Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 02, 2018 FBO #6035
DOCUMENT

66 -- Electrophoresis Equipment and Reagents - Attachment

Notice Date

5/31/2018
 

Notice Type

Attachment
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

Department of Veterans Affairs;Ann Arbor Healthcare System;Network Contracting Office 10;2215 Fuller Road;Ann Arbor MI 48105
 

ZIP Code

48105
 

Solicitation Number

36C25018Q0794
 

Response Due

6/7/2018
 

Archive Date

6/22/2018
 

Point of Contact

John Saunders
 

E-Mail Address

aunders2@va.gov<br
 

Small Business Set-Aside

Total Small Business
 

Description

This is a combined synopsis/solicitation for brand name or equal commercial items prepared in accordance with the format in FAR 13.5, as supplemented with additional information included in this notice for the VAMC Ann Arbor, 2215 Fuller Rd. Ann Arbor, MI 48105-2603. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. 36C25018Q0794 is issued as a request for quotes. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-94, 2005-95/ 01-19-2017. The North American Industry Classification System (NAICS) number is 325413. The NAICS size is 1,250 employees. This request for quote is being conducted as a small business set aside. Responses shall include: (1) Business Name and Address, (2) FSS Contract Number (3) Vendor Point of Contact Name, Phone Number and E-mail Address (4) DUNS and NAICS code (5) Business Size (6) Type of Business: service disabled veteran owned, veteran owned small business, 8a, HUBZone, woman-owned, etc. (7) If the concern is the manufacture and the sole distributor, the concern shall provide documentation supporting the claim. Contractors that deem themselves capable of meeting the requirement shall provide a quote that includes the below information to John Saunders, Contracting Officer, at john.saunders2@va.gov no-later-than Thursday, June 7, 2018 at 4:30PM, EST referencing 36C25018Q0794. Contractor must be registered with https://www.sam.gov Supplies are to include only TAA compliant items. Items that are not TAA compliant must be clearly identified by the contractor on the contractor s quote. Supplies not listed on the offeror s FSS shall be clearly identified as open market items on the offeror s quote. FOB is Destination. Offeror shall state a period of performance that includes the offers projected final delivery date. Delivery is needed 120 days ARO. Vendor shall submit documentation supporting that the proposed analyzers is FDA approved when responding to this solicitation. Delivery location is: VAMC Ann Arbor 2215 Fuller Rd. Ann Arbor, MI 48105-2603 The following clauses and provisions apply: 52.203-17 - Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (APR 2014). 52.203-99 - Prohibition on Contracting With Entities That Require Certain Internal Confidentiality Agreements (DEVIATION 2015-02) (FEB 2015). 52.204-4 - Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (MAY 2011) 52.204-7 - System for Award Management. The offeror shall provide its DUNS, or if applicable it s DUNS+4 number, with its offer which will be used by the contracting officer to verify that the offeror is registered in the SAM database. Lack of registration in the SAM database will make an offeror ineligible for award. Offerors and contractors may obtain information on registration via the internet at http://fedgov.dnb.com/webform, or if the offeror does not have internet access it may call Dun and Bradstreet at 1-866-705-5711. 52.212-1 - Instructions to Offerors - Commercial Items applies to this acquisition and offerors must comply with all instructions contained within it. 52.212-2 - Evaluation - Commercial Items, the Government will award a purchase order resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation is the lowest price technically acceptable; that is most advantageous to the government; price and other factors considered. 52.212-3 - Offeror Representations and Certifications - Commercial Items. A completed copy of this provision shall be submitted with the offer unless ORCA registered which must be noted in quotation. 52.212-4 - Contract Terms and Conditions - Commercial Items. 52.212-5 - Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items to include: 4, 8, 14, 22, 25, 26, 27, 28, 29, 30, 33, 44, 48 and 50. 52.217-9 - Option to Extend the Term of the Contract (MAR 2000). 52.219-6 - Notice of Total Small Business Set Aside. 52.232-40 - Providing Accelerated Payments to Small Business Subcontractors (DEC 2013). 52.252-2 - Clauses Incorporated by Reference. The following additional clauses apply: VAAR 852.203-70 - Commercial Advertising, 852.211-73 - Brand Name or Equal (JAN 2008), 852.232-72 - Electronic Submission of Payment Requests, 852.246-70 - Guarantee and 852.246-71 - Inspection. FOR MORE INFORMATION PLEASE SEE THE STATEMENT OF WORK BELOW STATEMENT OF WORK CAPILLARYS AND/OR AUTOMATED GEL ELECTROPHORESIS SYSTEMS 506-18-3-1030-0090 C.0 SCOPE: C.0.1 VA ANN ARBOR HEALTHCARE SYSTEM (VAAAHS): VAAAHS requests a Cost per Test (CPT) base year contract with four (4) additional option years; base year starting once the instrument is placed on line. The Contractor shall provide one (1) Capillarys/Gel system and operating software that performs protein electrophoresis studies on serum, urine. Offer shall include: one (1) automated agarose gel electrophoresis system and operating software, one (1) auto- sampler, Personal Computer, monitor, scanner, and high definition color printer, Uninterrupted Power Supply (UPS), and all parts materials, labor, supervision, test equipment, Material Safety Data Sheets (MSDS), reagents, capillaries, agarose gels, calibrators, control materials, supplies, consumables, technical manuals, service manuals provided in hard copy format and in electronic format, operator training, preventative maintenance, troubleshooting of the various units, installation and integration, service, support and preventative maintenance, 24 hour telephone hot-line service 365 days a year, with a Cost-Per-Test (CPT) schedule. VA Ann Arbor Healthcare System (VAAAHS) is located at: VAAAHS Pathology and Laboratory Medicine Service (PALMS) (113) 2215 Fuller Road Ann Arbor, Michigan 48105 DEFINTION OF NEED: VAAAHS requests a Cost per Test (CPT) contract with one base year and four (4) additional contract option years in order to provide protein electrophoresis studies on serum, urine, and cerebrospinal fluids (CSF). VA ANN ARBOR HEALTHCARE SYSTEM: The contract includes one (1) Capillarys/Gel system and operating software, one (1) automated agarose gel electrophoresis system and operating software, one (1) auto-sampler, Personal Computer, monitor, scanner, and high definition color printer, Uninterrupted Power Supply (UPS), and all parts materials, labor supervision, test equipment, technical manuals, Material Safety Data Sheets (MSDS), reagents, capillaries, agarose gels, calibrators, control materials, supplies, consumables, technical manuals, service manuals, provided in hard copy format and in electronic format that may be edited to meet our laboratory requirements. The vendor will provide training in the operation, preventative maintenance, troubleshooting of the various units, installation and integration of the system with service, support, and preventative maintenance, 24-hour telephone hot-line service, 365 days a year. Offer shall comply with the requirements listed in section C.3 OPERATIONAL FEATURES REQUIREMENTS section within, which outlines a list of tests to be done on the various electrophoresis platforms. Additional assays may be assayed on the analyzers as they become available from the vendor. DUTIES OF CONTRACTOR: VA ANN ARBOR HEALTHCARE SYSTEM: The Contractor shall provide all supplies, maintenance agreement, consumables, including shipping and handling of reagent orders. The vendor shall provide VAAAHS with (1) Capillarys/Gel system and operating software, one (1) automated agarose gel electrophoresis system and operating software, one (1) auto-sampler, Personal Computer, scanner, and high definition color printer, Uninterrupted Power Supply (UPS), and all parts materials, labor supervision, test equipment, technical manuals, service manuals, provided in hard copy format and in electronic format, Material Safety Data Sheets (MSDS), reagents, capillaries, agarose gels, calibrators, control materials, supplies, consumables. The vendor will provide training in the operation, preventative maintenance, troubleshooting of the various units, installation and integration of the system with service, support, and preventative maintenance, 24-hour telephone hot-line service, 365 days a year. Cost-Per-Test (CPT) program is requested. The system will be placed in room E312 at the VA Ann Arbor Healthcare System, located at 2215 Fuller Road, Ann Arbor, Michigan, 48105. OPERATIONAL FEATURES REQUIREMENTS: Test Menu MUST include test kits for the various assays involved in: *Serum Protein Electrophoresis (SPEP): Fractionation of various proteins in serum. *Immunotyping (IT): Identification of abnormal proteins in serum. *Immunofixation (I-Fix): Identification of abnormal proteins in human sera or other biological fluids. *Urine Protein Electrophoresis (UPEP): Fractionation of various proteins in urine. *CSF Oligoclonal Banding detection and Isoelectric Focusing (IEF). *Detection and identification of gammopathies in human sera or other biological fluids. *Detection and identification of Bence Jones protein in human urine or of free light chains in human serum. *High Resolution (HR) multifractionation of proteins in neat or diluted human serum or urine, concentrated cerebrospinal fluid. Capillarys/ Gel system must have automatic delimiting of curves and identification of fractions in order to minimize operator editing. Capillarys/ Gel system must have the ability to import quantitative specific protein results with correct measuring unit required to provide a comprehensive chartable report. System must have patient s demographic information available. Capillarys /Gel system must be able to import comment from a word processor for unlimited comment entry. Capillarys/ Gel system must allow for customized, compressed printouts of results and curves. The Capillarys/ Gel electrophoresis is the technique employed in the separation of proteins. Proteins are detected directly at a precise wavelength providing a high degree of precision and accuracy. The Capillarys/ Gel system must have eight capillary tubes, which will increase throughput. The Capillarys/ Gel system must provide walk-away technology from start to finish. System has the capability to read barcodes and provide for a continuous feed of samples. The system must have Positive Sample Identification (PSI) capability for full traceability from primary tube placement to final result recovery. The Capillarys/ Gel system should process approximately 80 samples per hour. The Capillarys/ Gel system must have a system that controls the temperature during sample migration for consistent reproducibility from analysis-to-analysis and from capillary to-capillary. The Capillarys/ Gel system must have reagent traceability technology. An interpretive software package must be available to facilitate reporting of results. A Personal Computer (PC), keyboard, mouse, monitor, imaging scanner and high definition color printer must be provided with connection cables for communication between the Capillarys and agarose gel electrophoresis systems. This will allow for importing and storage of immunofixation scans and Capillarys/ Gel results and images. The automated multiparametric agarose gel electrophoresis instrument must have high resolution and clarity of the electrophoresis bands for easy interpretation. The densitometry system is integrated into the instrument. The software provides editing and quantification of results, customization of reports, archival and recall of patient results. The system must have a color LCD touch-screen display. Vendor must update the new version of software as available to the customers. The automated multiparametric agarose gel electrophoresis system must provide a sequential processing of each electrophoresis step from application, migration, incubation, staining, destaining, drying, and final reading allowing for walk-away operation. The automated multiparametric agarose gel electrophoresis system throughput should be at least 80 protein samples per hour and at least 15 Immunofixation samples per hour. The automated multiparametric agarose gel electrophoresis system must automatically regulate voltage, current, power and volt hour, and stable temperature for consistent results from agarose gel to agarose gel. The automated multiparametric agarose gel electrophoresis system must have an easy to use keyboard and screen with up to 40 migration programs available. The automated multiparametric agarose gel electrophoresis system must have at least 8 different reagents on-line that are available at once. Reagents need to be water based. The system has a processing system for sample preparation and dilution designed to complement the automated multiparametric agarose gel electrophoresis system. A processing system will deliver precise micro-volumes of sample directly from primary tubes to the sample applicators, therefore allowing accurate and precise delivery of sample to agarose gel. Automated multiparametric agarose gel electrophoresis system compresses printouts of results and curves and allows the operator to customize the report(s). Automated multiparametric agarose gel electrophoresis system must be able to import comments from a word processor for customizable comment entry. Report options should include items such as patient history, immunofixation image, UID, name, age, ordering physician, specimen collection date and time. Automated multiparametric agarose gel electrophoresis system must have a three level quality control per analysis program, and Levey-Jennings statistical program. The Capillarys/ Gel and Automated multiparametric agarose gel electrophoresis system must have bidirectional (broadcast download & host query) Laboratory Information System (LIS) capabilities. Automated multiparametric agarose gel electrophoresis system must have software to allow for extensive curve editing capabilities, including deletion of minima and fractions, baseline modifications, fraction identification, and curve overlay. System must also have automatic alignment, centering of the electrophoretic pattern during reading, and automatic demarcation of the electrophoretic patterns. An auto-sampler is required for full standardization of all pre-analytical steps associated with the agarose gel electrophoresis system. The auto sampler must have Positive Sample Identification (PSI) capabilities. All systems that have Positive Sample Identification (PSI) must be able utilize and read barcode type: Code 128. All systems must be compatible with 110 120 volt power outlets. Adequate Uninterruptible Power System (UPS) to support each analyzer system. Each system must have an on-board type of waste disposable system for liquid output with options of connecting to floor drains. See the attached diagram for more information. Sampling systems must accommodate primary sample tubes sizes of 13mm x 75mm; 13 mm x 100 mm; and 16 mm x 100 mm; 5, 7, 10 mL tubes, and micro tubes. Systems must be able to accept plastic tubes meeting current safety requirements. System and tests must meet College of America Pathologists (CAP), Clinical Laboratory Improvement Act of 1988 (CLIA 88), Clinical and Laboratory Standards Institute (CLSI; formerly NCCLS) standards, and demonstrate satisfactory performance on CAP peer group comparisons. System must be able to analyze serum, urine, and cerebrospinal fluid (CSF) when applicable/dependent on the electrophoresis process. System must have cap piercing mechanism. System must be capable of integrating the work station to pathologist s desk. QUALITY CONTROL: The Capillarys/Gel must have a comprehensive quality control (Q.C.) program with statistical reduction of three Q.C. levels including Levey-Jennings charts. Automated multiparametric agarose gel electrophoresis system must have a statistical program with 3 levels of quality control per analyte, including Levey-Jennings charts. C4.3 The multiparametric agarose gel electrophoresis system has an automatic calibration system that ensures the light source maintains homogeneity throughout all of the readings. Units must provide ability to print monthly Levey-Jennings graphs on 8 x 11 paper or units must have the ability to backup data to a storage device. System will have electronic archiving and corrective action documentation capability. C.5 VENDOR FLEXIBILITY: C.5.1 Must provide ability to incorporate new methodologies from company as new products are released. TECHNICAL SUPPORT: Ability to provide on-site technical support to perform test/assay method validations, precision, method comparison with current analyzer, accuracy (recovery) and linearity (analytical measurement range) studies, carry over studies, calibration verification, establishment of standardized reference ranges, operator training, and all other tasks that are necessary for implementation of this agreement. Vendor shall perform all required statistical analyses and report data in an organized, clearly comprehensible format in a binder for on-site staff approval. This process must be completed within two weeks of installation of the analyzers. Vendor will provide a twenty-four hour/seven-day/365 days per year technical service hotline with support through one contractor; this includes on-site service during normal business hours 8:00 a.m. to 5:00 p.m., Monday through Friday. Updates to all procedure manuals and Material Safety Data Sheets (MSDS) in electronic format shall be provided when package inserts are modified. Provide written procedures in CLSI format on electronic media at the time of installation and whenever a new assay is added using software compatible with the VAAAHS laboratory s computer system. CONFORMANCE STANDARDS: Vendor must maintain full compliance with applicable Federal and State regulations. All services provided under this contract must be performed in conformance with the Nation Fire Protection Agency (NFPA), Occupational Safety and Health Administration (OSHA) and other applicable national, state and local regulatory agencies if applicable. Vendor must maintain a CLIA certificate of accreditation, and The Joint Commission (JC), and/or the College of American Pathology (CAP) accreditation. On-site warranty, for the Ann Arbor Healthcare System, includes annual preventative maintenance visits (per recommendation of the manufacturer), replacement parts, service, repairs, travel, for the entire agreement period with unlimited, on-demand service during normal business hours 8:00 a.m. to 5:00 p.m., Monday through Friday. The contractor shall perform annual preventative maintenance inspections during the contract period arranged with the Contracting Officer Representative (COR), in accordance with the published preventative maintenance manuals for the equipment. The contractor shall utilize the Original Equipment Manufacturer s established procedures and checklists (or Contractor-supplied equivalent satisfactory to the Contracting Officer Representative). A Field Service Report shall be supplied to the Contracting Officer Representative at the completion of each preventative maintenance inspection and repair service call. During the service call, the Field Service Representative will inform the technologist on-duty of problems found and corrective action taken while performing the maintenance and repair call. The contractor shall notify the Contracting Officer of the existence or development of any defects in, or repair to the equipment covered under this contract, which the contractor considers he/she is not responsible for under the terms of the contract (such as operator misuse). All exceptions to the Preventative Maintenance Inspection schedule shall be arranged and approved in advance with the Contracting Officer. The Contractor shall notify the Contracting Officer of the existence or development of any defects in, or repair to the equipment covered under this contract which the Contractor considers he/she is not responsible for under the terms of the contract (such as operator misuse). The instrumentation shall perform all analysis for the required tests with safety and precision as defined by the Clinical Laboratory Improvement Act of 1988(CLIA 88), the Clinical and Laboratory Standards Institute (CSLI), the College of American Pathologists (CAP), and the Food and Drug Administration (FDA). All analyzers shall be FDA approved. HOURS OF WORK: Warranty for the entire agreement period to include unlimited, on-demand, service during normal business hours, 8:00 a.m. to 5:00 p.m., Monday through Friday, or as otherwise arranged with the Contracting Officer Representative. Contractor s technical support hotline shall return all technical service request calls within two hours. Technical hotline will be available 24 hours per day, 7 days per week and will perform emergency repair service within 24 hours of the time of notification of the malfunction. The vendor shall provide, at no charge, all labor, travel and parts necessary to make repairs. The ten holidays observed by the Federal Government are Veterans Day, New Year s Day, Martin Luther King Day, President s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Thanksgiving Day, and Christmas Day. Also, any other day declared by the President of the United States to be a national holiday. PARTS: The contractor shall furnish all parts as necessary to maintain the equipment covered by this contract. The contractor stipulates that he/she has ready access to new standard parts (manufactured, supplied by the manufacturer, or equal thereto). All parts supplied shall be of current manufacturer specifications and have compatibility with existing equipment. Documentation of intended parts source(s) shall be provided to the Contracting Officer upon request. MEDICAL LIABILITY INSURANCE LIMITS: In accordance with VAAR 852.237-7, Indemnification and Medical Liability Insurance, the contractor shall maintain liability insurance or self-insurance of not less than $1,000,000.00 per specialty per occurrence. PAYMENT: Payment for services satisfactorily performed will be made quarterly in arrears upon receipt of a proper invoice at the designated office. Payment will be made by certified invoice and money will be distributed from the appropriate VAAAHS control point to pay obligations. The Contracting Officer Representative or designee will make certification for PALMS for the VAAAHS. All invoices will be processed in accordance with the Prompt Payment Act. Any discrepancy between the terms of the contract and the amount of the invoice will be promptly referred to the VA Contracting Officer for resolution. A copy of invoices for contract services for the VAAAHS should be mailed to: Resource Office (20V) VA Ann Arbor Healthcare System 2215 Fuller Road Ann Arbor, MI 48105 C.12 TERM OF CONTRACT: C.12.1 The contract will be effective for one year from the date of the contract award, with four additional contract option years. The contract is subject to the availability of appropriated funds. MISSION, VISION AND VALUES STATEMENT: Mission: Honor America s veterans by providing exceptional health care that improves their health and well-being. Vision: To be a patient centered integrated health care organization for veterans, providing excellence in health care, research, and education; an organization where people choose to work; and an active community partner and back-up for national emergencies. ACCREDIATION COMPLIANCE STANDARDS: GENERAL: The contractor shall continuously meet or exceed all Joint Commission standards. All applicable VA and VHA policies, procedures and directives shall be followed by the contractor. The patient population treated at the VA Ann Arbor Medical Center, located in Ann Arbor, Michigan, Toledo Community Based Outpatient Clinic, Toledo, Ohio, Flint Community Based Outpatient Clinic, Flint, MI and Jackson Community Based Outpatient Clinic, Jackson, MI consists of veterans with varying physical, psychiatric, and psychological needs. PATIENT RIGHTS: Protection of all patients rights is of highest priority. Patient privacy and confidentiality shall be maintained at all times. SAFETY: The VAAAHS shall inform the contractor of all applicable Safety Alerts received by the VAAAHS. For every applicable alert, the contractor shall take the necessary steps to redesign processes to prevent occurrence, and provide written feedback to the Contracting Officer Representative (COR) describing prevention actions taken within one (1) business day or sooner if the VAAAHS COR or medical center requests action. PERFORMANCE IMPROVEMENT: Upon completion of installation and final calibration, the contractor shall comply with the VAAAHS Pathology and Laboratory Medicine Service Performance Improvement (PI) program when developed. Pathology and Laboratory Medicine Service will monitor the vendor s response time to requests for service, and time the service report is sent, e-mail, to the designee of the chemistry laboratory on a quarterly basis. Contractor PI activities may be directed by the VAAAHS, VISN or VHA, as well as accreditation or licensing bodies. The contractor shall abstract, compile and report PI data as requested by the VAAAHS. VA Data collection methodology, report format, and reporting deadlines will be defined by the VAAAHS. Examples of required PI activities may include the VHA Performance Measures/Clinical Practice Guidelines program, and the Joint Commission ORYX or Core Measurement program. It is noted that PI activities are dynamic and subject to change, as driven by current priorities and resources. In all cases, the contractor shall continually assess for, and act upon, clinical and administrative improvement opportunities. High priority shall be given by the contractor to the prevention of risk for the patient. The contractor shall implement process-related internal controls to prevent risk to the veteran. VA monitoring for continuous compliance with Joint Commission standards shall be directed by VAAAHS staff, and communicated to the contractor through the COR. VA aggregate and/or practitioner-specific data collected by the VAAAHS will be provided to the contractor in accordance with established reporting schedules. VA measures related to contract compliance will be identified by the COR. LEADERSHIP: The contractor shall effectively manage daily operations, information and support systems, and conserve physical and financial assets while meeting the mission of the VAAAHS. INFORMATION MANAGEMENT: The VAAAHS Information Management plan shall be followed by the contractor. Documentation and record keeping shall be in accordance with VAAAHS policies and procedures. VAAR-852.273-75 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (Interim Oct 2008) must be included in the document. CONFLICT OF INTEREST: Conflict of Interest acknowledgement document(s) must be signed by all procurement officials and copies filed in the OPF in accordance with VHA Handbook 1660.3. Contracting Officials, CORs, selection officials, and others involved in the contracting processes are free from any actual or perceived conflicts of interest. The Contracting Officer will monitor compliance and will review the selection board for conflicts. C.15 DOCUMENTATION/REPORTS: C.15.1 The contractor shall submit a legible field service report which shall include detailed descriptions of the preventive maintenance inspection or emergency repair services performed, including replaced parts and estimated prices required for the service call. NOTE: Any additional charges not outlined by the original terms and conditions of the award must have been approved by the Contracting Officer, prior to the contractor performing such services to receive payment for said services. C.16 REPORTING REQUIREMENTS: C.16.1 The contractor shall be required to report to the Pathology and Laboratory Medicine Service chemistry department where the equipment is located (Building 1, Room E312) for maintenance or service calls. The Contractor must document the service call in the vendor log book. When the service is completed, the contractor shall document services rendered on a legible field service report and present to the Contracting Officer Representative or designee for signature, during normal working hours. After normal business hours, the contractor will leave the service ticket with the medical technologist assigned to the chemistry section who will place the document in chemistry supervisor s mailbox. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT: The contractor s staff shall include a fully qualified Field Service Representative assigned to this area and a fully qualified Field Service Representative who shall serve as the Backup. Fully qualified is based upon training and on experience in the field. For training, the Field Service Representative must have successfully completed a formalized training program for the equipment covered under the contract. For field experience, the Field Service Engineers must have a minimum of one (1) year of experience providing preventative maintenance and emergency repair services on the same make and model of equipment covered under this contract. The contractor shall provide written assurance of the competency of their personnel by detailing a list of Field Service Representative along with applicable training and years of service experience on the specific devices used in this agreement. C.18 TEST EQUIPMENT: C.18.1 Upon request of the Contracting Officer Representative of the Contracting Officer, the Contractor shall provide copy of the current Calibration Certification of all test equipment which is to be used by the Contractor to perform service under this contract. Calibration of equipment shall be traceable and in conformance with test equipment Original Equipment Manufacturer standards. C.19 SAFETY REQUIREMENTS: C.19.1 In the performance of this contract, the contractor shall take such safety precautions as the Contracting Officer may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer shall notify the contractor of any safety issues and the action necessary to correct these issues. Such notice, when served on the contractor or his representative at the work site shall be deemed sufficient for the corrective actions to be taken. If the contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work and hold the contractor in default. HARDWARE/SOFTWARE: Computer Interfacing Requirements The fully operational interface (both hardware and software) must be available for implementation to the VA Vista hospital information system no later 90 days after contract award. Computer access will be granted on a need-to-know basis, and security of computerized information will be maintained at all times. All medical center facilities will be interfaced as well as the outpatient clinics for which instrumentation is being provided. Provide interfacing for all instrumentation offered. The contractor is responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see requirements below). Likewise, the vendor will provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirement for the communication of the data streams will be unique to the instrument system in involved and dictated by the manufacture itself. If a site already has a universal interface box, the contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables software, etc.) to the universal interfacing system. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VistA. If there are any software upgrades in the instrument during its life the contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VistA. Currently, VAAAHS is operating with one universal interfacing system, i.e. Data Innovations. The contractor shall provide all ancillary support equipment to fully operate the instrumentation as defined in these specifications. Remote access for system troubleshooting shall be provided only through a VPN interface subject to Department of Veterans Affairs Information Management Service approval. Modems are no longer considered acceptable by the VA Information Security Office. The contractor shall include all ancillary components that are customarily sold or provided to support the model of equipment proposed, (e.g., starter kits, tables/stands, etc.). The contactor shall provide their technical manual on a portable storage device (i.e. CD-ROM, disk, etc.) or an on-line technical manual in the instrument software in addition to a hard copy (printed) version for the respective analyzers. The technical manual shall be formatted in accordance with current, approved CLSI guidelines (GPS- A2 or GP2-A3). The instruments must provide availability of printed (hard copy) patient results routinely and in the event of interface downtime. Electronic archiving that complies with College of American Pathologist (CAP) and Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requirements. Computer Hard Drives: Per VA information Security Policies, no hard drives or computers disks containing VA patient information shall be removed from VA facility. At the time of turn-in or removal due to failure, the VA facility shall remove all sensitive data from information systems storage devices or render the data from these systems unreadable. This could mean that the hard drive is destroyed. No Federal Information Processing equipment shall be discontinued from rental/lease or exchange without compliance with this requirement. Value added Items: all value-added items provided by the Vendor shall be the property of the VA Ann Arbor Healthcare System and shall not be returned at the end of the agreement. Uninterruptible Power Supply (UPS) shall be provided for each analyzer. System shall be installed and maintained by the vendor. Preventative maintenance shall be performed in accordance with manufacturer s recommended guidelines. TRAINING: The contractor, without additional charge to the Government, shall provide onsite training for four (4) operators on all systems provided by the vendor. In addition, the contractor shall provide supplemental operating training to the Government personnel, without additional charge to the Government, upon initial installation and during any upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished under this solicitation. At the Government s request, the contractor shall furnish training for additional personnel. Additionally, the contractor, at its discretion may make training available at its facility, at the expense of the contractor, and on the terms and conditions mutually agreed upon by the agency and the contractor that are consistent with commercial offerings. TRANSITION AND IMPLEMENTATION: Implementation/transition timeframe: The implementation of the services/requirements described in the solicitation shall be completed no later than 90 days after the award of the contract. This timeline is based on a reasonable attempt of the vendor to complete all of the necessary implementation requirements within the stated timeframe. Vendors will not be penalized for implementation timelines that extend beyond the 90-day timeframe, if the extension is through no fault of the vendor and is a result of delays due to the Government. The transition period for the awarded contract to have all equipment and peripherals installed and operational at each participating facility shall be from date of award through 90 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed. The contractor shall provide with its quotation a plan for transitioning services from the incumbent contractor to the new awarded contactor. Contractor s submitted transition plan shall not exceed 90 days for the transition of all services, including installation and training of personal, transition of all testing materials, reagents and supplies, etc., performance of all correlations, linearity studies, analytical range studies, and validations. Failure of the contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. At the end of 90 days from award, the awarded contractor shall have full and sole responsibility for services under the award. Page 14 of 14 Page 14 of 14 C.23 SUPPORT FEATURES: C.23.1 The contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format, a sample of which is to be provided with the proposal. The contractor shall provide assistance with reference ranges to include handling of data with appropriate software to establish reference intervals. C.24. BUSINESS ASSOCIATE AGREEMENT MUST BE INCLUDED. See attached document: Chem -CAD 1-29-18.
 

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SN04939096-W 20180602/180531231158-97c4f45e94cf69f5b22fce798f71dd54 (fbodaily.com)
 

Source

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