OTTRBMT & FACT 6 Edition Standards - CareDx

OTTRBMT & FACT 6th Edition StandardsLinda M. Laub RN, MSN, MSHCI

Brandon Lederer BS

OUI 2015

At the completion of this session you will:

◦ Have a basic understanding of the Foundation for the Accreditation of Cellular therapy (FACT) and their guidelines for programs, facilities, and individuals performing stem cell transplantation

◦ Learn how the OTTRBMT solution can currently support compliance around many of FACT’s clinical program standards

◦ Gain an understanding of planned developments to the solution to further enhance clinical program support

Objectives

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Linda M. Miller, MPA - Chief Executive Officer FACT

Alisa L. Forsythe - IT Business Analyst FACT

Kara Wacker, MBA - Director of Operations FACT

Introduction of FACT representatives:

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Founded in 1996- central office in Omaha, NE

Establishes standards for high quality medical and laboratory practice in cellular therapies

Non-profit corporation co-founded by the ◦ International Society for Cellular Therapy (ISCT)

◦ American Society of Blood and Marrow Transplantation (ASBMT)

Founded for the purposes of voluntary inspection and accreditation in the field of cellular therapy

FACT Overview

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FACT Standards are evidence-based requirements set by experts in the field of transplantation.

The Standards represent the timeline of a cell product from donor selection to collection, processing, storage, release, and administration to a patient.

The voluntary FACT accreditation program is rooted in a peer network to help each other improve cellular therapy practices.

Comprehensive inspections are conducted on multiple levels of review to ensure that programs meet minimum standards.

Organizations that achieve FACT accreditation have high-quality practices that benefit patient care.

FACT Overview

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Over 90% of all eligible US facilities and programs are FACT Accredited.

Because stem cell transplant is an international effort:◦ European Group for Blood and Marrow Transplantation ( EBMT) and

◦ ISCT-Europe

FACT standards represent the only international standard used in Europe, Canada, Australia, New Zealand, and the United States.

In 2012, FACT announced its first Blood & Marrow Transplantation Center in Latin America to receive its accreditation.

FACT Overview

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FACT supports comprehensive training programs.

Training and Development Programs are based upon current issues, needs, and outcomes within the cellular therapy community.

To access workshops, or online training: www.factwebsite.org

FACTWeb account to receive most recent updates

FACT Overview

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http://www.factwebsite.org/

Core Strengths:

◦ A Clinical and Administrative management system

◦ Gathers data through standardized workflow management within BMT milestones

◦ Drives Recipient and Donor Evaluation & Eligibility

◦ All fields available for query, analysis & visualization-simple to end user

◦ Data aggregation builds mandated reports like ASBMT RFI

OTTRBMT Overview

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Core Strengths:

◦ Registry Agent/ AGNIS tools to electronically submit CIBMTR data

◦ Platform also supports the ability to retrieve data back from CIBMTR offering additional discrete data for clinical or programmatic review and analysis

◦ Population reporting through lists, graphing, data export, Kaplan-Meier or Berkson-Gage survival curves, and life tables, support data query

◦ Comprehensive nature of solution naturally supports many of the minimum standards related to FACT accreditation. OTTR’s goal is to support more into the future!

OTTRBMT Overview

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Current State Support of Clinical Program Standards:

◦ B6- Allogeneic and Autologous Donor Selection,

Evaluation, and Management

◦ B7- Recipient Care

◦ B9- Data Management

Future/Expanded Support of Clinical Program Standards

OTTRBMT & FACT support overview:

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OTTRBMT Current State: B6- Donor Selection, Evaluation, and Management

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Allo & Auto donor information and informed consent

Standards

B6.2.1.1- The risks

and benefits of the procedure.

B6.2.1.2- Tests and procedures performed on the donor to protect the health of the donor and the recipient.

B6.2.1.3- The rights of the donor or legally authorized representative to review the results of such tests according to applicable laws and regulations.

B6.2.1.4- The donor shall have opportunity to ask questions.

B6.2.1.5- Protection of medical information and confidentiality.

Allo & Auto donor information and informed consent

Standard B6.2.8- The allogeneic donor shall give informed consent and authorization prior to release of the donor’s health or other information to the recipient’s physician and/or the recipient.

Standard B6.2.10- Documentation of consent shall be available to the Collection Facility staff prior to the collection procedure.


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Allo & Auto Donor Suitability

Standard B6.3.1- There shall be criteria and evaluation policies and procedures in place to protect the safety of donors during the process of cellular therapy product collection.


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Allo & Auto Suitability

Standard B6.3.1.1- Any abnormal finding shall be reported to the prospective donor with documentation in the donor record of recommendations made for follow-up care.


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Standard B6.3.1.1 (Continued)


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Allo and Auto Donor Suitability

Standard B6.3.1.2- Allogeneic donor suitability shall be evaluated by a licensed health care professional who is not the primary health care professional overseeing care of the recipient.


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Standard B6.3.4- A pregnancy test shall be performed for all female donors with childbearing potential within seven (7) days prior to starting the donor mobilization regimen and, as applicable, within seven (7) days prior to the initiation of the recipient’s preparative regimen.

System Alerts assist clinical team in ensuring that pregnancy assessment is performed.

Action “Female not of Childbearing Potential”- removes alert notification


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Standard B6.4.7- Allogeneic donors shall be tested for evidence of clinically relevant infection by the following communicable disease agents using tests required by applicable laws and regulations:

Standard B6.4.9.1- Blood samples for communicable disease testing from allogeneic HPC donors shall be obtained within thirty (30) days prior to collection.

System Alerts assist clinical team in ensuring that IDMs stay current prior to collection

Other system alerts: ( initial/ confirmatory typing; post-TX vaccinations; pre-cert documentation prior to TX admission; missing Diagnosis/ Disease Status; height: weight variance)


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Standard B6.4.5- Allogeneic donors shall be evaluated for risk factors that might result in disease transmission from the cellular therapy product by medical history, physical examination, examination of relevant medical records, and laboratory testing.


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Standard B7.3- Records shall be made concurrently with each step of recipient care in such a way that all steps may be accurately traced.

OTTRBMT Current State: B7- Recipient Care

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Standard B7.3- There should be policies and procedures in place for allogeneic recipient post-transplant vaccination schedules and indications.

System Alert automatically triggers when post-transplant vaccinations are due. Documentation tracking.


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Standard B7.6.8- There should be policies and procedures in place for monitoring by appropriate specialists of recipients for post-transplant late effects, including at a minimum endocrine and reproductive function, osteoporosis, cardiovascular risk factors, respiratory function, chronic renal impairment, secondary cancers, and the growth and development of pediatric patients.


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Transplant Essential Data Forms of the CIBMTR or the Minimum Essential Data-A forms of the EBMT.

“Patient lists” are included in OTTR’s standard workflow and can be customized to contain site specific, or regulatory, data elements.

Limit/ Analysis/ Graphing features on defined lists offer additional visualization of required data.

OTTRBMT Current State: Data Management

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Transplant type

OTTRBMT – Data Query/ Data Visualization

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Transplant Volume by Year

Patient’s by Disease

Patient’s by Primary Diagnosis


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Current State: OTTRBMT & FACT support

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Data Management Audit Form which includes: • Unique ID • Transplant Date• Pediatric/ Adult • Recipient Type• Disease• Stem Cell Source• Donor Type• Engraftment date• Survival

System Program Reports: Patient Review Meeting Report

Capacity Planning Reports ( Apheresis/ Admissions)

Census Report Creation


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System Program Reports:


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Patient Level Reports:

Stem Cell Product Collection and Issue Reports

Donor Education Calendars with required teaching materials


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Reviewed entire clinical standards (Section B)

“How can OTTR support this standard in the best possible way?”

Developed a “to-do list”◦ Enhancements/corrections/updates to existing functionality

◦ Completely new ideas

More than what I will cover

Focus this talk mostly on the new ideas

OTTRBMT & FACT support overview

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Current State Support of Clinical Program Standards:

Future/Expanded Support of Clinical Program Standards

◦ B1.5- New Patients

◦ B4.5.3- Report Versioning

◦ B4.7- Outcome Analysis

◦ B4.8- Auditing

◦ B6.3- Auto & Allo Suitability

◦ B6.4- Allo Suitability

◦ B7.6.8- Transplant Late Effects

◦ B7.9- ECP

◦ C11.6.9– Electronic Record Systems

◦ D13.2.6- Electronic Record Systems

◦ D13.2.7- Electronic Record Systems

OTTRBMT & FACT support overview

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Standard B1.5- The Clinical Program shall comply with the Minimum Number of New Patients for Accreditation table in Appendix I.

Developing a new "Transplant Volumes Report", built to resemble the "New Patient Numbers Form" provided by FACT.

OTTRBMT Future State: B1.5 New Patients

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Standard B4.5.3- The document control policy shall include:◦ Standard B4.5.3.2- Assignment of numeric or alphanumeric identifier and

title to each document and document version regulated within the system.

Add "OTTRbmt Report Version X Revision Y - Date Modified: DD-Mon-YYYY" to the bottom of every standard Report.

Add Page # and Date Printed to the bottom of every standard report.

Add a consistent header to every patient report that is Last Name, First Name and DOB on 2nd and subsequent pages.

OTTRBMT Future State: B4.5.3 Report Versioning

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Standard B4.7.3- Review of outcome analysis and/or product efficacy shall include at a minimum:◦ Standard B4.7.3.1- For HPC products intended for hematopoietic

reconstitution, time to engraftment following product administration.

Developing a new "Engraftment Summary" report, stratified by stem cell source, donor type. Individual graphs for each stratification plus additional details for the grouping.

"One-click" run as a Crystal Report.

OTTRBMT Future State: B4.7 Outcome Analysis

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Standard B4.7.3.2- Overall and treatment-related morbidity and mortality at one hundred (100) days and one (1) year after transplantation.

Developing a new "Patient Survival Data" report, stratified by Disease, stem cell source, donor type, and cell dose.

For each grouping, ex:◦ 49/50, 98% Alive @ 100 Days

◦ 47/50, 94% Alive @ 1 Year

◦ 45/50, 90% Alive @ 2 Years

Include pie-chart for causes of death


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Standard B4.7.3.3- Acute GVHD grade within one hundred (100) days after allogeneic transplantation.

Standard B4.7.3.4- Chronic GVHD grade within one (1) year after allogeneic transplantation.

For each, developing report stratified by stem cell source, donor type, match grade, age (categories from RFI) and Donor CMV.


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Standard B4.7.3.5- Central venous catheter infection.

Start documenting central venous catheter infections using the existing infection tab.

Develop patient list to show all documented central venous catheter infections. [looks like Excel spreadsheet]


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Standard B4.7.4- Data on outcome analysis and cellular therapy product efficacy, including adverse events related to the recipient, donor, and/or product, shall be provided in a timely manner to entities involved in the collection, processing, and/or distribution of the cellular therapy product.

We will support adverse events.

Documentation for adverse events is already in place.

Develop patient list to show all documented infusion adverse events.


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Standard B4.8.1- Audits shall be conducted on a regular basis by an individual with sufficient expertise to identify problems, but who is not solely responsible for the process being audited.

Develop new "auditing" document, providing minimal discrete fields available for querying, including:◦ Result

◦ Auditor

◦ Date Audit Completed

◦ Notes

◦ Ability attach detailed audit results file (usually Excel)

Content of the audit left up to the site's discretion

OTTRBMT Future State: B4.8 Auditing

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Standard B4.8.3- Audits shall include, at a minimum:◦ Standard B4.8.3.1- Periodic audit of the accuracy of data contained in the

Transplant Essential Data Forms of the CIBMTR or the Minimum Essential Data-A Forms of the EBMT.

◦ Standard B4.8.3.2- Annual audit of donor screening and testing.

◦ Standard B4.8.3.3- Annual audit of verification of chemotherapy drug and dose against the prescription ordering system and the protocol.

◦ Standard B4.8.3.4- Annual audit of management of cellular therapy products with positive microbial culture results.

Develop and/or use existing patient lists to provide a list of patients available to audit.

Develop new lists to show each audit, when they were performed, the auditor, results, and notes.

The methodology could be reproduced to satisfy any site-specific auditing needs.

OTTRBMT Future State: B4.8 Auditing

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Standard B6.3- ALLOGENEIC AND AUTOLOGOUS DONOR SUITABILITY FOR CELLULAR THERAPY PRODUCT COLLECTION◦ Standard B6.3.1- There shall be criteria and evaluation policies and

procedures in place to protect the safety of donors during the process of cellular therapy product collection.

◦ Standard B6.3.2- The risks of donation shall be evaluated and documented, including:

◦ Standard B6.3.2.1- Possible need for central venous access.

◦ Standard B6.3.2.2- Mobilization therapy for collection of HPC, Apheresis.

◦ Standard B6.3.3- The donor should be evaluated for the risk of hemoglobinopathy prior to administration of the mobilization regimen.

◦ Standard B6.3.5- Laboratory testing of all donors shall be performed by a laboratory that is accredited, registered, or licensed in accordance with applicable laws and regulations.

Updating the fields for documenting these to match the latest standards.

OTTRBMT Future State: B6.3 Auto & Allo Suitablilty

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Standard B6.4- ADDITIONAL REQUIREMENTS FOR ALLOGENEIC DONORS◦ Standard B6.4.1- A donor advocate shall be available to represent

allogeneic donors who are minors or who are mentally incapacitated, as those terms are defined by applicable laws.

◦ Standard B6.4.4- A red cell antibody screen shall be performed on allogeneic recipients.

◦ Standard B6.4.6-The medical history for allogeneic donors shall include at least the following:

◦ Standard B6.4.6.1-Vaccination history.

◦ Standard B6.4.12.4-There shall be a policy for anti-HLA antibody testing for mismatched donors and recipients.

Updating the fields for documenting these to match the latest standards.

Adding support for Anti-HLA antibody workflow and lab documentation.

OTTRBMT Future State: B6.4 Allo Suitability

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Standard B7.6.8- There should be policies and procedures in place for monitoring by appropriate specialists of recipients for post-transplant late effects, including at a minimum endocrine and reproductive function, osteoporosis, cardiovascular risk factors, respiratory function, chronic renal impairment, secondary cancers, and the growth and development of pediatric patients.

Developing Post-Transplant testing order sets by Transplant Type and Milestone Visit (30/60/180/1year/annual).

Developing Post-Transplant testing order sets by Disease.

OTTRBMT Future State: B7.6.8 Late Effects

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Standard B7.9- There shall be a policy addressing indications for and safe administration of ECP if utilized by the Clinical Program.◦ Standard B7.9.2- Before ECP is undertaken, there shall be a written

therapy plan from an attending physician specifying the patient's diagnosis and GVHD grade, involved organs, timing of the procedure, and any other factors that may affect the safe administration of ECP.

◦ Standard B7.9.3- A report of the details of ECP administered, including an assessment of the response, shall be documented in the recipient's medical record.

Developing an ECP Encounter and complete workflow around ECP.

OTTRBMT Future State: B7.9 ECP

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Standard B9.1- The Clinical Program shall collect all the data necessary to complete the Transplant Essential Data Forms of the CIBMTR or the Minimum Essential Data-A forms of the EBMT.

For FACT, the center must provide a list of recipients to the CIBMTR for review, with specific columns of data.

Develop a patient list to meet this specific need.

OTTRBMT Future State: B9.1 Data Management

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Standard C11.6.9- For all critical electronic record systems, there shall be validated procedures for and documentation of:◦ Standard C11.6.9.1- Training and continued competency of personnel in

systems use.

◦ Standard C11.6.9.2- Monitoring of data integrity.

◦ Standard C11.6.9.3- Back-up of the electronic records system on a regular schedule.

◦ Standard C11.6.9.4- System assignment of unique identifiers.

Providing statements about how OTTR supports/meets these requirements.

OTTRBMT Future State: C11.6.9 Electronic Records

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Standard D13.2.6- For all critical electronic record systems, there shall be validated procedures for and documentation of:◦ Standard D13.2.6.1- Systems development.

◦ Standard D13.2.6.2- Numerical designation of system versions, if applicable.

◦ Standard D13.2.6.3- Prospective validation of systems, including hardware, software, and databases.

◦ Standard D13.2.6.4- Installation of the system.

◦ Standard D13.2.6.5- Training and continued competency of personnel in systems use.

◦ Standard D13.2.6.6- Monitoring of data integrity.

◦ Standard D13.2.6.7- Back-up of the electronic records system on a regular schedule.

◦ Standard D13.2.6.8- System maintenance and operations.

◦ Standard D13.2.6.9- System assignment of unique identifiers.

Providing statements about how OTTR supports/meets these requirements.

OTTRBMT Future State: D13.2.6 Electronic Records

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Standard D13.2.7- All system modifications shall be authorized, documented, and validated prior to implementation.

Providing recommendations on best practices to meet these requirements.

OTTRBMT Future State: D13.2.7 Electronic Records

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OTTR will be providing detailed responses to all of the standards that are being met, or partially met by OTTR.

Response will include best practice recommendations and where to obtain the information from OTTR.

Other answers may include details about how OTTR functions internally in order to ensure data integrity, security, etc.

Apply these answers along with the information obtained from OTTR reports, lists, etc. when filling out your own response to the FACT standards.

OTTRBMT Future State: Documentation

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Your feedback on these items and needs is welcomed

We will continue to improve on the FACT standards even after this work is delivered

Collaborative Effort

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Questions/Feedback

Documents

OTTRBMT & FACT 6 Edition Standards - CareDx