FBODaily.com | FedBizOpps: PRESOL | 65 | Microbial Identification Test Analyzer

FBO DAILY - FEDBIZOPPS ISSUE OF NOVEMBER 22, 2016 FBO #5478
SOLICITATION NOTICE

65 -- Microbial Identification Test Analyzer

Notice Date: 11/20/2016
Notice Type: Combined Synopsis/Solicitation
NAICS: 325413 — In-Vitro Diagnostic Substance Manufacturing
Contracting Office: Department of the Army, U.S. Army Medical Command, MEDCOM, North Atlantic Regional Contracting Office, 8901 Rockville Pike, Bldg 54, Bethesda, Maryland, 20889, United States
ZIP Code: 20889
Solicitation Number: W91YTZ17R0003
Archive Date: 1/4/2017
Point of Contact: Valerie DeVeaux, Phone: 7067873894
E-Mail Address: valerie.j.deveaux.civ@mail.mil
(valerie.j.deveaux.civ@mail.mil)
Small Business Set-Aside: N/A
Description: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, and for support 13.5, Test Program for Certain Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. Solicitation W91YTZ-17-R-0003 is issued as a request for Quotation (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-91 and Defense Federal Acquisition Supplement Publication (DPN) 20161104. This acquisition is issued on an unrestricted basis under NAICS code 325413, In-Vitro Diagnostic Manufacturing, and the business size standard for NAICS code 325413 is 1,250. The purpose of this solicitation is for an automated Microbial Identification, Antibiotic Susceptibility Testing instrument (ID/AST) and a Matrix Assisted Laser Desorption Ionization Time of Flight (MALDI-TOF) Mass Spectrometry Microbial Identification Instrument; including Reagents, Supplies and Consumables for the Department of Pathology & Area Lab Services at Eisenhower Army Medical Center, Fort Gordon, GA. Ordering period is DATE OF AWARD - 30 September 2017. Quotes are due by 20 December 2016 at 4:00 pm EST. Questions must be submitted via email not later than 5 December 2016 (no questions will be entertained after this date). Quotes and questions shall be submitted via email to Valerie.J.DeVeaux.civ@mail.mil. SALIENT FUNCTIONAL CHARACTERISTICS/INTENDED USE: a. MALDI-TOF Mass Spectrometry Microbial Identification Instrument The instrument shall be a 110-240 (V) volt, self-contained, FDA-approved with software system designed for rapid identification of clinically-relevant bacteria, yeasts, and filamentous fungi. System must facilitate sample preparation, identification of intact cells without extraction or purification. Instrument must not require further manual sample extraction steps other than on target slide addition of matrix (α- Cyano-4-hydroxycinnamic acid, CHCA) for GP and GN or formic acid (FA) and matrix for yeast. The matrix and Formic Acid (FA) must be ready to use and light stable at +4C. 1) Shall be geared towards walkaway operation. 2) Shall be a high throughput platform capable of processing up to 192 clinical samples plus QC controls in a single, uninterrupted run. 3) Each target slide should have a dedicated QC control spot for acquisition groups of 16 clinical samples 4) The system shall offer flexibility in workflow with multiple remote sample preparation stations and ability to load up to 4 target slides. 5) The system shall include an integrated software system that performs all required calculations as needed for a final result and is fully compatible with composite healthcare system (CHCS) in such a manner that results generated by the analytical platform are seamlessly transferred to CHCS. 6) The system shall report the identification (ID) result with a confidence value. 7) The system shall analyze raw spectral data not just by comparing a spectrum with a reference spectrum database but using a method that assigns probability values to individual peaks in a spectrum and calculates the confidence levels of a choice ID. 8) The system shall be able to distinguish Streptococcus pneumonia from non-pneumococcal species of Streptococcus mitis group. 9) The mass spec system shall provide a mass range no less than 1DA-500kDa. 10) The MALDI TOF shall have a linear flight tube length of 1.2 meters. 11) The MALDI TOF shall have the ability to run in both positive and negative ion modes (standards) 12) The MALDI TOF shall meet minimum sensitivity of 250amol Glu-Fib peptide, 250 fmol BSA protein with a resolution of 5000 FWHM ACTH 18-39 peptide. 13) The software shall maintain records of quality control materials. Results for non-clinically validated species shall be displayed in the report, alerting lab staff that additional testing should be conducted. These can include organisms with insufficient clinical performance data and organisms not found in human clinical samples as reported in the scientific literature. Such organisms shall be automatically highlighted in all printed, exported or audited files. 14) Users must be able to export all organisms via network-based software (middleware) for audit trail purposes or ID/AST trending, epidemiology, statistics, antibiogram, or other purposes. Furthermore, the same software shall be able to directly link the MALDI-TOF with the AST/ID instrument and BacT/Alert 3D (BIOMERIEUX) using common nomenclature. 15) The MALDI-TOF and AST platform shall be able to provide consolidated reporting for identification and antibiotic susceptibility testing. 16) The system shall meet standards set by the Risk Management Framework (RMF) for Department of Defense (DoD) Information Technology (IT). 17) The system shall have sensors to detect and notify the user of conditions that may result in erroneous results. Systems checks and maintenance should be performed and documented by the system at specified intervals. 18) The contractor shall provide all necessary personnel, reagents and consumable items to conduct validation of instrument and assays in accordance with the requirements of CAP and DDEAMC. 19) The instrument shall be delivered and installed by the contractor at no cost to the government. The instrument/assays shall be validated within sixty (60) days after 01 October 2016, or date of award. Microbial ID and Antibiotic Susceptibility Testing Instrument (1) The system shall provide self-contained, fully automated testing of suspensions of bacteria and yeast isolated from patient specimens. (2) The instrument shall be a 110-240 (V) volts, FDA-approved or cleared (3) The system shall be designed to provide identification and antimicrobial susceptibility test (ID/AST) results in as little as 5 to 8 hours. (4) The system shall provide reduced hands-on time, and require no additional reagents (no on-board reagents). (5) The system shall optimize user safety with closed, disposable testing devices. (6) The system shall provide maximum traceability with the pre-applied testing device barcodes. (7) The testing devices shall reduce disposable costs by being lightweight and sealing all reagents and bio- hazardous waste. (8) The system shall include software that enables easy access to ID and AST results. The software shall allow rapid result searches by patient, tech, date tested, and organism and accession number. (9) The system software shall facilitate selection of appropriate antibiotics by providing rapid, accurate fingerprint recognition of bacterial resistance mechanisms. In addition, the software shall be capable of generating antibiogram. (10) The system shall have sufficient capacity and throughput to meet the volume and service demands as defined in the Prices and Terms. Bar-code System. All bar code readers must be capable of reading and decoding any label when manually applied to a specimen tube in accordance with the guidelines described in the Clinical and Laboratory Standards Institute (CLSI) standard, Laboratory Automation: Bar Codes for Specimen Container Identification, CLSI Document Auto2-A, Approved Guideline, Vol. 20, No. 19, October 2005. Data Management System. Integrated central processing unit with sufficient data storage and printing capability to accommodate and provide immediate access to patient records. Ability to manage rules for optimal specimen handling with alert system with ability to send automated comments based on the rules to patient host record. Linearity limits, "Add-on" or reflex tests, repeats for critical value tests, review for specimen integrity and delta checks on previous patient results are examples of automatic rules functions required. Specimen Integrity based rules to cancel/edit tests based on the test performed and the interfering substance. Cancelled test shall be able to transmit to the host along with the appropriate comment. Interfacing pending Pathology & Laboratory Medicine and Lab Information System technology. Bi directional Interface - shall be able to interface and automate the Microbiology instruments with orders and results separated for optimal transmission capable of automatically uploading test results. Back up to network data management handling. Software management features with rules capable of preparing data for auto validation prior to host transmission. Data Management with record storage including instrument of record for all patient results. All software and software licenses, interfaces, and hardware (e.g. servers, printers, monitors, UP, etc.) shall be included with cost of hardware required disclosed for removal if needed. Safety. The system must have sufficient safety features to avoid unnecessary exposure to bio-hazardous and chemical materials. The exposure to and the volume of bio-hazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. ITEM NO. 0001 COST PER TEST Base Period: Cost Per Test program at Eisenhower Army Medical Center, Fort Gordon GA. Contractor shall deliver in accordance with the Statement of Objective. This Cost per Test program includes the equipment, consumables, all reagents, controls and calibrators necessary to operate the system. POP: DATE OF AWARD - 30 September 2017. ITEM NO. 0001AA Microbial Identification Test Analyzer QTY: 1 UNIT: EACH UNIT PRICE: _______________ TOTAL: ______________ See Statement of Objective for salient characteristics POP: Date of Award - 30 Sept 17 ITEM NO. 0001AB Antibiotic Susceptibility Test Analyzer QTY: 1 UNIT: EACH UNIT PRICE: ________________ TOTAL: __________________ See Statement of Objective for salient characteristics POP: Date of Award - 30 Sept 17 ITEM NO. 0001AC Identification Test QTY: 6190 UNIT: EACH UNIT PRICE: ______________ TOTAL: _________________ Identification Test POP: Date of Award - 30 Sept 17 ITEM NO. 0001AD Susceptibility Test QTY: 5,256 UNIT: EACH UNIT PRICE: ________________ TOTAL: __________________ Susceptibility Test POP: Date of Award - 30 Sept 17 ITEM NO. 0001AE Training QTY: 1 UNIT: EACH UNIT PRICE: ________________ TOTAL: _________________ Annual Training includes two (2) off-site training for key operators, includes room, board and airfare for each completed year of the customer agreement upon request at no additional cost to the government. The contractor provides supplemental off- site training for all four (4) option years, excluding airfare Twenty-four hours a day, 7 days a week maintenance at no additional cost to the government. All travel transportation/lodging should conform to the requirements of the Joint Travel Regulation (JTR). Onsite training will be provided to staff at mutually agreed upon times and dates according to a pre-set training schedule formulated at time of installation. All travel transportation/lodging should conform to the requirements of the Joint Travel Regulation (JTR). POP: Date of Award - 30 Sept 17 ITEM NO. 1001 COST PER TEST Option Year 1: Cost Per Test program at Eisenhower Army Medical Center, Fort Gordon GA. Contractor shall deliver in accordance with the Statement of Objective. This Cost per Test program includes the equipment, consumables, all reagents, controls and calibrators necessary to operate the system. POP: I October 2017 - 30 September 2018. ITEM NO. 1001AA Microbial Identification Test Analyzer QTY: 1 UNIT: EACH UNIT PRICE: _______________ TOTAL: ______________ See Statement of Objective for salient characteristics POP: 1 Oct 17 - 30 Sept 18 ITEM NO. 1001AB Antibiotic Susceptibility Test Analyzer QTY: 1 UNIT: EACH UNIT PRICE: ________________ TOTAL: __________________ See Statement of Objective for salient characteristics POP: 1 Oct 17 - 30 Sept 18 ITEM NO. 1001AC Identification Test QTY: 6190 UNIT: EACH UNIT PRICE: ______________ TOTAL: _________________ Identification Test POP: 1 Oct 17 - 30 Sept 18 ITEM NO. 1001AD Susceptibility Test QTY: 5,256 UNIT: EACH UNIT PRICE: ________________ TOTAL: __________________ Susceptibility Test POP: 1 Oct 17 - 30 Sept 18 ITEM NO. 1001AE Training QTY: 1 UNIT: EACH UNIT PRICE: ________________ TOTAL: _________________ Annual Training includes two (2) off-site training for key operators, includes room, board and airfare for each completed year of the customer agreement upon request at no additional cost to the government. The contractor provides supplemental off- site training for all four (4) option years, excluding airfare Twenty-four hours a day, 7 days a week maintenance at no additional cost to the government. All travel transportation/lodging should conform to the requirements of the Joint Travel Regulation (JTR). Onsite training will be provided to staff at mutually agreed upon times and dates according to a pre-set training schedule formulated at time of installation. All travel transportation/lodging should conform to the requirements of the Joint Travel Regulation (JTR). POP: 1 Oct 17 - 30 Sept 18 ITEM NO. 2001 COST PER TEST Option Year 2: Cost Per Test program at Eisenhower Army Medical Center, Fort Gordon GA. Contractor shall deliver in accordance with the Statement of Objective. This Cost per Test program includes the equipment, consumables, all reagents, controls and calibrators necessary to operate the system. POP: I October 2018 - 30 September 2019. ITEM NO. 2001AA Microbial Identification Test Analyzer QTY: 1 UNIT: EACH UNIT PRICE: _______________ TOTAL: ______________ See Statement of Objective for salient characteristics POP: 1 Oct 18 - 30 Sept 19 ITEM NO. 2001AB Antibiotic Susceptibility Test Analyzer QTY: 1 UNIT: EACH UNIT PRICE: ________________ TOTAL: __________________ See Statement of Objective for salient characteristics POP: 1 Oct 18 - 30 Sept 19 ITEM NO. 2001AC Identification Test QTY: 6190 UNIT: EACH UNIT PRICE: ______________ TOTAL: _________________ Identification Test POP: 1 Oct 18 - 30 Sept 19 ITEM NO. 2001AD Susceptibility Test QTY: 5,256 UNIT: EACH UNIT PRICE: ________________ TOTAL: __________________ Susceptibility Test POP: 1 Oct 18 - 30 Sept 19 ITEM NO. 2001AE Training QTY: 1 UNIT: EACH UNIT PRICE: ________________ TOTAL: _________________ Annual Training includes two (2) off-site training for key operators, includes room, board and airfare for each completed year of the customer agreement upon request at no additional cost to the government. The contractor provides supplemental off- site training for all four (4) option years, excluding airfare Twenty-four hours a day, 7 days a week maintenance at no additional cost to the government. All travel transportation/lodging should conform to the requirements of the Joint Travel Regulation (JTR). Onsite training will be provided to staff at mutually agreed upon times and dates according to a pre-set training schedule formulated at time of installation. All travel transportation/lodging should conform to the requirements of the Joint Travel Regulation (JTR). POP: 1 Oct 18 - 30 Sept 19 ITEM NO. 3001 COST PER TEST Option Year 3: Cost Per Test program at Eisenhower Army Medical Center, Fort Gordon GA. Contractor shall deliver in accordance with the Statement of Objective. This Cost per Test program includes the equipment, consumables, all reagents, controls and calibrators necessary to operate the system. POP: I October 2019 - 30 September 2020. ITEM NO. 3001AA Microbial Identification Test Analyzer QTY: 1 UNIT: EACH UNIT PRICE: _______________ TOTAL: ______________ See Statement of Objective for salient characteristics POP: 1 Oct 19 - 30 Sept 20 ITEM NO. 3001AB Antibiotic Susceptibility Test Analyzer QTY: 1 UNIT: EACH UNIT PRICE: ________________ TOTAL: __________________ See Statement of Objective for salient characteristics POP: 1 Oct 19 - 30 Sept 20 ITEM NO. 3001AC Identification Test QTY: 6190 UNIT: EACH UNIT PRICE: ______________ TOTAL: _________________ Identification Test POP: 1 Oct 19 - 30 Sept 20 ITEM NO. 3001AD Susceptibility Test QTY: 5,256 UNIT: EACH UNIT PRICE: ________________ TOTAL: __________________ Susceptibility Test POP: 1 Oct 19 - 30 Sept 20 ITEM NO. 3001AE Training QTY: 1 UNIT: EACH UNIT PRICE: ________________ TOTAL: _________________ Annual Training includes two (2) off-site training for key operators, includes room, board and airfare for each completed year of the customer agreement upon request at no additional cost to the government. The contractor provides supplemental off- site training for all four (4) option years, excluding airfare Twenty-four hours a day, 7 days a week maintenance at no additional cost to the government. All travel transportation/lodging should conform to the requirements of the Joint Travel Regulation (JTR). Onsite training will be provided to staff at mutually agreed upon times and dates according to a pre-set training schedule formulated at time of installation. All travel transportation/lodging should conform to the requirements of the Joint Travel Regulation (JTR). POP: 1 Oct 19 - 30 Sept 20 ITEM NO. 4001 COST PER TEST Option Year 4: Cost Per Test program at Eisenhower Army Medical Center, Fort Gordon GA. Contractor shall deliver in accordance with the Statement of Objective. This Cost per Test program includes the equipment, consumables, all reagents, controls and calibrators necessary to operate the system. POP: I October 2020 - 30 September 2021. ITEM NO. 4001AA Microbial Identification Test Analyzer QTY: 1 UNIT: EACH UNIT PRICE: _______________ TOTAL: ______________ See Statement of Objective for salient characteristics POP: 1 Oct 20 - 30 Sept 21 ITEM NO. 4001AB Antibiotic Susceptibility Test Analyzer QTY: 1 UNIT: EACH UNIT PRICE: ________________ TOTAL: __________________ See Statement of Objective for salient characteristics POP: 1 Oct 20 - 30 Sept 21 ITEM NO. 4001AC Identification Test QTY: 6190 UNIT: EACH UNIT PRICE: ______________ TOTAL: _________________ Identification Test POP: 1 Oct 20 - 30 Sept 21 ITEM NO. 4001AD Susceptibility Test QTY: 5,256 UNIT: EACH UNIT PRICE: ________________ TOTAL: __________________ Susceptibility Test POP: 1 Oct 20 - 30 Sept 21 ITEM NO. 4001AE Training QTY: 1 UNIT: EACH UNIT PRICE: ________________ TOTAL: _________________ Annual Training includes two (2) off-site training for key operators, includes room, board and airfare for each completed year of the customer agreement upon request at no additional cost to the government. The contractor provides supplemental off- site training for all four (4) option years, excluding airfare Twenty-four hours a day, 7 days a week maintenance at no additional cost to the government. All travel transportation/lodging should conform to the requirements of the Joint Travel Regulation (JTR). Onsite training will be provided to staff at mutually agreed upon times and dates according to a pre-set training schedule formulated at time of installation. All travel transportation/lodging should conform to the requirements of the Joint Travel Regulation (JTR). POP: 1 Oct 20 - 30 Sept 21 The following FAR and DFAR provisions and clauses apply to this solicitation: 52.212-1-INSTRUCTIONS TO OFFERORS - COMMERCIAL ITEMS (OCT 2016) ADDENDUM TO 52.212-1 Offeror shall submit signed and dated quotes to Gordon Health Contracting Cell (GHCC) office no later than the date and time specified above. The quote shall have a title page identifying the offeror, the full address, phone and facsimile numbers, points of contact (POCs) of the offeror, the solicitation number and its contents. Any questions with respect to the solicitation shall be submitted in writing to Ms. Valerie DeVeaux at valerie.j.deveaux.civ@mail.mil by 4 PM EST 20 December 2016. Telephone calls will not be accepted nor responded to. Responses will be emailed to all interested offerors. Note: Facsimile offer and electronic (e-mail) offer is also acceptable, provided they meet the requirements listed above. Electronic (e-mail) is the preferred method. Quote can be faxed to 706-787-6573 ATTN: Valerie DeVeaux Offer shall clearly identify each part of their quote, as described below. Administrative a. Request for Quote. The offeror shall include a copy of the completed SF 1449, with the signature and include the name of the offeror, address, phone and fax numbers in Block 17a. b. The offeror shall submit a completed copy of FAR 52.212-3, Representations and Certifications - Commercial Items. Vendors may obtain information on registration and annual confirmation requirements by calling 1-866-606- 8220 or via Internet at https://www.sam.gov. All offerors must be registered in the System for Award Management (SAM) prior to award, and lack of registration shall make an offer ineligible for award. Technical a. The technical quote shall be addressed in sufficient written detail for the Government to determine if the offeror's product(s) adequately perform the specific requirements as stated in 52.212-2. b. Offeror must meet the salient physical, functional, or performance characteristic specified in this solicitation and clearly describes any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification. c. THE FOLLOWING MUST BE SUBMITTED WITH THE QUOTE - A copy of the product brochure, pamphlet, or technical manual - Attachment A: Pricing Cost-Per- Test spreadsheet - Signed and dated Solicitation Pricing a. Pricing for Requirements. The offeror shall submit proposed pricing for all Contract Line Item Numbers (CLINs) identified in the Request for Quote, unless otherwise noted. Include the unit price and the total extended price for each CLIN. Special Delivery Mail a. Offeror is cautioned that the United States Postal Service (USPS) does not deliver directly to the Gordon Health Contracting Cell (GHCC). All USPS mail is delivered to a central location at Eisenhower Army Medical Center. Offer should be sent in sufficient time to ensure arrival at the contracting office by the specified date and time. Offeror should consider the additional time needed for mail distribution when preparing their offers. b. Offeror may drop-off their proposal at the Gordon Health Contracting Cell, (GHCC) prior to the specified due date and time. For directions to the contracting office, contact Valerie DeVeaux at valerie.j.deveaux.civ@mail.mil. (End of Addendum to 52.212-1) 52.203-2 -- CERTIFICATE OF INDEPENDENT PRICE DETERMINATION (APR 1985) 52.203-11 - CERTIFICATION AND DISCLOSURE REGARDING PAYMENTS TO INFLUENCE CERTAIN FEDERAL TRANSACTIONS (SEP 2007) 52.204-5 -- WOMEN-OWNED BUSINESS OTHER THAN SMALL BUSINESS (OCT 2014) 52.211-6 -- BRAND NAME OR EQUAL (AUG 1999) 52.214-34 - SUBMISSION OF OFFERS IN THE ENGLISH LANGUAGE (APR 1991) 52.222-56 - CERTIFICATION REGARDING TRAFFICKING IN PERSONS COMPLIANCE PLAN (MAR 2015) 52.225-25 -- PROHIBITION ON ENGAGING IN SANCTIONED ACTIVITIES RELATING TO IRAN-CERTIFICATION (OCT 2015) 252.222-7007 -- REPRESENTATION REGARDING COMBATING TRAFFICKING IN PERSONS (JAN 2015) 52.209-2 -- PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC CORPORATIONS - REPRESENTATIONS (NOV 2015) 52.209-11 - REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016) 52.209-12 - CERTIFICATION REGARDING TAX MATTERS (FEB 2016) 52.215-20 -- REQUIREMENTS FOR CERTIFIED COST OR PRICING DATA AND DATA OTHER THAN CERTIFIED COST OR PRICING DATA (OCT 2010)ALTERNATE IV (OCT 2010) (b) Submission of other than certified cost or pricing data may be requested by the Contracting Officer. 52.216-1 -- TYPE OF CONTRACT (APR 1984) Firm Fixed Price 52.233-2 -- SERVICE OF PROTEST (SEP 2006)Southern Reg Contr Office, 3551 Roger Brook Dr, Bldg 3600, Ft Sam Houston, TX 73234-6200. 52.252-1 -- SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998); http://farsite.hill.af.mil/ 52.252-5 -- AUTHORIZED DEVIATIONS IN PROVISIONS (APR 1984) (Insert "DoD FAR Supplement (48 CFR Chapter 2)" in paragraph (b)) 252.203-7005 -- REPRESENTATION RELATING TO COMPENSATION OF FORMER DOD OFFICIALS (NOV 2011) 252.204-7004 - ALTERNATE A, SYSTEM FOR AWARD MANAGEMENT (FEB 2014) 252.204-7008 - COMPLIANCE WITH SAFEGUARDING COVERED DEFENSE INFORMATION CONTROLS (DEVIATION 2016-O0001)(OCT 2015) 252.204-7011 -- ALTERNATIVE LINE-ITEM STRUCTURE (SEP 2011) (See Clins) 252.213-7000 -- NOTICE TO PROSPECTIVE SUPPLIERS ON USE OF PAST PEFORMANCE INFORMATION RETRIEVAL SYSTEM - STATISTICAL REPORTING IN PAST PERFORMANCE EVALUATIONS (JUN 2015) 252.215-7007 -- NOTICE OF INTENT TO RESOLICIT (JUN 2012) 252.215-7008 -- ONLY ONE OFFER (OCT 2013) 252.222-7007 - REPRESENTATION REGARDING COMBATING TRAFFICKING IN PERSONS (JAN 2015) 252.225-7050 -- DISCLOSURE OF OWNERSHIP OR CONTROL BY THE GOVERNMENT OF A COUNTRY THAT IS A STATE SPONSOR OF TERRORISM (DEC 2014) 252.247-7022 -- REPRESENTATION OF EXTENT OF TRANSPORTATION BY SEA (AUG 1992) 52.212-2 -- EVALUATION -- COMMERCIAL ITEMS (OCT 2014) HCAA Local Clause 5006 (Tradeoffs) Addendum to 52.212-2 Award will be made using the Tradeoff source selection process. This process permits tradeoffs among cost or price and non-cost factors and allows the Government to accept other than the lowest priced proposal. Award will be made to the responsible offeror whose proposal conforms to the solicitation and is deemed best value to the Government. Award maybe made without discussions with offerors (except communications conducted for the purpose of minor clarification). Therefore, each initial offer should contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the contracting officer to be necessary. Paragraph (a) is hereby replaced with the following: (a). The Government will award a Firm-Fixed-Price contract resulting from this solicitation, to the responsible offer conforming to the solicitation that is best value to the Government, technical acceptablilty and other factors considered. The following factors shall be used to evaluate offers: In Accordance with Brand Name or Equal FAR 52.211-6. Microbiological Analyzer identification (MALDI TOF) and Antiobiotic Suspectibility VITEK 2 GN/GP, with Reagents, Supplies and Consumables. To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must - (1) Meet the salient physical, functional, or performance characteristic specified below and in this solicitation; (2) Clearly identify the item by- (i) Brand name, if any; and (ii) Make or model number; (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previous furnished descriptive data or information available to the Contracting Officer; and (4) Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification. 1. Technical Ability to provide all mandatory tests in Attachment A (brand name or equal) as evidenced by offeror submitting pricing for all mandatory tests. Acceptable: Proposal clearly meets the minimum requirements of the solicitation. Unacceptable: Proposal clearly does not meet the minimum requirements of the solicitation. 2. Price Price will be evaluated will be evaluated for fairness and reasonability in terms of: A. That the prices are consistent with and reflect the proposed requirement. B. Pricing will be evaluated for fair and reasonable in terms of the Government's requirements. The Government is interested in proposals that meet the requirements with acceptable risk, at a fair and reasonable price. 3. Quoters shall submit quotes to Gordon Health Contracting Cell, Office to arrive no later than 4:00 PM eastern standard time on December 20, 2016. Quotes can be submitted via email to valerie.j.deveaux.civ@mail.mil or Fax to 706-787-6573. Mailed submissions are not acceptable. 4. Evaluation Process: All quotes will be evaluated on overall technical acceptability and price. Must meet the functional characteristics referenced. The award decision will be based on the best value to the Government quote. (End of Provision) (End of Addendum to 52.212-2) 52.212-3 -- OFFEROR REPRESENTATIONS AND CERTIFICATIONS -- COMMERCIAL ITEMS (MAR 2015) ALTERNATE I (OCT 2014) CONTRACT CLAUSES 52.212-4 -- CONTRACT TERMS AND CONDITIONS -- COMMERCIAL ITEMS (DEC 2014) Addendum to 52.212-4 (Local Clause (LC) 5003 The following policy applies only if the contractor will be on the Government installation for more than thirty (30) days. (v) Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP). The contractor shall comply with OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP), 12 Nov 2013. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract. The contractor shall require all Contract Service Providers (CSP) with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals. The contractor shall require all CSPs with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incidentto the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals. (w) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 for locations where full text can be found. Also, the full text of a clause may be accessed electronically at this/these address(es): http://farsite.hill.af.mil/ https://acquisition.gov/far/index.html (End of Addendum to 52.212-4) 52.203-3 -- GRATUITIES (APR 1984) 52.203-6 -- RESTRICTIONS ON SUBCONTRACTOR SALES TO THE GOVERNMENT (SEP 2006) ALTERNATE I (OCT 1995) 52.203-12 -- LIMITATION ON PAYMENTS TO INFLUENCE CERTAIN FEDERAL TRANSACTIONS (OCT 2010) 52.203-17 -- CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (APR 2014) 52.204-4 -- PRINTED OR COPIED DOUBLE-SIDED ON POSTCONSUMER FIBER CONTENT PAPER (MAY 2011) 52.204-7 - SYSTEM FOR AWARD MANAGEMENT (OCT 2016) 52.204-10 -- REPORTING EXECUTIVE COMPENSATION AND FIRST-TIER SUBCONTRACT AWARDS (OCT 2015) 52.204-21 - BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN 2016) 52.209-6 -- PROTECTING THE GOVERNMENT'S INTEREST WHEN SUBCONTRACTING WITH CONTRACTORS DEBARRED, SUSPENDED, OR PROPOSED FOR DEBARMENT (OCT 2015) 52.209-9 - UPDATES OF PUBLICLY AVAILABLE INFORMATION REGARDING RESPONSIBILITY MATTERS (JUL 2013) 52.219-4 -- NOTICE OF PRICE EVALUATION PERFERENCE FOR HUBZONE SMALL BUSINESS CONCERNS (OCT 2014) 52.219-8 -- UTILIZATION OF SMALL BUSINESS CONCERNS (OCT 2014) 52.222-3 -- CONVICT LABOR (JUN 2003) 52.222-19 -- CHILD LABOR-COOPERATION WITH AUTHORITIES AND REMEDIES (JAN 2014) 52.222-21 -- PROHIBITION OF SEGREGATED FACILITIES (APR 2015) (EEO) 52.222-50 -- COMBATING TRAFFICKING IN PERSONS (MAR 2015) 52.223-3 - HAZARDOUS MATERIAL IDENTIFICATION AND MATERIAL SAFETY DATA (JAN 1997) 52.223-5 -- POLLUTION PREVENTION AND RIGHT-TO-KNOW INFORMATION (MAY 2011) 52.223-18 -- ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT MESSAGING WHILE DRIVING (AUG 2011) 52.225-13 -- RESTRICTIONS ON CERTAIN FOREIGN PURCHASES (JUN 2008) 52.228-5 -- INSURANCE -- WORK ON A GOVERNMENT INSTALLATION (JAN 1997) 52.232-18 -- AVAILABILITY OF FUNDS (APR 1984) 52.232-33 -- PAYMENT BY ELECTRONIC FUNDS TRANSFER-SYSTEM FOR AWARD MANAGEMENT (JUL 2013) 52.232-39 -- UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS (JUN 2013) 52.232-40 -- PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) 52.233-3 -- PROTEST AFTER AWARD (AUG 1996) 52.233-4 -- APPLICABLE LAW FOR BREACH OF CONTRACT CLAIM (OCT 2004) 52.237-2 -- PROTECTION OF GOVERNMENT BUILDINGS, EQUIPMENT, AND VEGETATION (APR 1984) 52.237-3 -- CONTINUITY OF SERVICES (JAN 1991) 52.242-13 -- BANKRUPTCY (JUL 1995) 252.203-7000 -- REQUIREMENTS RELATING TO COMPENSATION OF FORMER DOD OFFICIALS (SEP 2011) 252.203-7002 -- REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (SEP 2013) 252.204-7003 -- CONTROL OF GOVERNMENT PERSONNEL WORK PRODUCT (APR 1992) 252.209-7004 -- SUBCONTRACTING WITH FIRMS THAT ARE OWNED OR CONTROLLED BY THE GOVERNMENT OF A TERRORIST COUNTRY (OCT 2015) 252.225-7012 -- PREFERENCE FOR CERTAIN DOMESTIC COMMODITIES (FEB 2013) 252.225-7021 -- TRADE AGREEMENTS (OCT 2015) 252.225-7036 - BUY AMERICAN-FREE TRADE AGREEMENTS-BALANCE OF PAYMENTS PROGRAM (NOV 2014) 252.225-7048 -- EXPORT CONTROLLED ITEMS (JUN 2013) 252.232-7003 -- ELECTRONIC SUBMISSION OF PAYMENT REQUESTS AND RECEIVING REPORTS (JUN 2012) 252.232-7006 -- WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013) 252.232-7010 -- LEVIES ON CONTRACT PAYMENTS (DEC 2006) 52.209-10 -- PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC CORPORATIONS (DEC 2014) 52.219-28 -- POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (JUL 2013) 52.252-2 -- CLAUSES INCORPORATED BY REFERENCE (FEB 1998) 52.252-6 -- AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984) (Insert "DoD FAR Supplement (48 CFR Chapter 2)" in paragraph (b)) 252.203-7999 -- PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMEMNTS (DEVIATION 2015-O0010) (FEB 2015) 252.204-7012 -- SAFEGUARDING OF UNCLASSIFIED CONTROLLED TECHNICAL INFORMATION (NOV 2013) 252.211-7003 -- ITEM UNIQUE IDENTIFICATION AND VALUATION (DEC 2013) 252.244-7000 -- SUBCONTRACTS FOR COMMERCIAL ITEMS (JUN 2013) 252.247-7023 -- TRANSPORTATION OF SUPPLIES BY SEA (APR 2014) iRAPT (LC 5002) (Formaly known as WAWF) HIPPA (LC 5001) 52.212-5 -- CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS -- COMMERCIAL ITEMS (JUL 2014) (DEVIATION 2013-O0019) Statement of Objective (SOO) Dwight David Eisenhower Army Medical Center (DDEAMC) Fort Gordon GA 30905 EQUIPMENT: The requirement is for an automated Microbial Identification, Antibiotic Susceptibility Testing instrument (ID/AST) and a Matrix Assisted Laser Desorption Ionization Time of Flight (MALDI-TOF) Mass Spectrometry Microbial Identification Instrument; including Reagents, Supplies and Consumables. The contractor shall provide equipment and reagents on a cost per test basis beginning 01 January 2017, or date of award. The contractor shall provide all upgrades to the equipment hardware and operating system software to the extent without additional charge to the Government to the extent required to operate equipment according to the manufacturer's original specification. The contractor is required to provide new equipment. Discontinued models are not acceptable. The system shall have the capability to communicate with existing interface equipment which shall provide automatic uploading of patient results into CHCA. Those results, once verified, will be updated in the patient record, eliminating transcription errors. This is a base plus four (4) option year contract (if exercised), through 30 September 2021. Funding will be subject to the availability of funds. Title and ownership of contractor-furnished equipment and components will remain with the contractor. The contractor shall perform complete correlation, precision, carry-over, and validation studies at the time of installation and for all new test added throughout the contract period on manufacturer supplied and or 3rd party assay. All studies shall meet guidelines recommended by CLSI, CAP and CLIA. Reagents shall be provided bearing the same lot number within the designated shipments. The contractor shall provide stock that meets the proficiency testing standards of the College of American Pathologist (CAP), the Joint Commission on Accreditation of Health Organizations (JCAHO), the Clinical Laboratory Standards Institute (CSLI), and be approved by the Food and Drug Administration (FDA). In the event that consumables are found to be defective, back order or recalls, the contractor agrees to shipping items overnight at no additional cost to the government. The Government assumes liability for damage to or loss of contractor furnished equipment when such damage or loss is caused by negligence, wrongful acts or equipment misuse by Government users. The contractor owned equipment will be located in the room 1L31, Microbiology Laboratory at DDEAMC, Fort Gordon GA. INSTALLATION AND SITE PREPARATION: Site preparation specifications shall be furnished in writing by the Contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer's claimed specifications. The Contractor shall be responsible for assessing the space available in the facility in order to ensure the right size equipment is provided; thereby not creating a safety hazard. The government shall prepare the site at its own expense and in accordance with the specification(s) furnished by the contractor. Any alterations or modifications in site preparations, which are attributable to incomplete or erroneous specifications provided by the contractor, which would involve additional expense to the government, may result in request for reimbursement at the expense of the contractor. The Contractor shall furnish, install, support, exchange, and replace any system improvements, including modifications, enhancements, upgrades, updates or revisions and supporting documentation, supply items and consumables at no additional cost to the Government. The Government has the option to reject or accept any changes. Such rejection shall not relieve the contractor of the responsibility to continue to provide the required supplies. REMOVAL OF EQUIPMENT: All costs associated with the removal of contractor's equipment shall be at the contractor's expense. Within 15 days after expiration or termination of the contract the contractor shall remove the equipment from the Government premises, to include disconnection, packaging and shipping. All devices furnished by the contractor except those purchased by the Government under separate contract or credit card purchase, shall accompany the equipment when returned to the contractor. In the event the contractor fails to remove the equipment within the time specified herein, the Government shall return the equipment to the contractor at the contractor's expense. MAINTENANCE: The Contractor, in accordance with the manufacturer's recommended PM schedule to meet the serviceability requirements and standards of the manufacturer and Joint Commission must perform PM inspections. If at any time the equipment malfunctions or becomes inoperable, the contractor must perform on-site repairs to the equipment at no cost to the Government. If the equipment is unable to be repaired on-site, the contractor must provide equitable replacement equipment while the off-site repair is conducted. In no event shall the Government alter, repair or replace any parts or components on contractor-owned equipment. TRAINING: Annual Training includes two (2) off-site training for key operators, includes room, board and airfare for each completed year of the customer agreement upon request at no additional cost to the government. The contractor provides supplemental off-site training for all four (4) option years, excluding airfare Twenty-four hours a day, 7 days a week maintenance at no additional cost to the government. All travel transportation/lodging should conform to the requirements of the Joint Travel Regulation (JTR). Onsite training will be provided to staff at mutually agreed upon times and dates according to a pre-set training schedule formulated at time of installation. All travel transportation/lodging should conform to the requirements of the Joint Travel Regulation (JTR). Salient Characteristics: MALDI-TOF Mass Spec Microbial Identification Instrument The instrument shall be a 110-240 (V) volt, self-contained, FDA-approved with software system designed for rapid identification of clinically-relevant bacteria, yeasts/fungi. System must facilitate sample preparation, identification of intact cells without extraction or purification. Instrument must not require further manual sample extraction steps other than on target slide addition of matrix (CHCA) for GP and GN or formic acid (FA) and matrix (CHCA) for Yeast. The matrix (CHCA) and Formic Acid (FA) must be ready to use and light stable at +4C. 1) Shall be geared towards walkaway operation. 2) Shall be a high throughput platform capable of processing at least 192 clinical samples plus QC controls in a single, uninterrupted run. 3) Each target slide should have a dedicated QC control spot for acquisition groups of 16 clinical samples 4) The system shall offer flexibility in workflow with multiple remote sample preparation stations and ability to load up to 4 target slides. 5) The system shall include an integrated software system that performs all required calculations as needed for a final result and is fully compatible with composite healthcare system (CHCS) in such a manner that results generated by the analytical platform are seamlessly transferred to CHCS. 6) The system shall report the ID result with a confidence value. 7) The system shall analyze raw spectral data not just by comparing a spectrum with a reference spectrum database but using a method that assigns probability values to individual peaks in a spectrum and calculates the confidence levels of a choice ID. 8) The system shall be able to distinguish Streptococcus pneumonia from non-pneumococcal species of Streptococcus mitis group. 9) The mass spec system shall provide a mass range no less than 1DA-500kDa. 10) The MALDI TOF shall have a linear flight tube (TOF) length up to 1.2 meters. 11) The MALDI TOF shall have the ability to run in both positive and negative ion modes (standards) 12) The MALDI TOF shall meet minimum sensitivity of 250amol Glu-Fib peptide, 250 fmol BSA protein with a resolution of 5000 FWHM ACTH 18-39 peptide. 13) The software shall maintain records of quality control materials. Results for non-clinically validated species shall be displayed in the report, alerting lab staff that additional testing should be conducted. These can include organisms with insufficient clinical performance data and organisms not found in human clinical samples as reported in the scientific literature. Such organisms shall be automatically highlighted in all printed, exported or audited files. 14) Users must be able to export all organisms via network-based software (middleware) for audit trail purposes or ID/AST trending, epidemiology, statistics, antibiogram, or other purposes. Furthermore, the same software shall be able to directly link the MALDI-TOF with the AST/ID instrument and blood culture instrument currently in use by the laboratory using common nomenclature to facilitate seamless data archiving, mining, and retrieval, and analysis. 15) The MALDI-TOF and AST platform shall be able to provide consolidated reporting for identification and antibiotic susceptibility testing. 16) The system shall meet standards set by the Risk Management Framework (RMF) for DoD Information Technology (IT). 17) The system shall have sensors to detect and notify the user of conditions that may result in erroneous results. Systems checks and maintenance should be performed and documented by the system at specified intervals. 18) The contractor shall provide all necessary personnel, reagents and consumable items to conduct validation of instrument and assays in accordance with the requirements of CAP and DDEAMC. 19) The instrument shall be delivered and installed by the contractor at no cost to the government. The instrument/assays shall be validated no later than 01 January 2016. Microbial Identification (ID) and Antibiotic Susceptibility Testing (AST) Instrument (1) The system shall provide self-contained, fully automated testing of suspensions of bacteria and yeasts isolated from patient specimens. a. Instrument shall be capable of identification of yeasts/fungi b. Instrument shall be capable of identification of Coryneform bacteria and anaerobic bacterial species c. Instrument shall be capable of identification of Neisseria, Haemophilus, and Campylobacter species d. Instrument shall be capable of antifungal susceptibility testing of yeasts/fungi e. Instrument shall be capable of identification of gram negative bacteria f. Instrument shall be capable of identification of gram positive bacteria (2) The instrument shall be 110-240 (V) volts, FDA-approved or cleared (3) The system shall be designed to provide identification and antimicrobial susceptibility (ID/AST) results in as little as 5 to 8 hours. (4) The system shall provide reduced hands-on time, and require no additional reagents (no on-board reagents). (5) The system shall optimize user safety with closed, disposable testing devices. (6) The system shall provide maximum traceability with the pre-applied testing device barcodes. (7) The testing devices shall reduce disposable costs by being lightweight and sealing all reagents and bio-hazardous waste. (8) The system shall include software that enables easy access to ID and AST results. The software shall allow rapid result searches by patient, tech, date tested, and organism and accession number. (9) The system software shall facilitate selection of appropriate antibiotics by providing rapid, accurate fingerprint recognition of bacterial resistance mechanisms. In addition, the software shall be capable of generating antibiogram. (10) The system shall have sufficient capacity and throughput to meet the volume and service demands as defined in the Prices and Terms. Bar-code System. All bar code readers must be capable of reading and decoding any label when manually applied to a specimen tube in accordance with the guidelines described in the Clinical and Laboratory Standards Institute (CLSI) standard, Laboratory Automation: Bar Codes for Specimen Container Identification, NCCLS Document Auto2-A, Approved Guideline, Vol. 20, No. 19, October 2005. Data Management System. Integrated central processing unit with sufficient data storage and printing capability to accommodate and provide immediate access to patient records. Ability to manage rules for optimal specimen handling with alert system with ability to send automated comments based on the rules to patient host record. Linearity limits, "Add-on" or reflex tests, repeats for critical value tests, review for specimen integrity and delta checks on previous patient results are examples of automatic rules functions required. Specimen Integrity based rules to cancel/edit tests based on the test performed and the interfering substance. Cancelled test shall be able to transmit to the host along with the appropriate comment. Interfacing pending Pathology & Laboratory Medicine and Lab Information System technology. Bi directional Interface - shall be able to interface and automate the Microbiology instruments with orders and results separated for optimal transmission capable of automatically uploading test results. Back up to network data management handling. Software management features with rules capable of preparing data for auto validation prior to host transmission. Data Management with record storage including instrument of record for all patient results. All software and software licenses, interfaces, and hardware (e.g. servers, printers, monitors, UP, etc.) shall be included with cost of hardware required disclosed for removal if needed. Safety. The system must have sufficient safety features to avoid unnecessary exposure to bio-hazardous and chemical materials. The exposure to and the volume of bio-hazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.
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Place of Performance: Address: DD EISENHOWER ARMY MEDICAL CENTER, 300 E. HOSPITAL RD. ROOM 1H05, FORT GORDON, Georgia, 30905, United States; Zip Code: 30905
Record: SN04332745-W 20161122/161120233143-35940b55a69775a7c272c6d331b37f6e (fbodaily.com)
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65 -- Microbial Identification Test Analyzer