Amendment 1 - QnA_13DEC24.docx

Questions received by 6 December 2024, 16:00 EST.

1. Will the system need to integrate with any specific existing platforms or databases used by the Department of Defense (DoD) laboratories?

As outlined within the Salient Characteristics document:

a) The system must be 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).

b) Must be listed as an approved participant of the College of American Pathologist (CAP) Accreditation Checklist Distribution Program (ACDP).

c) Provide 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).

d) 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 platforms to include MediaLab.

e) Ability to receive E-mail notifications.

2. Can you clarify the breakdown of user roles (e.g., administrators, authors, general users) and the permissions associated with each?

As outlined within the Salient Characteristics document, the platform must allow for various users’ roles and permissions for the different applications and functions as part of a Quality Management System in line with the accreditation and regulatory requirements. Some common examples for the document control application and their permission-based abilities are listed below:

a) Laboratory Director: Final approval of new documents and ability to perform periodic reviews.

b) Administrator: Administrators write documents and make changes to existing documents. They can upload new documents, edit documents, print controlled copies, view reports, change document information including effective dates, and view history, etc. Administrators can set up approval processes, periodic review processes, and editing / collaboration workflows.

c) Author: Authors write documents and make changes to existing documents. They can upload new documents, edit documents, view reports, and view history, etc.

d) Performing Employee: Are the regular employees that perform the procedure described in documents. They must sign off on a New Document or Major Revision (not Minor Revision). Performing employees can only see approved documents.

e) Non-Performing Employee: Have view access only.

f) Inspector: Inspectors have temporary, read-only access to current and retired versions of all documents, approval and periodic review history, controlled copy printing history, and reports. Inspectors cannot make any changes to the system.

3. Will end users be responsible for creating course content from PowerPoints, or is this a task exclusively handled by the contractor?

As outlined within the Salient Characteristics document both is applicable:

a) Import checklist responses and deficiency into newest accreditation event from previous.

b) Provide module to create, monitor, and document training and competencies IAW CLIA competency assessment frequency and procedures.

c) 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.

d) 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.

e) 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).

f) 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.

4. If the solution is cloud-based, is FEDRAMP compliance a requirement for the platform?

All vendors must follow all applicable guidelines and laws to conduct business and provide products to the federal government and its entities.

5. Is the preference for the solution to be hosted on a government cloud, vendor-managed cloud, or on-premise infrastructure?

As outlined within the Salient Characteristics document, the subscription does not require local IMD support and includes a subscription to a vendor based online, user-friendly, platform.

6. Are there plans for additional sites, users, or modules in the future that the system should accommodate?

There are no plans at this time for additional sites, users, or modules.

7. Will the government provide data or assistance during the initial setup and data migration for integration?

As outlined within the Salient Characteristics document, the subscription does not require local IMD support and includes the capabilities and functions detailed within the Salient Characteristics document. The government will provide the existing documents/information and user information in use.

8. Can you share any specific use cases for the Quality Management System (QMS)?

As outlined within the Salient Characteristics document, the QMS for the Department of Pathology in line with the accreditation and regulatory requirements of:

a) The College of American Pathologist (CAP)

b) Association for the Advancement of Blood & Biotherapies (AABB)

c) The Joint Commission (TJC)

d) The Food and Drug Administration (FDA)

e) 21 CFR Part 11 subpart B, the Code of Federal Regulations (CFR) Title 42

f) The Clinical Laboratory Improvement Amendments (CLIA)

g) The DoD Clinical Laboratory Improvement Program (CLIP

h) The International Standardization Organization (ISO) 15189

i) OSHA safety training and packaging, shipping, and transport Division 6.2 hazardous materials

j) P.A.C.E.-approved

k) MLT/MLS Board of Certification (BOC) material for American Society for Clinical Pathology (ASCP), American Medical Technologists (AMT), and American Association of Bioanalysts (AAB)

9. Regarding scalability, are the expected user numbers anticipated to fluctuate?

See answer to Question 6.

10. What are the specific requirements concerning user rights and access levels?

See answer to Question 2.

11. What are the information security requirements for this project?

All vendors must follow all applicable guidelines and laws to conduct business and provide products to the federal government and its entities.

12. Regarding document management: What types of documents will be handled, and what are the anticipated document volumes?

All the Department of Pathology documents (Policies, Procedure Manuals, JobAids, Forms, Quality Assurance and Maintenance events, Nonconforming events, Validations, etc.) including but not limited to tens of thousands of documents, some of which have hundreds of pages, will be digitally managed and retained for the CAP Minimum Period of Retention of Laboratory Records including up to ten years and indefinitely.

13. Are there any geographical restrictions or preferences for data hosting locations?

All vendors must follow all applicable guidelines and laws to conduct business and provide products to the federal government and its entities.

14. Should USAF / RAF Alconbury, UK be included in the contract?

Yes, while users for these sites were already accounted for under the Lakenheath site, the Alconbury and Croughton sites were added to the Technical Exhibit 1.

15. Could you please provide the current contract number?

This is a new requirement without a current contract.