Statement of Work - Revised.docx

36C26125Q0065 Statement of Work (SOW)

1. INTRODUCTION

VA CENTRAL CALIFORNIA HEALTH CARE SYSTEM has a requirement for a Cost Per Reportable Results (CPRR) Indefinite Delivery, Indefinite Quantity (IDIQ) contract for clinical laboratory and immunoassay analyzers. The contractor agrees to provide a price schedule with Cost Per Reportable Results (CPRR) Pricing structures only, in accordance with the terms and conditions of the SOW to the Veterans Integrated Service Network 21 (VISN 21), identified as the Government herein. The services and prices are specified in the sections entitled Schedule of Supplies/Services of this contract.

Period of Performance: 5-year ordering period with five one-year pricing periods.

The proposed period of performance is:

Place of Performance: The scope of this contract covers the entire area of responsibility (AOR) of VA CENTRAL CALIFORNIA HEALTH CARE SYSTEM, including any clinic. The Government may add onto this IDIQ for any Community-Based Outpatient Clinic (CBOCs), clinics, etc.

1.1 Participating Facilities: Points of contact per facility are listed below.

STATION 570 VA CENTRAL CA HEALTHCARE SYSTEM

VA Central CA Healthcare System 2615 E. Clinton Ave Fresno, CA 93703 Point of contact:__________________________________

1.2 VA CENTRAL CALIFORNIA HEALTH CARE SYSTEM has provided estimated volumes of tests performed in the attached Price List (S02 36C26125Q0065 Price List) for each individual medical center and outpatient clinic laboratory. The Government estimates the volumes listed in the attached spreadsheet per facility but does not guarantee volumes as listed. Volumes may fluctuate up or down during the term of the IDIQ.

Types of Analyzers at each location:

STATION 570 VA CENTRAL CA HEALTHCARE SYSTEM

2. Required Specifications

2.1 General

· The desired instrumentation will have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrumentation will be able to perform the profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (Hereafter referenced as CLIA) and the Clinical and Laboratory Standards Institute (Hereafter referenced as CLSI). Equipment will be new, state of the art, and not recertified nor refurbished. Equipment will be acquired for each of the clinical laboratories located at VA CENTRAL CALIFORNIA HEALTH CARE SYSTEM.

· The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items will be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Unexpected changes in methodology/technology will be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the local Point of Contact (Hereafter referenced as POC). These individuals will be identified upon award of the delivery order/s.

· Special Handling for Emergency Orders of Supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor will deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they will be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

· Industry Standards – Unless otherwise stated, all equipment will be held to current industry standards for such equipment as present within the current market for Chemistry, Immunoassay, and automation equipment, supplies and services.

· Only instruments which are FDA approved will be considered. Instruments will be operational and must interface with VA Laboratory Computer systems and upgrades.

· Test methods will be FDA approved.

2.2 Definitions

Cost-Per-Reportable-Result (CPRR) – Contractors are required to provide a price for a reportable patient result. The cost per reportable result price will include costs covering (a) equipment use, (b) all reagents, standards, controls, 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 of a patient reportable result. This does not include those items approved for exclusion by the government such as printer paper, labels etc. This per patient reportable result price will also encompass all costs associated with dilution, repeat and confirmatory testing required to produce a single patient reportable result. It will also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by National Committee for Clinical Laboratory Standards (NCCLS). (c) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs and (d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

Clinical Laboratory Chemistry Analyzer - Automated system for the robotic specimen handling and accurate analysis, data review, and reporting of human chemistry testing.

Clinical Laboratory Immunoassay Analyzer – Automated system for the robotic specimen handling and accurate analysis, data review, and reporting of human immunoassay testing.

Primary analyzer(s) – Base equipment offered that will fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s), likewise, be considered primary instrumentation, and will be compatible with the primary analyzer, and meet the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer will be equivalent to a back-up analyzer (see definition below) and replace the requirement for offering that category of equipment.

Back-up analyzer(s) – Equipment required to support the operations of the NCO laboratories when the primary analyzer(s) is not operational/functional. However, this equipment may also be used in conjunction with the Primary Analyzer to meet NCO program requirements as determined by the NCO, such as but not limited to “the simultaneous operation of both instruments to run additional testing as needed to meet program requirements.” This category of equipment must be capable of operation during periods of time when the primary instrumentation is not available for use. The back-up analyzers will be of the same model as the Primary Analyzers to allow the facility to continue operation at appropriate levels.

Business Associate Agreement (Hereafter referenced as BAA) -¬ A business associate is an entity, including an individual, company, or organization that, on behalf of the VHA facility, 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 everyone that receives, uses, or discloses VHA PHI in order 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.

Community Based Outpatient Clinic (Hereafter referenced as CBOC) – CBOC’s are smaller facilities with smaller throughput than their larger parent facilities. Specific CBOC laboratories with test volumes listed in Attachment A – Volume Estimates and Individual Test Pricing will require equipment placements.

2.3 Chemistry Instrumentation:

The instrumentation capabilities:

a) Using third-party analyzer(s) to meet test menu requirements is not acceptable.

b) Using third-party equipment for automation is acceptable.

c) Third party open channel assay on contractors’ solution is acceptable.

a) Relocated equipment within the laboratory space must stay within the same room.

b) “Affixed equipment” means equipment affixed or anchored to real property or requiring dismantlement for relocation.

11. Perform the creatinine, hemoglobin A1C and cholesterol assay testing using a method referenced to an international standard (e.g., WHO standard). If the methodology changes and warrants patient re-baselining, the Contractor to provide necessary services and materials.

27. Equipment provide(s) an Uninterruptible Power Supply (UPS). If possible, provide a single UPS with the capacity to maintain continuous operations for 30 minutes allowing for a controlled shutdown or to shut-down the instrument in an orderly manner in the event power outage.

28. The contractor has the capability to establish a remote connection for the purpose of instrument troubleshooting, software updates, and delivering test volumes for invoice generation.

29. Calibration frequency not to exceed once per 24 hours per instrument for ISE.

30. Ability for long calibration stability for all other testing.

31. Ability to pre-calibrate new lots of reagents prior to use.

32. Quality control testing requirement frequency not to exceed once per 24 hours per instrument.

33. Ability to lock out/suppress test analytes if there are QC failures.

34. No requirements for sample pre-treatment.

35. Test volumes are listed by facility in Attachment A – Volume Estimates and Individual Test

2.4 Immunoassay Instrumentation

The instrumentation capabilities:

1 Provide immunoassay analyzers with consistent methodology for load balancing (workload) and back up purposes as indicated in the equipment list. Secondary or backup analyzer(s) specified to be manufactured by the same Contractor receiving the award and use(s) the same reagents for each test to allow for standardized test builds.

a) Third-party analyzer(s) to meet test menu requirements is not acceptable.

b) Using third-party equipment for automation is acceptable.

c) Third party open channel assay on contractors’ solution is acceptable.

21 Provide solutions for STAT turnaround time on Immunoassay testing.

22 Immunoassay incubation times not to exceed 30 minutes, to meet or exceed current turnaround times.

23 A Troponin which meets the IFCC definition of high sensitivity i.e., can be detected in at least 50% of normal reference population.

24 State carryover claim and design solutions to mitigate carryover.

2.6 Automation for Chemistry and Immunoassay:

1. Relocated equipment within the laboratory space must stay within the same room.

1. “Affixed equipment” means equipment affixed or anchored to real property or requiring dismantlement for relocation.

10. Automation includes input sorting technology (such as a hopper) and the ability to aliquot.

11. Has the capability to establish a remote connection for the purpose of instrument troubleshooting, software updates, and delivering test volumes for invoice generation.

12 Ability to make bar code labeled aliquot tubes that mirror the primary tube labeling for offline processing.

13. De-capper has/have the ability to remove different cap types (e.g., hemogard, screw caps, rubber stoppers). This is necessary to maintain employee safety by reducing the exposure to body fluids and maintain workflow and turnaround time.

14. Uncapping and recapping/sealer system in an enclosed environment to prevent distribution of bio- hazardous aerosols.

2.7 Data Management for Chemistry and Immunoassay:

11. Listed as preferred but not required: Will automatically calculate and report to the LIS both Free and BioAvailable Testosterone, using values from Total Testosterone, Albumin, and Sex Binding Globulin Hormone.

12. Has/have the capability to transmit QC data to an external real-time QC service.

2.8 Software for Chemistry and Immunoassay:

3. Installation/Site Preparation:

1. Site preparation specifications for each facility to be furnished in writing by the Contractor as a Site Preparation Report after award of the delivery order/s. The report to be provided to the Contracting Officer no later than one week after award of the delivery order/s and all other site reports to be provided at least forty-five (45) days before installation.

All proposed equipment should fit in the available lab space square footage with proper egress for safety.

a) Relocated equipment within the laboratory space must stay within the same room.

b) “Affixed equipment” means equipment affixed or anchored to real property or requiring dismantlement for relocation.

4. Service and Maintenance

1. Contractor provides equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g., water system, covered under the delivery order/s award, and UPS.

2. Support Services: Contractor provides telephone assistance 24-hours/day, 365 days per year with a call back response of 2 hours. Following determination that service is required, technical on–site support provided under the terms of the contract and provided for emergency repairs 365 days per year within twenty-four (24) hours of the time of notification of the malfunction for medical center labs. For CBOC labs, during normal operating hours, within twenty-four (24) hours of the time of notification of the malfunction. If both primary and backup analyzers are not able to perform a test listed as STAT, Contractor has/have defined, approved contingency plan(s) to ensure continuation of testing. Contractor provides maintenance (labor and parts) to keep the equipment in good operating condition and subject to security regulations. The government will provide the Contractor access to the equipment to perform maintenance service according to the maintenance and service terms.

3. Contractor to furnish a malfunction incident report to the installation upon completion of each repair call. The report includes, at a minimum, the following: (a) date and time notified; (b) date and time of arrival; (c) serial number, type and model number(s) of equipment; (d) time spent for repair; (e) description of malfunction and repair; and (f) proof of repair that includes documentation of quality control being performed and within range, as applicable. Notify the site management if repair is significant enough to require calibration and/or validation following the repair and Contractor performs calibration and/or validation.

4. Maintenance plan: Contractor provides manufacturer’s daily, weekly, monthly, quarterly and periodic maintenance plan, outlining time required for hands on and automated tasks.

5. Daily maintenance: Instrumentation requires minimal hands-on daily maintenance.

6. Preventative Maintenance: Contractor provides regular, scheduled maintenance coordinated with the site management to assure the continued reliable operation of the equipment. These preventive maintenance visits are of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment.

7. Emergency Repair: Emergency repairs performed after notification that the equipment is inoperative. Contractor provides the government with a designated point of contact and shall make arrangements to enable its maintenance representative to receive such notification. Contractor performs emergency repair service within 24 hours of time of notification of the malfunction. Contractor provides all parts and labor needed to repair the malfunction. Travel, per diem and other expenses associated with the repair shall be borne by the Contractor. Contractor furnishes a malfunction incident report to the installation upon completion of each maintenance call. The report includes, at a minimum, the following: (a) date and time of arrival. (b) Serial number type and model numbers(s) of equipment (c) time spent for repair, (d) description of malfunction and (e) proof of repair.

8. Maintenance Support: Service repair person locally based within the geographical area.

9. Maintenance Credit for Equipment Malfunction: If a machine remains inoperative due to a malfunction through no fault or negligence of the government for more than 24 hours, the Contractor is assessed damages at the rate of 1/30 of the preceding average three-month CPRR billings times the total number of days certified as downtime. Each incident starts from the time the user makes a bona fide attempt to contact the Contractor's designated representative at the prearranged contact point until the machine is returned to good operating order less any non-contracted maintenance (emergency repairs) days.

10. Replacement of Laboratory Equipment: During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination will be made by the representative of the government to replace the initial laboratory equipment with new equipment. The responsibility of maintaining the equipment furnished in good condition shall be solely that of the Contractor.

11. Failure Mean Time Disclosure: Contractor states the failure mean time (between failure and mean time to repair) for each piece of equipment offered. Contractor to provide redundant systems to eliminate need of emergency backup equipment.

12. Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, menu changes, technological upgrades, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually with communication to the Contractor for modification of the contract. A high incidence of problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. Removal of instrument by the Contractor performed within 60 days after request.

5. Training

1. Contractor provides an instrument training program that is coordinated with and 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 this contract. This includes training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, Contractor provides training at a minimum for one operator per installed analyzer per year for the duration of the contract at the discretion of the Government for each model of instrumentation or automation placed. Utilization of the training slots will be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel includes the cost of airfare, room, and board for each participant.

2. Onsite Training: During the validation process of the installation, the Contractor provides technical resources to train operators on all shifts of operation. This can be accomplished by holding training sessions for multiple employees on each shift.

3. Additional training required:

(1) Advanced training, either off-site or in-house, provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization

(2) On-site refresher training in renewal option years of the contract made available annually for the duration of the contract.

4. Contractor provides supplemental on-site operator training to government personnel, without additional charge to the government, upon installation of upgraded equipment hardware or operating system software connected with the operation of an instrument that has already been installed.

6. Upgrade/Updates Contractor provides updates to both the equipment hardware and software in order to maintain the integrity of the system and the state-of–the-art technology, at no additional charge to the Government. Upgrades are provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system updates” that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, update offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the delivery order/s; however, it does refer to significant changes in the hardware operational capability. Should any facility decide to upgrade their current equipment, i.e., replace existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement.

7. Information Technology

· A VA Directive 6550 – Appendix A completed for each analyzer offered under the solicitation.

· Primary and back-up instrument interfacing is required at all sites. The current type of interface system is Data Innovations.

· Contractor is responsible for providing all hardware and software licenses required for the connection, and implementation of the analyzer’s interface to the Laboratory’s Universal Interface.

· Contractor provides 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 involved and dictated by the manufacturer itself.

· Contractor provides any additional support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance, e.g., electronic procedure manual

· Contractor has/have the capability to establish a remote connection for the purpose of instrument troubleshooting, reagent management, software updates, and delivering test volumes for invoice generation. Has/have an ISA/MOU is established with the VA OI&T (Office of Information and Technology) to allow for the implementation of remote diagnostics connectivity. All connectivity hardware and installation is provided by the Contractor.

8. Ancillary Support Equipment

1. Contractor provides, installs, and maintains, as indicated, any and all ancillary support equipment to fully operate the analyzer or automation as defined in these specifications, e.g., cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), compressed air, and universal interface equipment, UPS, etc. Contractor includes all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits, tables/stands, etc.

9. Packaging and Marking

1. All supplies are adequately packaged to prevent damage during shipping, handling and storage. Bags or packages are whole, intact, and not otherwise torn or damaged. Contractor is required to replace unacceptable or damaged products at the Contractor’s expense.

2. Items are marked clearly with the delivery order number, purchase order number, and delivery location within the hospital i.e., Laboratory Services/113.

10. Installation/Implementation

1. PHASE-IN/PHASE OUT REQUIREMENTS - Due to the length of time required to implement the requirements.

2. Phase-in requirements: The implementation of the services/requirements described in this solicitation shall be completed no later than 180 days or based on the mutually agreed upon timeline by the Contractor and VA after award. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the 180-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government (i.e., construction/ remodeling of facilities). Upon award, the transition period for the awarded Contractor to have all equipment and peripherals installed and operational shall be 120 days from the date of award through 180 days or based on the mutually agreed upon timeline by the Contractor and VA. This requirement includes the implementation of auto verification and the transmission of QC data to an external real-time QC service. During this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed with exceptions due to delays at the fault of the Government.

a. The new Contractor must be able to coordinate with the laboratory and install the new equipment while the old Contractor’s equipment is still in operation in order to prevent any lapse of service for laboratory testing.

b. At the end of 180 days from award of the Contract, the awarded Contractor has/have full and sole responsibility for services under the awarded delivery order/s.

3. Phase-out Requirements: During the phase-out period, the incumbent contractor(s) shall be fully responsible for all work performed under this Statement of Work (SOW). Up to one hundred eighty (180) calendar day phase out period may be required. The incumbent contractor(s) shall cooperate fully to permit an orderly changeover of laboratory workload. The incumbent contractor shall allow the new contractor and government personnel access on a non-interference basis, to observe the day-to-day operations and to become familiar with the work requirements and procedures.

4. Within one week from the date of award, the CO, POCs and the Contractor will hold a kickoff meeting to discuss implementation.

5. Acceptance and Performance – This paragraph establishes a standard of quality performance that is to be met before any equipment listed on the delivery order/s 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 begins on the installation date. Acceptance will occur once the analyzers/equipment have met the standard performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as proposed in the contract at an effectiveness level of 90% or more.

6. Start-Up Reagents - The Contractor provides all reagents, calibrators, controls, consumable items, disposable items, parts, accessories, and any other item included on the list of supplies defined in the contract and required to establish instruments for operation for performance of acceptance testing. The Contractor performs, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, carryover studies, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government.

7. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests continues on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

8. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the Government may request a replacement or terminate the delivery order/s in accordance with the provisions of FAR 8.406-4 “Termination for cause.” (The Contractor will receive revenue for tests reported during the 90-day acceptance period.).

9. 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 of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident starts 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.

10. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work required begins as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours will be used when in excess of the minimum of 100 hours.

11. The Government will maintain daily records to satisfy the requirements of this paragraph and notifies the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime will be measured in hours and whole minutes.

11. Replacement of Malfunctioning Equipment

1. During the term of the delivery order/s, should 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 will be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, will be solely that of the Contractor. Each instrument provided by the Contractor will maintain an uptime of 90% in each month of the term of the contract.

12. Delivery

1. The Contractor will deliver all supplies and services identified in the schedule to the locations identified in Section 1.7.

2. The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The Point of Contact (POC) will be required to notify the Contractor when delivery locations have been changed.

3. All deliveries will be made during normal working hours from 8:00 a.m. to 4:00 p.m. and a copy of the packing list/slip will be provided at time of delivery. The packages packing list/slip will contain the complete purchase order number, delivery order number, shipping address, delivery location, items/quantity ordered, and items/quantity shipped.

4. Standard orders will be delivered within no more than 4 working days after receipt or placement of order. Emergency deliveries may be necessary on rare occasions. During these occasions, deliveries will be made within one (1) working day if the order is place before 10:30 am. Otherwise, the emergency deliveries will be made no later than two (2) working days from the time the order was placed. Emergency deliveries will be made at no additional cost to the government.

13. Government’s Responsibility

1. The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user will maintain appropriate records to satisfy the requirements of this paragraph.

14. Ownership of Equipment

1. Title to the equipment remains with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor will accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order/s, at termination and/or replacement of equipment, will remove the equipment at the expense of the Contractor. The Contractor will disconnect the analyzer (gas, water, air, etc.) and will be responsible for all packing and shipping required to remove the analyzer.

15. Equipment Removal

1. Following the expiration of this contract, the Contractor will remove all equipment within 30 days after notification of the completion of new Contractor’s equipment installation including cross over studies and approval for use for patient testing.

16. Invoice Information

1. The following information will be listed on all invoice(s) (Failure to comply may result in refusal of an invoice resulting in delayed payment at the fault of the Contractor)

· Facility’s Name and address where service was provided

· Delivery order number (For example: 36C26122NXXXX)

· Obligation number (For example: 662-C50001)

· A Line Item break down of usage for example:

· Line item 1 CBC CPRR: 10 ea. at $4.00 for a total of $40.00.

· Line item 4 Retic CPRR: 20 ea. at $10.00

· Period of time that is being invoiced for in the invoice.

· Delivery order holder’s internal contract number (if applicable)

· Point of contact for concerns and questions. Must name a specific person, phone number and email.

· One monthly invoice per purchase order number required (For example: VA662-C50001)

· The serial numbers of each analyzer.

Note 1: Contractor to supply meter software training if meter software can be changed by the end user, if applicable.

Note 2: Timely invoices are to be submitted to the acceptable government system with 30 calendar days following the period of service.

Note 3: No invoices can be generated until after successful installation and user reporting the go live date to generate patient results for clinical application.

17. Hours of work

1. Service is generally performed during normal work hours. If a work stoppage occurs due to failure of backup systems, emergency after hours service will be required.

2. Holidays. Only emergency services are provided on National Holidays and only if authorized by the POC in advance.

When a National Holiday falls on a Sunday, the following Monday is observed as a National Holiday. When a National Holiday falls on a Saturday, the proceeding Friday is observed as a National Holiday by U.S. Government agencies. Also included, would be any other day, specifically declared by the President of the United States of America to be a National Holiday.

18. Requirements While Working at VISN 21 Facilities