36C24818Q9519-003.docx

NF/SG Veterans Healthcare System Pathology & Laboratory Medicine Service (PLMS)

Attachment 3: Statement of Need

NF/SG Veterans Healthcare System Pathology & Laboratory Medicine Service (PLMS)

Statement of Need

Electronic Document Control and Audit Program

TABLE OF CONTENTS

BACKGROUND………………………………………………………………………...……..……1

SCOPE OF WORK……………………………………………..……………………………......…..1

OBJECTIVES…………………………………………………………………………………....….1

EQUIPMENT REQUIREMENTS………………………………………………………………………2

WORK REQUIREMENTS /TASKS………………………………………………………………

DELIVERY, INSTALLATION, AND TRAINING…………………………………………………..……5

PERIOD OF PERFORMANCE…………………………………………………………………...…….6

PLACE OF PERFORMANCE…………………………………………………………………….....…6

PREVENTIVE MAINTENANCE/RESPONSIBILITIES………………………………………………...…6

SECURITY REQUIREMENTS………………………………………………………………..………..7

SALIENT CHARACTERISTICS………………………………………………………………………

TECHNICAL REQUIREMENTS………………………………………………………………………...11

1. Background

With the advancement in automation, and the growth of the Pathology & Laboratory Medicine Service (PLMS) in NF/SG Veterans Healthcare System (NF/SG VHS), some of the major challenges our service face is attaining and sustaining FDA, CAP, and CLIA document control compliance in the absence of a real-time Document Control Management program or application. Currently there are various alternatives for the clinical lab setting that provide an opportunity for our service to build and streamline our documents, policies, and procedures which will increase the efficiency and attainability of document compliance with accrediting agencies.

2. Scope of Work

Acquisition of a Document Control Management and Audit program or application will automate the current paper-based and excel spreadsheet document control system which involves a huge amount of effort to keep important documents and up-to-date policies and Standard Operating Procedures (SOPs) to its end users. This will speed up the approval process for test availability and edits to procedural and policy changes. The program will also provide the tools necessary to allow the PLMS to be inspection ready for accrediting agencies.

The required service is required for an electronic cloud/web-based software platform to manage the NF/SG VHS PLMS document control. Additional services, including a competency assessment program and CAP (College of American Pathologists) checklist responses, are desirable but are beyond the minimum requirements sought. However, as this procurement is not being done based on Lowest-Priced, Technnically- Acceptable (LPTA), vendors are encouraged to quote additional services. Services to be provided include complete software set up and configuration, onsite or web based training, software upgrades and ongoing client support.

3. Objectives

The services defined within this Statement of Work follow a detailed, best practice consulting methodology that will help ensure NF/SG Veterans Healthcare System, Pathology & Laboratory Medicine Services’ (PLMS) defined goals and objectives are met. An Electronic Document Control Management and Audit software application will provide a solution that adds maximum value by establishing policy and procedure management best practices and consistencies to support our organizational objectives. To ensure successful and efficient cloud/web-access to the Document Control Management Program and the PLMS will coordinate the following activities and deliverables:

· An off-the-shelf configurable product designed for rapid installation, implementation, and validation with minimal IT involvement

· Multiple account Kick-Off meeting to validate accessibility, team responsibilities and maximize user efficiency

· Set up and configure system corporate accounts by station: Hospitals and Outpatient Centers (OPCs)

· Application configuration based on documented and approved client requirements

· Post-configuration review, validation, and receipt of final client approval

· Document Control Administrator training and User training

It will effectively address and meet the following objectives:

· Automation of routing and delivery of Standard Operating Procedures (SOPs), policies, and other documentation for document control

· Obtain electronic approval signatures

· Centralizes document repository that will make search and retrieval easy during inspections and audits

· Eliminates communication breakdown because of separate document control processes across departments and locations.

· Speeds up the process of bringing new and modified tests and services by streamlining document change, approval, notification, and distribution to authorized end users

· The Audit check program or application will facilitate the PLMS readiness for inspections from accrediting agencies

· Service employees will have access to the most recent up-to-date approved policies and procedures

· Upload checklists, link evidence, review & approve responses for internal audits and inspection readiness

4. Equipment Requirements

· Security Measures Supported (Physical)

· Servers are hosted at gated, lock and key facilities. These facilities implement locked server as well as biometric (fingerprint) scanning. Only authorized technicians may handle the servers.

· All servers are dedicated, not shared.

· Internet Access

· Each user needs Internet access (http and https).

· Web Browser

· Internet Explorer 7+, Firefox (any), Chrome (any), Safari (any)

· ActiveX Controls and Plug-Ins

· Not required or requested.

· Flash Support

· Not required or requested.

· Cookies

· Used, but not required.

· Hardware Requirements

· None

· Software Requirements

· Only an Internet browser required for using the application. No software needs to be installed.

· Creating and editing documents to upload into Document Control requires a word processor or office suite. Viewing documents does NOT require any word processor or office suite to be installed on the user’s computer.

· Support of word processing documents (DOC, DOCX), spreadsheets (XLS, XLSX), and presentation files (PPT, PPTX) from Microsoft Office (any version from Office ’97 to current), OpenOffice, and LibreOffice, as well as PDF files created by any program. Additionally, Visio files, HTML, and image files are supported.

5. Work Requirements/Tasks

General Requirements The software must provide unlimited (24/7/365) access for approximately 250 unique user profiles.

Operational Features

· Must include software upgrades for new versions of the software including updates to the current version.

· Software must be compatible with the current browser that VHA subscribes to (currently Internet Explorer 11).

· Additional supporting software or plug-ins that is required to be installed (including new versions) on VA owned hardware to operate the system properly must be on the VA Technology/Standard List.

· 99% annual uptime of software.

· Backup solution including an off-site, live fail-over server which can be activated within a brief time in case of catastrophic failure.

· Complete data retrieval capability if the company ceases operations or at the completion of the contracted time.

Technical Features

· Software package must be an off the shelf, ready to use (without development) product.

· Product must be ready for installation within 30 days of contract award, it may take longer for all training to be completed.

The software must have the ability to enable multiple users at multiple sites to access the system simultaneously.

· Must be web based.

· Ability to connect into our active directory for log in and email functions.

· System must be compatible with a PIV (Personal Identity Verification) card, 2 factor authentication log in system.

Document Control

· Software must have the ability to handle over 2000 documents.

· Software must allow customizable templates which may include headers, footer, numbering.

· Software must allow several types of documents to be used within the system, such as, but not limited to word, PDF, Excel, and PowerPoint.

· Software must allow multiple approvers on a single document.

· Software must allow documents to be linked to other documents within the system.

· Document editing option must be contained within the software package.

· Documents can be tagged to more than one laboratory department and or location.

· Ability for users to submit a change requests on a live document.

· Bank of available reports to monitor user compliance.

· Can reassign documents when someone leaves. Can transfer ownership and approvals of documents when an employee leaves.

· Option of document not being released immediately after approval.

· A minimum of 3 permission levels:

· Level 1 (i.e. Administrator) – complete access configuration of the system.

· Level 2 (i.e. Owner) – access to create, edit and all other features needed for the document lifecycle.

· Level 3 (i.e. General Users) – access to read documents applicable to their jobs.

· Document print option based on permissions.

· Multiple document approvers do not have to approve in a sequential order.

CAP (College of American Pathologist) Audit* (above technical acceptance)

· Software Company uploads checklists as new checklists are released.

· Ability to link internal documents, external documents and external website links to CAP checklist requirements.

· Ability to free text answers/comments to CAP checklist requirements.

· Print/download completed audit.

Competency*(above technical acceptance)

· The software may have the ability to customize employee competency profiles based on their job duties.

· The software may provide a unique password for all employees with the ability to track supervisory and employee electronic signatures as needed.

· The software must have the ability to configure customized levels of permissions and responsibilities with multiple system administrators allowed.

· The software may have the ability to manage all six elements of competency for all test systems as mandated by Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) including 1) direct observation of test performance, 2) monitoring and recording of test results, 3) review of test results, 4) direct observation of maintenance performance, 5) assessment of test performance through blind sample testing or proficiency sample testing and 6) evaluation of problem solving skills.

· The software may have the ability to manage all six elements of competencies listed above for the defined timeframes of semiannually during the first year of the employee’s duties and annually thereafter. In addition, the software must be able to manage remediation of a failed element.

· The software may have the ability to auto grade for all six elements of competency listed above.

6. Delivery, Installation, and Training

Delivery Delivery of links, internet addresses, training webinars required for the Electronic Document Control Management program and Audit software application platform accessibility for all NF/SG VHA facilities included in this statement of work* should be no longer than 7 business days after the award of this Equipment Procurement Request Package. If any backorder or technical difficulties to deliver items were to occur, an additional 7 business days will be granted.

(*see section 8 Place of Performance)

Installation

· Install all equipment, if applicable, to manufacturer’s specifications maintaining Federal, and Local safety standards.

· Installation must be completed within 90 days after contract is awarded. All work shall be completed between 8:00 a.m. and 5:00 p.m. Monday – Friday. All federal holidays, excluded. Federal holidays are available at the Federal Holiday OPM Site.

· If there is an operational conflict with installation, night or weekend installation may be required.

· Government will provide a 72 hours' notice of change of installation hours.

· The contractor shall provide an implementation plan, with timelines, and coordinate the initial conversion of all documents into the system.

Training

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

7. Period of Performance

The period of performance (POP) is one base year plus four 1-year options to extend services (to be exercised at the Government’s discretion). The Government hopes to make award by 09/15/2018, however it is also understood that it may take up to 90 days for the vendor to begin to perform. Therefore, the POP will begin on award date, but it may take up to 90 days for the vendor to begin to perform.

8. Place of Performance

Participating NF/SG Veterans Healthcare System facilities are as follows:

· Malcolm Randall VA Medical Center

· Lake City Medical Center

· Jacksonville Outpatient Clinic

· Tallahassee Outpatient Clinic

· The Villages Outpatient Clinic

· The Mohs/Dermatology Clinic

9. Preventive Maintenance/Responsibilities

· Assistance with full implementation of the system including account setup and configuration of application website based on our organization needs.

· Assistance with initial document upload including importing of important dates associated with the documents including but not limited to release date, next review date and previous review dates.

· Initial training for all administrators and end users.

· Additional training must be available upon request.

· Access to other training materials for end users.

· Unlimited technical support, during core business hours Monday through Friday, approximately 8:00am to 4:00pm, 8 hours per day.

· Minimal server maintenance.

· Document backups available to staff during downtimes.

· Advance notification during server updates or down times.

· 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.

10. Security Requirements

System

· Access to the application can be restricted to visitors originating from certain IPs or IP ranges.

· All communication, including login and all visited pages, occurs over HTTPS.

· All users must log into the system with a username and password.

· All failed login attempts are captured and analyzed for threat detection.

· All successful login attempts are captured with the IP address of the user who logged into the system.

· Administrators can disable a user’s access at any time.

· Administrators can set password requirements, including length, complexity, and schedule for resetting.

Documents and Records

· Documents and records cannot be found using search engines (such as Google or Bing).

· Documents and records can only be accessed once logged into the system and only if the user has the necessary permissions to retrieve them.

· ONLY non-sensitive information will be uploaded or downloaded into the system by authorized end-users according to their configured administrative end user level.

· Users sign off documents using a PIN with electronic signature that meet 21 CFR Part 11 (ELECTRONIC RECORDS; ELECTRONIC SIGNATURES).

· backup of data is created in-office weekly. Server redundancy is in place in the event of a server outage.

Salient Characteristics (Detailed) Electronic Document Control Management Program & Audit Software Application

1.0 SALIENT CHARATERISTICS: The DOCUMENT CONTROL software shall meet the following Specifications:

1.1.0 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 may 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.

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

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

1.2.4 Ability to print controlled copies of documents

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

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

1.2.7 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.

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

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

1.2.10 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.

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

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

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

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

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

1.2.16 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.

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

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

1.2.19 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.

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

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

1.2.22 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.

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

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

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

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

1.3.0 Regulatory Inspection Checklist Auditing and Management

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

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

1.3.3 Ability to search checklists

1.3.4 Ability to link evidence or documents to checklist items

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

1.3.6 Ability to view or print report on current compliance.

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

1.3.8 Comparison of previous year to current year standards.

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

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

1.4.0 Compliance and Continuing Education

1.4.1 Access to Safety and Compliance training

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

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

1.4.4 Competency forms created and linked through document control.

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

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

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

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

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

Technical Requirements for Document Management Web Applications

Summary Document Management web applications require only a web browser. No hardware, software, or plug-ins are required. Users need Internet access to vendor website. An office suite is required to edit Document Control files, but not to view them.

Web Applications These technical requirements apply to all Document Management web applications, including:

· Compliance & CE

· Document Control

· Inspection Proof

· Exam Simulator

· Histology Compliance & CE Internet Access Each user needs Internet access to vendor website (http and https). IPs available on request.

Web Browser Internet Explorer 7+, Firefox (any), Chrome (any), Safari (any) ActiveX Controls and Plug-Ins Not required or requested.

Flash Support Not required or requested.

Cookies Used, but not required.

Hardware Requirements None Software Requirements Only an Internet browser required for using the application. No software needs to be installed.

Creating and editing documents to upload into Document Control requires a word processor or office suite. Viewing documents does NOT require any word processor or office suite to be installed on the user’s computer.

We support word processing documents (DOC, DOCX), spreadsheets (XLS, XLSX), and presentation files (PPT, PPTX) from Microsoft Office (any version from Office ’97 to current), OpenOffice, and LibreOffice, as well as PDF files created by any program. Additionally, Visio files, HTML, and image files are supported.

Security Measures Supported (Physical)

Document Management web application servers are hosted at gated, lock and key facilities. These facilities implement locked server as well as biometric (fingerprint) scanning. Only authorized technicians may handle vendor servers.

All Vendor servers are dedicated, not shared.

Security Measures Supported (Digital)

System

· Access to the application can be restricted to visitors originating from certain IPs or IP ranges.

· All communication, including login and all visited pages, occurs over HTTPS.

· All users must log into the system with a username and password.

· All failed login attempts are captured and analyzed for threat detection.

· All successful login attempts are captured with the IP address of the user who logged into the system.

· Administrators can disable a user’s access at any time.

· Administrators can set password requirements, including length, complexity, and schedule for resetting.

Documents and Records

· Documents and records cannot be found using search engines (such as Google or Bing).

· Documents and records can only be accessed once logged into the system and only if the user has the necessary permissions to retrieve them.

· Users sign off documents using a PIN with electronic signature (created through Vendor) that meet 21 CFR Part 11 (ELECTRONIC RECORDS; ELECTRONIC SIGNATURES).

· Document backups are generated and presented to those users who have been defined to download such files.

Disaster Recovery

Vendor Data on Vendor servers is backed up nightly at an off-site facility. An additional backup of data is created in-office weekly. Server redundancy is in place in the event of a server outage.

Customer Document Control provides a mechanism by which the customer can download a full system backup within Document Control and Inspection Proof. These are generated either weekly or monthly (depending on user settings) and contain all documents, sign offs, inspection checklists, and any other information that was entered into the Vendor system. Additionally, a manual backup copy can be requested at any time (10-15 minutes processing time).