FBODaily.com | FedBizOpps: FILE | 66 | Automated Immunoassay Analyzer - Procalcitonin Cost-per-Test - Attachment

FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 24, 2017 FBO #5600
DOCUMENT

66 -- Automated Immunoassay Analyzer - Procalcitonin Cost-per-Test - Attachment

Notice Date: 3/22/2017
Notice Type: Attachment
NAICS: 334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing
Contracting Office: Department of Veterans Affairs;Network Contracting Office;NCO 19;4100 E. Mississippi Avenue, Suite 900;Glendale CO 80246
ZIP Code: 80246
Solicitation Number: VA25917Q0280
Archive Date: 4/21/2017
Point of Contact: Cynthia Reese
Small Business Set-Aside: N/A
Description: Page 17 of 28 AUTOMATED IMMUNOASSAY ANALYZER-PROCALCITONIN COST-PER-TEST This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested. The proposed contract action is for the acquisition of equipment (laboratory diagnostic analyzers), supplies (i.e. reagents), maintenance and training for Eastern Colorado Healthcare System in Denver, CO. Offerors may identify their interest and capability by submitting proposals. All quotes must be received prior to 5:00pm EST on March 30, 2017. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. NAICS code is 334510, Diagnostic Equipment/Electromedical, Manufacturing; size standard is 1250 employees. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-91 effective September 30, 2016. Potential offerors are to complete the pricing schedule. Award will be made to the lowest priced offeror who can fulfill the requirements stated in the statement of work and has an acceptable past performance. Quotes are due no later than 5:00 PM EST, March 30, 2017. Telephone calls will not be accepted. All quotes are to be sent electronically to Cynthia.reese@va.gov INSTRUCTIONS FOR SUBMITTING RFQ The Government will evaluate quotes on the basis of the material presented in the written offer. The Offeror s quote shall contain: 1) responses to Factor 1 Past Performance; 2) CLIN (contract line item number) structure in schedule. Section B shall be completed including unit prices and total prices; 3) Quotes shall be submitted via email; 4) Each quote section shall not exceed 5MB in size. This procurement will be awarded to the lowest priced offeror who can fulfill the requirements stated in the statement of work and has an acceptable past performance. FACTOR - 1: PAST PERFORMANCE The Past Performance attachment (letter and questionnaire) are included in this solicitation. Offeror shall complete Section A of the attachment and send the letter and questionnaire to three (3) references that can provide the Automated Immunoassay Analyzer specializing in Procalcitonin Cost per Test. Instructions are in the letter for returning the questionnaire to Network Contracting Office 19. At a minimum, one reference must be received by the closing date to be considered. FACTOR 2: PRICE Pricing for this task order shall be Firm Fixed Price and include any discount being offered. Price shall be presented separately from the Technical quote. Price will be submitted by completing the Schedule/CLIN form under Section B.2. CONTRACT ADMINISTRATION DATA Offerors shall complete Section B.1 with company, point of contact, DUNS and TIN information. SECTION B: SCHEDULE The Government estimates the volumes listed in the attached spreadsheet, but does not guarantee volumes as listed; they are ESTIMATES ONLY. Vendor will work with the laboratory to adjust reagent supply to match workload changes. Line Items for Base and 4 Option Years. Line Item Description Estimated Annual Volume Cost per Kit Estimated Total Cost 0001 Base Year Procalcitonin Cost-per-test 24 1001 Option One Procalcitonin Cost-per-test 24 2001 Option Two Procalcitonin Cost-per-test 24 3001 Option Three Procalcitonin Cost-per-test 24 4001 Option Four Procalcitonin Cost-per-test 24 ALL YEARS TOTALS: ________________________ B.1 CONTRACT ADMINISTRATION DATA (continuation from Standard Form 1449, block 18A.) B.1.1. Contract Administration: All contract administration matters will be handled by the following individuals: B.1.1.1. CONTRACTOR: Name ____________________________ Title ____________________________ Company ____________________________ Address ____________________________ Telephone # _________________ FAX # _________________ E-mail address ____________________________ B.1.1.2. GOVERNMENT: Cynthia Reese Contract Specialist Department of Veterans Affairs Rocky Mountain Network NCO 19 Contracting 4100 E. Mississippi Avenue, Suite 900 Glendale, CO 80246 Telephone: 303-202-8274 FAX: 303-691-6558 E-mail: Cynthia.Reese@va.gov B.1.2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with: [X] 52.232-34, Payment by Electronic Funds Transfer Other Than System for Award Management, or [N/A] 52.232-36, Payment by Third Party B.1.3. GOVERNMENT INVOICE ADDRESS: Invoices shall be submitted in arrears: a. Quarterly [] b. Semi-Annually [] c. Other [Monthly in Arrears] B.1.4. GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be submitted electronically to the VA Financial Services Center for payment processing, free of charge. For any questions about the e-invoicing program, please contact the FSC at the phone number or email address listed below: OB10 e-Invoice Setup Information: (877) 752-0900 OB10 e-Invoice email: USClientServices@ob10.com FSC e-Invoice Contact Information: (877) 353-9791 FSC e-invoice email: vafsccshd@va.gov The following two codes will be required when creating a vendor profile in OB10: OB10 Buyer Number AAA544240062 Promo Code: VAPC7Y18 B.1.5. DUNS NUMBER: Please provide the Dun and Bradstreet Number assigned to your firm in the space provided: ________________________________________. B.1.6. TAX IDENTIFICATION NUMBER: Please provide the tax identification number to be utilized for this contract: ________________________________________. B.1.7. PERIOD OF PERFORMANCE: Services required herein shall be for a one year period with four one-year pre-priced options for renewal, as follows: Base Year: April 1, 2017 March 31, 2018 Option Year 1: April 1, 2018 March 31, 2019 Option Year 2: April 1, 2019 March 31, 2020 Option Year 3: April 1, 2020 March 31, 2021 Option Year 4: April 1, 2021 March 31, 2022 Pathology and Laboratory Medicine Service Procalcitonin Statement of Work GENERAL: The Denver VA Medical Center requires an automated immunoassay analyzer to perform Procalcitonin testing on their veteran s patient population. All work is to be performed in accordance with the guidelines established by Federal, State and local ordinances, with FDA and manufacturer s guidelines, and with all terms, conditions, provisions, schedules and specifications provided herein. SCOPE: The immunoassay analyzer shall perform biochemical tests to detect or measure specific proteins or other substances through their properties as antigens or antibodies. Modern analyzers can run an assay in multiple steps with various reagents being added and washed away so that multiple results can be obtained from one sample. The vendor shall provide a Cost- Per-Test (CPT) Program with consumables to include: Reagents for Patient Testing - Calibration and control material - Disposables / Accessories. The Government will purchase consumables as needed at the calculated price and be invoiced at time of shipment. The Denver VA Medical Center is located at 1055 Clermont Street, Denver, CO 80220. TERM OF CONTRACT: The contract structure shall include a base period (not to exceed 1 year) and 4 option years (each not to exceed 1 year). EQUIPMENT REQUIREMENTS: Title to all equipment provided remains with the Vendor. This requirement is for a NEW Immunoassay analyzer in a counter top configuration, not to exceed 31 inches in width, depth or height (30"w x 26.8" d x 25.7" h) Electrical Voltage: 100-240 VAC, Frequency 50-60Hz, Power: 150 Watts. Functionality and Performance Specifications: The analyzer must be capable of processing different assays simultaneously. The analyzer must be equipped with automated barcode identification of reagents and specimens. The analyzer must provide sensitive and accurate measurement of Procalcitonin in less than 30 minutes. The analyzer test menu must also include assays for Rubella IgM, CMV IgG + IgM, Mumps IgG + IgM, Rubeola IgG + IgM, etc. but not only limited to Procalcitonin. SYSTEM REQUIREMENTS: Offered analyzer shall be capable of producing accurate and reproducible results by established diagnostic methods. The analyzer shall provide accurate test assay results without excessive malfunctions, breakdowns, or service calls. The vendor(s) shall furnish all clinical laboratory supplies, materials, equipment, and services necessary for the performance of the work as described herein to the Denver VA Medical Center. Vendors shall provide the participating facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibrators, disposables, and any consumable part necessary for analyzing/testing. Vendor shall list the consumable parts provided. A list of the estimated yearly quantity will be provided. It is not a guaranteed minimum. Vendor shall specify calibration frequency, time required to perform calibration and any specific steps that must be followed prior to calibration. Vendor to provide at least two levels of commercial quality controls to be analyzed to meet facility and regulatory agency requirements. Analyzer shall have the capability of providing printouts for all patient results, calibrators, and controls. All consumable supplies (reagents, calibrators, controls, paper, disposable, etc.) required for the proper operation of the vendor s equipment and that are necessary to perform tests on the equipment shall be included and furnished by the vendor. The system shall have a design that supports the result integrity/removes the possibility of sample carryover. Vendor shall provide documented evidence confirming the system design removes the possibility of any sample carryover. The vendor shall list all of the reagents/supplies needed for Procalcitonin testing, state if the reagents/supplies are stored at room temperature or refrigerated, and state if the reagent/supplies are color-coded and state the size of the kit (as it relates to the amount of storage space required for a quarterly shipment). The vendor shall state the open date stability for the reagents/supplies in the kit. The vendor is to define the actual hands-on maintenance time required for daily, weekly, monthly, quarterly, and as needed maintenance. The vendor is to include the analyzer/technologist time required to perform each maintenance task. The vendor shall list which tasks are user level and which tasks are service level. The pricing shall be based on new state of the art equipment. The vendors offered immunoassay analyzer shall conform to the facility s existing space. The vendor shall supply equipment that shall perform satisfactorily at any laboratory relative humidity between 15 and 85 percent and any laboratory temperature between 50 and 90 degrees Fahrenheit (10 to 30 degrees Celsius). If at any point during the contract period the vendor releases a new instrument with random access capability that meets the requirements defined in this statement of work, the facility will be allowed to upgrade to an updated/ new instrument without additional charges to the facility. Test assay time must not exceed 30 minutes. Vendor is to state the time required from start to finish to obtain a patient result. The analyzer shall streamline all aspects of testing, thereby enhancing operational efficiency, improving turnaround time, supporting improved patient outcomes, and improving the productivity of the using facility. Special Consideration The Denver VA Medical Center requires special consideration during the solicitation and contract period of performance. A new Denver VA ECHCS will be opening sometime in the future (within the next 5 years). The vendor will potentially be required to provide the same type and quantity of instruments for the new Denver VA Medical Center as provided for the current Denver VA Medical Center. The additional instruments shall be installed at the new facility four to six months before the new medical facility s grand opening, so that all method validations can be completed on time. The original instruments will continue on result operations at the current Denver VA Medical Center while the mirrored image (secondary) of instrument undergo their validations at the new VA hospital to ensure test coverage. Once the secondary instruments have been validated, reviewed and approved for patient testing by the Medical Director and placed in use for patient testing at the new facility, the instruments at the old facility shall be decontaminated and removed by the vendor, at no additional cost to the Government. INSTRUMENTATION AND SOFTWARE: The equipment shall include 120 volt UPS that has a 2-3 hour back-up capability. The vendor shall be responsible for replacing the UPS should it become dysfunctional and provide battery replacement as needed at no cost to the Denver VA Medical Center. The system shall support multiple barcode formats that may be enabled concurrently. The system shall have a barcode reader for sample identification. The barcode reader must be able to read current standardized VA barcode formats. The vendor is to state how many sample results can be stored in the analyzer. VA patient information may not reside at the vendor s location or on removable media. Only the instrument configuration can be stored on removable media. The vendor shall provide all upgrades to the equipment hardware, software, and operating systems without additional charge to the Government. Requests for upgrades or replacement, due to workload increase, excessive instrumentation/ test kit failures/ malfunctions, breakdowns, or service calls will be evaluated as needed/annually by the facility with communication to the vendor for modification of the contract. A high incidence of problems with any instrumentation/ test kits may indicate probable non-compliance with the terms of this contract and will entitle the facility to replacement with equipment/ test kits that can produce the required criteria of this BPA satisfactorily to the user. The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this BPA, but not until the completion of new vendor s equipment installation inclusive of completed cross over studies; decontamination and removal of the equipment will be of no cost to the Government. The facility, per their protocol, will be responsible for the removal/erasing of the hard drive at analyzer removal/upgrade. If the VA facility chooses to retain the hard drive, it will be at no additional cost to the VA. The vendor and their personnel shall be subject to the same Federal laws, regulations, standards of VA policies as regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST s Web site at: http://checklists.nist.gov To ensure that appropriate security controls are in place, vendor must follow the procedures set forth in VA Information and Information System Security/Privacy Requirements for IT Contracts located at the following Web site : http://www.iprm.oit.va.gov The instrument must interface with laboratory information system (VISTA) through the Data Innovations interface and any other future laboratory interfaced systems. The instrument-LIS interface must be, at minimum unidirectional. The vendor shall provide the instrument LIS physical connection and translation (drivers) for the interfacing of the analyzer. INSTALLATION AND VALIDATION: The vendor shall list analyzer/utility requirements (electrical, water, plumbing, etc.). The vendor is to provide the local, state and federal Environmental Protection Agency (EPA) guidelines for the disposal of waste materials (reagents, calibrators, and all bio-hazardous disposed material, etc.). Vendor is to supply a document for the waste determination/evaluation of their proposed products. The vendor shall provide weight and dimensions of proposed analyzer. Footprint of system should be small and fit on a typical laboratory counter top. The vendor shall indicate any routine and/or special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to: paper, printer cartridges, drainage systems, surge suppressors, UPS, etc. Any items excluded by the vendor shall be delineated in their offer. The cost of the excluded items must be incorporated in the price offer. The vendor shall provide the participating facility with all reagents, calibrators, controls, linearity material, and any supplies needed at installation and during training of staff. The vendor shall pay all shipping costs for the analyzers and all supplies needed for the installation, correlation studies and training of staff. At installation of new equipment, vendor will provide all of the manpower and technical support specialist(s) to assist in equipment installation/set-up, correlation studies (evaluation/comparison of data sufficient to satisfy CAP standards, CLSI and related documents, and Federal Regulations), staff training, methodology problems, and questions. Method Performance/Comparison shall include but is not limited to: Accuracy studies for the analyte: A minimum of 25 samples, consisting of an adequate number of both high and low samples will be run by the present and the proposed method. Vendor will analyze results and provide data to support acceptance of the new method. The evaluation will include validation of accuracy, in concordance to current method and meet current standards defined by Clinical Laboratory Standards Institute (CLSI). Precision study using low and high control material: This will consist of a within run precision study of at least 10 low and 10 high controls. Specificity Studies: Manufacturer s package insert, including any limitations and/or interferences, will be provided by the vendor. Sensitivity Studies: Manufacturer s package insert will be provided by the vendor. Carryover Studies: Presence of assay carryover shall be ruled out during the vendor s instrument validation process. Documentation of carryover studies performed during the validation process will be provided by the vendor. At installation/set-up the vendor/technical support specialist shall perform and place in a labeled binder all validation studies including: installation/set-up, correlation studies, linearity and cross-over studies. Evaluation/comparison data shall be sufficient to satisfy CAP standards and shall be completed within two weeks of installation at the facility. The support specialist shall assist with staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. The vendor shall provide equipment installation. The vendor shall supply a quarterly shipment and indicate how much storage space would be needed. The vendor shall ensure that all reagents/supplies received quarterly shall have at least a six month expiration date. The vendor shall work with the facility to adjust reagent supply to match workload changes and to provide the option annually for the facility to adjust the shipment table. The vendor shall state what their policy is in regards to adjusting a standing order or ordering an additional shipment of supplies. SUPPORT SYSTEMS (SERVICE, PREVENTATIVE MAINTENANCE AND SHIPPING OF SUPPLIES) Vendor will provide technical support services at no additional charge to the facility. Technical support by telephone shall be available 7 days a week, 24 hours a day. Technical support shall return all downtime calls within one hour. Should on-site service be required, the vendor s field service organization shall provide on-site service response within 24 hours after being contacted. The repair person shall also, prior to departure, provide the visited site with written documentation of services performed. Technical support shall place a service call for repairs if the technologist is unable to repair the analyzer within one hour of trouble-shooting with the hotline or on weekends/holidays/irregular tours when technologists may be unable to work with the hotline due to the facilities staffing. Service is to include, at no charge, all labor, travel, and parts necessary to make repairs. The vendor shall provide instrument support service sufficient to provide assistance with troubleshooting and repair of the analyzer. The vendor may list their service options available. Or the following service option may be available: 24 hours/day, 7 days/week. The support service shall follow-up all down calls within 1 hour. The Field Service Engineer (FSE) at all times shall keep the facility informed of the time line for when repairs are to be completed. All repairs on instrument shall be complete (at no cost to the facility) within 24 hours from the time the field service engineer arrives. The vendor shall pay for the laboratory testing at a reference facility if the equipment requiring repair is inoperative due to malfunction through no fault or negligence of the facility for a total of more than 24 hours. Downtime for each incident shall start from the time the facility makes a bona fide attempt to contact the vendor s designated representative until the analyzer is returned to good operating order. In the event that the consumables are found to be defective and unsuitable for use with the vendor's equipment, or the vendor has failed to comply with the requirements for routine supply delivery, the vendor shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the vendor shall deliver to the requesting facility, in the most expeditious manner possible, without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the vendor's equipment for one week (under normal Government test load volume). Vendor will pay all routine shipping fees for all supplies, consumables, and equipment to perform testing. Vendor shall have the ability to ship all temperature sensitive reagents/supplies in a manner to control temperature variation. The vendor must provide replacement parts at no charge and any components necessary for the operation of the instrument(s) to produce patient results. The vendor s technical service representatives must comply with the facility s requirements for onsite vendor representatives. This may require a low risk background investigation by federal authorities paid for by the vendor. PRICING SCHEDULE: Two kits per month as a minimum and 10 kits as maximum per month for quantities are estimated based upon volume and are intended to provide the potential vendor a basis for calculating their pricing. NOTE: Workload increases on the average of 3.0 5.0 % each year. A schedule of items offered and per item cost with any tiered pricing for volumes and/or percentages of use should be included as a separate attachment to your offer. TRAINING: On-site training shall be provided for 2 Key Operators. Vendor must provide all education/training during the on-site installation or after any update to the equipment. Training to include staff on all shifts. Training must include basic operation, quality control, interpretation, and reporting of results, required user performed maintenance, and troubleshooting. Vendor must provide a documented record of training (training checklist) completed for all trained staff before leaving site following installation at the site. Provide initial in-depth training for two key operators at the facility. The vendor may provide additional key operator training during the option years if requested. The vendor shall provide on-site refresher instrument training in renewal option years of the contract if so exercised. Vendor must supply all necessary procedure manuals, troubleshooting manuals, operator manuals, and MSDSs (also available on CD format or on-line). Procedures must be in the Clinical and Laboratory Standards Institute (CLSI) format. Vendor must provide assistance in creating preventive maintenance and quality control records or logs to meet the needs of the facility. PAST AND PRESENT PERFORMANCE QUESTIONNAIRE When Filled In, This Document Is Source Selection Sensitive IAW FAR 2.101 and FAR 3.104 SUBJECT: Request for Past Performance Evaluation TO: [Evaluator name] You have been identified as a point of contact for a past and/or present performance evaluation of the firm listed in Section A. This firm is currently being considered for a Procalcitonin Cost per Test contract at the Eastern Colorado Healthcare System (Denver) in VISN 19. Your prompt attention to this questionnaire will be greatly appreciated. Please complete Sections A through D (including the evaluation questionnaire) and email Sections A through D to Cynthia.reese@va.gov. The forms must be sent no later than Thursday, March 30, 2017 by 5:00pm EST. If you have any questions concerning this request, I can be contacted at 303-202-8274 orCynthia.reese@va.gov. Cynthia Reese Contract Specialist NCO 19 Glendale, CO Attachment - Past and Present Performance Questionnaire PAST AND PRESENT PERFORMANCE QUESTIONNAIRE Section A: Contractor Information 1. Contractor s Name and Address: __________________________________________________ __________________________________________________ __________________________________________________ 2. Point of Contact: __________________________________________________ 3. Phone Number: ___________________________________________________ 4. Project Title: Blood Culture and Respiratory Panel Cost per Test 5. Period of Performance: ____________________________________________ Section B: Respondent information (To Be Completed By Evaluation Respondent) 1. Evaluator s Company Name and Address: ___________________________________________ ___________________________________________ ___________________________________________ 2. Evaluator s name: _________________________________________________ 3. Phone Number: ________________________________________ Fax: ___________________________ 4. Email: _______________________________________________________________________________ 5. Contract Number: __________________________________ contract Type: ____________________ 6. Project Title: ___________________________________________________ 7. Period of Performance: __________________________________________ Section C: Email COMPLETED QUESTIONNAIRE FORM TO: Cynthia Reese, Contract Specialist, Network Contracting Office 19, Glendale, CO. Cynthia.reese@va.gov THIS FORM MUST BE RETURNED NO LATER THAN: Thursday, March 30, 2017, 5:00pm EST Section D: PERFORMANCE INFORMATION: Choose the letter on the scale that most accurately describes the contractor s performance or situation. PLEASE PROVIDE A NARRATIVE EXPLANATION FOR ANY RATINGS OF U or M. U M NA S AA O Unsatisfactory Marginal Not Available Satisfactory Above Average Outstanding Performance did not meet most contractual requirements. There were serious problems and the contractor s corrective actions were ineffective. Performance did not meet some contractual requirements. There were problems, some of a serious nature, for which corrective action was only marginally effective. No record of past performance or the record is inconclusive. Performance met contract requirements. There were some minor problems and corrective actions taken by the contractor were satisfactory. Performance met all contract requirements and exceeded some to the government s benefit. There were a few minor problems which the contractor resolved in a timely, effective manner. Performance met all contract requirements and exceeded many to the government s benefit. Problems, if any, were negligible and were resolved in a timely, highly effective manner 1. Completed installation, training and transition of laboratory analyzer within the scheduled timeline of 30-60 days and was able to perform testing no later than 90 days from contract award. U M NA S AA O COMMENTS/REMARKS:__________________________________________________________________________________________________________________________________________________ 2. Provided experienced, competent, customer service oriented and resolution minded maintenance, sales, administrative and supervisory staff / team to provide services and resolve issues. U M NA S AA O COMMENTS/REMARKS:__________________________________________________________________________________________________________________________________________________ 3. Adequately coordinated and controlled performance of subcontractors. U M NA S AA O COMMENTS/REMARKS:__________________________________________________________________________________________________________________________________________________ 4. Responded to maintenance and repair requests in atimely manner and provided high quality work for maintenance and repair of laboratory analyzers. U M NA S AA O COMMENTS/REMARKS:__________________________________________________________________________________________________________________________________________________ 5. Identified problems as they occurred. Suggested approaches to resolving problems. Displayed initiative and cooperation in solving problems. Provided adequate information and pricing for change orders and negotiated them in good faith. U M NA S AA O COMMENTS/REMARKS:__________________________________________________________________________________________________________________________________________________ 6. Provided timely and accurate/correct invoicing for laboratory cost per test. U M NA S AA O COMMENTS/REMARKS:__________________________________________________________________________________________________________________________________________________ 7. Contractor communicated professionally and in a timely manner of any changes, recalls, upgrades, and issues. U M NA S AA O COMMENTS/REMARKS:__________________________________________________________________________________________________________________________________________________ OVERALL PERFORMANCE RATING U M NA S AA O Signature of Rater: __________________________________________________ Date: ________________ E.10 ADDENDUM TO 52.212-2 EVALUATION-COMMERCIAL ITEMS (JAN 1999) E10.1 Introduction Evaluation of Offerors are being made IAW FAR Part 12.602. The contract shall be awarded to the lowest priced offeror who can fulfill the requirements stated in the Statement of Work and has an acceptable past performance. E10.2 Procedures All offerors will be required to prepare and submit their complete quote submission in accordance with the instructions in Provision 52.212-1 of this Request for Quote. Quotes and other information will be evaluated to ensure the requirements in the statement of work can be met. E10.3 Factors E10.3.1 Factor 1 Past Performance Offerors shall send the Past Performance letter and questionnaire to three references who have also received instruments for Procalcitonin on a cost per test basis. The past performance questionnaire has instructions for the references to send the final evaluations to the contract specialist at NCO-19. The Government will review and evaluate past performance questionnaires. Overall evaluations of satisfactory or better will be considered an acceptable past performance. At a minimum, one reference must be received by the closing date to be considered. E10.3.2 Factor 2 - Price Factor Assessment: This criterion evaluates the overall price to determine if the offered price is fair and reasonable. C.9 IT CONTRACT SECURITY VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 3. VA INFORMATION CUSTODIAL LANGUAGE a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR. 4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required. c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall. d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges. e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle. f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties. g. The contractor/subcontractor agrees to: (1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies: (a) The Systems of Records (SOR); and (b) The design, development, or operation work that the contractor/ subcontractor is to perform; (1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and (2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR. h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency. (1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records. (2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph. (3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems. j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 3 days. k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 10 days. l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology. 5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation. b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks. d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary. e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost. f. VA prohibits the installation and use of personally-owned or contractor/ subcontractor-owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE. g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: (1) Vendor must accept the system without the drive; (2) VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or (3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. (4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; (a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and (b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract. (c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. 6. SECURITY INCIDENT INVESTIGATION a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/ subcontractor has access. b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. 7. LIQUIDATED DAMAGES FOR DATA BREACH a. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. b. The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 8. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day's notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. 9. TRAINING a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document - e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. (End of Clause) (End of Addendum to 52.212-4)
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