ATTACHMENT A - SOW v2 - VISN22 GLUCOSE METERS.docx

STATEMENT OF WORK

VISN 22 GLUCOMETER

SECTION A

1. INTRODUCTION, DESCRIPTION, AND SCOPE OF THE CONTRACT

1.1. It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 22) to establish an Indefinite Delivery Indefinite Quantity (IDIQ) for Point of Care Glucose meters/analyzers. The IDIQ shall be procured as Cost Per Test (CPT) Clinical Laboratory Analyzers.

1.2. TheThe Contractor shall provide all equipment, reagents, standards, controls, supplies, parts, accessories, service maintenance, including network support, training, installation, shipping, and any other item required for the proper operation of its’ contractor owned analyzers and peripherals necessary for the generation of fingerstick glucose cost per test (CPT) services on behalf of VISN 22.

1.3. Participating Facilities: VISN 22 facilities participating in this requirement are listed below. Additional Facilities within VISN 22 may be added to this contract with an exercise of a supplemental agreement between the CO and Contractor. Line items within the schedule should reflect the overall volume of all sites below and should take into consideration the potential of additionaddition Onal quantities for all line items needed to support of future facilities within VISN 22.

1.3.1. VA San Diego Healthcare System

3350 La Jolla Village Dr., San Diego, CA 92161

1.3.2. VA Loma Linda Healthcare System

11201 Benton St, Loma Linda, CA 92357

1.3.3. VA Long Beach Healthcare System

5901 E 7th St, Long Beach, CA 90822

1.3.4. VA Greater Los Angeles

11301 Wilshire Blvd, Los Angeles, CA 90073

1.3.5. Phoenix VA Health Care System

650 E. Indian School Rd., Phoenix AZ 85012

1.3.6. Northern Arizona VA Healthcare System

500 North Hwy 89, Prescott, AZ 86313

1.3.7. New Mexico VA Healthcare System

1501 San Pedro Dr. SE, Albuquerque, NM 87108

1.3.8. Southern Arizona VA Healthcare System

3601 S 6th Avenue, Tucson, AZ 85723

1.4. Analyzers are specialized instruments for the testing of specific parameters of whole blood for therapeutic monitoring and routine testing. The analyzer(s) provided by the contractor shall be portable, bedside units for use primarily in the clinical areas of the hospital and Community Based Outpatient Clinics (CBOCs). Services shall be provided to all facilities listed above in VISN 22.

1.5. VISN 22 has provided estimated requirements for each facility below. Additional quantities for analyzers, downloaders, base unit light and multi-meter hubs, and consumables may be added.

VA San Diego Healthcare System plus CBOCs

Base Unit Light - 35 Multi-Meter HUBs – 14 VA Loma Linda Healthcare System plus CBOCs Analyzers – 123 Downloaders – 100 Base Unit Light - 23 Multi-Meter HUBs – 25 Analyzers – 123 Downloaders – 100 Multi-Meter HUBs – 25 VA Long Beach Healthcare System plus CBOCs Analyzers – 100 Downloaders – 70 Base Unit Light – 30

Multi-Meter HUBs – 17 VA Greater Los Angeles Healthcare System plus CBOCs Analyzers – 135 Downloaders – 69105 Base Unit Light - 66 Multi-Meter HUBs – 2530 Phoenix VA Healthcare System plus CBOCs Analyzers – 116 Downloaders – 74 Base Unit Light - 42 Multi-Meter HUBs – 20 New Mexico VA Healthcare System plus CBOCs Analyzers – 998 Downloaders – 365 Base Unit Light - 63 Multi-Meter HUBs – 21 Southern Arizona VA Healthcare System plus CBOCs Analyzers – 865 Downloaders – 865 Base Unit Light - 0 Multi-Meter HUBs – 0

Northern Arizona VA Healthcare System plus CBOCs Analyzers – 3831 Downloaders – 3825 Base Unit Light - 0 Multi-Meter HUBs–0

Totals:

78374 Analyzers –with additional units as needed 51874 Downloaders – with additional units as needed 259 Base Unit Light - with additional units as needed 1227 Multi-Meter HUBs – with additional units as needed

2. PERIOD OF PERFORMANCE:

2.1. Base Period: (To Be Determined (TBD) upon award)

2.2. Overall with Options: (TBD upon award)

3. DEFINITIONS/ACRONYMS

3.1. Cost Per Test (CPT): The loaded cost charged to the VA by the contractor each time the equipment is used by the VA. The loaded cost shall be all inclusive and incorporate, as a minimum, the following:

3.1.1. equipment use,

3.1.2. all reagents, standards, controls, supplies, parts, accessories, and any other item required for the proper operation of the contractor’s equipment and software necessary for data management and the generation and reporting of a test result in VISTA.

3.1.3. all necessary maintenance to keep the equipment in good operation condition (this element includes both preventive maintenance and emergency repairs) .

3.1.4. training for Government personnel

3.1.5. delivery, installation and removal of equipment at no additional charge.

3.2. JC – Joint Commission

3.3. QC – Quality Controls

3.4. CBOCs- Community Based Outpatient Clinics

3.5. Analyzer- Meter and charging station if applicable

3.6. Downloader- Base unit for downloading information from meter to data management system.

3.7. Base Unit Light- Individual downloader with charging functionality that can connect into a HUB.

3.8. Multi-meter HUB- HUB unit that allows for connection of multiple meters with downloaders with using one a single ethernet data connection.

4. 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 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 (see Attachment D – Business Associate Agreement Template).

SECTION B

5. MINIMUM TECHNICAL REQUIREMENTS

5.1. The capability of performing analysis on 100% of the tests listed in Attachment A.

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5.2. Provide traceable standard materials for calibration, calibration verifications, and linearity spanning the analytical measuring range of the equipment.

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5.3. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A, with a 5% repeat rate and 3% increase each year.

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5.4. All equipment shall be current state-of-the-art equipment. Remanufactured and discontinued models will not be accepted.

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5.5. Contractors’ analyzer shall conform to all facilities’ existing space constraints. The analyzers shall fit within a 12” X 12” X 12” space.

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5.6. The contractor’s unit shall have firmware and software that has full interface compatibility with VISN 22 universal POC middleware (currently Siemens UniPOC), capable of simultaneous data transfer from the unit to VISN 22 middleware (currently UniPOC) to the electronic health record (EHR) system (without upgrade or other software modification), and all hardware/software necessary to transfer data into patient files in EHR shall be provided at no additional cost to VA. This may require the use of middleware to get patient results from the instrument to EHR (which will be under a separate contract). For purposes of positive patient identification at the glucometer, devices and/or associated middleware must have ability to subscribe to Admissions, Discharge, Transfer (ADT) Feed utilized in VA. Vendor must provide ability for devices to receive firmware, software, or other operational updates remotely via VISN 22 universal POC middleware (currently UniPOC). All provided hardware and software must meet all VA privacy and security requirements.

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5.7. Must connect with standard HL7 interface.

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5.8. The system must be FDA approved for waived point of care blood glucose testing for professional use.

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5.9. QC shall be available in Levy Jennings format, and statistical reporting available (may be middleware).

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5.10. Must accept the following sample types; fresh capillary, venous, and arterial whole blood for testing.

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5.11. Shall provide data management of patient and QC results included with remote access (may be middleware).

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5.12. Shall be capable of operating normally at high altitudes with no interferences.

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5.13. Must perform an automated check for sample quantity, temperature, and humidity variation.

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5.14. Instruments shall be moveable for transport to bedside without recalibration.

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5.15. Instrument must have scanning capabilities for operator ID, patient ID, and reagent lot numbers.

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5.16. Information contained in transmission to external data management system must include device unique identifier, operator ID, patient ID, test results, QC identifiers, reagent lot numbers and comments.

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5.17. Analyzer must be capable of test result entry for manual point of care tests such as but not limited to Glucose, Rapid Strep A, Pregnancy, HCV, HIV.

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5.18. Analyzer must contain a durable (6-8 hrs.) rechargeable low maintenance battery.

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5.19. Provide download interval lock out, QC lock out and operator lock out.

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6. STATEMENT OF WORK

6.1. In addition to the general requirements for the Cost-Per-Test stated above, the contractor shall meet the following requirements for instrumentation and consumables pertaining to all Glucometer related testing.

6.2. The contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. The contractor shall provide technical support for the software programs required for data management and interfacing results into VISTA. These enhancements shall be delivered and installed at the medical facility within 60 days of issuance.

6.3. Each instrument supplied to the VA shall include its own operator’s manual. New manuals shall be provided when there are updates, changes, or revisions to the manual.

6.4. Contractor shall supply all facilities with a minimum six-month supply of a single lot of reagents.

6.5. Contractor shall supply a meter specific carrying case/tote box for each meter.

6.6. The system shall be easily able to accommodate standard infection control practices such as isolation protocols and cleaning in-between patients with most common hospital approved disinfectants and/or wipes.

6.7. All equipment, controls, calibrators, and reagents shall be included in the CPT.

6.8. Additional supplies purchased through this IDIQ shall be covered for all necessary, training, installation, service, and maintenance to keep the equipment in good operation condition (this element includes both preventive maintenance and emergency repairs) stated in the SOW and RFQ.

7. MAINTENANCE REQUIREMENTS

7.1. Emergency repairs shall be performed after initial telephone notification that the equipment fails any parameters. The contractor shall provide the Government with a designated point of contact and telephone number and shall make arrangement to enable his maintenance representative to receive such notification.

7.2. The contractor shall repair or replace (replace defined as in place and functioning in the facility), at any/all locations specified in the Statement of Work, any malfunctioning equipment within forty-eight (48) hours after receipt of initial telephone notification of a malfunction. Contractor shall provide maintenance coverage 24-hours per day, seven days per week including all Federal holidays. Contractor shall provide technical support service to assist in troubleshooting 24-hours per day, seven days per week including Federal holidays.

7.3. Contractor shall provide written report/email of notification of corrective action.

7.4. Should the repair record of any individual piece of laboratory equipment reflect a downtime of 5% of greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government at the using facility to replace the initial laboratory equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instruction, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 95% in each month of the term of the agreement.

7.5. Training: Contractor shall provide training and end user training resources required to fully train 85% of end users at each facility.

8. TRANSITION PERIOD:

8.1. Upon award, the transition period for the awardee to have all required analyzer’s, peripherals, consumables, training, correlation studies, reagents, controls, interfaces, etc., installed and fully operational shall be within 5-months of award. Offerors shall provide with its’ proposal a plan for transitioning services from the incumbent contractor to the new awarded contractor. Contractor’s submitted transition plan shall not exceed the required 30-day period contained herein. Failure of the contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. The VA shall have sole discretion in the decision to terminate for failure to comply.

9. DELIVERY: The Contractor shall deliver all supplies and services identified in the schedule to the locations identified in Section 1.5.

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

9.2. Deliveries shall be made during normal working hours from 8:00am to 4:00pm and a copy of the packing list/slip shall be provided at time of delivery. The packages packing list/slip shall contain the complete purchase order number, contract number, shipping address, delivery location, items/quantity ordered and items/quantity shipped. Standard orders shall be delivered within no more than 30 working days after receipt or placement of order.

9.3. 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 shall 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 shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

10. HOURS OF WORK

10.1. The contract shall include a full-service agreement to include all necessary service calls minimum equal to five (5) days a week, nine (9) hours a day. Contractor shall also provide technical support via phone seven (7) days a week, twenty-four (24) hours a day. After hours and weekends in person service are chargeable as per line items within Attachment A.

10.2. Any service performed during other than normal work hours must be approved in advance by the facility POC or CO.

10.3. Holidays: Only emergency service shall be provided on National Holidays and only if authorized by the facility POC in advance as approved in the delegation of authority. The rates shall be chargeable as per Attachment A.

10.4. When a National Holiday falls on a Sunday, the following Monday shall be 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.

SECTION C

11. SECURITY INFORMATION /PRIVACY REQUIREMENTS

11.1. VA INFORMATION CUSTODIAL LANGUAGE

11.1.1. 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).

11.1.2. 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.

11.1.3. 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.

11.1.4. 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.

11.1.5. 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.

11.1.6. 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.

11.2. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

11.2.1. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

11.2.2. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

11.2.2.1. Vendor must accept the system without the drive;

11.2.2.2. VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

11.2.2.3. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

11.2.2.4. 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;

11.2.2.5. The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

11.2.2.6. Any fixed hard drive on the device must 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 preapproved and described in the purchase order or contract.

11.2.2.7. 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 ISO needs to maintain the documentation.

11.3. SECURITY INCIDENT INVESTIGATION

11.3.1. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

11.4. TRAINING

11.4.1. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

11.4.2. Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

11.4.3. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

11.4.4. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document– e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

11.4.5. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

11.4.6. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.