Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 16, 2016 FBO #5441
DOCUMENT

66 -- 506-17-1-1030-0016 CPT base + 4 - Attachment

Notice Date

10/14/2016
 

Notice Type

Attachment
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 10;8888 Keystone Crossing;Suite 1100;Indianapolis IN 46240
 

ZIP Code

46240
 

Solicitation Number

VA25017Q0021
 

Response Due

10/21/2016
 

Archive Date

11/20/2016
 

Point of Contact

Lee Morris
 

Small Business Set-Aside

N/A
 

Description

This is a solicitation for commercial items prepared in accordance with the format in far subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation shall not be issued. This solicitation is issued as a Request for Quote (RFQ)VA250-17-Q-0021. The North American Industry Classification System (NAICS) 325413 in-vitro diagnostic substance manufacturing and 334516 analytical laboratory instrument manufacturing that are Service Disable Veterans Owned Small Business (SDVOSB) and Veterans Owned Small Business (VOSB). Business size standard of 500 employees is applicable (FAR 19.102 (f) (1). This solicitation document and incorporated provisions and clauses are those in effect through federal acquisition circular (FAC) 2005-91. No telephone requests shall be accepted. Quote is requested for the following: The Department of Veterans Affairs Ann Arbor VAMC, 2215 Fuller Road Ann Arbor, MI 48105 is hereby soliciting offers to provide items listed below. We anticipate entering into a fixed price contract with the contractor meeting the Brand Name or Equal requirements and providing the best value to the Government. Items shall be delivered to the VA Center location noted above. Please include warranty information and delivery/shipping terms and conditions and cost clearly on your quote. All quotes must provide the above items/options in as much detail as possible to assist the VA with determining the most advantageous selection. This award shall be made based on the lowest price technically acceptable. It is the responsibility of the offeror to demonstrate compatibility of items offered other than the part numbers described above. Invoices shall be submitted in accordance with Federal Regulations 52.212-4(g) to VA Financial Services Center through the Tungsten (OB10) electronic invoicing system. Full text of the following clauses and/or provisions can be viewed through Internet access at http://farsite.hill.af.mil. The provisions at FAR 52.212-1, Instructions to Offerors-Commercial Items, applies to this acquisition. Offerors shall submit with their offer, a completed copy of the provisions at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items or confirm this has already been completed in their SAM registration. The clause at 52.212.4 Contract Terms and Conditions-Commercial Items, applies to this acquisition. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items, applies to this acquisition which shall include the following clauses: 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.232-34. Offerors shall submit their quotation by e-mail to lee.morris@va.gov. Offers are due no later than 3:00 pm. EST, 21 OCT 2016 2016. NO LATE QUOTES SHALL BE ACCEPTED OR CONSIDERED. Any question must also be submitted in writing and shall be addressed by the Contract Officer as quickly as possible. The successful offeror must be registered with SAM to be awarded a contract. You may register or update your registration on-line at https://www.sam.gov. PATHOLOGY AND LABORATORY MEDICINE SERVICE VA ANN ARBOR HEALTHCARE SYSTEM STATEMENT OF WORK Immunohistochemical Staining System C.0. SCOPE: C.0.1. VA ANN ARBOR HEALTHCARE SYSTEM: The Contractor shall provide one (1) automated immunohistochemical (IHC) staining system that performs the staining of human tissue to target specific proteins. The instrument, ancillary equipment, quality controls, slides, disposables, consumables, antibodies, reagents, supplies, shipping and handling costs associated with receipt of reagents, technical manual, service manual, operator training, hardware and software, preventative and repair maintenance agreement, and operator training in the operation of and performance of preventive maintenance on the automated IHC system must be provided to VA Ann Arbor Healthcare System. The VA Ann Arbor Healthcare System (VAAAHS) requests a base year Cost per Test contract with four (4) additional contract option years. C.1. DEFINITION OF NEED: C1.1 VAAAHS requests one (1) base year Cost Per Test (CPT) contract with four (4) additional contract option years to provide immunohistochemical patient specimen testing. C.2 DUTIES OF CONTRACTOR: C.2.1 The Contractor shall provide: "One (1) automated IHC analyzing system "All ancillary equipment including waste containers and tubing "All reagents and supplies needed to perform testing provided in test menu "Antibodies (see attachment) "Slides "Consumables supplies "Software "Hardware (including computers, keyboards, cords/cables, printers, and mouse) "All software and hardware upgrades and updates "UPS (uninterrupted power supply) sufficient for equipment size "Maintenance service agreement "Customer support telephone service "Technical manuals in both hard and electronic copy "Operator training for operation of system "Operator training for maintenance of system "Shipping and handling costs associated with receipt of reagents C.3 OPERATIONAL FEATURES AND REQUIREMENTS: C.3.1 System shall provide: "IHC staining process "Workflow flexibility supporting continuous slide loading as well as batch processing "Capabilities for deparafinization, rehydration, staining, and counterstaining with parallel processing "Several slide racks that optimize utilizations "Utilization of discrete slide staining by applying fresh reagent and stain to each individual slide in order to allow for standardization of quality of stain and protect against cross-contamination "Full automation to support the pre-treatment and staining of slides, from initial slide load to removal of stained slides "On-board temperature control monitoring system, at 18oC, for reagent storage for all antibodies and visualization systems "Capability to process slides in a temperature, 32oC, and in a humidity controlled environment "Separate loading and off-loading stations with the ability to have completed slides on-board while also loading new slides "IHC turn-around time not to exceed 150 minutes "Throughput of 165 IHC slides per day "Dynamic gap staining which reduces tissue loss and even staining of folded and wrinkled tissue "Maintenance that is computer prompted and guided "Reagent and slide loading at any time without process interruption. Reagents and bulk fluids can be added after a run has been initiated "Reagents must be prepackaged, pre-diluted, and ready to use "Reagents must be sealed in air tight containers, negatively pressurized until discretely dispensed onto the slide, therefore preventing reagent oxidation "Capacity to hold up to 5 different target retrieval solutions on board simultaneously "Capacity to accommodate 60 reagent vials "Capacity of loading 60 slides per hour "Hazardous and Non-Hazardous waste is segregated "The volume of chromogen which is mixed is precisely proportional to the total number of slides which shall receive the chromogen "Automatically track reagent lot number, expiration dates and reagent volume levels "Accommodation for both IHC and in-situ hybridization (ISH) testing on the same instrument platform in a simultaneous run without compromising run times "Touch screen interface with software that allows for easily generated Quality Assurance (QA) and Quality Control (QC) reports "One-touch "walk-away" automation "Capability to read 2D bar codes and track individual patient slides through the system "Data logging, reporting and access rights for tractability and College of American (CAP) accreditation "Data management system that allows the user to monitor quality control and includes flagging for failed quality control "Precautionary measures in place to eliminate human error and ensure correct use of slide processing and reagent loading "System to not allow the possibility of slides and/or reagents to be accidentally or incorrectly utilized "Completely modular, to provide redundancy and maintain throughput "Separate workstation that includes personal computer (PC), keyboard, mouse, and printer "Footprint shall not exceed 61" H x 58" W x 32" D "Stand-alone floor model "No additional construction costs C.4 QUALITY CONTROL: C.4.1 Daily quality control slides shall be performed on equipment and are reviewed by the Pathologists to ensure that the proper staining quality is maintained. C.4.2 System shall have a data management system that allows the user to monitor quality control. System includes "flags" for failed quality control. C.4.3 The systems shall have precautionary measures in place to eliminate human error and ensure correct use of slide processing and reagent loading. The instrument must not allow the possibility of slides and/or reagents to be accidentally or incorrectly utilized. C.5 VENDOR FLEXIBILITY: C.5.1 Contractor shall provide ability to incorporate new methodologies and provide all software and hardware updates if required at no charge. C.5.2 Contractor shall provide free software and hardware upgrades as they become available to expand test menu. C.6 TECHNICAL SUPPORT: C.6.1 During installation of the new equipment, Contractor shall provide technical support specialist(s) to assist in equipment installation set-up, validation studies, staff training, and assist with the investigation of methodology problems and questions. C.6.2 Contractor shall provide all labor, new non-refurbished parts, reagents, supplies, procedures, travel expenses, technical manuals and procedures to complete initial validation studies. C.6.3 Contractor shall provide technical service sufficient to meet the needs of VAAAHS, Pathology & Laboratory Medicine Service (PALMS) Monday through Friday, 4:00 a.m. to 6:00 p.m., excluding Federal Holidays. All repairs on instrument/equipment must be complete within 24 hours from the time the field service engineer arrives. C.6.4 Contractor shall provide a twenty-four hour/seven-day/365 days per year telephone service hotline with technical support. All service request calls must be answered within two hours via telephone. C.6.5 Contractor shall provide, at no charge, all new non-refurbished parts, shipping and installation necessary for the operation the system. Service is to include all technical engineers' travel, parts for repair or replacement, and labor. C.6.6 Contractor is to define the frequency and type of instrumentation preventative maintenance required. Contractor to indicate which maintenance is performed by user and which are performed by vendor field service engineers. Contractor is to define actual hands-on maintenance time. The vendor shall coordinate with the Contracting Officer Representative (COR) or designee, to perform preventative maintenance inspections during the contract period in accordance with the Contractor's published preventative maintenance manuals. C.6.7 Contractor shall provide written procedures in 1988 Clinical and Laboratory Standard Institute (CLSI) format on electronic media at the time of installation and provide additional procedures when methodologies are added to the instrument. Electronic media must conform to software compatible with VAAAHS' computer system to allow for remote access monitoring. C.6.8 Contractor shall provide in-house assistance with instrument validation. C.6.9 Contractor shall provide all necessary electronic and hard copy Safety Data Sheets (SDS) records. C.6.10 Contractor shall utilize the original equipment, manufacturer's established procedures and checklists, (or contractor-supplied equivalent satisfactory to the Contracting Officer (CO) and COR). C.6.11 A Field Service Report shall be supplied to the COR or designee at the completion of each preventative maintenance inspection, and repair service call. In addition, the Field Service Representative shall inform the Histology Technician on duty during the service call of problems found and explain any corrective action taken while performing the maintenance and repair call. C.7 TRAINING AND PROCEDURE MANUALS: C.7.1 The Contractor shall provide an instrument training program for two (2) key operators that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the VAAAHS. In addition, the Contractor shall provide at least one (1) key operator training for each option year. The Contractor shall provide sufficient training on-site for all other operators at no extra charge. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of travel, room and board for each participant. Contractor shall provide a documented record of completed training for all VAAAHS Anatomic Pathology staff before leaving site once installation is complete. C.7.2 The contractor shall provide supplemental operator training to the government personnel, without additional charge to the government, upon initial installation of and during any upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished under this solicitation. C.7.3 Contractor shall supply all necessary procedure manuals, troubleshooting manuals, and operator manuals (hard copy and CD/electronic copy). A service manual for Biomedical Engineering Department must also be provided (hard copy and CD/electronic copy). Procedures must be in the 1988 CLSI format. C.8 CONFORMANCE STANDARDS: C.8.1. Contractor shall maintain full compliance with applicable Federal and State regulations. All services provided under this contract must be performed in conformance with the Food and Drug Administration (FDA), Nation Fire Protection Agency (NFPA), Occupational Safety and Health Administration (OSHA), College of American Pathologists (CAP), The Joint Commission (TJC) and other applicable national, state and local regulatory agencies. C.8.2. Contractor shall provide an on-site warranty for the VAAAHS that includes maintenance and equipment service for the entire agreement period, to include unlimited, on-site service visits: Monday through Friday, 4:00 a.m. to 6:00 p.m., excluding Federal Holidays, for the IHC Staining System at the VAAAHS. Maintenance agreement includes: service, new non-refurbished parts, labor, travel expenses and preventative maintenance visits per recommendation of the manufacturer. C.8.3. The contractor shall report to the CO and COR or designee 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 (i.e. as operator misuse). C.8.4. Routine and recurrent preventative maintenance inspections shall be the responsibility of the Contractor. All significant problems shall be reported verbally to the COR or designee within 24 hours. A written corrective plan of action shall be submitted to the COR within 5 working days. VAAAHS timeframes and priorities for completion of action plan items shall be mutually agreed upon by the contractor and the VAAAHS Safety Officer. An annual compliance report addressing all exceptions to the preventive maintenance inspection schedule shall be arranged and approved in advance with the VAAAHS Safety Officer. The contractor shall notify the CO and COR or designee of the existence of development of any defects in equipment or reagents or consumables. Contractor shall repair the equipment covered under this contract unless the contractor considers he/she is not responsible for repairs under the terms of the contract (i.e.: as operator misuse). C.8.5. The instrumentation shall perform the required tests with safety and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CSLI) and the College of American Pathologists (CAP) and the Food and Drug Administration (FDA). All analyzers must be FDA approved. C.8.6 Upon award of a Blanket Purchase Agreement (BPA), the transition period for the awarded contract to have all equipment and peripherals installed and operational at shall be from date of award through 90 days. Initial training of VAAAHS personnel in the operation and maintenance of said equipment shall also be completed during this same period. C.8.7 When applicable, the contractor shall provide with the quotation, a plan of services for transitioning services from the incumbent contractor to the new awarded contactor. The contractor's submitted transition plan shall not exceed 90 days for the transition of all services under the awarded BPA such as installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations, linearity studies, analytical studies, and validations. Failure of the contractor to conform to the transition period plan shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. C.8.8 At the end of 90 days from award of the contract, the awarded contractor shall have full and sole responsibility for services under the awarded BPA. C.8.9 The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, "current production" shall mean that the immunohematology analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Any repairs to analyzer or system shall be repaired or exchanged with new equipment, parts, and hardware. C.8.10 Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order, at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer. C.8.11 The Contractor shall identify if removable media is required to perform their duties. The Clinical Engineering Department shall ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility. C.8.12 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 or completion of the contract. C.8.13 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 retained by 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 45 days of termination or completion of the contract or disposal or return of the IT equipment, whichever is earlier. C.8.14 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 Contractor at the end of lease, for trade-in, or other purposes. The options are: "Contractor must accept the system without the drive "VA's initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in "VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. C.9 HOURS OF WORK: C.9.1. Warranty for the entire agreement period to include unlimited, on-demand, on-site service visits for the IHC Staining System, Monday through Friday, 4:00 A.M. to 6:00 P.M. excluding federal holidays, or as otherwise arranged with the COR or designee. C.9.2. Contractor shall provide Technical Hotline 24 hours per day, 7 days per week excluding federal holidays and shall perform emergency repair service within 24 hours of the time of notification of the malfunction. C.9.3. The ten holidays observed by the Federal Government are New Year's Day, Martin Luther King Day, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving Day, and Christmas Day. Also, any other day declared by the President of the United States to be a national holiday. C.9.4. Work performed outside of normal working hours of coverage at the request of the Contracting Officer (CO) or COR shall be billed separately. C.10 PARTS AND SUPPLIES AND CONSUMABLES: C.10.1 The contractor shall furnish all new non-refurbished parts as necessary to operate and maintain the equipment covered by this contract, in accordance with the Conformance Standards Section of the FSS contract. The contractor guarantees that he/she has ready access to new standard parts and supplies (manufactured, supplied by the manufacturer, or equivalent). All parts and reagents supplied shall have full compatibility with existing equipment. Documentation of intended parts source(s) shall be provided to the CO upon request. C.10.2. Frequency of shipments. Contractor shall provide initial inventory based on expected use, then establish a standing monthly shipment based on current use, with capacity to fill emergency requests on-demand. Initial inventory shall be provided with Contractor's standard install kit. C.10.3. Contractor shall pay all standard shipping and handling fees for all supplies, consumables, reagents and equipment to perform testing and shall pay for shipping for volume adjustments should additional testing supplies be required. C.10.4. Instruments and reagents are to be delivered to the following location: VA Ann Arbor Healthcare System Pathology & Laboratory Medicine Service (PALMS) Anatomic Pathology 2215 Fuller Road Ann Arbor, Michigan 48105 C.11 SCHEDULE OF SUPPLIES / SERVICES The estimated annual volume is 5,000 tests per year, with an anticipated 5% increase annually. C.12.0 MEDICAL LIABILITY INSURANCE LIMITS: C.12.1 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. C.13.0 PAYMENT: C.13.1 The COR shall make certification of invoices for Pathology and Laboratory Medicine Service (PALMS) for the VAAAHS. All invoices shall be processed in accordance with the Prompt Payment Act. Any discrepancy between the terms of the contract and the amount of the invoice shall be promptly referred to the VA Contracting Officer for resolution. Invoices for contract services shall be submitted online through the e-invoice/Tungsten website. C.14 TERM OF CONTRACT: C.14.1 The contract shall 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. C.15 MISSION, VISION AND VALUES STATEMENT: C.15.1 Mission: Honor America's veterans by providing exceptional health care that improves their health and well-being. C.15.2 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. C.16 MISSION AND VISION STATEMENT: C.16.1 Mission: Honor America's veterans by providing exceptional health care that improves their health and well-being. C.16.2 Vision: VHA shall continue to be the benchmark of excellence and value in health care and benefits by providing exemplary services that are both patient centered and evidence based. This care shall be delivered by engaged, collaborative teams in an integrated environment that supports learning, discovery and continuous improvement. It shall emphasize prevention and population health and contribute to the nation's well-being through education, research and service in national emergencies. C.17 THE JOINT COMMISSION COMPLIANCE STANDARDS: C.17.1 GENERAL: The contractor shall continuously meet or exceed all Joint Commission Hospital standards. All applicable VA and VHA policies, procedures and directives shall be followed by the contractor. The patient population treated at the VAAAHS, located in Ann Arbor Michigan consists of veterans with varying physical, psychiatric, and psychological needs. Their conditions are, in many cases, directly related to the individual's service to this country. C.17.2 PATIENT RIGHTS: Protection of all patients' rights is of highest priority. Patient privacy and confidentiality shall be maintained at all times. Computer access shall be granted on a need-to-know basis, and security of computerized information shall be maintained at all times. No patients shall be subject to any research activity without his fully informed consent, subject to study approval by the Investigational Research Board (IRB). The contractor shall abide by the VAAAHS Code of Ethics, which addresses marketing, admission, transfer, referral, and discharge processes, and billing issues. C.17.3 PATIENT SAFETY: The VAAAHS shall inform the contractor of all applicable Sentinel Event or other Patient 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 COR describing prevention actions taken. All events related to patient injury, medication errors, and other breeches of patient safety shall be reported to the COR utilizing the VAAAHS Incident Report. The VAAAHS shall provide the contractor with VAAAHS Sentinel Event definitions in the start-up phase. The contractor shall verbally notify the VAAAHS COR immediately when a Sentinel Event has occurred, which is to be followed by written notification within one (1) business day or sooner if requested by the medical center. The VAAAHS shall determine when a Root Cause Analysis (RCA) is required of the contractor. The contractor shall conduct all Root Cause Analysis according to VAAAHS policy and within 45 days. Completed RCAs shall be provided to the VAAAHS COR. C.17.4 PERFORMANCE IMPROVEMENT: The contractor shall fully participate in the VAAAHS Performance Improvement Plan (PI) program. This shall entail monitoring of clinic processes, data analysis, and collaborative design and operationalization of improvement opportunities. 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 request by the VAAAHS. VA Data collection methodology, report format, and reporting deadlines shall be defined by the VAAAHS. In all cases, the contractor shall continually assess for, and act upon, clinical and administrative improvement opportunities. 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 shall be provided to the contractor in accordance with established reporting schedules. VA measures related to contract compliance shall be identified by the COR. C.17.5 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. The provision of contracted services shall be described in writing the nature and scope of services provided through contractual agreement. Leaders monitor contracted services by establishing expectations for the performance of the contracted services. Leaders take steps to improve contracted services that do not meet expectations. C.17.6 ENVIRONMENT OF CARE: All significant problems identified shall be reported verbally to the COR within 24 hours. A written corrective plan of action shall be submitted to the COR within 5 working days. VA timeframes and priorities for completion of action plan items shall be mutually agreed upon by the contractor and the VAMC Safety Officer. The contractor shall maintain a safe environment at all times. C.17.7 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. Documentation and authentication in the medical record must adhere to all timeframes. VAAR-852.273-75 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGYRESOURCES (Interim - Oct 2008) must be included in the document. C.17.8 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 must be free from any actual or perceived conflicts of interest. The CO shall monitor compliance and shall review the selection board for conflicts of interest. C.18 DOCUMENTATION/REPORTS: C.18.1 The contractor shall submit a legible field service report which shall include detailed description of the preventive maintenance inspection or emergency repair services performed, including replaced parts and estimated prices required for the service call. All field service reports shall include: date work was performed, name of Field Service Technician, and contact number for Field Service Technician. NOTE: Any additional charges claimed must have been approved by the CO and COR before service was performed. C.18.2 Quality Management Plan and Quarterly Reports: The contractor shall maintain a Quality Management Plan consistent with Accreditation and CAP standards. This shall entail monitoring of processes, patient outcomes and satisfaction, data analysis and collaborative design and operationalization of improvement opportunities. The contractor shall evaluate the quality of the Automated Staining Instrumentation. C.19 REPORTING REQUIREMENTS: C.19.1 Upon arrival, the Contractor shall be required to report to the Pathology and Laboratory Medicine Service histology department where the equipment is located for maintenance and service calls. The Contractor shall notify the Anatomical Pathology Supervisor or designee of arrival. When the service is completed, the Contractor shall document services rendered on a legible field service report and present to the COR or designee for signature, during normal working hours. After normal business hours, the contractor shall leave the field service report in the designated inbox in the Anatomic Pathology Department. C.20 COMPETENCY OF PERSONNEL SERVICING EQUIPMENT: C.20.1 The contractor's service personnel staff shall include a "fully qualified" Field Service Representative assigned to the VAAAHS and a "fully qualified" Field Service Representative who shall serve as the backup to ensure unlimited coverage. "Fully qualified" is defined as training and experience in the field. The Field Service Representative has successfully completed a documented 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. C.20.2 The contractor shall provide written assurance of the competency of their personnel by detailing a list of Field Service Representatives along with applicable training and years of service experience on the specific devices covered in this agreement and a written assurance of competency. C.21 TESTING EQUIPMENT: C.21.1 Upon request of the COR, or the CO, the contractor shall provide copy of the current Calibration Certification of all test equipment which is 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.22 SAFETY REQUIREMENTS: C.22.1 In the performance of this contract, the contractor shall take such safety precautions as the CO and COR may determine to be reasonably necessary to protect the lives and health of the occupants of the building. The CO and COR shall notify the contractor of any safety issues and the action required to correct these issues. Such written or verbal 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 within 24 hours on the notification of the safety issue, the CO may issue an order stopping all or part of the work and hold the contractor in default. C.23 HARDWARE/SOFTWARE: C.23.1 Computer Interfacing Requirements - The fully operational interface (both hardware and software) must be available for implementation to the VAAAHS hospital information system at the time of contract award. Computer access shall be granted on a need-to-know basis, and security of computerized information shall be maintained at all times. The contractor shall ensure necessary connection and interfacing to complete the remote equipment technical analysis for the requested instrumentation. C.23.2 The contractor is responsible for providing all hardware required for the connection, implementation, and operation of the remote-care interface which provides instrument analysis and technical operation data and technical support service. Likewise, the contractor shall provide any and all necessary software support and software upgrades for ensuring that successful interfacing is maintained. C.23.3 The contractor shall provide all ancillary support equipment to fully operate the instrumentation as defined in these specifications. Contractor is to provide proactive remote diagnostic monitoring (24 hours a day/7days a week). The instrument must proactively monitor itself and then notify the user and manufacturer (Contractor) if instrumentation issue arises. Any software problems need to be fixed and/or upgraded immediately via bi-directional internet connection, decreasing downtime and increasing productivity. Remote access for system troubleshooting shall be provided only through a VPN interface subject to Department of Veterans Affairs IMS approval. Modems are no longer considered acceptable by the VA Information Security Office and are prohibited from use. C.23.4 The contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, (e.g., starter kits, tables/stands, etc.). The contactor shall provide their procedure manual on a portable storage device (i.e. CD-ROM, disk, etc.) and/or an on-line procedure manual in the instrument software. A hard copy (printed) format for the respective analyzer must also be provided. The procedure manual shall be formatted in accordance with current, approved CLSI guidelines (GPS-A2 or GP2-A3). C.23.5 If a site already has a universal interface box, the Contractor is responsible for Contractor provided equipment and hardware that leads to the interface box. This responsibility includes 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 the system with the VAAAHS VISTA. Cost for all extra connections and licenses for middleware to a third party shall be at no charge to VAAAHS. If there are any software upgrades in the instrument during the life of the contract, the contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VAAAHS VISTA. The Contractor shall provide all necessary updates and upgrades at no additional charge. C.23.6 The IHC Staining Instrumentation, located at the VAAAHS, must provide quality control and maintenance (when applicable) archiving that complies with College of American Pathologist (CAP) and The Joint Commission (TJC) requirements. C.24. REAGENTS AND CONSUMABLES: C.24.1 The Contractor shall supply all reagents and consumables required for operating the IHC staining system required to produce superior quality results. C.24.2 Contractor shall provide mechanism for the laboratory to meet local discharge requirements. Any additional costs such as Industrial Funding Fees, special shipping and handling fees, or other usage fees must be clearly indicated and defined in the price quote. C.25 COR DESIGNATION: C.25.1 The COR for this contract is Joseph Masson, Technical Specialist, Pathology and Laboratory Medicine Service (113), VAAAHS, 2215 Fuller Road, Ann Arbor, MI, 48105. Email address is: joseph.masson@va.gov. Telephone number is 734-845-5530. This individual is a VA employee and is free from any financial or organizational conflict of interest related to this contract. C.26. BUSINESS ASSOCIATE AGREEMENT MUST BE INCLUDED Vendor's Information Vendor's Name: _____________________ Address: ____________________________ City: _______________________________ State: _______________________________ Zip code: ____________________________ DUNNS# ___________________________ Point of Contact: _____________________ Telephone: __________________________ Email: _____________________________ Government Contract: _________________
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/InVAMC538/InVAMC538/VA25017Q0021/listing.html)
 

Document(s)

Attachment
 

File Name: VA250-17-Q-0021 VA250-17-Q-0021.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3054788&FileName=VA250-17-Q-0021-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3054788&FileName=VA250-17-Q-0021-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Ann Arbor VAMC;2215 Fuller Road;Ann Arbor Michigan 48105

Zip Code: 48105
 

Record

SN04305032-W 20161016/161014234200-0dbe22491115ecbe004f6856a0220f72 (fbodaily.com)
 

Source

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

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