36C25023Q0933.docx

36C25023Q0933

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

506-24-1-1030-0004 36C25023Q0933 07- -2023 Noah Bruck 734-222-6181 08-1 -2023

2:00 PM

EDT

36C250 Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105 X 334516 1000 Employees N/A X 36C506 Department of Veterans Affair VA Ann Arbor Healthcare System 2215 Fuller Road Ann Arbor MI 48105 36C250 Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105

Department of Veterans Affairs Financial Management System PO Box 149971 Austin TX 78714-9971 877-353-9791 512-460-5540 X See CONTINUATION Page RFQ for Hematoxylin & Eosin Cover Stainer System 5 Year Ordering Period. Period of Performance 10/1/2023 - 9/30/2028 TMS 20939 Privacy training required on an annual basis See CONTINUATION Page 506-3640160-1030-822300-2560 010022390 X X X Kellie Konopinski Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: ____________________________________

ADDRESS: ____________________________________

POC: ____________________________________

EMAIL: ____________________________________

PHONE: ____________________________________

b. GOVERNMENT: Contracting Officer 36C506 Kellie Konopinski Contract Specialist Noah Bruck, noah.bruck@va.gov Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

36C25023Q0933

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B.2 STATEMENT OF WORK

Hematoxylin and Eosin Staining System 5 Year Ordering Period

C.0. SCOPE

C.O.1 VA ANN ARBOR HEALTHCARE SYSTEM: The contractor shall provide a standalone open automated Hematoxylin and Eosin (H&E) slide staining system that performs heating, baking, deparaffinization, rehydration, staining, differentiation, bluing, dehydration, clearing and glass coverslipping of glass microscope slides. The instrument, equipment, consumables, supplies, shipping and handling costs associated with receipt of reagents, supplies and consumables, technical manual, service manual, operator training, hardware and software, software updates, maintenance agreements, and transportation necessary to perform maintenance and preventative maintenance must be provided to VA Ann Arbor Healthcare System. The VA Ann Arbor Healthcare System (VAAAHS) requests a 5-year ordering period IDIQ with a period of performance from 10/1/2023 through 9/30/2028.

VA Ann Arbor Healthcare System (VAAAHS) is located as follows:

C.1. DEFFINITION OF NEED: VAAAHS requests a 5-year ordering period IDIQ Cost Per Test (CPT) with a period of performance from 10/1/2023 through 9/30/2028.

C.1.1. VA ANN ARBOR HEALTHCARE SYSTEM: The contract includes one (1) automated staining system, ancillary equipment, consumables, supplies, shipping and handling costs associated with receipt of reagents, supplies and consumables, technical manual, service manual, operatory training, hardware and software, software updates, maintenance agreement, and transportation necessary to perform maintenance and preventative maintenance must be provided to the VA Ann Arbor Healthcare System.

C.2 DUTIES OF CONTRACTOR:

C.2.1 VA ANN ARBOR HEALTHCARE SYSTEM: The contractor shall provide:

· One open automated Hematoxylin and Eosin System with built in glass coverslipping

· All supplies, including shipping and handling

· Cover glass: 25 x 50 mm

· Maintenance agreement including the transportation necessary to perform maintenance and preventative maintenance

· Consumables, including shipping and handling of reagent orders. Test volumes are estimated, based on prior history of actual volumes and are not a guaranteed minimum

· Technical Manual in both hard and electronic copy

· Service Manual

· Operator Training

· Hardware and Software to include all upgrades and updates

· Customer support telephone service

· UPS system sufficient for equipment size, to include battery replacement every 2 years

· Initial training on instrumentation at the locale of vendor’s choice, to provide maximum learning opportunity and instrument knowledge and troubleshooting experiences. Minimum of two personnel training with room, board, and airfare without charge to the Government.

C.3 OPERATIONAL REQUIREMENTS

C.3.1 SYSTEM SHALL PROVIDE:

· Instrument should be new equipment. Previously used or discontinued models that are only being made available as remanufactured/refurbished equipment are not acceptable.

· The instrument must not require more than 10 mins of maintenance per day.

· Entire system of Stainer, cover-slipper, inclusive of swing out CRT and module covers which must be opened upward must not exceed the dimensions of 84” W x 30”D x 70”H.

· Instrument must constantly circulate stains and reagents.

· Instrument must provide continuous loading, staining, coverslipping and unloading of slides.

· Instrument must have the capability to program multiple staining protocols.

· Instrument must have the capability to perform multiple staining protocols simultaneously.

· System must fully integrate the processes of Heating, Staining and Glass Cover-slipping of slides with automated transfer between steps

· Instrument must function fully at a sound level of, or below, 38 decibels.

· Instrument must have touch screen capability to select staining protocol.

· Instrument must have capability for user to fully customize any protocol as desired. Including, but not limited to layout of reagents and exposure time.

· Instrument must have the capability to perform ‘coverslip only protocol’.

· Instrument must have the capability to perform ‘heat, deparaffinization, and rehydration only protocol’.

· Instrument must provide ease of troubleshooting in the unfortunate episode of unit error. This includes rescue and recovery of slides without compromise to section integrity and user safety.

· Heating and baking oven must have the capacity of holding a minimum of 120 at one time.

· Heating and baking must be performed in a convection oven.

· Instrument must perform Hematoxylin and Eosin staining on a minimum of 240 slides per hour.

· Slide racks must be of lean design to promote minimal workload batching.

· Slide racks must be designed for minimal slide contact and minimal reagent and stain carryover to promote reagent cost savings.

· Cover slipped slides must be cured on board.

· Cover slipped slides must have proven same day archiving capability.

· Instrument must provide on board ventilation.

· Instrument must provide waste separation and minimal waste volume.

· Instrument must have the support of a pump to assist in the evacuation of used water. Pump helps to keep outgoing water line from clogging.

· Reagents must be prepackaged, prediluted, and ready to use.

· Instrument must provide Touch Screen interface with software that provides intuitive prompting to ensure instrument is properly ‘set-up’ and ready to stain.

· Instrument must provide on board quality control.

· Instrument must have the capability to interface with barcode scanning system.

· Instrument must have the ability to perform on board bar code reading of every slide stained.

· Instrument must provide two levels of password access. (User and Administrative).

· Instrument must include a UPS system sufficient for equipment size, to include battery replacement every two years.

· Instrument must use voltage 110-120V.

INSTRUMENTATION AND SOFTWARE:

· The vendor will supply all equipment, reagents and supplies required for operating the H&E system and producing superior quality results.

· Vendor to 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.

INSTALLATION AND VALIDATION:

· At installation of new equipment, vendor will provide technical support specialist(s) to assist in equipment installation / set-up, staff training, and methodology problems and questions.

· Vendor will provide all manpower, reagents/supplies, procedures/instructions to complete set-up studies to include full optimization and validation of all protocols.

· The 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 and other applicable national, state and local regulatory agencies. Vendor must maintain a CLIA certificate of accreditation, and The Joint Commission, and/or the College of American Pathology (CAP) accreditation.

C.4 QUALITY CONTROL:

· Daily quality control slides will be performed and reviewed by the Pathologists to ensure that the proper staining quality is maintained.

· Staining must meet quality standards establish by VAAAHS Pathologists.

C.5 VENDOR FLEXIBILITY:

· Vendor shall provide ability to incorporate new methodologies and provide all software and hardware updates if required at no charge.

· Vendor shall provide free software and hardware upgrades as they become available.

C.6 TECHNICAL SUPPORT:

· At installation of new equipment, vendor will provide technical support specialist(s) to assist in equipment installation set-up, validation, staff training, and assist with the investigation of methodology problems and questions.

· Vendor will provide all labor, reagents, supplies, procedures, technical manuals, and procedures to complete initial validation studies.

· Vendor will provide 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 or as otherwise arranged with the Contracting Officer Representative. All repairs on instrument/equipment must be complete within 24 hours from the time the field service engineer arrives.

· Vendor will provide a twenty-four hour/seven-day/365 days per year service hotline with technical support through one contractor. All calls must be answered within two hours via telephone.

· Vendor will provide, at no charge, labor, all parts, shipping, and installation necessary for the operation of the system.

· Service is to include all technical engineers’ travel, non-furbished parts for repair or replacement, and labor.

· The vendor is to define the frequency and type of instrumentation preventative maintenance required. Vendor is to indicate which maintenance is performed by user and which are performed by vendor field service engineers. Vendor 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 published preventative maintenance manuals.

· The vendor shall provide written procedures in 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.

· The vendor shall provide in-house assistance with instrument validation.

· Vendor will provide all necessary electronic and hard copy MSDS records.

· The contractor shall utilize the original equipment, manufacturer’s established procedures and checklists, (or contractor-supplied equivalent satisfactory to the COR).

· A Field Service Report shall be supplied to the COR at the completion of each preventative maintenance inspection, and repair service call. In addition, the Field Service Representative will inform the technologist on duty during the service call of problems found and any corrective action taken while performing the maintenance and repair call.

C.7 TRAINING AND PROCEDURE MANUALS:

· Vendor must provide all education/training on site during installations or updates/upgrades to the equipment. Training must include basic operation, quality control, required user performed maintenance, and troubleshooting. Vendor must provide a documented record of completed training for all VAAAHS Anatomic Pathology staff before leaving site once installation is complete.

· Vendor must supply all necessary procedure manuals, troubleshooting manuals, operator manuals. (Must also be available on CD format or online). A service manual for Biomedical Engineering Department must also be provided (hard copy or CD/electronic copy). Procedures must be in the 1988 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 to maintain all College of American Pathologists (CAP), Joint Commission (JC), and Food and Drug Administration (FDA) regulations and requirements.

· The contractor, without additional charge to the Government, shall provide initial key operator’s training on instrumentation to locale of the vendor’s choice, providing maximum learning opportunity and instrumentation knowledge and troubleshooting experiences. Minimum of two operator with room, board, and airfare.

· At the VAAAHS’s request, the contractor shall furnish training for additional personnel.

· In addition, the contractor shall provide supplemental operating 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.

· Additionally, the contractor may make training available at its facility on terms and conditions mutually agreed upon by the VAAAHS and the contractor consistent with commercial offerings.

C.8 CONFORMANCE STANDARDS:

C.8.1. 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 and other applicable national, state and local regulatory agencies. Vendor must maintain a CLIA certificate of accreditation, and The Joint Commission, and/or the College of American Pathology (CAP) accreditation.

C.8.2. On-site warranty, for the VA Ann Arbor Healthcare System, to include maintenance for the entire agreement period, to include unlimited, on-demand, on-site service visits: 24 hours a day, seven days a week, 365 days per year for the Staining System, at VAAAHS, PALMS. Maintenance agreement includes service, parts, labor, travel and preventative maintenance visits, per recommendation of the manufacturer.

C.8.3. The contractor shall report to the Contracting Officer (CO) 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 vendor. All significant problems 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. VAAAHS timeframes and priorities for completion of action plan items will 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 CO. The contractor shall notify the CO of the existence of development of any defects in equipment or reagents or consumables. Contractor will 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 shall be FDA approved.

C.8.6 Upon award of a IDIQ, the transition period for the awarded contract to have all equipment and peripherals installed and operational at shall be from date of award through 45 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 45 days for the transition of all services under the awarded IDIQ 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 45 days from award of the contract, the awarded contractor shall have full and sole responsibility for services under the awarded IDIQ.

C8.9 The equipment model 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 stainer model being offered is new equipment. Previously used or discontinued models that are only being made available as remanufactured/refurbished equipment are not acceptable. Any repairs to the instrument or system shall be repaired or exchanged with new non refurbished equipment, parts, and hardware.

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 H&E Staining System, Monday through Friday, 4:00 A.M. to 6:00 P.M. excluding federal holidays, or as otherwise arranged with the Contracting Officer Representative.

C.9.2. Contractor will provide Technical Hotline 24 hours per day, 7 days per week excluding federal holidays and will perform emergency repair service within 24 hours of the time of notification of the malfunction.

C.9.3. The eleven holidays observed by the Federal Government are New Year’s Day, Martin Luther King Day, President’s Day, Memorial Day, Juneteenth 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.

C.9.4. Work performed outside of normal working hours of coverage at the request of the Contracting Officer or Contracting Officer Representative shall be billed separately.

C.10 PARTS AND SUPPLIES AND CONSUMABLES:

C.10.1. The contractor shall furnish all parts as necessary to operate and maintain the equipment covered by this 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 Contracting Officer upon request.

C.10.2. Frequency of shipments. Vendor will provide initial inventory based on expected use, then establish a standing weekly/monthly/quarterly shipment based on current use, with capacity to fill emergency requests on-demand. Initial inventory shall be provided with Vendor’s standard install kit.

C.10.3. Vendor will pay all routine shipping and handling fees for all supplies, consumables, reagents, and equipment to perform testing and will pay for shipping for volume adjustments should additionally testing supplies be required.

C.11 SCHEDULE OF SUPPLIES / SERVICES

The estimated annual volume is 78,282 slides, with a 10% increase in slides each year as per Anatomic Pathology.

H&E Test Volume

C.13.0 PAYMENT:

C.13.1 Payment for services satisfactorily performed will be made monthly in arrears upon receipt of proper invoices for contract services at the VAAAHS that are submitted electronically though the Tungsten System. Payment will be made by certified invoice and money will be distributed from the appropriate VAAAHS control point to pay obligations for the Cost Per Test Contract.

C.13.2 The Medical Technologist – Contracting Technical Specialist (COR) 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.

C.14 TERM OF CONTRACT:

C.14.1 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.

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 THE JOINT COMMISSION COMPLIANCE STANDARDS:

C.16.1 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.16.2 PATIENT RIGHTS: Protection of all patients’ rights is of highest priority. Patient privacy and confidentiality shall be maintained at all times. Computer access will be granted on a need-to-know basis, and security of computerized information will 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/discharge processes, and billing issues.

C.16.3 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 preventative actions taken. All events related to patient injury, medication errors, and other breeches of patient safety will be reported to the COR utilizing the VAAAHS Incident Report. All events related to patient injury, medication errors, and other breeches of patient safety will be documented utilizing the contractor’s format, and reported to the COR. 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 Analyses according to VAAAHS policy and within established guidelines. Completed RCAs shall be provided to the VAAAHS COR.

C.16.4 PERFORMANCE IMPROVEMENT: The contractor shall fully participate in the VAAAHS Performance Improvement (PI) program. This will 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 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 will be provided to the contractor in accordance with established reporting schedules. VA measures related to contract compliance will be identified by the COR.

C.16.5 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 will 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.16.6 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 will be mutually agreed upon by the contractor and the VAAAHS Safety Officer. The contractor shall maintain a safe environment at all times.

C.16.7 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.

C.17 DOCUMENTATION/REPORTS:

C.17.1 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 claimed must have been approved by the COR before service was performed.

C.17.2 Quality Management Plan and Quarterly Reports: The contractor shall maintain a Quality Management Plan consistent with Joint Commission and CAP standards. This will 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.18 REPORTING REQUIREMENTS:

C.18.1 Upon arrival, the contractor will only have controlled and defined access to the medical center facility and the access is permitted only to the extent that such activity does not interfere with the patient care or the mission of the medical center. Contractor will need to schedule an appointment in advance prior to the visit. Sales representatives will need to create and maintain SEC3URE account at https://www.sec3ure.com/login or its successor with the appropriate category relevant to the duties and locations within the healthcare facility. Any staff personnel observing vendor representatives in the medical center without a visitor sticker, shall directed to the vendor check in area to obtain proper credentials. When the service is completed, the contractor shall document services rendered on a legible Field Service Report and present to the COR for signature, during normal working hours.

C.19 COMPETENCY OF PERSONNEL SERVICNG EQUIPMENT:

C.19.1 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. “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 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.19.2 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.20 TEST EQUIPMENT:

C.20.1 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.21 SAFETY REQUIREMENTS:

C.21.1 In the performance of this contract, the contractor shall take such safety precautions as the CO may determine to be reasonably necessary to protect the lives and health of the occupants of the building. The CO 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.22 HARDWARE/SOFTWARE:

C.22.1 Computer Interfacing Requirements – The fully operational interface (both hardware and software) must be available for implementation to the VAAAHS hospital information system Vista/Cerner Millennium, at the time of contract award. Computer access will be granted on a need-to-know basis, and security of computerized information will be always maintained. The contractor will ensure necessary connection and interfacing to complete the remote equipment technical analysis for the requested instrumentation.

C.22.2 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 will provide all necessary software support and software upgrades for ensuring that successful interfacing is maintained.

C.22.3 The contractor shall provide all ancillary support equipment to fully operate the instrumentation as defined in these specifications. Vendor to provide pro-activity remote diagnostic monitoring (24 hours a day/7days a week). The instrument must pro-actively monitor itself and then notify the user and manufacturer (vendor) 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.22.4 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.22.5 The Staining Instrumentation, located at the VAAAHS must provide quality control and maintenance (when applicable) archiving that complies with College of American Pathologist (CAP) and Joint Commission (JC) requirements.

C.23: REAGENTS AND CONSUMABLES:

C.23.1 The vendor will supply all reagents, and consumables required for operating the H&E system required to produce superior quality results.

C.23.2 Vendor will 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.24 COR DESIGNATION:

C.24.1 The COR for this contract is Neelam Palande Medical Technologist – Contracting Technical Specialist, Pathology and Laboratory Medicine Service (113), VAAAHS, 2215 Fuller Road, Ann Arbor, MI, 48105. Email address is Neelam.Palande@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 NOT REQUIRED.

B.3 Records Management Language:

The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

1. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

1. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

1. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

1. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

1. The Government Agency owns the rights to all data/records produced as part of this contract.

1. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

1. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

1. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

1. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

B.4 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.