N6264521R0057.docx

N6264521R0057

Combined Synopsis/Solicitation for Non-Personal Services in support of the Navy Bloodborne Infection Management Center This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Parts 12, Acquisition of Commercial Items and 15, Contracting by Negotiation, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. It is the contractor’s responsibility to be familiar with the applicable FAR and DFARS clauses and provisions. The FAR and DFARS clauses may be accessed in full text at FAR Clauses: https://www.acquisition.gov/browse/index/far DFARS Clauses: https://www.acquisition.gov/dfars

This requirement is competed as full and open competition. The North American Industry Classification System (NAICS) code is 621511, Medical Laboratories with a business size standard of $35 million.

The solicitation number is N6264521R0057 This solicitation will result in an award of a single Indefinite Delivery, Indefinite Quantity (IDIQ) single award task order (SATO) contract for all requirements. The contract will have a five-year ordering period.

Proposal Submission Proposals shall be submitted in accordance with the Solicitation (Addendum to 52.212-1 – Instructions to Offerors – Commercial Items) to usn.detrick.navmedlogcomftdmd.mbx.matrix@mail.mil by 2:00 pm eastern time on 17 November 2021.

Initial HIV AB Ag Screen

FFP

The contractor shall provide Initial Human Immunodeficiency Virus Antibody Antigen Screenings in accordance with the Performance Work Statement (PWS) requirements set forth herein. Prices include all supplies, shipping, storage, testing, and reporting services.

Total Ceiling Price: To be filled in at contract award.

Unit Prices for each Period of Performance will be incorporated via Attachment 18 Pricing Table at contract award.

FOB: Destination

PSC CD: Q301

NET AMT

Duplicate HIV AB Ag Screen

The contractor shall provide Duplicate Human Immunodeficiency Virus Antibody Antigen Screenings in accordance with the PWS requirements set forth herein. Prices include all supplies, shipping, storage, testing, and reporting services.

Total Ceiling Price: To be filled in at contract award.

Unit Prices for each Period of Performance will be incorporated via Attachment 18 Pricing Table at contract award.

NET AMT

HIV 1/2 AB Differentiation

The contractor shall provide Human Immunodeficiency Virus type-1 and type-2 Antibody Differentiation in accordance with the PWS requirements set forth herein. Prices include all supplies, shipping, storage, testing, and reporting services.

Total Ceiling Price: To be filled in at contract award.

Unit Prices for each Period of Performance will be incorporated via Attachment 18 Pricing Table at contract award.

NET AMT

Nucleic Acid Testing

The contractor shall provide Nucleic Acid Testing in accordance with the PWS requirements set forth herein. Prices include all supplies, shipping, storage, testing, and reporting services.

Total Ceiling Price: To be filled in at contract award.

Unit Prices for each Period of Performance will be incorporated via Attachment 18 Pricing Table at contract award.

NET AMT

Initial anti-HCV Screen

The contractor shall provide Initial Antibody Hepatitis C Virus Screenings in accordance with the PWS requirements set forth herein. Prices include all supplies, shipping, storage, testing, and reporting services.

Total Ceiling Price: To be filled in at contract award.

Unit Prices for each Period of Performance will be incorporated via Attachment 18 Pricing Table at contract award.

NET AMT

Duplicate anti-HCV Screen

The contractor shall provide Duplicate Antibody Hepatitis C Virus Screenings in accordance with the PWS requirements set forth herein. Prices include all supplies, shipping, storage, testing, and reporting services.

Total Ceiling Price: To be filled in at contract award.

Unit Prices for each Period of Performance will be incorporated via Attachment 18 Pricing Table at contract award.

NET AMT

HCV RNA PCR Screen

The contractor shall provide Hepatitis C Virus Ribonucleic Acid Polymerase Chain Reaction Screenings in accordance with the PWS requirements set forth herein. Prices include all supplies, shipping, storage, testing, and reporting services.

Total Ceiling Price: To be filled in at contract award.

Unit Prices for each Period of Performance will be incorporated via Attachment 18 Pricing Table at contract award.

NET AMT

Initial HBsAg Quant Screen

The contractor shall provide Initial Hepatitis B surface Antigen Quantification Screenings in accordance with the PWS requirements set forth herein. Prices include all supplies, shipping, storage, testing, and reporting services.

Total Ceiling Price: To be filled in at contract award.

Unit Prices for each Period of Performance will be incorporated via Attachment 18 Pricing Table at contract award.

NET AMT

Duplicate HBsAg Quant Screen

The contractor shall provide Duplicate Hepatitis B surface Antigen Quantification Screenings in accordance with the PWS requirements set forth herein. Prices include all supplies, shipping, storage, testing, and reporting services.

Total Ceiling Price: To be filled in at contract award.

Unit Prices for each Period of Performance will be incorporated via Attachment 18 Pricing Table at contract award.

NET AMT

HBsAg Neutralization

The contractor shall provide Hepatitis B surface Antigen Neutralization in accordance with the PWS requirements set forth herein. Prices include all supplies, shipping, storage, testing, and reporting services.

Total Ceiling Price: To be filled in at contract award.

Unit Prices for each Period of Performance will be incorporated via Attachment 18 Pricing Table at contract award.

NET AMT

Initial HBsAb Quant Screen

The contractor shall provide Initial Hepatitis B surface Antibody Quantification Screenings in accordance with the PWS requirements set forth herein. Prices include all supplies, shipping, storage, testing, and reporting services.

Total Ceiling Price: To be filled in at contract award.

Unit Prices for each Period of Performance will be incorporated via Attachment 18 Pricing Table at contract award.

NET AMT

Duplicate HBsAB Quant Screen

The contractor shall provide Duplicate Hepatitis B surface Antibody Quantification Screenings in accordance with the PWS requirements set forth herein. Prices include all supplies, shipping, storage, testing, and reporting services.

Total Ceiling Price: To be filled in at contract award.

Unit Prices for each Period of Performance will be incorporated via Attachment 18 Pricing Table at contract award.

NET AMT

Pour-Off Samples

The contractor shall provide Pour-Off Samples in accordance with the PWS requirements set forth herein. Prices include all supplies, shipping, storage, testing, and reporting services.

Total Ceiling Price: To be filled in at contract award.

Unit Prices for each Period of Performance will be incorporated via Attachment 18 Pricing Table at contract award.

NET AMT

Pour-Off Samples (Emergency)

Provide Pour-Off Samples (Emergency) in accordance with the PWS requirements set forth herein. Prices include all supplies, shipping, storage, testing, and reporting services.

Total Ceiling Price: To be filled in at contract award.

Unit Prices for each Period of Performance will be incorporated via Attachment 18 Pricing Table at contract award.

NET AMT

PWS

PERFORMANCE WORK STATEMENT

l. GENERAL. This is a non-personal services contract to provide customized shipping, storage services, and infectious diseases testing, to include reporting services. The Government shall not exercise any supervision or control over the contractor personnel’s performance of the services herein. Such contract service providers shall be accountable solely to the Contractor, who in turn is responsible to the Government.

1.1. BACKGROUND. The Navy Bloodborne Infection Management Center (NBIMC) provides leadership and expertise to ensure mission readiness and to support the National Military Strategy. NBIMC oversees the administration and aids in the development of policies concerning the Human Immunodeficiency Virus (HIV), Hepatitis B, and Hepatitis C screenings for the Department of the Navy (DON), as directed by the Navy Bureau of Medicine and Surgery (BUMED) for the Bureau of Personnel (BUPERS).

1.2. SCOPE OF WORK. The Contractor shall provide customized shipping; storage services & infectious diseases testing to include reporting services to support readiness, force protection, and notification requirements necessary for U.S. Navy, Marine Corps, and Coast Guard operations. The Government estimates submitting approximately 60,000 to 90,000 specimens per month for testing, shipped directly to the Contractor, at the Contractor's expense, from approximately 1,300 submitting activities (SA) world-wide, including remote facilities. Refer to Technical Exhibit (TE) 1 – Locations for a list of all current SAs. The Contracting Officer may negotiate a modification with the contractor to add or remove locations provided an increase of locations does not exceed the scope of the contract. An increase of up to 20% of the quantity of tests may be determined to be within scope subject to higher-level approval.

2. TASKS. The Contractor shall provide services for shipping, storage, and infectious disease testing as outlined in the below subsections. The quality for all services rendered hereunder shall conform to the highest standards in the clinical pathology and medical laboratory professions.

2.1. SUPPLIES. The Contractor shall ensure all supported sites (CONUS, OCONUS, and remote locations, i.e. USCG or Navy sites) are provided with the necessary supplies, standard operating procedures, and training necessary to deliver specimens to the Contractor's site. Shipping supplies shall meet Department of Transportation (DOT) requirements for transshipping infections and non-infectious specimens. The Contractor shall provide shipping schedules and transportation for supplies to designated Government SA locations.

2.1.1. The Contractor shall ensure that each shipment contains the proper amount of shipping containers, pre-printed barcode labels (where necessary), transfer and mailing envelopes, packing, packaging, tamper proof transshipment system, transshipment containers (pre-labeled and addressed), and other items necessary to serve each SA.

2.1.2. The Contractor shall provide barcode labels for the initial serum separator tube and pour-off transfer tubes shall be constructed by specifications set forth in TE-7 with the provision that the label material circumvent and overlap on the tube (16 X 100 mm) to prevent detaching during transshipment to the Contractor facility and/or storage.

2.1.3. The Contractor shall provide five (5) ml volume screw top storage transfer tubes to pour off and store/transport individual serum/plasma specimens. The tube selected must possess: (a) tight seal, (b) round bottom, (c) a diameter of no more than 12.5 mm, and (d) meet long storage requirements in accordance with PWS section 5.3.2.7.

2.1.4. That Contractor shall deliver an initial supply quantity to the SA(s) that stays within the Government task order. This initial supply shipment shall be made at least fifteen (15) working days before the contract start date.

2.1.5. The Contractor shall deliver supplies, as required by the task order, to each SA quarterly. This does not imply the Government site must request supplies, but states the Contractor is obligated to send supplies quarterly. If requested in writing by the SA POC, then the Contractor may deliver supplies more or less frequently by mutual agreement. The SA POC shall notify the COR of the request. The Contractor shall ensure special request supply delivery to each site within ten (10) working days of request.

2.1.6. The Contractor shall ensure that supply shipment does not exceed five (5) working days for CONUS and ten (10) working days for OCONUS from the scheduled shipment date and/or SA POC request.

2.1.6.1. The Contractor shall ensure upfront coordination with the submitting activities' security department to ensure that shipping Contractors are capable of accessing the installation.

2.1.7. The Contractor shall provide the COR via electronic mail a shipping schedule presenting the source of supply origin with applicable vendor name, contract/purchase order numbers), supply description, scheduled delivery arrival dates at activity listed by UIC/RUC and address, and actual tracking numbers when available.

2.1.7.1. The Contractor shall provide this schedule within:

a) Five (5) calendar days before the first supply shipment.

b) Fifteen (15) calendar days before the next subsequent shipments.

c) Twenty-four (24) hours or same day of special order supply shipments.

2.1.7.2. The Contractor shall ensure that each shipment includes a DD-250 Materials and Inspection Report (TE-15). The Contractor shall further support tracking each shipment and ensure that all pertinent data exists on the DD-250 (TE-15) to ensure delivery to the actual POC in the activity.

2.2. SPECIMEN DELIVERY TO CONTRACTOR.

2.2.l SA personnel will collect and centrifuge primary specimen tubes (including red cells, inert double gel, and separated serum) and submit to the Contractor no later than 4 days after collection date.

2.2.1.l SA personnel will collect and centrifuge primary specimen tubes (including red cells, inert double gel, and separated serum) and submit to the Contractor. If a site cannot ship the specimen to arrive at the Contractor's facility within 4 days of venipuncture, then personnel at the Government site will centrifuge the primary specimen tube, separate the serum, pour the separated serum into a screw-capped transfer tube (as provided by the Contractor), freeze the serum at 0 degrees Centigrade (⸰C), and submit the separated serum specimen to the Contractor.

2.2.2. SA personnel will label, package, process paperwork, and contact the Contractor courier for shipping specimens to the Contractor site. SA personnel (where available) will use the hospital information Composite Health Care System or MHS Genesis to print specimen identification barcode labels for the primary plastic SST to be sent to the Contractor. When CHCS or MHS Genesis is not available or during emergency cases of CHCS or MHS Genesis downtime or mobilizations, SA personnel will use Contractor provided pre-printed barcode labels as presented in TE-7.

2.3. SHIPPING.

2.3.1. The Contractor shall provide shipping transportation for specimens that meet Department of Transportation (DOT) requirements for transshipping infectious and non-infectious specimens to and from designated locations. The Contractor shall provide shipping transportation for designated specimens to the DoD Serum Repository (DoDSR) in Silver Spring, Maryland.

2.3.2. Upon request of the Government with COR approval, the Contractor shall provide shipping transportation for:

2.3.3. The Contractor shall meet all domestic and international regulations and base security requirements for delivery of material, specimen, equipment, software, and reports. The Contractor shall understand that local shipping companies may be precluded from making required pick-ups and deliveries at submitting activities worldwide due to security requirements. The Contractor is responsible for upfront coordination with the installation's security department to ensure that subcontractors will be capable of accessing the installation.

2.3.4. Each shipment of Government specimens meets time requirements for pick-up, delivery, temperature, and specimen protection requirements during transshipment. If the shipment warrants shipping etiologic agents, then the Contractor shall ensure labeling materials, CDC permit (applicable international sites), and instructions for application on container are provided to each SA POC.

2.3.4.l. Scheduling specimen pick-up Monday through Saturday (NLT 1630 in the appropriate time zone) from each SA (or altered by SA POC request). The Contractor shall ensure all OCONUS pour off specimen transshipment remains in the range of 4°C-l 0°C from pick-up through transshipment to Contractor or Government facilities. The Contractor shall ensure CONUS specimen delivery does not exceed eighteen (18) hours and OCONUS does not exceed seventy two (72) hours from pick-up. Pick-up will be provided for a minimum of one specimen.

2.3.4.2. Scheduling specimen pick-up on an on-call basis Monday through Saturday for Reserve, NOSC, USCG, or mobilization sites. Pick-up will be provided for a minimum of one specimen.

2.3.4.3. In the event of troop mobilization (i.e., war or national emergency), the Contractor may be required to provide additional pick-ups of specimen daily and on Sunday. In such cases, the Contractor will be given, at minimum, a twenty-four (24) hour telephonic notice. This provision may be utilized when warranted by events deemed essential for military readiness. Direction to implement this provision will come only from the CONTRACTING OFFICER.

2.3.5. Personnel are provided and utilize a completed DD-250 Material Inspection and Receiving Report (TE-15) to document each shipment delivery using minimum requirements in Table A-1.

TABLE A-1 SHPPING VALIDATION REQUIREMENTS

2.3.6. The Contractor shall provide shipping transportation for reports to designated Government addresses.

2.4. GOVERNMENT DATA TRANSFER TO CONTRACTOR.

2.4.1. The Contractor shall ensure accepting test order information is in the specified formats designated by the Government.

2.5. ACKNOWLEDGEMENT OF ACCEPTANCE.

2.5.1. The Contractor shall ensure acknowledgement of receipt/acceptance of all electronic data received and shipments.

2.5.1 Electronic acknowledgement formats will be discussed at the time of contract award. All other will use DD 250 forms or equivalent as described in Table A-1.

2.6. SPECIMEN ACCESSIONING. Upon specimen receipt, the Contractor shall process incoming specimen according to Contractor designated laboratory procedures.

2.6.1. The Contractor shall inventory each shipment for compliance with shipping instructions; identify discrepancies and possible tampering during transshipment.

2.6.2. If the Contractor identifies no deficiencies, the Contractor shall provide full services. Contractor personnel shall scan each specimen barcode into the Contractor's computer system and verify the existence of an electronic record received from the Government.

2.6.2.l. The Contractor shall perform identity matching of the barcode on the incoming serum separator tube with electronic data record received from the Government.

2.6.3. The Contractor shall ensure that initial specimen processing includes: (a) centrifuging all specimens prior to initial dilution (when necessary); (b) using an automated positive identification dilution system; and (c) maintaining specimen integrity while eliminating the possibility of contamination.

2.6.3.1. Upon enactment of the COOP or other emergency situations, at the request of the Government with COR/ACOR approval, the Contractor will pour-off and freeze any specimens received in serum separated gel tubes to avoid rejections for “D-4-Too Old for Testing”.

2.6.4. The Contractor shall hold all initial SST specimen tubes submitted thirty - (30) calendar days following pour off. The Contractor shall discard the specimen tubes according to industry standards and comply with HIPAA.

2.6.5. Deficiency Issues. The Contractor shall provide electronic notification twice a day (or upon request) of discrepant specimen receipt to the COR at NBIMC, Naval Support Activity, Bethesda, MD.

2.6.5.1. The Contractor shall define specimen receipt deficiencies based on the following general deficiency code in Table B-1: [For definition of deficiency code descriptions see TE-8)

TABLE B-1. DEFICIENCY CODES

2.6.5.1.1. If the deficiency issue requires a Hold (Dl-D2) the Contractor shall provide the available information, including deficiency type and description and retain for the specified time period established. The Contractor shall process the remaining specimen through the Contractor full service system. For the No Specimen Received (D-2) the Contractor will wait 10 days before converting to the Action of Hold to Reject.

2.6.5.1.2. If the deficiency issue requires rejection (D3-D9), then the Contractor shall send the Government a record of the issue within four (4) hours of receipt discrepant specimen(s). COR may require Contractor to send (email) a photograph of the rejected sample(s). The Contractor shall process the remaining specimens through the Contractor full service system.

2.6.5.2. If resolution of the deficiency issue has not occurred within five (5) working days from verified notification, the COR shall be notified prior to discarding all deficient specimen(s).

2.6.5.2.1. The Government will provide a new specimen for each discarded specimen.

2.6.5.3. If the Contractor identifies tampering with the shipment, then the Contractor shall notify the Government within four (4) hours of receipt.

2.6.5.3.l. The Contractor shall initiate an investigation of the shipment handling by the Contractor courier during the entire transshipment process.

2.6.5.3.2. Upon completion of the investigation, the Contractor shall provide a full report to the Contracting Officer with a copy to the COR. The Contractor shall ensure the Government receives a final report within three (3) working days of the occurrence. In the event the issue cannot be closed within 3 working days, the Contractor shall provide weekly updates to the COR until resolution.

2.7. STORAGE.

2.7.1. The Contractor shall provide onsite specimen storage and specimen storage box locations. This applies to specimens arriving in SST tubes without orders, SST’s stored after testing is completed to be poured-off and SST tubes stored for 30 days after pour-off step is completed. Average daily volume is about 3,000-4,000/day

2.7.2. The Contractor shall inventory, collate, prepare, and store supplies to be shipped to each SA.

2.7.3. The Contractor shall accession, process, and store specimens obtained from SA for immediate testing. The Contractor shall maintain all specimens received at 5 degrees Celsius through the entire processing cycle. This section applies to specimens poured-off and stored to be sent to the DoD Serum Repository per SECNAV 5300.30 F and DODI 6485.01

2.7.4. The Contractor shall maintain on-site, secured storage of specimens and temporary storage of specimens pending correction, resolution, or shipping to SA locations.

2.7.5. The Contractor shall store reagents utilized to test specimens.

2.8. TESTING. The Contractor shall provide screening and confirmatory testing for HIV, Hepatitis B and C using an FDA-licensed test methodology on serum/plasma specimen. Based on historical usage approximately 60,000-90,000 per month have been required.

2.8.1. The Contractor shall use FDA-licensed products and equipment for testing. The Contractor shall follow all FDA rules and regulations as related to the testing.

2.8.2. The Contractor shall notify the COR in writing within fifteen (15) workings days of an anticipated shortage or change in reagent type to perform tests. The Contractor's notification shall include the method evaluation and data validation study conducted by the Contractor under requirements of CLIA 88, College of American Pathologists, and the Clinical Laboratory Standards Institute before changing test methodologies or reagent manufacturer(s).

2.8.2.1. For reagent changes, the Contractor shall provide normal ranges, test kit names, and other information for documentation.

2.8.3. The Contractor shall utilize a certifying official to complete results for final reporting.

2.8.4. The Contractor shall ensure providing a mechanism for data certification, validation, and transfer of final results within specified contract time frames.

2.8.5. Tests. The Contractor shall follow the specific manufacturer's package insert information to perform the following tests (DoD Standard Test Names included) and determine whether a specimen meets the acceptance criteria to resolve the test screening status.

a) Screening Test HIV Ag/Ab

b) HIV/HCV Screening Test Panel HIV Ag/Ab

HEPATITIS C VIRUS AB

c) Recruit Screening Test Panel HIV Ag/Ab

HEPATITIS B VIRUS SURFACE AG

HEPATITIS B SURFACE AB QUANT

HEPATITIS C VIRUS AB

d) Confirmatory/Supplemental Testing HIV-1/2 AB Differentiation HbsAg Neutralization Nucleic Acid Testing-HIV

HCV PCR

2.8.5.1. The Contractor shall perform initial and repeat screening tests on all specimens containing a volume of serum/plasma capable of meeting assay requirements. The Contractor shall use an automated diluting system that eliminates specimen contamination and carryover.

2.8.5.2. The Contractor shall utilize FDA-approved test method(s) to perform initial, repeat screening and confirmatory tests.

2.8.6. Screening Test Interpretation. Screening Test Interpretation shall follow the manufacturer's guidelines for testing and interpreting results.

2.8.6.1. If the initial screening test is interpreted reactive, then the Contractor shall repeat an aliquot of the same specimen screening test in duplicate using a separate dilution for each test. If there are any discrepancies between the initial screening and the duplicate screening, the Contractor shall document review/repeat of tests and have documentation available for Government review.

2.8.7. HIV/HCV Screening Test. The Contractor shall perform initial and repeat HIV and HCV screening tests on all specimens identified under SEVNAVINST 5300.30(series) requiring readiness screening for both antibodies and containing a volume of serum/plasma capable of meeting assay requirements. The Government requires the Contractor use an automated diluting system that eliminates specimen contamination and carryover.

2.8.7.1. The Contractor shall utilize FDA-approved test method(s) to perform initial, repeat screening tests, confirmatory and supplemental testing.

2.8.7.2. The Contractor shall ensure all specimens presented with SOT G receive HIV Nucleic Acid Testing. The Contractor will request NBIMC approval before testing specimens received with SOT G. Transfer file for these results will follow TE-9.

2.9. CONTRACTOR TEST REPORTING REQUIREMENTS.

2.9.1. The Contractor shall provide secure electronic file transfer of final results from Contractor processing to the Government for each specimen submitted.

2.9.2. The Contractor shall ensure the Government receives final reported resolutions within the specified timeframes of Contractor specimen receipt defined in Table C-1.

TABLE C-1. TESTING TURN-AROUND-TIME SCHEDULE TABLE

2.9.2.1. The turn-around-time requirements specified in paragraph 2.9.2. and Table C-1 may be waived and/or extended solely in instances beyond the Contractor's control, for example kit non-availability, kit limited availability, and FDA kit release issues, as mutually agreed upon and authorized in writing by the Contracting Officer.

2.9.3. Correspondence Transmittal Report. The Contractor shall ensure each shipment of courier reports or correspondence include a DD-250 (TE-15) to be signed and returned by the designated addressee for verification of shipment contents packaged by the Contractor and received by the Government.

2.9.4. File Transfers. The Contractor shall ensure secured, encrypted file transfers occur within established timeframes and use Government specifications.

2.9.4.1 The Contractor shall ensure secured transmission of internal laboratory work sheets to NBIMC before certified confirmatory testing final results are sent to the Government

2.10. DATA TRANSMISSION REQUIREMENTS. The Contractor shall use the approved encryption protocol directed by the Government for all electronic delivery methods and media for shipping data at rest to designated activity locations.

2.10.l. The Contractor shall ensure the performance of each specific task listed below, to process, transfer, and compile data/information concerned with receiving test orders, specimen testing, and reporting test results.

2.10.2. The Contractor shall provide secure electronic communications using Health Level 7 (HL7) protocol to receive test orders and transmit results to/from the Government. The HL7 message shall include, as a minimum: FMP, SSN/DOD ID, Name (full last name, full first name, middle initial), date of birth, date drawn, barcode, and source of test. The Contractor shall provide the Government data transfers according to the following requirements:

2.10.2.l. Test Orders. The Contractor shall send the test order messages from the MHS Genesis to the Government (NBIMC) using a protocol compatible with the government HMS (HIV Management Service). This requirement allows the Government to reconcile all of the orders generated by MHS Genesis, which currently are not being received by the Government (NBIMC).

2.10.2.2. Test Results. The Contractor shall transmit test result messages securely using HL7 protocol compatible with the DoD CHCS Laboratory Interoperability Program (CHCS-LIO) or MHS Genesis. The Contractor shall ensure meeting the specified timeframes in Section 2.9.2.

2.10.2.2.1 The Contractor shall provide an electronic file of specimens requiring confirmation testing.

2.10.2.2.1.1. The Contractor shall transmit test result messages securely for test results from sites using MHS Genesis. The Contractor shall ensure meeting the specified testing timeframes in Section 2.9.2. The transfer file shall follow the format described in TE-12 and sent to NBIMC on agreed times as referenced in Table C-1 between NBIMC and testing Contractor.

2.10.2.2.1.2. The Contractor shall receive orders and transmit results using Contractor’s secure website as an alternate Mechanism to receive orders/send results.

2.10.2.2.1.3. Data Transfer Failures. The Contractor shall ensure if electronic data transfer failures persists for more than a twenty-four (24) hour period, the Contractor shall prepare and deliver an encrypted data compact disk (CD). The data shall encompass the entire twenty-four (24) hour period and be stored in the required formats using approved DoD Data at Rest software for encryption. The Contractor shall provide security stickers on each CD as specified by DoD requirements when necessary.

2.10.2.3. ARMED FORCES HEALTH SURVIELLANCE BRANCH (AFHSB) Data Transfer Files. The Contractor shall provide weekly data transfer files of all active duty members test results and pour off samples in the format described in TE-12. The Contractor shall provide weekly data transfer files of all active duty members' specimen storage information. The Contractor shall provide weekly data transfer via secured encrypted protocol to AFHSC.

2.10.3. Transaction Report. The Contractor shall provide a daily (NLT 1400 EST) transaction documentation report for each data transmission.

2.10.4.3.1. The Contractor shall ensure each report arrives within one hour following the reporting period once per day.

2.11. Data Security.

2.11.1. The Contractor shall provide a mechanism for maintaining and protecting data integrity from intrusion, contamination, or unauthorized modification.

2.11.2. The Contractor shall provide a secure electronic data transfer using an approved Advanced Encryption Standard (AES) protocol that meets U.S. National Institute of Standards and Technology (NIST), FIPS PUB 197 (FIPS l 97) security guidelines (or approved protocol at time of award) between the Contractor and designated Government locations.

2.11.3 The Contractor shall provide encrypted data transfer of information.

2.11.4. The Contractor shall provide documentation certifying that all system interfacing with Contractor computer system meets FDA review standards for data accuracy.

2.11.5. The contract shall use DoD approved External Certification Authority (ECA) certificates to communicate securely with the DoD and authenticate to DoD Information Systems.

2.12. Disposition of Completed Specimens.

2.12.1. For all Active Duty completed specimens, the Contractor shall collate specimens in barcode or date of test order, duty code (TE-11), record measured volume, and pour off to labeled transfer storage tubes within six (6) hours of certified test completion.

2.12.1.1. For all other completed specimens, the Contractor shall collate specimens in barcode or date of test and duty code order and hold all specimens in the initial SST tubes submitted for six months. The Contractor shall discard specimens and SST tubes after designated period in accordance with industry standards and comply with HJPAA.

2.12.1.2. Each transfer tube shall be appropriately barcode labeled (with the SA original barcode number and date drawn) to ensure Government personnel accurate specimen identity.

2.12.1.3. The Contractor shall ensure that all specimens are stored at -20 °C or below.

2.12.1.4. The Contractor shall ensure the following is performed: (a) use of a secure, limited access area for specimen storage, (b) maintain specimens tested in labeled transfer boxes and (c) each transfer box shall meet TE-l and current IATA specifications.

2.12.2. The Contractor shall ensure preparing and providing a location matrix spreadsheet identifying the specimen location in the transfer boxes. Each spreadsheet shall contain the external barcode label for each box, specimen barcode number, internal specimen location within the box (row and column), and specimen volume.

2.12.2.1. If a specimen in paragraph 2.12.1.3. is quantity not sufficient, indicate QNS in the specimen volume field of the applicable barcode number.

2.12.3. The Contractor shall ensure that all completed specimens are stored on-site in containers to ensure timely locating and accurate shipping. The Contractor shall ship completed samples monthly or upon request within twenty-four (24) hours of certified test completion. The Navy reserves the right to change the shipping rotation to meet DoD requirements.

2.12.3.1. The outer part of the storage box shall be labeled with (a) a unique sequential barcode number, (b) the specimens barcode sequence number series contained within the storage box, and (c) specimens dates of test contained within the storage box.

2.13. Contractor Active Duty Completed Specimen Transfer.

2.13.1. The Contractor shall ensure completed specimens are ready for DoDSR scheduled pick-ups.

2.13.2. The Contractor shall ensure transshipping specimens, using IATA approved infectious packaging, according to the Government schedule.

2.14. Contractor Laboratory Management.

2.14.1. The Contractor shall ensure all specimens are transshipped and frozen for storage in a vertical position.

2.14.2. The Contractor shall ensure complying with Government contingency operations for specimen handling and data management when applicable. The Contractor shall ensure having the capability to receive and process data by alternative methods (i.e. Compact Disk) if required.

2.14.3. The Contractor shall ensure COR notification before discarding rejected specimen; and shall ensure complying with Government-POC final resolution reporting of discordant results.

2.14.4. The Contractor shall ensure a clear barcode specimen number is printed on the internal Contractor lab work sheet to identify each specimen being tested through completion.

2.14.4.1. The Contractor shall ensure that each original specimen retains the original barcode label.

2.14.4.2. The Contractor shall ensure that the barcode applied to the pour off transfer tube is a correct reproduction of the original barcode using specifications in TE-7.

2.14.4.3. The Contractor shall ensure the transfer tube barcode label includes and accurately matches the correct barcode number, and date drawn for the original specimen.

2.14.5. The Contractor shall ensure daily data transfer of all completed data (Monday through Sunday) to the Government within the specified timeframes.

2.14.6. The Contractor shall submit the necessary data and results to the Government to ensure that the Government can perform audits on such data and results within specified timeframes.

2.14.7. The Contractor may archive data every six months following audits and certified Government acceptance.

2.14.8. The Contractor shall ensure all specimens presented with a SOT H are poured off only and stored frozen on site until pick-up by the Government. These specimens will receive a test code number, processing procedure and be stored according to established procedures currently in place.

2.14.8.1 The Contractor shall provide daily data transfer files of all active duty members (TE-11) pour off samples in the format described in TE-12. The Contractor shall provide daily data transfer files of all active duty members' specimen storage information. The Contractor shall provide daily data transfer via secured encrypted protocol to NBIMC.

2.14.8.2 The Contractor shall provide a daily report of all active duty members pour off samples to NBIMC in the format described in TE-12.

2.14.9. The Contractor shall ensure that all internal Contractor lab work sheets, record copies, and copies of reports and results sent, required under the terms of this contract shall be maintained on-site, by the Contractor, through the entire contract period. The Contractor shall ensure all requirements relevant to the performance of this contract, mandated, by official accrediting agencies are met. The Government reserves the right to review, at any time, internal Contractor lab work sheets and records pertaining to testing specimen submitted from the Government.

2.14.10. The Contractor shall ensure record corrections are accurate and meets turn-around-time requirements for completion.

2.14.11. The Contractor shall ensure that all reports are formatted to print on standard size paper (8½ x 11 inch). The Contractor shall ensure that reports include the following specifications:

2.14.12. The Contractor shall implement and maintain a process to investigate and resolve discrepancies, discordances, and errors. The information shall be available to the Government from onset of incident(s) until resolution and final reporting on scheduled reports. Designated Government and Contractor supervisory personnel shall exchange information, specimens, etc. necessary to complete resolution of any issues. Upon completion of each investigation or with written notification, the Contractor shall correct erroneous results and provide the Government a corrected file.

2.14.12.1. If the Government or Contractor identifies or documents a Contractor performance issue(s) or system failure that results in error (such as specimen contamination, data mismatch, delivery and/or security breach, etc.), the Contractor shall investigate and correct all appropriate systems and meet reporting requirements.

2.14.12.1.1. The Contractor shall provide interim notification to COR within two (2) hours of occurrence and final written report (to include dates, cause, investigation discussion, initiating events, corrective actions and resolution) within twenty-four (24) hours. Government (COR) reserves the right to adjust time for final report depending of occurrence complexity.

2.14.12.1.2. The Contractor shall monitor follow-up and prepare an amended report documenting corrective action(s) effectiveness.

2.14.13. The Contractor shall ensure Government records, copies of original results and reports, verified original data, corrected data, backups, and corrected supporting reports are maintained.

2.14.14. Per request of authorized Government personnel, the Contractor shall ensure providing (via secure download or courier delivery) a duplicate copy of completed reports within specified timeframes.

2.14.15. The Contractor shall ensure the DD-250 (TE-15) is completed in entirety and enclosed with each courier shipment.

2.14.16. The Contractor shall ensure meeting Government protocols for documenting and transmitting data in addition to requirements set forth under Section C-5.

2.14.17. Customer Service Representative(s). The Contractor shall, as a minimum, ensure that representatives perform services cited below and do not provide any verbal or written communication of results to any unauthorized individuals. Representative(s) shall:

2.14.17.l. Provide customer support assistance to Government personnel in documenting requests/questions and triage the inquiry to the appropriate level or individual for resolution in a timely manner;

2.14.17.2. Document all inquiries, calls or written requests including the requestors name, location, authorized telephone identification, date/time, request, action and final disposition;

2.14.17.3. Report unusual occurrences to the designated Contract Manager for action and/or resolution.

2.15. Client Services Representative (CSR) Services. The Contractor shall provide CSR services, available by toll-free telephone twenty-four (24) hours per day, seven (7) days per week, to assist Government staff in:

a) Tracking shipments,

b) Modifying requests,

c) Obtaining information,

d) Troubleshooting data transmission errors,

e) Interpreting error codes,

f) Maintaining established links between systems, and other applicable related issues/problems that may arise in the performance of work under this PWS.

2.16. Statistical/Management Reports.

2.16.1. The Contractor shall prepare statistical/management reports according to the specified interval requirements outlined in Table E-1.

TABLE E-1. MANAGEMENT/STATISTICAL REPORTS

Statistical

X

Turn-Around-Times

Transaction

X

Inventory

Quality Assurance

X

AR=As Required, D=Daily, W=Weekly, M=Monthly, Q=Quarterly, A=Annually

2.16.1.1. The Contractor shall note the Government reserves the right to add, modify, or delete reports as needed.

2.16.1.2. The Contractor shall ensure that all reports are available to Government and Contract personnel following the established reporting period.

2.16.1.2.1 The Contractor shall ensure all statistical/managerial reports adhere to the following reporting schedule:

TABLE F-1. REPORT SUBMISSION TIME TABLE

Report

Submission Due Date

Submission Timeframe

2.16.1.3. The Contractor shall ensure that all reports, containing an accurate accounting of specified Government data be delivered to NBIMC following the established reporting period. If the delivery day is a legal Government holiday, Saturday, or Sunday the Contractor shall ensure delivery on the next workday.

2.16.2. The Contractor shall ensure that all reports are formatted to print on standard size paper (8 1/2, x 11 inch). The Contractor shall ensure that reports include the following specifications:

2.16.2.1. The Contractor shall ensure the following Contractor information is provided on each management/statistical report.

2.16.2.2. The Contractor shall ensure Government data information is provided on all management/statistical reports using data formats presented in TE-6.

2.16.2.3. All information prepared by the Contractor shall remain the property of the Government.

2.17. Contractor QC Program.

2.17.1. The Contractor shall develop and maintain a QC program to assure reliable performance of all tests, assure the accuracy of data generated, and to control the quality of all workmanship.

2.17.2. At a minimum, the Contractor shall follow the manufacturer guidelines of each FDA-licensed and approved test methodology utilized. The Contractor shall institute as part of the internal QC program, the testing of reactive and non-reactive specimens to assess the accuracy of each batch of specimens tested. The Contractor shall ensure that at least ten percent (10%) of all tests performed shall be internal control specimens (this may include manufacturer supplied control reagents, but does not include primary calibrators used in each run).

2.17.3. The Contractor shall institute as part of the internal QC program blind negative, weakly positive and strong positive specimen to assess the accuracy for each batch of specimens screened. The Contractor shall ensure that if any internal quality control specimen gives erroneous results, the results for the entire screen batch shall be discarded and the entire batch immediately retested at the Contractor's expense. The Contractor shall maintain all internal quality control results for inspection during each program review or immediately upon request by the Government.

2.17.4. The Contractor shall ensure that before use, 5% of each lot of screening reagents will be tested with control sera consisting of non-reactive (1%), weakly reactive (2%), and reactive (2%) sera.

2.17.4.1. The Contractor shall ensure that the new reagent lots are 100% correctly identified with the above control sera. All Kits and/or reagents not meeting this requirement shall not be utilized for testing Government submitted specimens.

2.17.5. Instrument Calibration. The Contractor shall follow manufacturer's guidelines to ensure accurate results. The Contractor shall document instrument performance and malfunctions. The Contractor shall furnish this information to the Government upon request.

2.17.6. Contractor External Reviews. The Contractor shall participate in all proficiency QC testing programs for all testing methodologies screening and/or confirmatory tests offered by the CAP, CLIA, and the state(s) in which the Contractor laboratory is physically located.

2.17.6.1. A copy of all external proficiency test performance evaluation reports shall be forwarded to the COR quarterly. Contractor shall respond immediately to the Government in writing as to which corrective action(s) was (were) taken on any proficiency specimen scored incorrectly.

2.17.7. Contractor Performance Criteria for Government QC Panels.

2.17.7.1. The Contractor shall maintain the following minimum acceptable accuracy scores on Government provided quality control panels at every testing location:

2.17.7.1.1. Ninety-five (95) percent on open screening panels;

2.17.7.2. The Government will notify the Contractor, in writing, of proficiency panel results within one week of receipt. The Government will provide an accuracy score and analysis of each panel tested.

2.17.7.3. In the event the Contractor fails to meet the minimum contract quality control criteria (as specified above in paragraphs 2.17.7.1. through 2.17.7.2.), the Contractor shall suspend testing for the method being evaluated. The Government will provide the Contractor a repeat panel, for immediate testing, in the same manner as prescribed for the appropriate panel type for repeat evaluation at the failing location.

2.17.7.3.1. The repeat panel shall be tested and results reported to NBIMC within two (2) calendar days of Contractor receipt. If an acceptable accuracy score of 95 percent or greater is met on the repeat panel, the Contractor shall be allowed to resume routine testing under terms of the contract.

2.17.7.3.2. In the event that a Contractor location fails both the original and the repeat panel, the Contractor shall completely retest all specimens originally tested at the location during the month of processing of the failed test panels.