ESBD_373512_1723848808558_Recall Management System SOW.pdf

Recall Management System (RMS) MD Anderson Confidential Rider 101 Scope of Work

Recall Management Systems (RMS) Request for Proposal (RFP)

Scope of Work (SOW)

1. General

The University of Texas M.D. Anderson Cancer Center (MD Anderson) requests proposals from qualified and experienced direct Suppliers and/or manufacturers that provide an off-the-shelf, industry standard, cloud-based Recall Management System (RMS) that will facilitate the strategy and mission of the organization.

MD Anderson is searching for an RMS solution that is commercially available and designed for the unique and complex needs of recall management requirements. Success in the academic healthcare environment is preferred but not required.

Objectives: To select a Supplier that meets the following criteria:

• cloud-based platform that is commercially available (no design-builds)

• demonstrated success in the academic health care environment is preferred, but not required;

• web-based access and simultaneous multi-user editing functionality such as posting comments to user community, copying alerts to other users, re-assigning alerts to other users, cancelling user response, and closing alerts.

• support for multiple operating systems (i.e. Windows OS, Mac OS);

• robust, user-friendly interfaces for desktop and mobile, support for Mac and Windows environments;

• search functionality that considers the specific needs of the user; examples include ability to easily search current and previous recalls, and by product categories, suppliers, and manufacturers,

• ease of review and approval by recall stakeholders,

• flexible workflow design that enables process customization and queue hierarchy without developer involvement;

• flexible administrative functionality that enables customization of user profiles, group permissions, and group restrictions;

• flexible reporting functionality that enables users to create customizable reports, as needed, and supports dashboard creation without developer involvement;

Recall Management System (RMS) MD Anderson Confidential Rider 101 Scope of Work

• ease of publication by delegated approvers and restrictions as to publishing authority: Accessing report restricted to recall Administrator (and Managers assigned by the Supply Chain department)/data for presentation to the institutional committees.

• dynamic content management driven by central repositories for commonly used data (definitions, department names) and a one-source-many-outputs infrastructure;

• synchronization with PeopleSoft and/or Active Directory for real-time authentication and reconciliation on active workforce members. Seamless integration with PeopleSoft for inventory data access and syncing recall data with inventory data. This will enable inventory-match to find if a recall affects MDACC, based on purchase history.

• redundant, secure information storage that precludes the need for manual backups.

2. Background Information:

MD Anderson has been utilizing software-based recall management for >10 years. It is a key element of complying with federal and state guidelines, but also in helping colleagues across the organization understand their responsibilities and outline how to perform their roles.

To date, we continue to be challenged in the areas noted below:

• A platform designed for rigorous accountability reporting, yet flexible enough to meet our changing needs (i.e.: new domains).

3. Compliance:

MD Anderson follows the FDA guidelines for recall management, RMS software must follow the same requirements:

A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. 21 CFR 7 provides guidance so that responsible firms may conduct an effective recall. Medical device recalls are usually conducted voluntarily by the manufacturer under 21 CFR 7. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer under 21 CFR 810, Medical Device Recall Authority. 21 CFR 810 describes the procedures the FDA will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act (Act).

Under 21 CFR 806, Medical Device Correction and Removals, manufacturers and importers are required to make a report to FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/showCFR.cfm?CFRPart=7 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/showCFR.cfm?CFRPart=7 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/showCFR.cfm?CFRPart=810 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/showCFR.cfm?CFRPart=810 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/showCFR.cfm?CFRPart=810 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/showCFR.cfm?CFRPart=806

Recall Management System (RMS) MD Anderson Confidential Rider 101 Scope of Work device or to remedy a violation of the Act caused by the device which may present a risk to health.1

4. Expectations:

Supplier will:

4.1. Offer an existing, robust, cloud-based, purpose-designed RMS with demonstrated success inclusive of reporting and data mining. Success in the academic health care environment is preferred but not required.

4.2. Ability to export all reported recall information to excel.

4.3. Preferable but not required: Ability to download reports preferably in the excel format (.xls and not just .csv); ability to upload documents in formats such as .doc, .pdf, .xls etc.

4.4. Maintain the quality of the platforms and services expected by the nation’s #1 cancer center.

4.5. Provide qualified staff and support by providing formal education and ongoing training. This training can be virtual.

4.6. Provide support services during normal business hours and as needed on an emergency basis as requested by MD Anderson.

4.7. Provide a dedicated point of contact and/or account representative which will be available during normal business hours.

4.8. Work with MD Anderson to establish recall reporting practices that meet MD Anderson’s needs.

4.9. Work with MD Anderson to design and deploy an integrated and seamless customer service process.

5. Minimum Requirements:

The supplier must offer a Recall Management System that:

5.1. Cloud-based: Supplier hosted solution/system 5.2. Operating Systems: Supports Windows and

Mac OS.

5.2. Integration with MDACC’s Enterprise Reporting System and it’s ad-ons (i.e.: PeopleSoft, Tecsys, or similar).

1 https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

Recall Management System (RMS) MD Anderson Confidential Rider 101 Scope of Work

5.3. Mobile/Browser: Supports Safari, Chrome, and Edge.

5.4. Ability to address issues at the location via mobile technology: Any software related issues:

Should be able to address password reset issue, software access issues, view issues, and any other issues relevant to access and use of the RMS tool.

5.5. Administration: Allows identification of system administrators. The administrator would be the Central point to review incoming recall information before distribution to all appropriate staff.

The administrator would oversee recall administration by various institutional departments at MDACC; ac t as the central point of contact for recalls, and would be the central point of contact withing MDACC for recall training.

5.6. Administration: System administrators may override or force any workflow item and may edit any recall and its metadata. For example, rerouting if a workflow stop is not required or owner is absent.

5.7. Administration: System administrators can mass email groups of recall stakeholders (Domain Coordinators, Alert Responders, Content Experts, etc.) from within the system.

5.8. Administration: Recall stakeholders may be identified for each individual recall category, and an individual stakeholder may serve on multiple policies in multiple roles (e.g., Joe Smith is a Responder for GI Lab and Cath Lab).

5.9. Security: Only recall Administrators can edit the recall policies, workflows, etc.

5.10. Recall content is not driven by siloed, standalone documents (Word, Excel, Visio, PDF, etc.).

5.11. Workflow: Supports creation of a set of default workflows.

5.12. Workflow: Supports creation of a set of default recall categories.

5.13. Workflow: Facilitates role-based stakeholder review (workflow based on roles, not unique individuals)

5.14. Workflow: Requires user to enter comments when a recall moves from one step in a workflow to another.

5.15. Notification: Emails notifications to relevant stakeholders when a recall requires action on their part (assign, consult, close out, etc.).

5.16. User experience: Allows users to readily identify the workflow state of a recall.

5.17. User experience: System allows users to “tag” recall policies.

5.18. Reporting: System offers custom report building for administrators.

5.19. Reporting: Administrators may create default reports and share with all users.

5.20. Search functionality: Searches recall content as well as recall metadata.

5.21. Support: Customer support availability during working hours (Monday through Friday, 8 a.m. to 5 p.m. CST).

6. “Nice to Have’s”

Recall Management System (RMS) MD Anderson Confidential Rider 101 Scope of Work

6.1. Ability to add/delete recall categories/domains.

6.2. Ability to copy individual recall alerts to non-default categories/domains.

6.3. Robust identification of affected inventory through inventory-match function.

6.4. Ability to match inventory to the purchasing departments and highlight the match.

6.5. Allows pulling a minimum of 12 months data for building reports in Excel format. Additionally, supports downloading monthly data.

6.6. Acts as a repository: Allows document uploads and automatically saves the uploaded documents.

6.7. Submission of acknowledgement: Shares vendor specific response forms and allows submission of response forms through the recall portal/service.

6.8. Designated vendor representative for MD Anderson.

7. Services:

7.1. Supplier staff shall, working in conjunction with MD Anderson Recall Administrators, develop a plan to migrate all existing recalls and their metadata into the selected platform.

7.2. Supplier staff shall, working in conjunction with Recall Administrators, develop an initial set of default workflows and create an initial set of recall categories. The RMS supplier will provide training to the MD Anderson staff on category generation so that separate additional categories can be generated by the MD Anderson staff later and as required.

7.3. Supplier staff shall, working in conjunction with Recall Administrators, identify key metadata elements to be used across all recall types.

7.4. Supplier staff shall provide initial training to Recall Administrators, as well as ongoing training to address system updates and functionality enhancements.

7.5. Supplier staff shall support Recall Administrators in the development of reports.

7.6. Supplier staff shall communicate with Recall Administrators during unplanned downtimes.

7.7. Supplier staff shall alert Recall Administrators of planned outages.

7.8. Supplier staff shall participate in quarterly business reviews with Recall Administrators to address issues in need of resolution, software updates, suggested changes to the platform, etc.

8. MD Anderson’s Responsibilities:

8.1. MD Anderson will appoint designated personnel who will be the primary contact for requesting and receiving all reports pertaining to this contract. The designated personnel shall be named after an award has been made. All reports requested performed hereunder shall be scheduled, Recall Management System (RMS) MD Anderson Confidential Rider 101 Scope of Work coordinated, reviewed and approved by the MD Anderson’s designated personnel. Reporting format will be agreed upon my MD Anderson and Supplier after award.

8.2. Audit: After contract execution, to ensure Supplier meets MD Anderson’s service level expectation, MD Anderson, at its own expense, shall perform auditory functions on an on-going as needed basis. These auditory functions shall be limited to reviewing MD Anderson specific inventory data integrity, supplier’s staff operational efficiencies, invoice accuracy and any other business process necessary to ensure management operations are not interrupted.

8.3. MD Anderson shall provide and maintain all regulatory permits, licenses, and clearances related to this SOW.

8.4. MD Anderson shall provide appropriate access to, use of, and training as required by MD

Anderson:

8.4.1. Access, safety and other training. No training required. However, supplier should have access to PeopleSoft data for syncing recall data with MD Anderson’s inventory data.

8.4.2. The RMS supplier will not require any dedicated space on campus.

9. Miscellaneous Provisions:

9.1. Supplier is required to provide single point of contact and escalation path should issues arise.

9.2. Personnel assigned to MD Anderson Account:

Supplier will ensure all persons connected with the Supplier directly in charge of the work are duly registered and/or licensed under all applicable federal, state and local, laws, regulations, and ordinances. Supplier will assign to the project a designated representative who will be responsible for the administration and coordination of the work. Supplier will furnish efficient business administration and coordination and perform the work in an expeditious and economical manner consistent with the interests of MD Anderson.

9.3. Supplier represents, warrants and agrees that it will (a) use commercially reasonable efforts to perform the work in a good and workmanlike manner and in accordance with commercially reasonable standards of proposer's profession or business, and (b) all of the work to be performed will be of the quality that prevails among similar businesses engaged in providing similar services in major United States urban areas under the same or similar circumstances.

9.4. Emergency:

An emergency situation is one in which the awarded Supplier is unable to fulfill one or more of their responsibilities for a period of more than 30 minutes; the emergency will be considered resolved when normal services resume.