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SOURCES SOUGHT NOTICE FOR: Document Control Software The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 15 has a requirement for Document Control Software at John Cochran St Lou... SOURCES SOUGHT NOTICE FOR: Document Control Software The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 15 has a requirement for Document Control Software at John Cochran St Louis VAMC 915 North Grand Blvd, St Louis, Missouri 63106. This is not a Presolicitation or Solicitation announcement. This is a sources sought notice only. The purpose of this sources sought notice is to gain market knowledge of potential small business sources and their size classifications; HUBZone, 8(a), Small Disadvantage Business, Woman Owned Business, Veteran Owned Business, Service Disabled Veteran Owned Business relative to NAICS Code 325120, with a small business size standard not to exceed 1,000 Employees. Responses to this sources sought synopsis will be used by the Government to make appropriate determinations about potential sources only. No solicitation is currently available at this time. After review of the responses to this sources sought announcement a synopsis and/or solicitation announcement may be published at a later time. Responses to this notice shall include company name, address, point of contact, size of business pursuant to North American Industrial Classification Code (NAICS) and must respond to the following questions: 1) Is your business a small business under NAICS code 513210? 2) Does your firm qualify as a small disadvantaged business? 3) If disadvantaged specify if your firm is certified under Section 8(a) of the Small Business Act? 4) Are you a certified HUBZone firm? 5) Are you a woman-owned or operated business? 6) Are you a certified Service-Disabled Veteran Owned or Veteran Owned business? 7) Is your business a large business? Please provide a capability statement addressing your organization s ability to perform as a prime contractor the work described in the draft PWS (below). Index your firm s capabilities to the tasks in the draft PWS so that your firm s capabilities can be readily assessed. This is not request for proposal and in no way obligates the Government to award any contract.  Please provide responses in writing no later than 7 March 2023 to: lisa.buchanan1@va.gov. Telephone responses will not be accepted. Responses to this sources sought announcement will not be considered as a response to any solicitation, a request to be added to a prospective offerors list, or to receive a copy of any solicitation. No solicitation is currently available at this time Contractor shall furnish. SCOPE OF PROCUREMENT: The system shall be acquired for each of the clinical laboratories located at the VASTLHCS facilities listed in Attachment A. Facilities within VASTLHCS may be added or deleted by supplemental agreement of the Government and the Contractor. Additional components may be added to the BPA as new modules become available on the market. VASTLHCS will provide an estimated volume by seats as reflected in Attachment A for each medical center. GENERAL REQUIREMENTS General Features: Simple, menu-driven, customizable portal, or user interface Modular software that components may be added or removed without requiring major upgrades or changing the functionality of the system Multiple roles or group-based permission levels that enable different levels of user access Easy addition and removal of user and level of access Total traceability tracks who performed what steps of task or approval Create customizable reports, set priority tasks and reminders that can be assigned to self or other users Seamless module integration that allows linking of documents, forms, events, training, assignments, CAPA, audits, etc. and minimizes the number of approval steps in the process Customizable workflows based on department or level of importance Generate, track, distribute and utilize wikis, links to other sites or content therein (cap.org, CLSI), web parts, discussion boards, shift hand-off communication tools, lists, surveys, competencies, calendars or shared videos Generate site usage reports allowing some determination of system effectiveness Operational Features: They system must provide a solution for the following areas: Competency and Learning Management System Ability to create training documents, links, and videos and assign to staff based on roles Ability to share, view and print documentation for employees Ability to provide automatic record-keeping and maintenance tasks for employees Ability to provide a complete history of training documentation Ability to document 6 forms of competency review Competency forms created and linked through document control Ability to schedule competency and performance evaluations with reminders and due dates Send alerts to employee and supervisor when competency or training is approaching due date or unacceptable Staff access to their competency and training files for their review Ability to build and track competency assessments for POCT & PPMP Ability to assign competency profiles to employees based on specialty and job description Inspections and Audits Management Ability to update inspection checklists from common accreditation agencies (e.g., CAP, TJC, AABB, A2LA, and FDA) Ability to complete inspection checklists by providing text responses, uploading supporting files, and linking to policies and procedures Ability to electronically send checklists responses to approvers for final approval Ability to update new checklists editions 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, begin CAPA workflow associated with non-compliant standards, or link to document control for revisions Creates links from standard to all appropriate supporting documentation Ability to send reminders about upcoming audits and reviews that must be performed before the due date Personnel Documentation Ability to maintain personnel documentation for employees: academic transcripts, licenses, certification, and duty descriptions Ability to set up requirements for different job titles or descriptions Ability to customize requirements to facility and locations to facility and location, based on the state's requirements Document Control Ability to manage the entire document lifecycle from creation, approval, editing, in-use status and retirement Facilitate the use of standardized reporting 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 may 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 must be updated automatically as documents, versions, and approvals are updated Standard file extension compatibility with backward compatibility (.xls, .xlsx, .pdf, .mht, .htm, .html, .doc, .docx) 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 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-PLMS) for notification of document availability and accessibility to the 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. Ability to audit/query records for timeliness/completion Maintains document history for the 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 are customizable Flexibility of workflows to accommodate fast track needs, vacations or extra approvals The contractor must be FEDRAMP approved Corrective and Preventive Action (CAPA) Ability to create a template and custom form building to capture the optimum data fields for your laboratory Ability to route nonconforming events to appropriate individuals Ability to track the progress of events as they flow through the CAPA process phases Assign corrective and preventive action (CAPA) tasks to employees as desired Ability to cross-laboratory, cross-department, cross-location reporting Ability to schedule follow-up tasks to make the process more efficient Access to edit or review corrective actions and preventive actions based on user role or permissions All users have the ability to enter nonconforming events Ability to customize forms, workflow, and responsibility for documentation and resolution of nonconformities Searchable relational database of nonconforming events that allows users to build queries, detect trends, and analyze data Customize and pull reports, statistics, and charts to monitor performance. Automatically routes nonconformities through CAPA workflow Client Complaint and Service Management Ability to document and track complaints Ability assign priorities and schedule tasks. Ability to evaluate progress through statistics. Risk Management Set of tools to identify, measure and implement controls for risk mitigation. Ability to document risk assessment and schedule reviews Ability to initiate risk assessment from other modules to associate with specific activities or equipment. Assign corrective and preventive action (CAPA) tasks to employees as desired Specimen Archiving Ability to document where specimens are stored for quick and easy retrieval Ability to search for by specimen, equipment, container, dept. Laboratory Test Directory Ability to maintain up-to-date test directory Ability to manage access to test directory to outside customers Ability to provide information regarding test menu, where the test is performed, specimen collection requirements, testing guidelines, protocols, specimen stability requirements, and expected TAT. Ability to provide additional information to lab staff only SYSTEM SUPPORT: Provide initial and ongoing training sufficient for all of the system users at different levels. Customer Service Support 24/7 phone support Admin support M-F business hours at a minimum of 2 requests per month Server Access Minimal maintenance System access must be password protected and PIV compliant according to VA Standards. Vendor to provide all necessary server hardware to host system Storage capacity to archives all document types and workflow histories for at least five years after removal from use to meet the more stringent transfusion medicine, and quality documents requirements is preferred. Alternatively, minimal storage capacity is needed for archiving transfusion service documents and review/approval histories for five years, and other laboratory section records for two years REQUIRED INTERFACES: This software may be either located on our local server or web-based. It will not be directly interfaced with any other programs. However, if it is located outside of our local server it must meet appropriate security requirements to protect potentially sensitive health information Any vendor selected must undergo One-VA TRM approval. It is also expected that the selected vendor would assist in creating and agree to an MOU-ISA. PERTINENT REGULATIONS, STANDARDS, AND GUIDELINES: In obtaining a Quality Management (QM) system, the following regulations, standards, and guidelines should be met or exceeded. The Joint Commission (TJC) DC.01.01.01 The laboratory establishes procedures for collecting specimens. (2) Current specimen collection procedures are made available to laboratory staff, nonlaboratory staff, and external providers who collect specimens for laboratory testing. Note: Electronic specimen collection procedure manuals may be used if they are accessible to staff. DRA.11485 Following a change in laboratory directorship, the new laboratory director approves the laboratory policies and procedures over a reasonable period. This approval must be documented. The approval should be completed within three months. The approval of the policies and procedures must be recorded. The format of such documentation is at the discretion of the laboratory director. It must include an itemization of the documents reviewed and approved, signatures and dates, and demonstrate that all procedure manuals have been approved. The approval should be completed within three months of the change of directorship. Different requirements for approval of new and substantially changed policies and procedures and for routine reviews (at least every two years) appear in the All Common Checklist. GEN.13806 - The laboratory has a written quality management (QM) program. GEN.16902 - For laboratories that have been CAP-accredited for more than 12 months, the QM plan is implemented as designed and is reviewed annually for effectiveness. Evidence that the plan has been implemented as designed requires all of the following: quality measurements/assessments specified in the plan are being substantially carried out; there is evidence of active review of quality measurements; if target performance levels are specified in the plan and the targets are not being met, there are records of follow-up action; any interventions/changes to operations that are specified in the plan have been carried out as scheduled, or the reason for delay recorded, AND any communication of information that is required by the plan have taken place GEN.20208 The QM program includes a process to identify and evaluate errors, incidents and other problems that may interfere with patient care services. GEN.20316 - The QM program includes monitoring key indicators of quality in the pre-analytic, analytic, and post-analytic phases. GEN.20325 - The laboratory has a procedure for employees and patients to communicate concerns about quality and safety to management. GEN.20375 The laboratory has a document control system to manage policies, procedures, and forms for all process and activities subject to CAP accreditation. This includes documents relating directly to laboratory testing, as well as others, such as quality management, safety, specimen collection, personnel, and laboratory information systems. The document control system must ensure that only current policies, procedures (including derivative documents such as card files and summary charts), and forms are in use and that records for approval, review, and discontinuance are available. GEN.40016 - There are records of review of the specimen collection/handling procedures by the current laboratory director or designee at least every two years. GEN.40032 - The laboratory director reviews and approves all new specimen collection and handling procedures, as well as substantial changes to existing procedures before implementation. GEN.40050 - The specimen collection manual includes instructions for all of the following elements, as applicable: Preparation of the patient Type of collection container and amount of specimen to be collected Need for special timing for collection (eg, creatinine clearance) Types and amounts of preservatives or anticoagulants Need for special handling between time of collection and time received by the laboratory (eg, refrigeration, immediate delivery) Proper specimen labeling Need for appropriate clinical data, when indicated GEN.40125 - For specimens sent to referral laboratories, the referring laboratory properly follows all requisition, collection and handling specifications of the referral laboratory. GEN.54400 - Personnel records are retained (in electronic or paper format) and readily available for all testing personnel, supervisory personnel, and other laboratory personnel, including all of the following, as applicable: For nonwaived testing and supervisory personnel, copy of academic diploma, transcript, or primary source verification (PSV) report confirming credentials Laboratory personnel license, if required by state, province, or country Summary of training and experience Certification, if required by state or employer Description of current duties and responsibilities as specified by the laboratory director: a) Procedures the individual is authorized to perform, b) Whether supervision is required for specimen processing, test performance or result reporting, c) Whether supervisory or section director review is required to report patient test results Records of continuing education Records of radiation exposure where applicable (such as with in vivo radiation testing), but not required for low exposure levels such as certain in-vitro testing Work-related incident Dates of employment GEN.55450 - There are records that all staff has satisfactorily completed initial training on all instruments/methods applicable to their designated job. GEN.55500 - The competency of personnel performing nonwaived testing is assessed at the required frequency at the laboratory (CAP/CLIA number) where testing is performed. COM.10000-A complete procedure manual is available at the workbench or in the work area. This is a derivative document and is subject to the above control requirement. If card files or similar system corresponds to the complete manual and is subject to document control. COM.10100 There are records of review of all technical policies and procedures by the current laboratory director or designee at least every two years. COM.10200 The laboratory director review and approves all new technical policies and procedures, as well as substantial changes to existing documents, before implementation. COM.10300 The laboratory has a system documenting that all personnel is knowledgeable about the contents of procedure manuals (including changes) relevant to the scope of their testing activities. COM.10500 When a policy or procedure is discontinued, a paper or electronic copy is retained for at least two years (five years for transfusion medicine), initial recording date of use, and retirement date. ISO 15189 (2012) (https://www.iso.org/obp/ui/#iso:std:iso:15189:ed-3:v2:en) Eight Requirements of the International Organization for Standardization (ISO) 15189 for charts, reference ranges, standard operating procedures, and posters: Review and approve documents before use. Maintain a document control log. Periodically review, revise and approve documents. Use only current documents. Remove obsolete documents to present inadvertent use. Label archived documents. Define and control procedures for hand edits. Define procedures for the computerized document control system. UPGRADES - The Contractor shall provide upgrades to the software in order 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 upgrades that enhance the model of equipment being offered, i.e., a new version of the software, upgrade offered to commercial customers at no additional charge. COMMERCIAL OFFERINGS - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g., Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software. IMPLEMENTATION/TRANSITION TIMEFRAME The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 120-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. Upon award of a BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational by March 1, 2023. During this same period, all initial training of VA personnel shall also be completed. Contractor shall provide with its quotation an implementation plan for the installation of new equipment. Contractor s submitted plan shall project for the transition of all services under the awarded BPA including installation and training of personnel, transition of all materials with a start date of April 1, 2023. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate BPA for cause under the Termination for Cause clause of the BPA. ASSESSMENT, AUTHORIZATION, AND CONTINUOUS MONITORING The information system solution selected by the Contractor shall comply with the Federal Information Security Management Act (FISMA). The Contractor shall comply with FedRAMP requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement. Following guidance from the Federal CIO, VA will utilize existing JAB ATO or agency ATO issued by another agency as a starting point for FedRAMP requirements. If neither of those exist, VA will sponsor FedRAMP ATO. VA will be using the FedRAMP baselines as a starting point, since they are specifically tailored for cloud services. The Contractor shall, where applicable, assist with the VA Authority to Operate (ATO) Process to help achieve agency authorization of the cloud service or migrated application. The Contractor shall afford VA access to the Contractor s and Cloud Service Provider s facilities, installations, technical capabilities, operations, documentation, records, and databases. If new or unanticipated threats or hazards are discovered by either VA or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party in accordance with the security appendix B. The Contractor shall not release any data without the consent of VA in writing. All requests for release must be submitted in writing to the COR/CO. OTHER CONSIDERATIONS: Trusted Internet Connection (TIC) Include TIC requirements for SaaS that interfaces with VA systems, SaaS must meet all VA Security requirements for non-SaaS. Include Addendum A Additional VA Requirements, Consolidated Include Addendum B VA Information and Information System Security/Privacy Language The above language can be found at Technology Acquisition Center s Virtual Office of Acquisition. *** This is not a Request for Quote (RFQ). This is a Sources Sought Notice only. A Solicitation is not available at this time. ***