D399--VISN-19 Laboratory Document Control System

THIS IS A SOURCE SOUGHT NOTICE / RQUEST FOR INFORMATION (RFI) ONLY. THIS IS NOT A REQUEST FOR PROPOSAL AND/OR QUOTE. The Department of Veterans Affairs (VA), Veterans Integrated Systems Network (VISN) 19 and the Network Contracting Office (NCO) 19 are performing market research to determine if there are sufficient numbers of qualified (1) Service Disabled Veteran Owned Small Business; (2) Veteran Owned Small Business; or (3) Small Business to set aside a Firm Fixed Price requirement for cloud based, laboratory document control system services for all 9 VISN-19 stations. The Government will use responses to this notice to help make the appropriate acquisition strategy decision. Contractor shall furnish everything necessary to warehouse, catalog, manage, and provide employee access to standard operating procedures and related documents which does not contain any patient identification or patient health information. The software will provide easy and accurate auditing of laboratory documents during accreditation inspections and will provide tracking of staff training, compliance, and continuing education. The document control system will also provide a paperless alternative to reporting and tracking deviations from standard operating procedures that will often include sensitive patient identification information, such as full name and full social security number, for error tracking. The DOCUMENT CONTROL software shall include simulators (White Cell Differential, Red Cell Differential, Urinalysis Case) and meet the following specifications: General Design Internet / Cloud based application, laboratory software with redundant servers and accessible from any computer 24/7, 365 days/year. Secure documents, passwords, and personal information using encryption and Secure Sockets Layer (SSL). Provide system server backup and contingency to ensure access to documents during planned or unplanned downtime. Simple and intuitive, menu-driven, customizable portal or user interface. Use already established VA employees sign-ons. Modular software that components can be added or removed without requiring major upgrades or changing the functionality of the system. Multiple role or group-based permission levels that enable different levels of user access. The system should enable easy addition and removal of user and level of access. Total traceability tracks who performed what steps of task or approval. Easy management of the entire life cycle of a document (create, edit, approve, issue and archive). Set priority tasks and reminders. Assign to self or other users. Customizable workflows based on department or level of importance. Document Viewer module or capability. Ability to create customizable reports. Ability to download full back-ups on demand. Generates site usage reports allowing some determination of system effectiveness. Fast supported implementation. If required, any vendor selected must undergo One-VA Technical Reference Model (TRM) approval. It is also expected that the selected vendor would assist in creating and agree to a Memorandum Of Understanding MOU-ISA. Document Control The ability to manage the entire document lifecycle from creation, approval, editing, in use status, and archiving. The ability to download multiple (in bulk) documents. Ability to link documents to forms (or to other documents). Ability to print controlled copies of documents. Facilitate the use of standardized headers and formats for all sections of the lab. Identify documents using a numeric or alphanumeric system and be traceable to associated forms, job aids, derivative documents or policies, etc. Offer customizable design elements for the system or document control log, which include but not be limited to, document number, name, implementation date, location of copies, last revision date/approval/version number, review date/approval, review due date, and date retired. It must capture the changes made between versions and have a link between the version and approval. Document control log is updated automatically as documents, versions, and approvals are updated. Standard file extension compatibility that allows upload of Word (.doc, .docx, .rtf, .odt), Excel (.xls and .xlsx), PDF (.pdf), Microsoft Vizio (.vsd, .vsdx), PowerPoint (.ppt and .pptx), image files (.png and .jpg/.jpeg), etc. without the need for conversion. The documents must display easily. Multiple options for document list, query, and categorize including keywords, departments, or review status. It must be secure from editing for both the draft and final except for those assigned. The document control system must ensure that only current policies procedures or forms are in use. The ability to show the 'status' of documents i.e.; draft, in approval routing, final, implemented, in review, retired. Ability to send notification emails with a link to selected employees to review new/revised procedures. Automatic, email notification (with embedded links) to approvers/ reviewers until tasks have been completed, with automatic escalation to a higher level after predefined number of failures to complete task. Automatic routing of new/revised documents to appropriate persons for review at appropriately determined intervals for draft review, approval, and periodic review. Ability of frequent reviewers to retrieve documents from a list of "in review' rather than having to open each email. Accessibility and communication to outside services (non-Pathology) for notification of document availability and accessibility to read document (full network/user accessibility). Examples include the ability to share manuals with distant CBOCs and to inform wards and clinics using point of care instruments about new policies, procedures, form and job aids, etc. Accessibility through VA Sharepoint with the ability to designate read-only permission to non-Pathology employees without additional licensing requirements Ability to audit/query records for timeliness/completion. Maintains document history for length of time required by regulations. Flexible version control to allow for major and minor changes, to enable versioning by dates or numbers and that can be enabled and disabled. Versioning should contain limits, history, restoration, archiving, and deletion. Enables the creation of specific metadata fields for each library. Current and default views of document libraries that are customizable. Flexibility of workflows to accommodate multiple approvers, fast track needs, delegations, or extra approvals. The ability of multiple users to access and edit documents. Multiple-user edits can be subsequently merged/reviewed for merge. Regulatory Inspection Checklist Auditing and Management Supplier must be an approved participant of College of American Pathologists (CAP) Accreditation Checklist Distribution Program Ability to import / upload custom accreditation standards from common accreditation agencies (e.g. - CAP, AABB, TJC, FDA, and others). Ability to search accreditation agency checklists Ability to link evidence or documents to checklist items Flexible workflow to delegate audits to multiple people with different levels of review. Ability to view or print report on current compliance. Ability to set and assign tasks to personnel, or link to document control for revisions. Comparison of previous year to current year standards. Option to transfer or update standards from previous year to current year. Reminders sent about upcoming audits and reviews that must be performed before due date. Compliance and Continuing Education Access to Safety and Compliance training. Access to Professional Acknowledgement for Continuing Education (P.A.C.E.) approved Laboratory Continuing Education courses. Ability to create training documents, links, and videos and assign to staff based on roles. Competency forms created and linked through document control. Ability to schedule competency quizzes and new procedure training with reminders and due dates. Ability to create on-line exams, grading, and file test results. Send alerts to employee and supervisor when competency or training is approaching due date or unacceptable. Ability for staff to access their own competency and training transcript files for their review. Ability to monitor and track continuing education credits, and transmittal to CE Broker Reporting and Tracking: Deviations from Standard Operating Procedures/QC/Maintenance Ability to customize reporting forms for tracking of errors/QC/Maintenance. Easy access to forms by front-line staff at work locations for easy and quick reporting. Ability of deviation reporting to be commenced by frontline staff with the option of report being forwarded to appropriate second level staff member for review and corrective action. Ability to track, monitor, and retrieve reports in real-time All interested firms shall submit a response demonstrating their capabilities regarding the above requirement and addressing each of the items in the following section. As stipulated in FAR 15.201, responses to this notice are not considered offers and cannot be accepted by the Government to form a binding contract. No solicitation exists; therefore, do not request a copy of the solicitation. The decision to solicit for a contract shall be solely with the Government discretion. Firms responding should indicate whether they are, or are not, a service-disabled veteran owned small business, a veteran owned small business, or any other type of small business business. The NAICS code to be used for this acquisition is 518210 (Data Processing, Hosting, and Related Services) is applicable to this acquisition, and the size standard is 35.0 milion. The Government reserves the right to consider all types of small business set-asides based upon responses hereto for any subsequent acquisition. Respondents are further requested to indicate their status as a foreign-owned/foreign-controlled firm and any contemplated use of foreign national employees on this effort. Any information submitted by respondents to this sources-sought synopsis is voluntary. This sources-sought notice is not to be construed as a commitment by the Government, nor will the Government reimburse any costs associated with the submission of information in response to this notice. Respondents will not individually be notified of the results of any Government assessments. The Government s evaluation of the capability statements received will factor into whether any forthcoming solicitation will be conducted as a full and open competition or as a set-aside for small businesses, or any small business designation (e.g. SDVOSB, HUB Zone, 8(a), WOSB, VOSB, etc). All prospective vendors must be registered and current within the System for Award Management (SAM). Visit www.sam.gov for details. In addition, all SDVOSBs and VOSBs must be registered and verified within VetBiz. Visit www.vetbiz.gov for details. All responses must be received by 10-16-2020 at 12:00 pm MT POC for this notice is Ian Boettcher / contact@example.gov