Salient Characteristics.docx

Salient Characteristics Online Subscription to a Quality Management System

Subscription to an online, user-friendly, platform that has the ability to connect all compliance content – policies, procedures, training, assessments, non-conforming events, audits, and professional development in a single repository. Provides the structure for the Quality Management System in line with the accreditation and regulatory requirements of the College of American Pathologist (CAP), Association for the Advancement of Blood & Biotherapies (AABB), The Joint Commission (TJC), the Food and Drug Administration (FDA) 21 CFR Part 11 subpart B, the Code of Federal Regulations (CFR) Title 42, the Clinical Laboratory Improvement Amendments (CLIA), and the DoD Clinical Laboratory Improvement Program (CLIP). Subscription does not require local IMD support and includes the following capabilities and functions for the user sites listed in Technical Exhibit 1:

a) Document Control (23 Sites, 800 Users) ─ A comprehensive and centralized document management system that manages the whole document life cycle according to the International Standardization Organization (ISO) 15189, section 4.3. Includes: Automated document initiation, editing, review and approval process; Controlled printing; Customizable categorization of document types and numbering; Archival; Complete record and review history; Customizable workflows and approval processes by employee roles; ability to collaborate on documents simultaneously; document linking; ability to track the status of all documents; electronic signatures; version control; employee notification; notification of review.

b) Inspection/Accreditation (23 Sites) ─ An approved participant of the College of American Pathologist (CAP) Accreditation Checklist Distribution Program (ACDP), allowing for multiple CLIP/CAP numbers and links customized CAP Checklists to specific documents and other evidence of compliance. Able to differentiate/track changes from previous to current/updated custom inspection checklist. Import checklist responses and deficiency into newest accreditation event from previous. Customized permissions and approval processes for end users.

c) Competency Assessments (23 Sites, 850 Users) ─ Provide module to create, monitor, and document training and competencies IAW CLIA competency assessment frequency and procedures. Ability to link to document control, have customizable checklist and graded exams.

d) Event Management (23 Sites) ─ Provide a module for documentation of events. Provides easy to use, intuitive tools right from the start to help effectively handle non-conforming events consistently, thoroughly, and quickly. From initiation, investigation, risk assessment, corrective/preventive action (CAPA) development, and evaluation of quality and other events. This function will not be used for any patient PHI.

e) Personnel Documentation (15 Sites, 650 Users) ─ Provide a module to store regulatory required qualification records of personnel. system that shows which users need to provide documentation, which users' need to upload the necessary files, and how long it's been since that documentation was reviewed or updated. Able to search by user or document type to pull up documentation any time.

f) Continuing Education (23 sites, 500 users) ─ Provide a learning management system for continuing education. Preloaded database for mandatory laboratory specific training such as OSHA safety training and packaging, shipping, and transport Division 6.2 hazardous materials. Up-to-date and P.A.C.E.-approved continuing education courses and ability to custom design unlimited courses and checklists. Provide CE opportunities through at a minimum 80 hours of continuing education in hematology, chemistry, microbiology, blood banking, and other fields, as appropriate. Provide reports that show employee training history and detailed question data. Able to Print certificates of completion and CE transcripts at any time. Must meet CAP GEN.54200 requirement for a functional continuing clinical laboratory education program adequate to meet the needs of all personnel.

g) Education and Training (23 sites, 500 users) ─ Customizable training classes and presentations facilitate development of training and learning management for maintaining compliance and tracking education. Build unlimited custom courses with easy-to-use online tools. Provide the ability to turn existing PowerPoint presentations into online courses.

h) Licensing and Exam Simulator (20 Seats) ─ Adaptable and user specific exam simulator for current MLT/MLS Board of Certification (BOC) material for American Society for Clinical Pathology (ASCP), American Medical Technologists (AMT), and American Association of Bioanalysts (AAB).

i) Case Simulators (up to 150 Seats) ─ Relevant and expert reviewed clinical case reviews and materials enabling additional science and task specific employee development and standardization of case evaluation and grading across employees. Simulators should include (but not be limited to) blood culture gram stain cases, bacteriology cases, body fluid cases, urinalysis cases, red blood cell morphology cases, white blood cell differential cases, and a certification exam simulator. (Number of seats required will vary based on the specific simulator.)

j) Additional System wide requirements:

i) Customer support ─ Customer and IT support within 24 to 72 hours from submitting a support ticket and regular system updates and as needed bug fixes. Provide initial integration of all sites in one consolidated enterprise.

ii) User Manuals and Guides ─ Comprehensive help system with on-demand end user training, how to documents, quick references and feature specific guides.

iii) Sharing/Collaboration ─ Discrete end user access via single log in. The ability to exchange/transfer documents/files, as part of the standardization and collaboration with other DHA laboratories and their contracted platform. Functionality of facilitating/sharing the access to view and interact with products of non-registered end users requiring no login credentials. Ability to create and customize groups of users. Ability to assign user specific tasks, questions and other collaboration for registered and external users.

iv) User To Do Lists ─ Automated and triggered Assignments, E-mails, Reminders, and To-Do Lists are sent to users at defined intervals. Users and authors/administrators receive E-mail notifications when new documentation is assigned to them and for as long as it remains to be completed. Reminders are sent when documentation needs to be reviewed or updated, either before it expires or on an as scheduled basis.

v) Report System ─ Provide the ability for management to access standardized and comprehensive reports, dashboards, graphics and charts, CAP Personnel Evaluation Rosters, audit trails, and historical information as well as being able to create custom queries.

vi) Backup ─ Able to download full and customized backups as scheduled and at any time the need arises.