Attachment A - Statement of Work.pdf

Statement of Work: Blood Bank Software Solution

An FDA approved, Blood Bank commercial off the shelf software solution is needed to address the "sun-setting" of the RPMS Blood Bank Package that was no longer supported by the IHS Office of Information Technology after December 31, 2019. The acquired Blood Bank Software Solution (SS) and associated server are required in the core laboratory of Gallup Indian Medical Center (GIMC), 516 East Nizhoni Blvd., Gallup, NM 87301. The acquired software solution, hardware and accouterments will be used to support efforts to diagnose, monitor and treat American Indians residing in the Navajo

Area of the Indian Health Service.

The new software solution (SS) will be independent of RPMS. The proposed software solution would permit medical providers to enter orders for blood bank testing and, orders for specific blood products. It would permit logging and tracking of all blood component inventories and, inventory of all testing reagents. Blood component data would be barcode scanned into the inventory, as can testing reagents and specimen samples. The blood bank SS will record testing data at all stages of testing both for patients, components and quality control and, can readily be interfaced with automated blood bank instrumentation so that testing results can be automatically entered to the software solution's database. As each event occurs, that event, patient or, test result must be automatically recorded. Additionally, the software should have available algorithms to provide blood type and blood compatibility interpretations and, to verify acceptability of blood unit assignments with respect to any patient's blood type and available testing history data.

Blood component checkout should be able to occur electronically and, the SS should afford compatibility with other hardware adjuncts that would permit remote transfusion monitoring of patient vitals during the infusion process. All SS monitors and activities should be readily auditable.

Installation of the SS will require its installation onto a dedicated server obtained through this acquisition. The server can use either a LINUX, IBM AIX or, Microsoft operating system. It will have to have an IP address assigned to it as well as network pre-installed safe-guards. The vendor will then configure the software with all necessary fields and customization to suit our operations. Patient demographic data (Name, patient ID#, DOB) will need to be migrated from RPMS using HL7 ADT messages. The facility's information technology team will manage this part of the process with vendor's personnel adjusting communication settings and rules for receiving and storing the data.

The vendor must also provide technical support and, equipment repair support to include routine preventive maintenance plus required parts, tubing, spectrophotometer bulbs, syringes, sample needles, pumps and other parts integral to the testing analyzer.

Costs of Travel, lodging and per diem for technical support personnel, as well as freight for reagents and materials to be included in vendor’s bid. Further, the vendor’s bid will include 5 day a week service for the equipment installed at Gallup Indian Medical

Center, Monday – Friday, 08:00 AM to 5:00 PM. 24/7 electronic performance monitoring, from remote location, of all equipment is to be provided by the vendor.

GENERAL REQUIREMENTS (Applicable for all equipment)

1. Vendor shall provide new state-of-the-art equipment.

2. Vendor shall provide all upgrades to equipment hardware and operating system software, without additional charge to the Government. These enhancements to the contractor’s equipment shall be delivered to the Government site and installed within sixty (60) days of their issuance or date of first commercial availability.

3. The models being offered are in current production. For purposes of this SOW, “current production” shall mean that the hardware provided is being manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

4. Offered computer hardware shall perform satisfactorily at any laboratory temperature between 50 and 90 degrees Fahrenheit, (10 and 32 Celsius).

5. Offered computer hardware shall perform satisfactorily at any laboratory relative humidity between 14 and 85 percent.

6. Networked instrument data terminals are required to be able to convey data electronically via HL7 protocol and, must be capable of using 128-bit SSL encryption.

7. Security software associated with the hardware and vended software should be in compliance with the prevailing government requirements. Blood Banking specific software solution must be FDA approved for use in a transfusion center.

8. An operator’s manual shall be furnished for the computer hardware, its accouterments and, the operating system, as well as blood bank software solution supplied.

SITE PREPARATION

Site specifications will be ascertained through analysis of the published requirements in the manufacturer’s literature.

The Government shall prepare the site at its own expense and in accordance with the specifications furnished by the vendor awarded the contract..

The government will also:

1. Provide an active Network line

2. Provide a dynamic or static IP address

3. Provide the address of any proxy servers and information about any necessary credentials.

Vendor shall inspect the site on the date and time acceptable to using activity.

Vendor shall report to the Government the inspection dates, any rejections, the reasons therefore and the final inspection and acceptance results. The results will be utilized to assure that the instrument would be in the appropriate environment for optimum use.

1. Vendor will submit a schedule for installation.

2. Vendor will submit an accurate listing of their or, subcontracted personnel. All vendor personnel will be responsible for completing a computer security awareness training, Privacy Act training and, HIPPA training. These will be yearly requirements.

DELIVERY AND INSTALLATION PROCEDURES

Plan of Implementation:

1. A meeting with the contractor and our IT staff to plan and map the install should be completed with in 30 days of award.

2. A Functional deployment of a server (if required) and, the software solution (SS) should be completed within 60 days of award will include the following:

a) installation onto a dedicated server obtained through this acquisition or, if FEDRAMP certified, be cloud-based. A local server-based application can use either a LINUX or

Microsoft operating system.

b) It will have to have an IP address assigned to it as well as network pre-installed safe-guards.

c) Vendor will configure software with all necessary fields and customization to suit our operations.

d) Patient demographic data (Name, patient ID#, DOB) will need to be migrated from

RPMS using HL7 ADT messages. The facility's information technology team will manage this part of the process with vendor's personnel adjusting communication settings and rules for receiving and storing the data.

e) Local IT management will have to modify the Electronic Health Record to establish a user portal. Additionally, lab personnel will initiate a lengthy process of manually adding older patient records and, this later process will continue throughout the term of the project.

3. Remediation of IT security pitfalls must be completed with the first 30 days of that 60 day period.

4. Broad user access should be established to include laboratory staff and, current medical providers. Establishing that access should be completed with 90 days.

5. Remediation of other software and, compatibility issues should be completed within the first year.

6. Contractor to provide continuous support of the software for a 5 year period. Each year of license and support fees to be accommodated via an annual PO.

TRAINING

The contractor, without additional charge to the Government, shall provide software training for two operating personnel (key operators) from GIMC upon installation completion. In addition, the contractor shall provide supplemental operating training to those Government personnel, without additional charge to the Government, upon installation of any upgrade in equipment hardware or, SS or operating system software connected with the utilization of already furnished hardware or software under this solicitation.

OWNERSHIP/DISPOSITION OF COMPUTER HARDWARE & SOFTWARE

Vendor, upon expiration of order(s), replacement thereof, or termination may uninstall or, deactivate their software according to the license agreement. All hardware will become the property of the government upon installation.

DISPOSITION OF PATIENT HEALTHCARE DATA

Databases containing private healthcare information of patients shall remain in the custody of GIMC. All hard drives and data stored on removable media must be removed from the respective data terminals and surrendered to the government’s contracting officer representative prior to return of any computer equipment. A vendor acting to protect proprietary non-patient data on those drives may wipe the applicable proprietary data from the drives prior to surrender of the hard drives and, portable media.

Technical staff of the vendor who will electronically monitor performance of equipment will be required to take mandatory HIPAA and Computer Security Awareness training. The vendor will also be responsible for obtaining Virtual Private Network (VPN) access to the Navajo Area computer network.

PREVENTIVE MAINTENANCE

Vendor will provide regular, scheduled software updates and maintenance to assure the continued reliable operation. These preventive maintenance visits shall be of a frequency that conforms to the manufacturer’s operation and maintenance instructions for the supported software and hardware. However, if scheduled maintenance services for commercial customers exceeds the manufacturer’s operation and maintenance instructions, a mirrored system (hardware and software) shall be provided to the

Government to afford continuity of patient services.

DAILY ROUTINE MAINTENANCE AND CLEANING

User will perform daily routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions.

EMERGENCY REPAIR

Vendor will staff and maintain a 24 hour / 7 day per week troubleshooting hotline for over the phone consultation, diagnosis and problem isolation. A remote access or dial-in account can be established for the vendor to electronically access the software solution or, accessory adjuncts. Smaller business concerns can be negotiates for abbreviated service periods with approval to be determined by the government.

As necessary, emergency repairs shall be performed after notification that the equipment is inoperative. Vendor shall provide the Government with a designated point of contact and shall make arrangements to enable his maintenance representative to receive such notification.

Vendor will perform emergency repair service within twenty-four (24) hours or, one regular business day from the time of notification of the malfunction. Vendor will provide all hardware and, or software components and labor needed to repair the malfunction.

Travel, per diem and other expenses associated with the repair will be borne by the vendor.

Vendor shall furnish a malfunction incident report to the installation upon completion of each repair call (remote or, in person). The report shall include, as a minimum, the following: (a) date and time notified; (b) date and time repair efforts were engaged; (c) serial number and, or software license 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 validation documentation.

INVENTORY CONTROL

All hardware and consumables required for the proper operation of the contractor’s equipment and software necessary to perform contracted functions shall be included in the vendor’s bid.

All deliverables must be accompanied by a bill of lading. Contractor must submit an itemized invoice for all deliverables for payment to be received. Shipping and packaging of hardware and software and other associated materials to be done in conformance with established law and regulations. Shipping charges for routine shipments are to be borne by the vendor. Expedited shipping fees will be allowed on a cost basis if such shipping is authorized by the project officer or, his/her designee.

Vendor, upon prompt notification, will bear the cost of orders received due to the vendor’s error and, will offer fair exchange when products ordered arrive in damaged condition.

POST AWARD ADMINISTRATION AND MONITORING

An annual report on contractor performance submitted to Procurement Officer and

Hospital QI Coordinator as requested: (a) problems encountered (b) How problems were resolved (c) overall satisfaction rating of services provided.

The Supervisory Medical Technologist at GIMC will monitor the project and report non-conforming issues to the Contract Officer’s Representative. Functionality hardware and software will be monitored daily and adequacy of compliance with issues such as functionality, security issues and timely address of software or equipment failures will be monitored and reported by same.

STATEMENT OF WORK PREPARED BY: James Selleck, Supervisory Medical

Technologist