time of 12 hours upon receipt of the specimens for testing by the contractor. Results will be available within 12 hours of receipt of donor specimens. Results will be sent by e-mail to the Fort Leonard Wood Blood Donor Center Point of Contact. Contractor will inform the blood donor center of any delay in test results. Contact information for the blood donor center under this contract is as follows:

Fort Leonard Wood Blood Donor Center General Leonard Wood, Missouri Office: TBD

FAX : TBD

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

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

1.3 Period of Performance. The proposed period of performance shall be for one (1) each a Base Year of twelve (12) months, and four (4) each 12-month option years.

1.4 Performance Quality

1.4.1 Quality Control. The Contractor shall develop and maintain an effective Quality Control Program to ensure services are performed in accordance with this PWS. The Contractor’s quality control program is the means by which the Contractor is assured that the work complies with the requirements of the contract. The Contractor shall develop and implement procedures for action to identify, prevent, and ensure non-recurrence of defective services known as the Quality Control Plan (QCP). The QCP is to be delivered within 30 days after award to the Contracting Officer (KO) and Contracting Officer Representative (COR), and within 5 working days when changes are made thereafter. After acceptance of the QCP, the Contractor shall receive the KO’s acceptance in writing of any proposed changes.

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

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

1.4.4 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 the COR or designee upon request.

1.4.5 The Contractor shall operate a quality control program as required by CLIA and FDA. Current CLIA requirements are located at the Health Care Financing Administration's website: http://www.phppo.cdc.gov/CLIA. Upon request of the COR and the Contractor shall provide documentation of quality assurance policies, quality control results for assays, on-going calculations of quality control performance (coefficient of variation, mean and standard deviation), monthly Levy-Jennings graphs, documentation of appropriate analyzer maintenance. Upon request, the Contractor shall provide verification results for assays of non-regulated analytes, and analytes for which proficiency testing does not currently exist.

1.4.6 All test methods, test kits and reagents, used for blood donor testing, shall be FDA approved. Any non-FDA approved method being performed shall have a documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

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

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

1.4.9 Quality Assurance. The government shall evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan primarily focuses on what the Government must do to ensure that the Contractor has performed according to the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.5 SECURITY REQUIREMENTS.

1.5.1. Physical Security.

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

1.5.2. Information Security. The computer system shall be processing and transferring data that is classified as Controlled Unclassified Information (CUI) 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, Defense Health Agency, U.S. Army, or other government agency basic policy of initial and periodic security training, and the need for physical controls to protect hardware.

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

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

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

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

1.5.4. Force Protection Condition (FPCON). The Contractor personnel shall comply with all personal identity verification requirements as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause, should the Force Protection Condition (FPCON) at any facility or installation change, the Government may require changes in Contractor security matters or processes.

1.5.5. Antiterrorism (AT) Level I Training. All Contractor requiring access to Army installations, facilities and controlled access areas, shall complete AT Level I Awareness training within 14 calendar days after starting performance under this contract. The Contractor shall submit certificates of completion for each affected CSP to the COR within 15 calendar days. AT level I Awareness training is available at http://jko.jfcom.mil.

1.5.6. Access and General Protection/Security Polict and Procedures. All Contractor and sub-contractor personnel performing tasks on this PWS shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures which will be provided to the Contractor by a Government representative within five working days of Task Order award. Contractor shall provide all information required for background checks to meet installation access requirements as performed by the installation Provost Marshal Office, Director of Emergency Services or Security Office. Requesting Contractor shall submit request for installation pass to the COR or KO at https://vcc1.icmvcc.com/im3500/. Contractor personnel shall comply with all personal identity verification requirements as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of the base contract to this task order, should the Force Protection Condition (FPCON) at any facility or installation change, the Government may require changes in Contractor security matters or processes.

1.5.7. IWatch Training. Within 10 calendar days of Task Order award and within 10 days of new Contractor employees commencing work on this Task Order, all Contractor and sub-contractor employees shall review the FLW Directorate of Emergency Services (DES) web link for iWatch training located at http://www.wood.army.mil/LEC/iWatch/iWatch.htm. This locally developed training will inform employees of the types of behavior to watch for and how to report suspicious activity. Suspicious activity shall be reported to the COR or KO. . Contractor employees must complete iWATCH training within 30 calendar days of reporting to duty

1.5.8. For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub‐contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC‐III) and Terrorist Screening Database (Army Directive 2014‐05/AR 190‐13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative); or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

1.5.9.For contracts that require OPSEC Training. Per AR 530‐1, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

1.5.10. Controlled Unclassified Information (CUI). Include DFARS clause 252.204-7012, which requires the contractor to comply with NIST 800-171. Also include DFARS provision 252.204-2019 into solicitations. Acquisition officials should follow procedures outlined in DFARS 204.73 and verify vendors have an adequate NIST SP 800-171 summary assessment score within the Supplier Performance Risk System (within PIEE). If the score doesn't show a medium- or high-level assessment with a score of 110 or better (as described in the "NIST SP 800-171 DoD Assessment Methodology"), include clause 252.204-7020 and obtain the vendor's "system security plan" and "plan of action" for NIST SP 800-171 verification and assurance by Army security officials.

1.5.11.Reserved

1.5.12. Post Award Conference/Periodic Progress Meetings. The Contractor agrees to attend any post award conference convened by the Contracting Activity or Contract Administration Office, in accordance with Federal Acquisition Regulation Subpart 42.5. The KO, COR and other Government personnel as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings, the KO will apprise the Contractor of how the government views the Contractor's performance and the Contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional expense to the government.

1.5.13. Contracting Officer Representative (COR). The COR will be identified by a separate letter issued directly to the COR, with a copy sent to the Contractor. The COR letter states the responsibilities and limitations of the COR, especially with regard to changes in cost, price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order. The COR monitors all technical aspects of the contract and assists in contract administration.

1.5.14. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract, perform inspections necessary in connection with contract performance, maintain written and oral communications with the Contractor concerning technical aspects of the contract, and issue written interpretations of technical requirements including Government drawings, designs and specifications. The COR will monitor Contractor's performance and notify both the KO and Contractor of any deficiencies. The COR will coordinate availability of government furnished property and provide site entry for Contractor personnel.

1.5.15 Data Rights. The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software produced under this contract, shall be Government owned and are the property of the Government, with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the Contractor without written permission from the KO. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

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

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

2.1.6. 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).

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

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

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

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

2.1.11. 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.

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

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

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

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

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

2.2. ACRONYMS.

CFR - Code of Federal Regulations

CPT - Current Procedure Terminology

VPN -Virtual Private Network

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3.1 RESPONSIBILITIES. The Government will:

3.1.1. Perform specimen collection.

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

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

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

3 . 2 . GOVERNMENT-FURNISHED ITEMS.

3. 2 . 1 . Specimens for testing.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1. CONTRACTOR-FURNISHED ITEMS

4.1.1. COMMERCIAL CATALOG OF LABORATORY SERVICES. The Contractor shall provide a copy of its commercial catalog of laboratory services. Information shall also be provided by the Contractor to the COR. The Contractor shall provide a hard copy or electronic copy during the start-up period to the COR. 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. Changes to procedures with less than 15 calendar days notice shall be made only with concurrence by the COR. The COR will notify the contracting officer in the event of noncompliance with this requirement.

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

4.1.3. SUPPLIES. If the contractor requires unique supplies, the Contractor shall provide an initial 6-week stock of materials or supplies to be used by the submitting facilities in preparation for shipment of specimens for testing requirements. Supplies required for the initial 6-week period shall be a part of the contract start-up period responsibilities. Government-held stock of Contractor-furnished items shall be routinely replenished by the Contractor to allow performance of all contract requirements without interruption. Maintenance of the stock will be by request from the COR to the contractor. On a case-by-case basis, emergency supplies may be requested by the COR and shall be provided by the Contractor as required. The Contractor shall meet with the COR within 5 working days after the award of a contract to determine the quantity required for each site.

The Contractor shall:

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

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

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

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

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

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

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

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

PART 5

SPECIFIC TASKS

5.1 TESTING. The Contractor shall maintain and be FDA licensed for the entirety of the performance period for blood donor testing and provide the full range of blood donor testing currently required by the FDA. Contractor will inform of any delay in test results within the 12 hour period via telephone, e-mail or secure fax. Approximately 9,000 units of whole blood annually from the blood donor center will require the routine blood donor testing panel and repeat testing, as well as confirmation testing. The Contractor will provide additional FDA licensed confirmatory testing if available for donor specimens that are initially reactive as required by regulatory and service agencies. The additional confirmatory testing results shall be available within 7 calendar days to the blood donor center. Any additional testing required by the FDA will be provided by the Contractor during the term of the contract. All blood donor laboratory testing shall be executed in accordance with standard industry practices. Contractor must have a sample surge capacity of at least 1000 samples per day to accommodate any unforeseen mission requirements or contingency missions that would require an upsurge in blood and blood product requirement, plus other new tests added during the term of the contract. Contractor will have a plan in case of a national emergency (example 9/11), that will ensure no delay or stoppage of service.

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

5.2. CONTRACTOR LABORATORY INFORMATION SYSTEM.

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

5.2.2. The Contractor's automation shall provide:

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

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

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

5.3. HANDLING OF SPECIMEN OR REQUEST. DISCREPANCIES.

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

5.3.2. 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 12 hours of receipt. Specimen discrepancies or additional specimen requirements shall be brought to the attention of Fort Leonard Wood Blood Donor Center within one business day after knowledge of discrepancy.

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. The COR may request repeat determinations or add-on tests by telephone during this 7-day or extended 30-day period.

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 costs 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 laboratory testing to Fort Leonard Wood Blood Donor Center. Results are to be sent immediately upon completion of review within 12 hours of receipt of specimens.

5.6.2. Blood donor testing reports meeting CLIA requirements shall be faxed and/or electronically transmitted to General Leonard Wood Blood Donor Center for local printing. In the Shipping/Receiving Section of each SA. 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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

PART 6

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

6.1. The Contractor shall comply with the most current version of all applicable Government documentation, regulations, policies, and directives pertinent to management of appointment services in effect at the time of award. Supplements, amendments, or changes to these publications may be issued during the life of the contract. Any such changes to mandatory publications which cause a change in performance that will either increase or decrease price will be incorporated into the contract by mutual agreement of the parties. All publications can be found on the World Wide Web. In the event that a publication cannot be found, the COR will provide assistance upon request. This list includes, but is not limited to the following:

Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act of 1992 Privacy Act of 1974 Title VI of the Civil Rights Act of 1964 Section 504 of the Rehabilitation Act of 1973 DoD Directive 5400.11-R, “The Freedom of Information Act of 1967” Electronic and Information Technology Accessibility Standards (36 CFR 1194) DoD Regulation 5200.2-R, “DoD Personnel Security Program,” January 1987 Standards for Privacy of Individually Identifiable Health Information, Final Rule, December 28, 2000 OMB Circular A-130 5 U.S.C. , 552a, as amended 32 CFR 199 Rehabilitation Act of 1973, Section 508 Military Health System’s Guide to Access Success (15 Dec 2008) DoD Instruction 8510.01, “Information Assurance Certification and Accreditation Process (DIACAP)” Subchapter III of Chapter 35 of title 44, United States Code, “Federal Information Security Management Act (FISMA) of 2002” and DoD Directive 8500.01E, “Information Assurance (IA),” October 24, 2002 and DoD Directive 8100.1, “Global Information Grid (GIG) Overarching Policy,” September 19, 2002, DoD Directive 8100.2, “Use of Commercial Wireless Devices, Services, and Technologies in the DoD GIG,” April 14, 2004, and DoD Instruction 8500.2, “Information Assurance (IA) Implementation,” February 6, 2003 DoD Instruction 8520.2, “Public Key Infrastructure and Public Key Enabling,” April 1, 2004 DoD Health Information Privacy Regulation (DoD 6025.18-R) DoD Privacy Program (DoD 5400.11-R) DoDI 5495.02, Sexual Assault Prevention and Response (SAPR) Program Procedures.

1.1. Reference Documentation

Defense Information Infrastructure (DII) Common Operating Environment (COE) Integration and Runtime Specification (I&RTS), Version 4.0, dated 4 October 99, and subsequent updates.

MHS Information Management (IM)/ Information Technology (IT) Strategic Plan (on TRICARE Web Site). MHS IM/IT Program Plan, Volume I and II, (on TRICARE web site) MHS IM/IT Standard Operating Procedures for Annual Performance Planning and Reporting, September 2005 (on TRICARE Web Site) MHS Information Assurance Policy Guidance, March 2007 MIL-STD 973, “Configuration Management,” 11 Feb 2000.

NBS SP500-153, “Guide to Auditing for Controls and Security: A System Development Life-Cycle Approach,” April 1988.

DoDD 8320.1M, “DOD Data Administration,” Mar 1994.

DoD Manual 8020.1-M, Functional Process Improvement, 15 January 1993.

Department of Defense Joint Technical Architecture, Version 3.0, January 28, 2000 (DISA web site). MHS Office Automation Guidance, August 3, 2007 MHS Personal Computer Hardware Requirements, September 7, 2000. MHS Minimum Standard Notebook Hardware, September 7, 2000.

Title 10, U.S.C., Chapter 55 DISA IAVA Process Handbook, Version 3, February 14, 2007

END OF THE PERFORMANCE WORK STATEMENT

SUPPLEMENT TO THE PERFORMANCE WORK STATEMENT

The following Government Holidays are observed:

New Year’s Day, January 1st Martin Luther King, Jr.’s Birthday, 3rd Monday in January President’s Day, 3rd Monday in February Memorial Day, Last Monday in May Juneteenth, June 19th Independence Day, July 4th Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran’s Day, November 11th Thanksgiving Day, 4th Thursday in November Christmas Day, December 25th

Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above. If the area in which a contractor is scheduled to perform maintenance is closed due to a holiday declared by an Executive Order and the contractor is not required to report in, contractor shall service equipment on the available day staff will be present. Closures of the installation due to inclement weather or other such acts of God shall be handled in the same manner.

2. INVOICING AND PAYMENT

The contractor shall submit, in arrears, itemized invoices in accordance with DFARS 252.232-7003 & 252.232-7006, for services rendered under this contract. Invoices must be submitted no more than 30 days after the completion of the annual period of performance. Information regarding Wide Area Workflow is available on the Internet at https://piee.eb.mil

3. TOBACCO FREE MEDICAL CAMPUS (TFMC)

The Contractor shall ensure that all contract personnel comply with the U.S. Army Medical Command and MTF smoking policies while performing services under this contract. Smoking restrictions will apply at any location or building where health care activities are performed under this contract.

In accordance with Army Regulation 600-63, paragraph 7-3, 14 April 2015; Operations Order 15-48 (Army Medical Command (MEDCOM) Tobacco Free Living – USAMEDCOM), 8 May 2015; and any Operations Order, regulation or other instruction implementing, defining or otherwise addressing the Tobacco Free Medical Campus (TFMC) on any military installation or DoD-controlled location, Contractor personnel are prohibited from using any tobacco product on or within any TFMC while performing under this contract. TFMCs are established at each installation or DoD-controlled location and include: (1) any property or non-residential building that is operated, maintained or assigned to support medical activities, including but not limited to, hospitals, medical laboratories, outpatient clinics (including medical, dental, and veterinary facilities), or aid stations operating for the primary purpose of delivering medical care and services for DOD eligible beneficiaries and /or meeting the mission of the Army Medical Command; (2) all other facilities in which medical activities or administration take place, to include HQ MEDCOM and Defense Health Headquarters; (3) all internal roadways, sidewalks and parking lots; and (4) all sidewalks, parking lots and grounds external but adjacent to the building or related to the migratory corridors surrounding the medical facility. The contractor shall obtain from the COR any orders, regulations, instructions or other documents implementing, defining or otherwise addressing the TFMC for any given installation or DoD-controlled location where contractor personnel may perform under this contract and shall instruct contractor personnel on the TFMC limitations for installations or DoD-controlled locations where they may perform under this contract.

4. EXCLUSION FROM PARTICIPATION IN FEDERAL HEALTH CARE PROGRAM Exclusion from Participation in Federal Health Care Programs (October 2015)

a. 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 h ttp://oig.hhs.gov/fraud/exclusions.asp, and the TRICARE Sanctioned Provider list at h ttp://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And-Safety-of- H ealthcare/Program-Integrity/Sanctioned-Providers. The LEIE and TRICARE Sanctioned Provider List are hereinafter collectively referred to as “the Lists.”

b. 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.

c. During performance of the contract, and prior to persons other than those whose names were queried in accordance with paragraph 2, above,…