Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 17, 2014 FBO #4710
MODIFICATION

65 -- Reagents for Chlamydia Trachomatis/Neisseria Gonorrhea

Notice Date

10/15/2014
 

Notice Type

Modification/Amendment
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

Medcom Contracting Center North Atlantic, ATTN: MCAA NA Bldg T20, 6900 Georgia Avenue NW, Washington, DC 20307-5000
 

ZIP Code

20307-5000
 

Solicitation Number

W91YTZ-15-R-0002
 

Response Due

10/22/2014
 

Archive Date

12/14/2014
 

Point of Contact

Stephanie Hunter, 910-643-1978
 

E-Mail Address

Medcom Contracting Center North Atlantic
(stephanie.a.hunter20.civ@mail.mil)
 

Small Business Set-Aside

N/A
 

Description

This is intended to be awarded non-competitively using authority FAR 13.501(a) Only One Responsible Source to GEN-PROBE. Please email Stephanie.a.hunter20.civ@mail.mil if your company is capable of providing whats required below. Contractor shall guarantee delivery of instruments and reagents. Contractor shall provide a site coordinator and an installation specialist to assist laboratory personnel with the entire implementation/installation process, ensuring the installation and validations be completed within 30-60 days of equipment arrival. The Clinical Application Specialist, furnished by the contractor, must perform system validation procedures to include calibration, precision, accuracy, sensitivity studies as applicable, and data stream verification for LIS interface capabilities. The contractor activities will include but not limited to the following: 1.Setting up interface. 2.Entering reference ranges. 3.Setting up QC files and entering QC limits. 4.Linearity verification utilizing commercial linearity material to validate all measured parameters. If commercial linearity material is not available for any parameter to validate linear range, appropriate patient samples may be used. 5.Carry-over studies on measured parameters using high patient samples or linearity material. 6.To obtain acceptable performance of the analyzer, all studies must be presented to the laboratory officer for acceptance prior to contractor departure. 7.Method comparison with old method versus new method with a minimum of 30 valid samples. 8.Correlation studies 9.Precision studies to include within run and day-to-day. 10.Monitor of positive rates to ensure no contamination problems. 11.Pump and pipette verification 12.Luminometer calibration LIS Interface: The contractor shall furnish interface assistance to ensure that the system is interfaced with the LIS prior to departure. If purchased of additional equipment is required to maintain the LIS system interface, an equipment credit must be allowed as a discount by the contractor. The system must have barcode capabilities and be fully interfaceable to the Composite Health Care System (CHCS). Contractor shall have equipment in place and ready for service by 1 November 14. Worst case scenario is 1 December 2014. Statement of Work: 1. The contractor shall provide one instrument that has the ability to perform testing for Chlamydia trachomatis/Neisseria gonorrhoeae using Nucleic Acid Amplification technology (NAAT) that is a fully automated walk-a-way enclosed system. 2. Contractor shall provide training two slots initially for the analyzer. This training will occur at the contractor's headquarters for two technologists per instrument provided for a minimum of 2.5 days in regards to assay performance, troubleshooting, preventive maintenance, and quality control. Contractor will also provide subsequent on-site technical training to pertinent testing personnel in regards to assay performance troubleshooting, preventative maintenance, and quality control. 3. Contractor shall provide service maintenance for the period of 1 November 2014 through 30 September 2015, with one 1-year renewable option. Service will be 7 days a week, 24 hours a day for all equipment. 4. Workload numbers for test performed are estimated. Payment will be made for actual items received. Estimated annual workload for Chlamydia trachomatis/Neisseria gonorrhoeae testing is 30,000 samples annually. 5. Assays must utilize nucleic acid amplification technology for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in endocervical swabs, male urethral specimens, female and male urine specimens, ThinPrep liquid pap specimen plus vaginal swabs, either patient collected and physician collected. 6.Assays must be approved by the Bureau of Biologics of the Food and Drug Administration (FDA) for in vitro diagnostic use with either symptomatic or non-symptomatic patients using either endocervical swabs, male urethral specimens, female and male urine specimens, ThinPrep liquid pap specimens and vaginal specimens. 7. All reagents and equipment must be provided on a reagent rental basis, i.e. reagent purchase/equipment provided basis. 8. Equipment design requirements should not exceed the area established for the current testing laboratory. 9. Assays must be automated such that at 450 samples can be tested by one technologist in an 8 hour period. 10. Assay procedures must be such that determinations are made and recorded electronically with output hardware capable of interface with the Laboratory's data processing system. 11. Reagents must be supplied in a ready-to-use- form or one requiring minimal preparation, and in a configuration and package size compatible with the projected user volume so as to minimize product wastage. 12. Delivery of reagent must be guaranteed within five (5) working days after receipt of an order. 13. Test kits must have at least two months of the expiration date remaining at the time they are received in the laboratory. 14. Back-up equipment must be provided initially, or onsite technical backup must be guaranteed within twenty-four hours of any reported failure for essential equipment and seventy-two hours of determination that in-house trouble-shooting was unsuccessful. 15. Vendor technical assistance via telephone must be available within four hours of a reported assay or equipment problem. On-site technical backup must be guaranteed within twenty four hours of any reported assay failure for equipment for which in-house troubleshooting was unsuccessful. 16. The vendor will supply at no additional cost all specimens, specimen collection kits and assay kits required to verify the system to satisfy the current CLIA-88 requirements for verification. Anticipated volume for method verification study is 100 tests. 17. During the course of the contract, if volume increases by 30% or more, the vendor must provide, at no cost to the consumer, additional or updated instrumentation and upgraded data management systems to accommodate the workload increase. 18. Specimen collection kits must be offered by the vendor for use with their NAAT assay. If the specimen collection kits differ from those currently used, the vendor will work with the laboratory and field personnel to ensure that an acceptable plan is in place to replace existing specimen collection kits with new specimen collection kits. 19. Specimen collection kits should not require refrigeration for storage. Collected specimen transport kit must be acceptable shipped under ambient conditions. 20. All collected specimens must be acceptable for testing at least 30 days post-collection with storage at ambient conditions. 21. All FDA approved specimen types must be able to be tested without further manipulations such as swab expression, swab removal, or centrifugation. 22. Specimen collection kits must have pierceable caps to be used on for use on automated instrumentation (cap piercing pipette) for pipetting to eliminate the need for swab removal from the collection tube, the need for manual removal of caps or for the added purchase of a cap remover device and replacement caps. 23. Assays must have FDA acknowledged sensitivity versus patient infected status of at least 94% (Chlamydia trachomatis)/91% (Neisseria gonorrhoeae) and specificity versus patient infected status of at least 97% (Chlamydia trachomatis)/97% (Neisseria gonorrhoeae) for all specimen types. 24. The instrument must have the following capability: a. The instruments should be controlled by a high performance microprocessor. b. The instruments should have a safe memory for programs with a file protection scheme. c. The user should be able to protect programs against unauthorized modifications. d.Software should be menu-driven with a full numeric keypad. e. All output hardware should be designed to interface with the Laboratory network drive. 25. Instrumentation must include at least the following: a. Must have the capability of positive specimen identification. b. Must have automated reagent and specimen pipetting capabilities. c. Must have liquid level detection for reagents and patient samples. d. Must have reagent lot number and expiration date tracking. Results should be tracked to reagent lot numbers used. e. Must have automated pipetting instrumentation. g. Must have load and go capability with random specimen loading. h. Must have on-board incubation. i. Must have cap pierceable pipetting. j. Must have throughput of 450 specimens in an 8 hour shift. k. Must be one integrated system requiring no manual (hands on) transfers from processing modules to detectors. 26. Naturally occurring components in patient samples (such as blood, mucous, or bilirubin) and other man-made components (such as vitamins or gynecological products) should not show interference with the performance of the assay in the detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae. 27. There should be no cross-reactions with organisms other than Chlamydia trachomatis and Neisseria gonorrhoeae noted in performance of the assays. 28. LIS Interface: The contractor shall furnish interface assistance to ensure that the system is interfaced with the LIS prior to departure. If purchase of additional equipments such as computer monitors, computer processing units, report printers, barcode label printers and barcode scanner are required to maintain the LIS system interface, the vendor must provide them and maintain them throughout the contract period at no cost to the government. Replacements must be made as needed at no cost to the government. The system must have barcode capabilities and be fully interfaceable to the Composite Health Care System (CHCS). Rules writing package for the middleware must be provided by the vendor. 29. All invoices will be entered into WAWF for Payment 30. If the unit of measure is Jobs, when entering invoice in WAWF contractor will attach their invoice so the COR can trouble shoot discrepancies (shortage, overage, and/or pricing). 31. NOTES FOR GATEPASSES Gate passes are to be for personal coming on post 3 to 5 times a week. All others may request for a 30 day pass when they enter the first time. Issue when an instrument breaks down a repair people can get stuck at the gate for hours. Per KO our work around is to issue all repair personnel for each contract a pass because if an instrument breaks down he or she may be here 3 to 5 times a week. Gate requirement to enter post Your personnel will have to go to the All American Gate - Visitor section for a background check. If the person has been convicted of a felony or 3 misdemeanors within the last 5 years (not including traffic tickets) they cannot come on post. This process itself only take about 5 minutes; but the issue may be how many people are in front of you. The website gives detailed information along with the DES Form 118: From the web site: http://www.bragg.army.mil/directorates/DES/pmo/Pages/AIE.aspx The registration process takes 3-5 mins to complete. AIE Registration to receive an access badge for sponsored contractors, partners, vendors, caregivers, DoD Civilian Employee Family members and Foreign Visitor students can be completed at the Fort Bragg All American Visitor Control Center (VCC) located at the All American Hwy, Access Control Point (ACP), Building H-1575, outside ACP 5, or if you are a sponsored commercial vendor or contractor please use the Truck Plaza VCC located off Cook Street in Building K-1153 outside ACP 16. AIE registration hours during the performance and endurance testing phases will be 24 hours at the All American VCC and 0500 a.m. to 2100 Monday -Friday at the Truck Plaza Truck Plaza weekend registration hours are from 0500 a.m. to 1300 p.m. located off Cook Street. Some of the frequently asked questions (for all visit the website listed above) Q: Where do I register my ID card in the AIE system? A: At Vehicle Registration Offices on Fort Bragg at All American Fwy Building H-1575, 7 days a week 24 hours a day. Commercial vendors and Contractors will register at the Truck Plaza on Cook St, Building K-1153 between the hours of 0500 - 2100, Monday through Friday (Weekends and Federal Holidays 0500-1300). Q: If I do not have a CAC or any of afore mentioned ID cards, how do I get on the Installation? A: To receive a visitor pass you must be registered in the AIE system at the Visitor Control Center (VCC) located at the All American or if you are a commercial vender use the VCC at the Truck Plaza located on Cook Street. Q: I'm a contractor how does AIE affect me? A: The badges will only be issued to non-D0D cardholder personnel who successfully pass an NCIC III check and meet the enrollment processing requirements but otherwise do not meet the requirement for issuance of a CAC or DoD Teslin card. This applies to contractors and vendors who are sponsored as having an official purpose and are approved for access by the installation commander or designated representative. Contractors and vendors requiring physical access to the Fort Bragg installation or facility longer than 24 hours but do not require logical access to a DoD computer network, will have a government employee sponsor/Contract Officer Representative who will provide the contractual agreement with an approved request for access application signed by a verifying officer vouching for the need to possess a long term Friend/Partner, Contractor or Vendor access badge. The expiration date of the credential will not exceed three years or the end date of the contract, or the expiration date of the sponsor's credential, whichever occurs first. Q: Can I Register On-Line? A: Fort Bragg has establish an AIE Pre-Registration On-Line Site for visitors requesting visitor passes. The link to this site is https://www.bragg.aie.army.mil/entrypoint less than https://www.bragg.aie.army.mil/entrypoint/ greater than. Once a visitor completes the on-line pre-registration process they will print the pre-registration pass with bar code and bring it with them to the VCC for final processing.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA15/W91YTZ-15-R-0002/listing.html)
 

Place of Performance

Address: Medcom Contracting Center North Atlantic ATTN: MCAA NA Bldg T20, 6900 Georgia Avenue NW Washington DC

Zip Code: 20307-5000
 

Record

SN03550594-W 20141017/141015234317-0aad6cd14e320c643ba19e9ae8ed2464 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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