Amendment 0001 Attachment - Revised Statement of Work.pdf

B.2 STATEMENT OF WORK

Large Volume Infusion Pumps, Syringe Pumps, and PCA Pumps

A. Requirement Overview The contractor shall provide all hardware, software, and professional services for large volume (LV) infusion pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, and infusion library/dataset software components.

The contractor shall provide goods and perform services to the Department of Veterans Affairs (VA) in accordance with the tasks and deliverables as described in this Statement of Work (SOW). The contractor shall provide technical support for the installation of each device as well as integration with the quality improvement, medication management, reporting infrastructure and Electronic Health Record (EHR) system at each VA facility (or VISN, if applicable). In addition, the contractor shall provide clinical and technical user training, as needed, to ensure safe operation of the new infusion pumps. Final acceptance is completed once all equipment has been delivered, training, implementation, and any integration has been accomplished, and turnover/go-live has been completed.

The contract will have a five-year ordering period.

B. Technical Requirements B.1 Large Volume, Syringe and PCA Pumps B.1.1 The pump shall be FDA approved.

B.1.2 Parts, consumables, and product support shall be available for the useful life of the device.

B.1.3 Remediation, vulnerability fixes, and upgrade services pertaining to recalls and medical device correction notices shall be available at no-cost to VA for the useful life of the device.

B.1.4 The pump shall be cleanable with hospital-grade disinfectant.

B.1.5 The pump shall have ingress protection for liquids.

B.1.6 The pump shall have free flow and unintentional bolus prevention mechanisms.

B.1.7 The pump’s display must be large enough to display critical information, such as the drug or fluid name, strength and volume or concentration, and dose over time or dose rate. The end user should be able to adjust the contrast between the text and background to operate effectively in varied lighting conditions.

B.1.8 Alarm settings must be configurable. The pump shall have alarm volume control and capability for the end user to momentarily silence it.

B.1.9 The pump shall have patient anti-tampering features.

B.1.10 The pump must be capable of delaying the start of an infusion when a time limit is specified.

B.1.11 The pump shall have automatic switching to battery power upon line-power interruption.

B.1.12 The pump shall be transportable and sustain a minimum 4-hour battery run time.

B.1.13 The pump shall have event storage capability.

B.1.14 Any serviceable pump shall have the ability to be maintained by qualified VA biomedical technicians.

B.2 Large Volume Pumps B.2.1 The infusion library/dataset can be transmitted to the pump wirelessly.

B.2.2 The pump shall be capable of continuous and intermittent delivery of fluids, medications, and blood products to patients.

B.2.3 The pump is capable of a flow rate of 0.5 mL/hr to 999 mL/hr with a precision of 0.1 mL/hr at flow rates up to 100 mL/hr and precision of 1 mL/hr for rates above 100 mL/hr. Volume to be infused allowed during programming must be at least 3000 mL.

B.2.4 The pump must be capable of delivering bolus doses programmed as either weight-based or non-weight based.

B.2.5 The pump shall allow entry of a metric patient weight for weight-based dose calculations.

B.2.6 The pump shall be validated by Oracle Health’s CareAware Platform to support medical device integration. Validation status will be evaluated upon receipt of response to each fair opportunity solicitation. See also Paragraph I, Ordering Procedures.

B.3 Syringe Pumps B.3.1 The infusion library/dataset can be transmitted to the pump wirelessly.

B.3.2 The pump is capable of a flow rate of 0.1 mL/hr to 999 mL/hr with a precision of 0.1 mL/hr at flow rates up to 100 mL/hr and precision of 1 mL/hr for rates above 100 mL/hr.

B.3.3 The pump is able to deliver bolus doses programmed as either weight-based or non-weight based.

B.3.4 The pump shall accommodate non-proprietary syringes (10 mL to 60 mL) for the delivery of medication.

B.3.5 The pump shall be validated by Oracle Health’s CareAware Platform to support medical device integration. Validation status will be evaluated upon

B.4 PCA Pumps B.4.1 The infusion library/dataset can be transmitted to the pump wirelessly or via a wired connection.

B.4.2 The pump must allow the programming of a continuous rate and bolus doses to be administered by the clinician. It must also be capable of delivering patient-initiated bolus doses requested via a pendant or similar.

B.4.3 The pump must be able to limit delivery of medication based on maximum accumulated dose values over a preset amount of time. The pump must also be capable of setting a minimum interval of time between patient-initiated dose requests.

B.4.4 The pump shall accommodate non-proprietary disposables (10-60 mL for syringe-driven devices or 50-250 mL for reservoir-based devices) for the delivery of medication.

B.4.5 The pump must be capable of securing controlled substances with a compatible external device or integrated lockable housing.

B.4.6 A history of medication doses delivered to the patient and total amount over a specified time must be readily accessible to the end user.

B.5 IV Stands Should the contractor provide IV stands with the VA’s purchase of infusion equipment, the stands shall meet the following minimum criteria:

B.5.1 Have hospital grade casters with locking brakes.

B.5.2 Be cleanable with hospital-grade disinfectant.

B.5.3 Be made of heavy-duty stainless steel.

B.5.4 Have an adjustable height.

B.5.5 Have a weighted base.

B.5.6 Have a minimum of 2 bag/bottle holders.

B.6 Dose Error Reduction System (DERS) Software (“Infusion Library”) B.6.1 DERS shall aid in prevention of infusion programming-related errors and will alert the end user to a potential under- or over-delivery of a medication or fluid by comparing values entered against preset limits defined in the infusion library/dataset.

B.6.2 Care areas, profiles, or similar allow customization of selectable products and associated limits.

B.6.3 Each entry allows for the addition of clinical uses, therapies, or similar, to modify the content to better reflect intended use.

B.6.4 An entry-specific alert or advisory can be clearly presented to the end user on the pump display.

B.6.5 Customizable limits are available for dose rate, dose, duration, concentration, bolus dose, and bolus rate of administration where applicable. These shall include lower hard limits, lower soft limits, upper soft limits, and upper hard limits.

Limits must allow for configuration of both weight-based and non-weight-based values. At least one lower and one upper limit must be required.

B.6.6 Allowable values for dose and concentration limits must align with commonly used medications in clinical practice. Specifications will be evaluated upon

B.7 Reporting B.7.1 Infusion pump reports and continuous quality improvement (CQI) data shall be available to authorized end users. Pumps enabled to communicate wirelessly with the VA network will also be able to provide any stored data in this manner on-demand, without manufacturer-imposed access restrictions.

B.7.2 CQI data will be robust and reports will include established metrics to optimize DERS and improve infusion safety. Metrics defined by the Institute for Safe Medication Practices shall be considered standard of care for reporting and available at no additional cost.

B.7.2.1 Facility compliance with DERS.

B.7.2.2 Compliance rate with DERS by care area/profile (or similar).

B.7.2.3 Compliance rate by medication or fluid entry.

B.7.2.4 Total number of alerts by alert type.

B.7.2.5 Total number of alerts by infusion parameter.

B.7.2.6 Total number of alerts by medication or fluid entry.

B.7.2.7 Percentage of alerts overridden by the end user.

B.7.2.8 Number and percentage of cancelled infusions.

B.7.2.9 Percentage of alerts resulting in reprogramming by the end user.

B.7.3 On-demand retrieval of pump event/alert logs, device utilization data, and cybersecurity status reports must be available to authorized end users.

C. Project Management C.1 Prior to device delivery, the contractor shall provide the following:

C.1.1 Server and workstation specifications.

C.1.2 Serial numbers.

C.1.3 MAC addresses of any wireless devices.

C.2 The contractor shall provide on-site installation services, to include the following (where applicable):

C.2.1 Unboxing.

C.2.2 Staging of equipment.

C.2.3 Incoming inspection on pumps.

C.2.4 Download of infusion library/dataset.

C.2.5 Asset sticker tagging.

C.2.6 Maintenance sticker tagging.

C.2.7 RTLS tagging.

C.2.8 Disinfection of equipment.

C.2.9 Removal of trash.

C.3 The contractor shall connect all applicable pumps to the wireless network and server. Performance shall be validated and documented.

C.4 The contractor shall provide project management services, including, but not limited to, the following:

C.4.1 Determining project tasks.

C.4.2 Scheduling meetings with stakeholders.

C.4.3 Developing timelines.

C.4.4 Closing out project with sustainment plan.

C.5 The contractor shall provide a formal report at the conclusion of deployment to include the following for each item:

C.5.1 Model.

C.5.2 Serial number.

C.5.3 Asset number.

C.5.4 Original deployment location.

C.5.5 Incoming inspection results.

C.5.6 Manufacturer inspection results (if applicable).

C.6 The cost of travel for onsite installation, training, implementation, and integration services must not exceed the federal Joint Travel Regulations (JTR) rates.

D. Information Security D.1 All VA sensitive information shall be protected at all times, in accordance with

VA Handbook 6500.6. The contractor shall follow all VA rules and regulations regarding information security to prevent disclosure of sensitive information to unauthorized individuals or organizations, and shall adhere to all VA Privacy & Security, the Privacy Act, and Health Insurance Portability and Accountability Act (HIPPA) requirements when obtaining and reviewing information.

D.2 The contractor shall report any known or expected security/privacy incidents, or any unauthorized disclosure of sensitive information, to the Contractor Officer’s Representative (COR) within 24 hours of discovery.

D.3 The infusion pumps shall comply with VA Directive 6550. Compliance will be determined using the VA Directive 6550 Appendix A upon receipt of response to each fair opportunity solicitation. See also Paragraph I, Ordering Procedures.

D.3.1 The infusion pumps shall run on an operating system currently supported by the operating system manufacturer.

D.3.2 The infusion pumps or wireless cards shall be FIPS 140-2 or FIPS 140-3 certified if using 802.11 wireless networking. For wireless-capable devices, document the FIPS certification number in the completed VA Directive 6550 Appendix A.

D.3.3 External, vendor-managed cloud systems shall be approved by the VA Digital Transformation Center (DTC) and associated authorizations prior to deployment of any and all equipment.

D.3.4 Any required remote service external to VA shall have a memorandum of understanding/interconnection security agreement (MOU/ISA) with the

VA.

E. Training Requirements Clinician and Biomedical Technician training offerings will be assessed upon receipt of response to each fair opportunity solicitation. See also Paragraph I, Ordering Procedures. The following is required:

E.1 The contractor shall provide face to face clinical training to VA Nursing staff, Pharmacy personnel, and designated super users.

E.2 The contractor shall coordinate education needs and competency assessments with Nursing Education Department or designee.

E.3 Training shall be completed for all Nursing and Pharmacy shifts.

E.4 The contractor shall provide technical training to Biomedical Technicians.

Training may occur on-site, off-site, or virtual.

E.5 The contractor shall provide access to Preventive Maintenance (PM) and

Corrective Maintenance (CM) procedures, including any calibration or maintenance software (if applicable).

F. Service Requirements F.1 The contractor shall provide the following infusion pump documentation:

F.1.1 Two (2) copies of operator instruction manuals (one (1) electronic and one (1) physical copy) per VA facility.

F.1.2 Two (2) copies of service manuals (one (1) electronic and one (1) physical copy) per VA facility.

F.1.3 Two (2) copies of Indications for Use (IFU) (one (1) electronic and one (1) physical copy) per VA facility.

F.2 Manuals shall be permitted to be uploaded to VA’s OneSource application.

F.3 The infusion pumps, software, and accessories shall be covered under the manufacturer’s warranty and shall include all parts and labor for one (1) year following acceptance by the VA facility.

G. Travel or Special Requirements The contractor shall submit all proposed travel plans to the Contracting Officer (CO) and Contracting Officer Representative (COR) for review and approval no less than five (5) business days in advance of the anticipated departure date.

Travel costs, if necessary, will be included in delivery orders. See also Paragraph I, Ordering Procedures.

Travel that occurs without pre-approval by the COR will NOT be reimbursed Travel and per diem expenses shall be in accordance with Federal Travel Regulations and FAR 31.205-46.

H. Performance Period Normal hours of work are defined by the local facility, excluding Federal holidays, or as otherwise arranged with the COR.

There are eleven (11) Federal holidays set by law (USC Title 5 Section 6103) that VA follows. Under current definitions, five (5) are set by date:

New Year’s Day January 1 Juneteenth National Independence Day June 19 Independence Day July 4 Veterans Day November 11 Christmas Day December 25

I. Ordering Procedures Orders will be placed with the multiple-award IDIQ contractors. Each delivery order must be placed during the IDIQ contract's ordering period. See FAR Clause 52.216-18.

Each delivery order will establish the delivery date and related incidental services required (e.g., installation, integration, training, go-live, etc.). All IDIQ contractors will be provided a fair opportunity to compete for each delivery order unless an order is supported by an approved exception to fair opportunity justification. Fair opportunity solicitations will be issued to all IDIQ contractors electronically by a contracting officer to the identified point of contact for each contractor. Each fair opportunity solicitation will identify the selection criteria for the applicable delivery order.

Offers in response to the fair opportunity solicitations will be evaluated as acceptable or unacceptable based on the Technical Acceptability Standard. Offers that receive a rating of unacceptable will not be considered for delivery order award. Technically acceptable offers will then be subject to a trade-off between the Capability and Price factors with the Capability factor being more important than the Price factor. The Government may award to other than the lowest-priced offeror if it is in the Government’s best interest to do so. Past performance will be reviewed as a general standard of responsibility only.

TECHNICAL ACCEPTABILITY STANDARD. Under the technical acceptability standard, offers will be evaluated to validate compliance with the requirements for Oracle Health’s CareAware Platform and FIPS certification. Offerors will need to submit a completed VA Directive 6550 Appendix A, and for wireless-capable devices, document the FIPS certification number in the completed Appendix A. Offerors will also need to provide evidence of Oracle Health’s CareAware Platform validation for specified device-level workflows and infusion management solutions, including successful bi-directional communications.

FACTOR 1 – CAPABILITY. Under the Capability Factor, offers will be evaluated to determine whether they provide any additional benefits to the Government:

• PROJECT IMPLEMENTATION PLAN. The Government will assess the offeror’s plan to deliver, install, and implement its proposed infusion pump system for use at the VA medical facility by the required go-live date.

• SPECIFICATIONS. The Government will assess the offeror’s product brochures, technical specification sheets, and other information presented for each proposed product solution, including warranty coverage, training offerings, allowable values for dose and concentration limits, and Dose Error Reduction System Software, against the technical requirements listed in the Statement of Work to determine whether the offer provides any advantages to the Government by exceeding the minimum requirements.

FACTOR 2 – PRICE. Under the Price Factor, the proposed unit prices will be multiplied by the quantity for each line item in the price schedule to determine a total proposed price for evaluation purposes. Proposed prices will be evaluated for reasonableness in accordance with FAR 15.404-1(b).

Delivery orders awarded in response to fair opportunity solicitations will contain the following information:

(i) Date of order.

(ii) Contract number and order number.

(iii) Line item number, subline item number (if applicable), description, quantity, and unit price. The corresponding line item number and subline item number from the base contract shall also be included.

(iv) Delivery or performance schedule.

(v) Place of delivery.

(vi) Any packaging, packing, and shipping instructions.

(vii) Accounting and appropriation data.

(viii) Method of payment and payment office, if not specified in the contract (see 32.1110(e)).

(ix) North American Industry Classification System code 339112.

J. References Institute for Safe Medication Practices (ISMP). ISMP Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps.

ISMP; 2020. https://www.ismp.org/node/972

(End of Statement of Work)