36C10A20Q0219.docx

Lab Document Control System

Contract Opportunity Sources Sought Notice

PRODUCT SERVICE CODE

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CONTRACTING OFFICE'S

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SOLICITATION NUMBER

RESPONSE DATE/TIME/ZONE

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

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ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field Contract Opportunity Sources Sought Notice MediaLab Software (VA-20-00071116) 78744 36C10A20Q0219 07-02-2020 12pm

CENTRAL TIME, CHICAGO, USA

N

SBA

541519 Department of Veterans Affairs Technology Acquisition Center - Austin 1701 Directors Blvd, Suite 600 Austin TX 78744 Contract Specialist Marcus Collier Marcus.collier@va.gov 512-981-4455

Marcus.collier@va.gov Marcus.collier@va.gov Performance Work Statement Brand name or equal MediaLab

1.0 INTENT: The Bay Pines VA Medical Center - Pathology and Laboratory Medical Service (PLMS) needs a document control system to warehouse, catalog, manage and provide employee access to standard operating procedures and related documents which does not contain any form of patient identification or patient health Information. The new document control package replaces current outdated system and meets VA directives to divest from the current version and move forward with modernization of the VA. Electronic document control is critical and necessary for maintaining effective compliance with industry standards, CAP, CLIA, Joint Commission, FDA, EPA, and 21 CFR Part 11 standards, as well as meeting VHA Patient Safety and Quality initiatives.

2.0 SALIENT CHARATERISTICS: The DOCUMENT CONTROL software shall meet the following specifications:

2.1 General Design

2.1.1 Internet / Cloud based application, laboratory software with redundant servers and accessible from any computer 24/7, 365 days/year.

2.1.2 Secure documents, passwords and personal information using encryption and Secure Sockets Layer (SSL).

2.1.3 Provide system server backup and contingency to ensure access to documents during planned or unplanned downtime.

2.1.4 Simple and intuitive, menu-driven, customizable portal or user interface.

2.1.5 Modular software that components can be added or removed without requiring major upgrades or changing the functionality of the system.

2.1.6 Multiple role or group based permission levels that enable different levels of user access.

2.1.7 The system should enable easy addition and removal of user and level of access.

2.1.8 Total traceability – tracks who performed what steps of task or approval.

2.1.9 Easy management of the entire life cycle of a document (create, edit, approve, issue and archive).

2.1.10 Set priority tasks and reminders. Assign to self or other users.

2.1.11 Customizable workflows based on department or level of importance.

2.1.12 Document Viewer module or capability

2.1.13 Ability to create customizable reports.

2.1.14 Ability to download full back-ups on demand

2.1.15 Generates site usage reports allowing some determination of system effectiveness.

2.1.16 Fast supported implementation

2.1.17 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.

2.2.2 The ability to download multiple (in bulk) documents.

2.2.3 Ability to link documents to forms (or to other documents)

2.2.4 Ability to print controlled copies of documents

2.2.5 Facilitate the use of standardized headers and formats for all sections of the lab.

2.2.6 Identify documents using a numeric or alphanumeric system and be traceable to associated forms, job aids, derivative documents or policies, etc.

2.2.7 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.

2.2.8 It must capture the changes made between versions and have a link between the version and approval.

2.2.9 Document control log is updated automatically as documents, versions, and approvals are updated.

2.2.10 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.

2.2.11 Multiple options for document list, query, and categorize including keywords, departments, or review status.

2.2.12 It must be secure from editing for both the draft and final except for those assigned.

2.2.13 The document control system must ensure that only current policies procedures or forms are in use.

2.2.14 The ability to show the 'status' of documents – i.e.; draft, in approval routing, final, implemented, in review, retired.

2.2.15 Ability to send notification emails with a link to affected employees to review new/revised procedures.

2.2.16 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.

2.2.17 Automatic routing of new/revised documents to appropriate persons for review at appropriately determined intervals for draft review, approval, and periodic review.

2.2.18 Ability of frequent reviewers to retrieve documents from a list of "in review' rather than having to open each email.

2.2.19 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.

2.2.20 Ability to audit/query records for timeliness/completion.

2.2.21 Maintains document history for length of time required by regulations.

2.2.22 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.

2.2.23 Enables the creation of specific metadata fields for each library.

2.2.24 Current and default views of document libraries that are customizable.

2.2.25 Flexibility of workflows to accommodate multiple approvers, fast track needs, delegations, or extra approvals.

2.2.26 The ability of multiple users to access and edit documents. Multiple-user edits can be subsequently merged/reviewed for merge.

2.3 Regulatory Inspection Checklist Auditing and Management

2.3.1 Supplier must be an approved participant of College of American Pathologists (CAP) Accreditation Checklist Distribution Program

2.3.2 Ability to import / upload custom accreditation standards from common accreditation agencies (e.g. - CAP, AABB, TJC, FDA, and others).

2.3.3 Ability to search checklists

2.3.4 Ability to link evidence or documents to checklist items

2.3.5 Flexible workflow to delegate audits to multiple people with different levels of review.

2.3.6 Ability to view or print report on current compliance.

2.3.7 Ability to set and assign tasks to personnel, or link to document control for revisions.

2.3.4 Comparison of previous year to current year standards.

2.3.5 Option to transfer or update standards from previous year to current year.

2.3.6 Reminders sent about upcoming audits and reviews that must be performed before due date.

2.4 Compliance and Continuing Education

2.4.1 Access to Safety and Compliance training

2.4.2 Access to Professional Acknowledgement for Continuing Education (P.A.C.E.) approved Laboratory Continuing Education courses

2.4.3 Ability to create training documents, links, and videos and assign to staff based on roles.

2.4.4 Competency forms created and linked through document control.

2.4.5 Ability to schedule competency quizzes and new procedure training with reminders and due dates.

2.4.6 Ability to create on-line exams, grading, and file test results.

2.4.7 Send alerts to employee and supervisor when competency or training is approaching due date or unacceptable.

2.4.8 Staff access to their own competency and training transcript files for their review.

2.4.9 Ability to monitor and track continuing education credits, and transmittal to CE Broker.

3.0 SYSTEM SUPPORT AND MAINTENANCE

3.1 Support (phone, email) must be available weekdays during normal business hours.

3.2 Minimal server maintenance.

3.3 Document backups available to staff during downtimes.

3.4 Advance notification during server updates or down times.

3.5 Storage capacity to archive all document types and workflow histories for at least 5 years after removal from use to meet the more stringent transfusion medicine and quality documents requirement is preferred. Alternatively, a minimal storage capacity is needed for archiving transfusion service documents and review/approval histories for 5 years, and other laboratory section records for 2 years.

4.0 SECURITY REQUIREMENT FOR CLOUD SERVICES

4.1 Per the Office of Management Budget (OMB), any cloud services that hold federal data must be authorized by the Federal Risk and Authorization Management Program (FedRAMP). All Federal data must be stored on a FedRAMP authorized systems, and loss of FedRAMP authorization is equivalent to the inability to house federal data via a cloud service. FedRAMP authorization applies to all third parties and subcontractors that the vendor uses to store federal data. Proof of FedRAMP authorization must be provided, and the vendor must disclose where all data is stored. If any data is stored by a third party and/or subcontractor, the vendor must provide proof of FedRAMP authorization for these third parties and subcontractors. FedRAMP authorization must always be maintained by the vendor and all third parties and subcontractors the vendor uses to store federal data.

4.2 All cryptographic modules and hardware security modules (HSMs) must be FIPS 140-2 certified. The vendor must provide proof of FIPS 140-2 certification via a NIST approved validator. The operating platform upon which the FIP 140-2 certification was obtain must be maintained.”

5.0 DELIVERY, INSTALLATION AND TRAINING

5.1 Delivery

The contractor shall deliver, if applicable, all equipment to the Bay Pines VA Medical Center Pathology and Laboratory Medicine Service at 10000, Bay Pines Florida, Bldg 110, St. Petersburg, Florida 33744, within 45 days after contract is awarded.

5.2 Installation

5.3 Training

4.3.1 Contractor shall provide initial training via WebEx or any form of online training and continued support for all system users at different levels.