36C25019Q0234_1.docx

36C25019Q0234

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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

Multiple 36C25019Q0234 12-19-2018 Brooke Hansen 269-223-6072 01-08-2019

4PM

Department of Veteran Affairs Network Contracting Office 10 5500 Armstrong Rd.

Battle Creek

MI

49037 x 325413 1250 Employees N/A X Multiple. See SOW.

Department of Veteran Affairs Network Contracting Office 10 5500 Armstrong Road Battle Creek

MI

49037

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin

TX

78714-9971 512-242-7300 N/A See CONTINUATION Page Multi-station Microbiology CPT. See continuation page 22 for full schedule of supplies/services and attached SOW for full specifications.

All quotes MUST comploy with the Supplemental Instuctions to Offerors on page 68 the solicitation to be considered for award.

All quotes must be received by the deadline, January 8, 2019 4:00PM EDT. No late quotes will be accepted.

See CONTINUATION Page See continuation page- Multiple X Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

None

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C250 Brooke Hansen

Network Contracting Office 10

5500 Armstrong Rd.

Battle Creek MI 49037

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.

Department of Veteran Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

STATEMENT OF WORK

AUTOMATED MICROBIOLOGY

SENSITIVITY AND IDENTIFICATION SYSTEM IN CURRENT USE AT THE VA FACILITIES LISTED BELOW

1 SCOPE OF PROCUREMENT:

a) The contractor shall provide to the Veterans Affairs facilities (listed below) a Cost-Per-Test contract that will include all equipment [including uninterruptible power supply (UPS)], installation ,middleware management system, , software, hardware, Printer, Toner, all parts and materials, technical manuals, reagents, consumable supplies, shipping and handling costs associated with receipt of reagents, all preventative and repair maintenance agreement, operator training in the operation of and performance of preventive maintenance, startup Quality Control (QC) and validation cards/panels, (if the contractor discontinues cards/panels, the contractor shall provide the requested number of cards/panels and reagents to perform the extra QC for validation studies at no charge), appropriate ATCC microorganisms for startup and weekly QC, bi-directional interface bar-coded computer interface compatible with the VA laboratory information system.

b) The contractor shall provide all equipment necessary to provide Cost-Per-Test analysis of susceptibility and identification of select microorganisms, any start up supplies for validation studies, monitors, keyboards, personal computers, barcode scanners, external hard drives, laser printers and ink cartridges/jets. The contractor shall provide all cables and hardware/software necessary to connect any of the system components. The contractor shall include all parts materials, labor supervision, calibrators, technical manuals, operator training, and necessary transportation to perform preventative maintenance.

VA Ann Arbor Healthcare System 2215 Fuller Rd.

Ann Arbor, MI 48105 Battle Creek VA Medical Center 5500 Armstrong Road Battle Creek, MI 49037

Richard L. Roudebush VA Medical Center 1481 W. 10th Street Indianapolis, IN 46202 John D. Dingell VA Medical Center 4646 John R St.

Detroit, MI 48201

Northern Indiana Healthcare System (VANIHCS) Ft. Wayne Campus 2121 Lake Avenue Fort Wayne, IN 46805 Aleda E. Lutz VA Medical Center 1500 Weiss Street Saginaw, MI 48602

2 DEFINITIONS:

a) Cost per Test (CPT) - as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 1 year equipment use with 4 one year options to be exercised at the sole discretion of the government; (2) all reagents, standards, quality controls, calibration and correlation study testing, validation material, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result; (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

b) Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

c) Contractor Middleware Management System - For the purposes of this solicitation, this is a separate component or module that electronically connects the testing instrumentation to manage data, results and workflow of 2 or more pieces of instrumentation. (Not to be confused with middleware for interfacing equipment with the hospital/laboratory information system.)

3 DEFINITION OF NEED:

The VISN 10 facilities request a base year Cost-Per-Test contract that includes 4 additional option years to be exercised at the sole discretion of the government for the selected automated microbiology susceptibility and identification system.

The contractor shall provide all equipment necessary to provide Cost-Per-Test analysis of susceptibility and identification of select microorganisms, any start up supplies for validation studies, monitors, keyboards, personal computers, barcode scanners, external hard drives, laser printers and ink cartridges/jets. The contractor shall provide all cables and hardware/software necessary to connect any of the system components. The contractor shall include all parts materials, labor supervision, calibrators, technical manuals, operator training, and necessary transportation to perform preventative maintenance.

a) All the equipment and ancillary supplies provided will be new (not refurbished, remanufactured, or previously used or demonstrated).

b) The system shall read bar-coded labels of patient identification, calibrators, and controls.

c) The system shall have a bi-directional bar-coded computer interface compatible with the VA laboratory information system (currently Data Innovations to VA VISTA/DHCP system)

d) The equipment must be user friendly and not be labor intensive, including ease of set-up.

e) The system, software and bottles shall meet the standards of: College of American Pathologists (CAP), Clinical and Laboratory Standards Institute (CLSI), The Joint Commission (TJC), 1988 Clinical Laboratory Improvement Act (CLIA), Federal Drug Administration (FDA), Federal, State, and local policies.

f) The accompanying software (and all no charge updates) will be user friendly, have the capability to modify organism nomenclature, modify susceptibility interpretations, to be able to create in-house rules for conditional reporting of ‘drug-bug’ combinations, ability to alert the user of any unusual susceptibility patterns including but not limited to: oxacillin resistance, vancomycin resistance, extended beta lactamase producers (presumptive and confirmatory testing), inducible clindamycin resistance, carbapenemase producers, and recommend suggestions for additional testing. The accompanying software will be able to provide accurate identification and recommend suggestions for additional testing. The system will also contain pre-determined rules and regulations as noted by the CAP, CLSI, CLIA and FDA.

g) The system shall have the capability of maintaining all data for up to 24 hours in the event of normal electrical power interruptions.

h) The system shall avoid any exposure to biohazardous material.

i) Equipment shall include continuous, on-board, reagent inventory monitoring i.e. lot number(s) reagent on board, expiration date monitoring, number of tests/pipettes/reagent left in assay material.

j) Patient samples and the results that are in progress and completed assays are displayed on instrument for technologist’s review.

k) Instrument has system to ensure no sample carry-over.

l) Contractor shall supply an adequate uninterruptible power system(s) (UPS) to support the testing equipment for life of the contract.

m) Contractor shall supply laser printer and ink cartridges/jets for life of the contract. Must have printed hard copy results for computer down time via analyzer remote printer.

n) Contractor shall supply barcode readers and have capability to read VA laboratory information system barcodes, as well, for life of the contract.

o) The system will be able to easily generate quality control reports and provide for workflow management capabilities.

p) Contractor shall supply secured external hard drives/flash drives (or similar technology) for automatic database backups/archiving. If CD/DVD/similar media are required then they will be supplied by contractor for the life of the contract.

q) Contractor will supply actual testing/analyzing equipment, personal computers, monitors, cables, keyboards, wiring, etc. for the life of the contract.

r) Must provide ability to incorporate new methodologies.

s) Contractor will include regular service maintenance agreements in contract.

t) The CPT price must include all consumables required to perform testing.

u) The system will afford flexibility for the end user in the types of identification and susceptibility cards/panels being offered.

v) If any card/panel types in use experience recalls or limitations on reporting then contractor will supply at no cost the supplies/reagents/media/etc. necessary to continue an alternative form of testing until the situation is rectified to everyone’s satisfaction or the testing is no longer required by the VISN 10 facilities.

w) Technical, software, hardware, privacy, security and online help will be available through the contractor 24/7 by telephone, including weekends and recognized (federal) holidays. If on-site service call is necessary the contractor shall be present within 24 hours or less.

x) Contractor shall provide technical specialist to perform all necessary set up and to prepare all installation, validation, and quality control reports for the institution’s evaluation

y) Contractor shall provide an up to date procedure manual in CLSI format on a portable storage device (i.e. CD-ROM, disk, etc.) and/or an on-line CLSI formatted procedure manual in the instrument software. In addition, there is to be a printed hard copy version.

z) Contractor shall supply specialized instrument training at no additional cost, for 2 personnel and make available at time of equipment installation. This shall include training on the system operation, data manipulation, trouble shooting, maintenance and repair. This training is to be completed within 180 days of the purchase order completion. Same training will apply for 1 (one) additional personnel for each remaining valid contract year. The contractor shall also make available a technical specialist for on-site, in-house training for all shifts in the laboratory. The contractor, at its discretion may make training available at its facility on terms and conditions mutually agreed upon by the Agency and the contractor consistent with commercial offerings (Preferred method).

aa) Contractor will provide without additional cost all ancillary components that are customarily sold or provided with the model of equipment proposed.

ab) PARTS: The contractor shall furnish all parts as necessary to maintain and update the equipment covered by this contract, in accordance with the Conformance Standards. The contractor guarantees that it has ready access to new standard parts (manufactured, supplied by the manufacturer, or equivalent substitute) for needed repairs. All parts supplied shall have full compatibility with existing equipment. Documentation of intended parts source(s) shall be provided to the Contracting Officer upon request

ac) NOTE: Contractor acknowledges the fact that upon termination of the contract by any means that any components of the system which contain any type of demographics, or personal identifying information will be sanitized according to VA regulations.

4 BRIEF SUMMATION OF SUPPORT FEATURES:

a) The contractor shall provide all labor, materials, equipment, and equipment parts and service, reagents, supplies, consumable, disposable items, parts, accessories, shipping and handling costs, and any other item(s) required to establish fully operational microbiology testing systems including appropriate start up and weekly ATCC quality control strains, to comply with CAP and CLSI regulations. Shipping and handling costs shall be the responsibility of the contractor and shall be included in the offer.

b) The contractor shall provide at no charge software upgrades to maintain the integrity of the system as a state of the art system. These shall be provided as they become released, installed by the contractor (as appropriate) and supported by in-house technical training (as appropriate).

c) The contractor shall provide all ancillary support equipment to fully operate the instrumentation as defined in these specifications. Remote access for the system troubleshooting shall be considered on a case by case basis. If provided, it shall only be through a VPN interface subject to the Department of Veterans Affairs IMS approval. Modems are no longer considered acceptable by the VA Information Security Office. The contractor shall provide all universal interface equipment to interface equipment with the VA laboratory information system.

d) Currently, the Veterans Affairs facilities utilize Data Innovations(DI) as the universal interface. Contractor equipment must offer a bi-directional interface with Data Innovations and VISTA/DHCP. The contractor shall provide everything required for the installation, implementation, testing, and operations of the interface right up to the universal interface box, including the software license fee that may be required each time an instrument or software update is added to an existing system (e.g. ports, cards, panels, software, flash drives, licenses, etc.). If there are any software/hardware/panel upgrades for the contractor system during the life of the contract, the contractor is responsible for ensuring that the interface support system can accommodate any changes in the data stream going to and from the VA’s laboratory information system and VA’s computerized patient record system (CPRS). Any additional costs, e.g. consulting fees, travel expenses, and extra equipment, etc. will be borne by the contractor. During the life of contract if DI becomes obsolete, contractor shall provide the support to its successor

e) Currently VA computer system is nationally supported by Microbiology Class III interface. Contractor shall provide support to any future upgrade to VA supported system and any enhancement to the universal interface.

f) In addition, 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 contractor shall provide an up to date procedure manual in CLSI format on a portable storage device (i.e. CD-ROM, disk, etc.) and/or an on-line CLSI formatted procedure manual in the instrument software. In addition, there is to be a printed hard copy version.

g) Training. The Contractor shall provide instrument training program for two (2) key operators for analyzer, middleware, from each facility that is coordinated with and is timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training defined in the Contractor’s Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one (1) key operator per facility per year at the discretion of the Government. 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 airfare, room and board for each participant.

4.g.1 In addition to the training above the following shall be provided:

4.g.1.1 Basic operator training shall be provided by Contractor on-site for all operators on all shifts, as applicable.

4.g.1.2 Advanced training shall be provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization.

5 HARDWARE/SOFTWARE:

a) Computer Interfacing Requirements – The fully operational interface (internal or native to the system) network (Ethernet) interface (Hardware and software) must be immediately available for implementation to the Veterans Affairs facilities laboratory information system at the time of contract award. Network interface shall be capable of supporting TCP/IP network protocol in both IPV4 and IPV6. If the contractor is not capable of supporting TCP/IP network interface, then it shall be the contractor’s responsibility to provide a Lantronix serial to Ethernet conversion unit with all associated cabling and connectors. The Veterans Affairs facilities laboratory shall determine the model or Lantronix requirement (MSS100 or MSS4) and provide the contractor with the model needed. Computer access will be granted on a need-to-know basis, and security of computerized information will be maintained at all times. The Veterans Affairs facilities shall be interfaced for instrumentation that is being provided. The contractor shall ensure interfacing for all instrumentation that is offered.

b) 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 contractor will provide all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system selected. All cables and hardware necessary to connect any of the systems together are included if required, and all parts materials, labor supervision, calibrators, technical manuals, operator training and transportation necessary to perform preventative maintenance on the selected system.

c) 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 assuming 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 all other parts, equipment, or other hardware needed to connect the system with the Veterans Affairs facilities laboratory information system. If there are any software upgrades in the instrument during the life of the contract, the contractor is responsible for assuring that the interface can accommodate any changes in the data stream going to the Veterans Affairs facilities laboratory information system.

d) 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 Systems (IMS) approval. Modems are no longer considered acceptable for use by the VA Information Security Office and are prohibited from use.

e) The contractor shall provide without additional cost all ancillary components that are customarily sold or provided with the model of equipment proposed, (e.g., starter kits, tables/stands, etc.). The contractor shall provide an up to date procedure manual on a portable storage device (i.e. CD-ROM, disk, etc.) and/or an on-line procedure manual in the instrument software. In addition, there is to be a printed hard copy version. The procedure manual shall be formatted in accordance with current, approved CLSI guidelines.

f) The contractor must provide availability of printed (hard copy) patient results routinely and in the event of interface downtime for the system.

g) The contractor must provide electronic patient data, quality control, and maintenance (when applicable) archiving that complies with College of American Pathologist (CAP), and The Joint Commission (TJC) requirements for the system.

h) In addition to software, the analyzer must have a hardware data manager to meet the facilities operational goals and shall include the following capabilities.

5.h.1 Archiving of results 5.h.2 Data collection 5.h.3 Interference management 5.h.4 LIS backup and storage management 5.h.5 Rule based decision processing 5.h.6 Auto verification, if applicable

i) Additionally, the contractor may make training available at its facility on terms and conditions mutually agreed upon by the Veterans Affairs facilities and the contractor that are considered with commercial offerings

6 SUPPORT FEATURES:

a) The contractor shall coordinate all validation analyses and report this data in an organized, clearly comprehensible format, a sample of which is to be provided with the proposal to the CO. The contractor shall provide assistance with the establishment of references to include the handling of data with appropriate software to establish references based on current CAP, TJC, and CLSI regulations.

b) Equipment should be Able to reconfigure to add third party vendor equipment.

7 TECHNICAL SUPPORT:

a) The contractor will provide technical support, perform method validation as outlined and submit all data and/or required statistical analysis in a binder(s) for on-site staff approval.

b) Availability of a support hotline 24 hours a day, 7 days a week including all holidays.

c) Provide in-house assistance in validating new test/assays.

8 IMPLEMENTATION/TRANSITION TIMEFRAME:

The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the contract with seamless transition for the patient care. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

a) Upon award of a contract, the transition period for the awarded Contractor to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial onsite training of VA personnel in the operation and maintenance of said award shall also be completed.

b) Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded contract including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate the contract for cause under the Termination for Cause clause.

c) At the end of 90 days, the awarded Contractor shall have full and sole responsibility for services under the awarded contractor.

9 HOURS OF WORK:

a) 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.

b) Warranty for the entire agreement period to include unlimited, on-demand, service 24 hours a day and 7 days a week, including holidays.

c) 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, 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.

10 STANDARD AND QUALITY OF PERFORMANCE:

This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any proposal at an effectiveness level of 90% or more.

a) If equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

b) If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled “Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

c) Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

d) During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when more than the minimum of 100 hours.

e) The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

f) During the term of the contract, shall the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR and/or contracting officer to replace the malfunctioning equipment with new equipment. The Contractor shall reimburse the VA facilities for any services (i.e. currier, reference lab, etc.) that were needed due to prolonged downtime. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. The same terms and conditions apply to ancillary/support equipment provided under this contract, i.e., water system UPS, etc.

g) An annual compliance report addressing preventive maintenance inspections, as well as Safety/Environmental/Infection Control inspections, shall be reported to the COR in the month of September.

h) Government’s Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

i) Ownership of Equipment- 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.

j) The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will 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 shall purge all patient sensitive information prior to departure from the facility.

10.m.1 Contractor shall accept the system without the drive;

10.m.2 VA’s initial medical device procurement includes a spare drive which shall be installed in place of the original drive at time of turn-in; or 10.m.3 VA shall reimburse the company for media at a reasonable open market replacement cost at time of purchase.

n) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

10.n.1 The Contractor shall have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and 10.n.2 Any fixed hard drive on the device shall be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

10.n.3 A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

11 ENVIRONMENT OF CARE/QUALITY CONTROL:

a) Routine and recurrent preventative maintenance inspections shall be the responsibility of the contractor. All significant problems shall be reported verbally to the Contracting Officer Representative (COR) AND Microbiology supervisor within 24 hours. A written corrective plan of action shall be submitted to the COR within 5 working days. The Veterans Affairs facilities timeframes and priorities for completion of action plan items will be mutually agreed upon by the contractor and the Contracting Officer. An annual compliance report addressing preventative maintenance inspections, as well as Safety, Environmental, and Infection Control inspections, shall be reported to the COR.

b) The contractor shall perform preventative maintenance inspections, during the contract period arranged with the COR or Microbiology supervisor, in accordance with the published preventative maintenance schedule for the selected system, but preventive maintenance shall be performed no less than annually. 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 and Microbiology supervisor 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 regarding problems found and any corrective action taken while performing the maintenance and repair call.

c) SAFETY REQUIREMENTS:

In the performance of the 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 its 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.

12 DOCUMENTATION/REPORTS:

a) 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 CO before service was performed.

b) The contractor shall perform all validation/statistical analyses and report this data in an organized, clearly comprehensible format, a sample of which is to be provided with the proposal to the CO. The contractor shall provide assistance with the establishment of reference parameters to include the handling of data with appropriate software to establish references based on current CAP, TJC, CLSI, and FDA standards.

13 TERM OF CONTRACT:

The contract will be effective for one (1) year from the date of the contract award, with four (4) pre-priced option years. The contract is subject to the availability of appropriated funds

14 THE JOINT COMMISSION COMPLIANCE STANDARDS:

a) GENERAL: The contractor shall continuously meet or exceed all The 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 Veterans Affairs facilities 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

b) PATIENT RIGHTS: Protection of all patients’ rights is of highest priority. Patient privacy and confidentiality shall be always maintained. 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/her fully informed consent, subject to study approval by the Investigational Research Board (IRB). The contractor shall abide by the VAMC Code of Ethics, which addresses marketing, admission/transfer/referral/discharge processes, and billing issues.

c) PATIENT SAFETY: The VAMC shall inform the contractor of all applicable Sentinel Event or other Patient Safety Alerts received by the VAMC. 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 VAMC 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 VAMC shall provide the contractor with VAMC Sentinel Event definitions in the start-up phase. The contractor shall verbally notify the VAMC 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 VAMC shall determine when a Root Cause Analysis (RCA) is required of the contractor. The contractor shall conduct all Root Cause Analysis according to VAMC policy and within established guidelines. Completed RCAs shall be provided to the VAMC COR.

d) PERFORMANCE IMPROVEMENT: The contractor shall fully participate in the VAMC 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 VAMC, VISN or VHA, as well as accreditation or licensing bodies. The contractor shall abstract, compile and report PI data as requested by the VAMC. VA Data collection methodology, report format, and reporting deadlines will be defined by the VAMC. In all cases, the contractor shall continually assess for, and act upon, clinical and administrative improvement opportunities. VA monitoring for continuous compliance with The Joint Commission standards shall be directed by VAMC staff, and communicated to the contractor through the COR. VA aggregate and/or practitioner-specific data collected by the VAMC will be provided to the contractor in accordance with established reporting schedules. VA measures related to contract compliance will be identified by the COR.

e) The contractor shall effectively manage daily operations, information and support systems, and conserve physical and financial assets while meeting the mission of the VAMC. 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.

f) INFORMATION MANAGEMENT: The VAMC Information Management plan shall be followed by the contractor. Documentation and record keeping shall be in accordance with VAMC policies and procedures. VAAR-852.273-75 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (Interim – Oct 2008) must be included in the document.

g) 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.

15 REPORTING REQUIREMENTS:

Upon arrival, the contractor (agent) is required to sign as required by each facility. When the service is completed, the contractor (agent) shall document services rendered on a legible Field Service Report and present to the COR and Microbiology supervisor for signature, during normal working hours. After normal business hours, the contractor will e-mail the Field Service Report to the COR or designee.

16 COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

a) The contractor’s service personnel staff shall include a “fully qualified” Field Service Representative assigned to each Veterans Affairs facilities and a “fully qualified” Field Service Representative (FSR) who shall serve as the Backup to ensure 7 days per week 8:00 am to 5:00 pm including holiday coverage. “Fully qualified” is defined as training and experience in the field.

b) The Field Service Representative (FSR) has successfully completed a documented formalized training program for the equipment covered under the contract. For field experience, the Field Service Representative (FSR) 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) 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 covered in this agreement and a written assurance of competency. All related documentation, such as completed competency checklists or educational training records, shall be maintained by the contractor and available for VAMC upon request. The contractor shall maintain a culture that promotes self-development and learning which is designed to maintain or enhance learning competencies.

17 TEST EQUIPMENT:

Upon request of the COR, Microbiology supervisor, 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 standard.

18 CONFORMANCE STANDARDS:

a) Contract shall maintain full compliance with applicable Federal and State regulations. All services provided under this contract shall be performed in conformance with the Food and Drug Administration (FDA), Nation Fire Protection Agency (NFPA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA) and other applicable national, state and local regulatory agencies. Contractor shall maintain a CLIA certificate of accreditation, and The Joint Commission (JC), and/or the College of American Pathology (CAP) accreditation.

b) 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).

c) 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.

19 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.

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