Attachment B - Statement of Work.docx

STATEMENT OF WORK

AUTOMATED PATIENT TEST RESULT TRANSCRIPTION SOLUTION

SECTION A – INTRODUCTION

1. Introduction to Required Specifications This application will generate and transmit formatted, organized, and customizable, textual documents of final lab test results for received orders from a "lab-visit," for the provider and patient notification and record documentation in the VA Hospital Information System. The application will collect the data for these transmissions from several links at several VA hospital-sites.

1. Scope Participating Facilities: (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 addition of future facilities within VISN 22.)

1. VA Greater Los Angeles Healthcare System | 11301 Wilshire Blvd, Los Angeles, CA 90073

1. VA Loma Linda Healthcare System | 11201 Benton Street Loma Linda, CA 92357

1. VA San Diego Healthcare System | 3350 La Jolla Village Dr, San Diego, CA 92161

1. VA Long Beach Healthcare System | 5901 E. 7th Street, Long Beach, CA 90822

1. VA Phoenix Healthcare System | 650 E Indian School Rd, Phoenix, AZ 85012

1. VA Prescott Healthcare System | 500 North Hwy 89, Prescott, AZ 86313

1. VA Tucson Healthcare System | 3601 S 6th Ave, Tucson, AZ 85723

1. VA Albuquerque Healthcare System | 1501 San Pedro Dr SE, Albuquerque, NM 87108

1. Period of Performance The period of performance of this Basic Purchasing Agreement (BPA) will start shortly after award for a One (1) Year Base Period with the Government having the option to exercise (4) four (1) one-year renewal periods for a total order period of five (5) years.

SECTION B - REQUIREMENTS

1. Minimum System Requirements

1.1 Must be able to produce and transmit HL7 messages, that are compatible with the VistA Generic HL7 interface, as described in the VistA/CPRS Text Integration Utilities Generic HL7 Interface Handbook. https://www.va.gov/vdl/documents/Clinical/CPRS-Text_Integration_Utility_(TIU)/tiuhl7.pdf Click or tap here to enter text.

1.2 Must be able to receive unsolicited HL7 v2.x messages from multiple VA sites and acknowledge receipt appropriately where each site utilizes several distinct TCP-MLLP connections for orders, results, and patient demographics.

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1.3 Must be capable of storing and analyzing components of incoming messages for real-time reflexive actions and future operations.

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1.4 Must utilize internal app-specific algorithms to determine when a patient lab-visit has been completed based on indications within messages received and global, hospital-site, and provider-specific rules.

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1.5 Must be able to produce messages using internally maintained templates of global, hospital-site, and provider-specific levels.

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1.6 Must be capable of performing an internal app analysis of testing completeness or a timeout window algorithm will trigger the generation, execution, and forwarding of formatted, organized messages by the application.

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1.7 Must be able to maintain a map of administrative data on each specific hospital-site and provider for use in message routing and message templates.

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1.8 Must be capable of capturing and logging all error events by the application.

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1.9 Must include a mechanism to notify facility-level admins when errors occur, and a tool to resolve outgoing message errors.

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1.10 Must have the ability to dynamically populate message templates based on items contained in the incoming messages indicating an abnormal or critical condition.

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1.11 Must be able to provide support services for the triage of errors and assistance with template and rule modifications.

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1.12 Must demonstrate future ability to solicit and receive data from the Data Innovations, laboratory middleware program for advanced test information not obtained from the incoming messages, and to utilize it in the modification of outcome actions and message templates.

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1.13 Must demonstrate future ability to produce other types of outgoing messages and API designed for utilization actions within ancillary services interfaced with this application. These utilization actions include but are not limited to order cancelations, order recommendations, and service expert review of an order for manual decisions and recommendations.

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2. Support Features

2.1 Service Maintenance / Warranty

2.1.1 The contractor provides 24 hour, 7 days a week Technical Support by calling a toll-free number.

2.1.2 Any reference range, reporting units, abnormal value flags or critical value flag updates will be at no cost to the medical center.

2.1.3 The Contractor provides documentation of services performed.

2.1.4 Emergency Repair - Technical Support is available Monday through Friday, 8:00 A.M. to 5:00 P.M., MST. After business hours including weekends and holidays, an answering service is available. Responses will be received from technical support within 30 minutes via phone call.

2.1.5 The Contractor shall provide a warranty for all items and services provided under the BPA for the duration of the BPA and all associated delivery orders.

2.2 Additional Features and Requirements

2.2.1 Training, instruction, and consultation must be provided by the contractor for both initial installation and post installation operations.

2.2.2 Contractor shall at minimum provide on-site or live virtual training for up to 8 hours per site as requested by the facility.

2.2.3 Contractor will provide example policies and procedures such as standard operating procedure templates.

2.2.4 The Contractor shall provide a training program that is coordinated with and timely to the equipment installation. Training shall include initial setup and user training; onsite or live virtual training for go-live support, super user training and follow-up training

2.2.5 The system will provide the customer a means of managing operator identification information, ongoing training and competency assessment dates, with analyzer lockout when not complete or equivalent solution.

2.2.6 User and Service Manuals: The Contractor shall provide downloadable PDF versions of operator manuals, service manuals, electronic schematics, troubleshooting guides, diagnostic software and tools Additionally, any upgrades to these documents shall be provided by the Contractor free of charge. These manuals shall include all components and subsystems, including those not manufactured by the Contractor. These manuals and documentation shall be identical to the ones supplied to the manufacturer's service representatives and shall contain the diagnostic codes, commands, and passwords utilized in maintenance, repair and calibration of the equipment/software and provided for the life of the system at no additional cost.

2.3 Upgrade/Updates

2.3.1 The Contractor shall provide updates to the software to maintain the integrity of the system and the state-of-the-art technology, at no additional charge to the Government. These shall be 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 system being offered, i.e., a new version of the software, correction of program defect, update offered to commercial customers at no additional charge, upgrade to replace components no longer Contractor supported, etc. This does not refer to replacing the original system provided under the BPA; however, it does refer to significant changes in the system’s operational capability.

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3. Installation / Delivery / Performance

3.1 Installation/Implementation

3.1.1 Implementation/transition timeframe: All sites shall have a complete installation and go-live of their system within one year of award of this BPA.

3.1.2 Contractor shall execute an implementation plan which includes:

3.1.2.1 Installation - The contractor shall make every effort to conduct a concurrent implementation at all sites with a weekly collaborative meeting. The contractor shall provide a dedicated project manager throughout the entire implementation. Installation shall also include conversion of all current data minimally, including operator profiles.

3.1.2.2 Testing- Shall include, at minimum a test of all analytes in addition through all testing phases (pre-analytical, analytical, and post-analytical). In addition, training must be provided to all sites.

3.1.2.3 Acceptance-Must meet the approval requirements of accrediting agencies and laboratory medical director approval at each facility to meet accreditation standards.

3.1.2.4 Go-Live- Dedicated project management and technical support must be available above the requirements of Section 5 on the day of go-live at each site for 3 days.

3.1.2.5 Post Go-Live Follow Up- Check-in should include at least two weeks and 30 days after the go-live date.

3.1.3 Installation/Site Preparation:

3.1.3.1 Site preparation specifications shall be furnished in writing by the Contractor as a Site Preparation Report after award of the delivery/task order. The Contractor shall provide coordinated professional installation and implementation project management services to implement the system specified in the SOW at all identified sites. The Contractor shall provide a firm estimate of working days required from the date of the delivery order to go-live based upon the SOW. The initial installation site report shall be provided to the CO no later than one week after the initial post-award conference, and all other site reports shall be provided at least forty-five (45) days before the installation of all those sites unless the CO approves for a shorter timeframe. Contractor shall assess each site and propose specific site prep requirements including but not limited to:

· VA responsibilities

3.2 Delivery: The Contractor shall deliver all supplies and services identified in the schedule to the locations identified in Section 2.

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

3.2.2 All deliveries shall be made during normal working hours from 8:00 a.m. to 4:00 p.m., and a copy of the packing list/slip shall be provided at the time of delivery. The packages packing list/slip shall contain the complete purchase order number, BPA 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.

3.3 Hours of work

2.1.1 The BPA shall include a minimum five (5) days a week, nine (9) hours a day full-service agreement to include all necessary service calls. 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.

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

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

2.1.4 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.

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3. Special BPA Requirements

3.1 Physical Security and Facility Considerations

3.1.1 Identification, Parking, Smoking and VA Regulations (For any onsite services):

3.1.1.1 The Contractor employees and/or Subcontractors approved by the VA POC shall wear visible identification at all times while on the premises of the facilities within the VISN. Identification shall include but not be limited to a company identification card, which shall include the company name, employee name, title, and a photograph of the employee. Contractor Employees shall maintain a professional appearance commensurate to their industry.

3.1.1.2 It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VA will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

3.1.1.3 Any interior or exterior doors that shall be unlocked to gain access shall be kept locked during the performance of work unless it results in the creation of a safety hazard. In those instances, the Contractor is responsible to take necessary actions to maintain the same level of security prior to gaining access/performing work. Should any other devices need to be unlocked like an entry gate, those devices shall be locked immediately upon entry or exit. At no time shall the Contractor allow any person into a locked area or loan keys/access cards to another person. Contractor may be held in default for failure to comply with this requirement and subject the Contractor and its employees to contractual and other legal remedies.

3.1.1.4 Contractor personnel are required to check into the facility Police & Security office at each visit to pick up a “contractor” badge prior to contacting the VA POC. The Contractor’s staff shall also be required to sign in and out each day at a designated location determined by the VA POC.

3.1.1.5 The Contractor agrees that none of its officers or employees shall use or reveal any research, statistical, medical, or security information which may be obtained during the performance of the work or as a result their presence on Government premises without the written consent of the Government

3.1.1.6 Smoking is prohibited inside any buildings at facilities within VISN 22.

3.1.1.7 Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

3.1.1.8 The Contractor shall not allow his/her employees, including Subcontractors’ employees, to open desk drawers, cabinets, or to use office equipment, including the use of non-pay telephones for any purpose other than a local emergency call. The Contractor shall be responsible to provide all necessary equipment, tools, parts, and materials to perform the work. The Government shall not be obligated to provide any equipment, tools, parts, and materials to assist the Contractor in performing the work.

3.2 Information Technology Security Considerations

3.2.1 A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

3.2.2 Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

3.2.3 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).

3.2.4 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 onsite 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.

3.2.5 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.

3.2.6 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.

3.2.7 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.

3.2.8 Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

3.2.9 For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

3.2.10 Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

3.2.11 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.

3.2.12 In addition, please see Attachment C - VA Handbook 6500.6 Appendix C for additional Information Technology terms and conditions.

3.3 Insurance Requirements for work performed on Facility Grounds

3.3.1 The Government shall be held harmless against any or all loss, cost, damage, claim expense or liability whatsoever, because of accident or injury to persons or property of others occurring in the performance of this Contract.

3.3.2 The Contractor shall be responsible for all damage to property, which may be done by him, or any employee engaged in the performance of this Contract.

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