Performance_Work_Statement_Tissue_Tracking_Subscription.pdf

Performance Work Statement

Tissue Tracking Subscription Application Madigan Army Medical Center, Tacoma, WA

1.0 Scope.

1.1 Objective. The objective of this performance-based contract is to obtain approval for the procurement of tissue tracking subscription capable of ensuring the Standard of Care determined by the Madigan Army Medical Center (MAMC) Clinical Leadership is achieved for the entire supported patient population. This will also meet the secondary objective of ensuring compliance with all Food and Drug Administration (FDA) and Joint Commission (JC) standards.

1.2 Background. MAMC currently employs a Web/Cloud based system meets the needs and requirements for MAMC Tissue Bank. This asset remaining in place at Madigan AMC Tissue Bank would greatly enhance the productivity and capabilities to patient care

2.0 Definitions and References.

2.1 Definitions.

Tissue Products: Tissue, grafts, or implants defined by the FDA as requiring quality control and accountability tracking from creation/procurement at the vendor level until implantation/destruction. Records must be maintained and readily accessible for a minimum of ten years.

Implant: Any device or material, (which may or may not be of an inert substance), used for repairing or replacing part of the body.

Cradle to Grave is the term used to describe the tracking requirement that requires management from production throughout the lifespan of the item. Cradle to Grave management of tissue only ends when destroyed or the lifespan of the item is complete. Implantation into a patient still requires tracking IAW FDA standards.

2.2 References.

Joint Commission Comprehensive Accreditation Manual for Hospitals: Used by the Joint Commission for establishing criteria required for gaining accreditation. Accreditation of all Army Medical Facilities is a DOD requirement.

Food and Drug Administration Tissue Tracking Standards: Establishes the minimum standards that must be met in the production/procurement, management, and use of tissue products.

Fiscal Year: A 12-month period over which a company budgets its spending. The fiscal year is referred to by the date in which it ends. The US Government fiscal year begins on

October 1st and ends September 30th. The fiscal year is designated by the year that the FY ends (example: A fiscal year that starts on 1 Oct 19 and ends 30 Sep 20 would be referred to as

FY20).

**3.0 Tasks. The Contractor shall perform the following tasks:**

3.0.1 Contractor must commit to meeting all Department of Defense Regulations regarding storage of Level 4 Protected Health Information (PHI) data in a Cloud-Based environment by being FEDRAMP Certified on the first day of the Period of Performance to comply with the Governments Cyber/OPSEC Regulations. The Government may consider FEDRAMP processing delays. However, no billable charges will be allowed during any delay periods encountered. For information on FEDRAMP see website: www.fedramp.gov

3.1 Provide a web based tissue tracking application capable of:

3.1.1 Tracking receipt, transfer, issuance and implantation of tissue products.

3.1.2 Tracking adverse reactions and recall data provided by the manufacturer.

This capability must be automated to ensure that the system recognizes all affected products within 24 hours of notification by the manufacturer. This notification must provide automated recall data down to the patient level, including showing implant data for patients that already used the tissue product as part of the medical procedure.

3.1.3 Maintaining the database to current FDA, JC published standards and FEDRAMP certification.

3.1.4 Monitoring and tracking tissue products throughout the entire facility.

3.1.5 Overseeing tissue product inventory with expiratory warnings that monitor expiration dates by lot number and ensure that written signals are issued when expired stock is utilized for use in medical procedures.

3.1.6 Linking product unique identification numbers to a patient’s clinical records. The site must comply with most current version of HIPAA requirements for the management and storage of any patient data stored on the contractor web server.

3.1.7 Tracking products used in the preparation/reconstitution of tissue products.

3.1.8 Documenting supplier FDA Registration and State Licensure or Accreditations.

3.1.9 Recording product quality checks to include temperature monitoring and package integrity.

3.1.10 If the current system/vendor is replaced by a new tissue tracking subscription application, the awarded contractor must reach an agreement within 90 days and meet all HIPAA regulatory guidelines to acquire all historical tissue data from the current contractor.

3.1.11 At any time, the Government may request all Legacy Patient Information and the Vendor must provide at no additional cost to the government within 10 days of request.

3.2 The Tissue Tracking Web Server Application shall provide output data that is readable by software platforms standardized throughout the Army.

3.3 The Tissue Tracking Web Server Application shall adhere the following minimum system requirements:

3.3.1 Encryption: Equal to or greater than, 128 bit

3.3.2 Browser: Application must be accessible by any web browser

3.3.3 Customizable: The Web Server Application must contain the ability to customize reports, web pages, and form design

3.3.4 Defense Information Security Agency (DISA) Network Compliance: The Web Server Application must meet all security requirements for web based applications and perform Anti-Virus Software updates no less than every seven days.

3.3.5 Certificate: The Contractor will provide an Secure Sockets Layer (SSL) certificate, or other equivalent security certificate, to enable secure and encrypted communications between the Government and Contractor systems.

3.3.6 Accessibility: The web based server application will be available to the Government 24 hours a day/ 7 days a week with the exception of scheduled maintenance periods.

Notification of scheduled maintenance periods will be published at least 4 calendar days prior to the execution of stated maintenance.

3.3.7 Data Redundancy: The Contractor will back up all Government files once every 24 hours to ensure redundancy of information. At least two weeks of back up data will be maintained by the Contractor.

3.3.8 Federal Risk and Authorization Management: The Contractor must be FEDRAMP certified at the time of award of the contract to ensure there is not a degradation in patient care between current utilization and future implementation.

3.4 Server Maintenance: If the Contractor web server becomes unavailable to users, other than scheduled maintenance, then the Contractor is required to have qualified personnel respond within two (2) hours of notification to remedy the problem.

3.5 The Contractor must provide 1 software license to the Government as part of this contract and provide a pricing option for the purchase of additional licenses that must be valid through the entirety of the contract.

3.6 Provide one year subscription for the Contractor tissue tracking web subscription application.

3.7 Delivery Timeline and User Training: The Contractor must have the capability to initiate user training at the time of contract award, as well as, database setup and system implementation if necessary. All web server functions must be in place and accessible by the Government immediately following contract award.

4.0 The Government shall provide the following:

4.1 Project Officer: A Project Officer trained in the FDA and Joint Commission standards for tissue product tracking.

4.2 COR: A Contracting Officer Representative (COR) to evaluate that performance based execution of the project and to ensure that the Contractor and Government agencies are adhering to the requirements outlined in the contracting document.

4.3 Process Evaluation and Initial Training: The Government will provide (1) personnel and support for the Contractor to evaluate the tissue product processes and participate in initial training. This includes:

4.3.1 The Contractor will have escorted access to all area where tissue products are received, stored, distributed and used. This access will include documentation that does not violate HIPAA standards.

4.3.2 An area for two weeks in order to facilitate training in the Contractor software subscriptions. The area will be outfitted with necessities for the training.

4.4 Information Management: The Government will provide:

4.4.1 Information on the security requirements and special considerations that must be met in order to gain firewall access.

4.4.2 Each Government user will have a Government provided laptop/PC system to load client software. An administrator will be available throughout the implementation stage to authorize software addition to the designated systems.

4.4.3 Any change in policy or regulator requirement will be submitted to the Contractor in writing as soon a they are identified. Any change in requirements that goes beyond the Contractor provided requirements outlined in Paragraph 3 will require the Government to create a contract modification.

4.5 The Government will provide the Contractor a POC (Point of Contact) list within 5 business days of contract award. This list will include:

4.5.1 Project Officer: The individual responsible for the technical application of the tissue tracking program within MAMC.

4.5.2 Contracting Officer Representative (COR): The person responsible for evaluating the Contractor’s compliance with the awarded contract.

4.5.3 Medical Materiel Branch POC: The Branch of the hospital responsible for receipt of tissue products and initial software documentation.

5.0 The Contractor shall provide points of contact (POCs) information for administration of the contract during business hours and during the designated hours of performance. The named representative(s) shall possess sufficient corporate authority to effectively deal with emergency situations and the contact/telephone number provided shall be functioning at all times other than normal business hours. If there are different POCs for different conditions, such as weekdays, weekends, or holidays, clearly provide such information.

6.0 Reports. The Contractor shall prepare the following reports and submit them as specified.

6.1. Unscheduled Maintenance Report: This report will be submitted to the COR whenever there is an unscheduled maintenance event that results in the loss of web server application use. This report will include the following data:

• Date and time the unscheduled maintenance requirement was identified.

• Date and time the unscheduled maintenance was resolved.

• Description of the maintenance problem

• Response time or amount of time before the Contractor began correcting the unscheduled maintenance event.

• Implications to data and/or back up redundant files

7.0 Performance Requirements Summary. This table specifies the standard for satisfactory performance of the tasks specified in this statement of work.

PERFORMANCE

OBJECTIVE

PERFORMANCE

STANDARD

ACCEPTABLE QUALITY

LEVEL (AQL)

INCENTIVE /

DISINCENTIVE

This capability must be automated to ensure that the system recognizes all affected products within 24 hours of notification by the manufacturer.

This notification must provide automated recall data down to the patient level, including showing implant data for patients that already used the tissue product as part of the medical procedure

(PWS 3.1.2 )

All recalls and quality control information are submitted and monthly compliance evaluations are provided within 24 hours.

Accuracy 100% throughout the Period of Performance of contract.

Continuous monitoring every month with (3) three QC Messages chosen at random. The tissue tracking records for those items will be evaluated for compliance.

Web based tissue tracking application capable overseeing tissue product inventory with expiratory warnings that monitor expiration dates by lot number and ensure that written signals are issued when expired stock is pulled for use in medical procedures. (PWS 3.1.5)

A written warning occur when a user attempts to access products that do not meet quality control requirements outlined in FDA and JC standards

Accuracy 100% of the time Continuous monitoring and first Wednesday of every month an attempt will be made to move an expired item to see if written warnings occur.

Maintaining the database to current FDA, JC published standards and FEDRAMP certification (PWS 3.1.3 )

No violation of FDA, JC or FEDRAMP standards as a result of software application deficiencies.

100% with FDA, JC and FEDRAMP standards

FDA and JC inspections based on published guidelines. Continuous server monitoring by DISA and MAMC Information Management Division (IMD).

The web based server application will be available to the Government 24 hours a day/ 7 days a week with the exception of scheduled maintenance periods. Notification of scheduled maintenance periods will be published at least 4 days prior to the execution of stated maintenance. (PWS 3.3.6)

Availability of access 24 hours a day, seven (7) days a week. Minimum of four

(4) days notification of any server/software maintenance.

Accessible 95% of the time per month

Continuous monitoring by Transfusion Medicine Subscription Supervisor, authorized Government users and COR.

If the Contractor web server becomes unavailable to users, other than scheduled maintenance, then the Contractor is required to have qualified personnel respond within two (2) hours of notification to remedy the problem. (PWS 3.4)

Availability of access 24 hours a day, seven (7) days a week. Minimum of four

(4) days notification of any server/software maintenance

Response within 2 hours 100% of the time

Continuous monitoring by Transfusion Medicine Subscription Supervisor, authorized Government users and COR.

Provide one year subscription for the Contractor tissue tracking web subscription application.

(PWS 3.6)

All client software applications are loaded, quality validated and to standard throughout the Period of Performance.

100% compliance with delivery timeline and installation/setup

Random inspection of Government user laptop/PCs.

The Contractor must have the capability to initiate user training at the time of contract award, as well as, database setup and system implementation if

All Government users trained in the use of web application immediately following installation of tracking subscription

100% compliance with delivery timeline and installation/setup

Random inspection of Government user training on software application and laptop/PCs.

necessary. All web server functions must be in place and accessible by the Government immediately following contract award. (PWS 3.7) The Government will provide (1) personnel and support for the Contractor to evaluate the tissue product processes and participate in initial training immediately following contract award. (PWS

3.7 and 4.3)

Minimum of one (1) Government users will be trained in the use of web application and reports and have the ability to train additional personnel as necessary

100% compliance Competency Folder documentation and physical inspection.