FEASIBILITY OF CENTRALIZED ACUTE LYMPHOBLASTIC LEUKEMIA TESTING IN MEXICO IN ALLIANCE WITH ST. JUDE (MAS) INSTITUTIONS THROUGH A QUALITY IMPROVEMENT METHODOLOGY APPROACH Nataly Mercado1, Naomi Echeandia-Abud2, Pablo González-Montalvo3, Hugo Antonio Romo-Rubio4, Dinora Aguilar-Escobar5, Daniela Arce-Cabrera6, Karla Guerrero-Gómez1, Julio Alejandro Moreno-Serrano5, Margarita González-Zamorano7, Sergio Garay-Sánchez5, Patricia Judith Mendoza-Sánchez8, Eliazar Parra-Cárdenas1, Ana Elena Soto-Fernández1, Paola Friedrich2 1Casa de la Amistad para Niños con Cáncer, México en Alianza con St. Jude, Ciudad De México, México, 2St. Jude Children's Research Hospital, Global Pediatric Medicine, Memphis, TN, United States of America,
3Hospital General "Dr. Agustín O'Horan", Servicios de Salud de Yucatán, Oncology, Mérida, México, 4Hospital Civil de Guadalajara "Dr. Juan I. Menchaca", Oncology, Guadalajara, México, 5Hospital Infantil Teletón de Oncología,
Laboratory, Querétaro, México, 6Hospital Pediátrico de Sinaloa, Oncology, Culiacan, México, 7Hospital General con Especialidades "Juan María de Salvatierra", Oncology, La Paz, México, 8Hospital Infantil Teletón de Oncología, Education and Research Department, Querétaro, México
BACKGROUND BACKGROUND BACKGROUND
METHODS METHODS RESULTS
The Bridge Project is a multi-site collaboration and quality improvement initiative to centralize diagnostic studies for children with suspected acute lymphoblastic leukemia (ALL) within the Mexico in Alliance with St. Jude (MAS) collaborative group. It has exposed the variability of techniques used to obtain samples, packaging, and shipment processes. We present the results of the first cohort of participant institutions that have implemented the Quality Improvement (QI) methodology to achieve standardization.
We collected data from 348 patients with suspected ALL from four institutions from June 2019 to June 2023. All patients benefited from a complete diagnostic report; 291 (83%) cases were confirmed with ALL diagnosis and 937 samples were shipped. We observed improvement in most outcome, process, and balance measures. We documented a reduction in prevalent critical errors, labeling, temperature and volume. Participants reported high satisfaction with the project (>90%). Successful change ideas were registered in a shared database to guide implementation in new participating centers. Outcome measure
OBJECTIVES
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14%
CL
12% 10%
11.7%
LCL
8%
6.5%
6% 4% 2%
1.3% 48
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0% 8
•Full MRD
UCL
16%
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•Full MRD
Month of participation
Process measure
The consensus-derived diagnostic panel includes morphology, immunophenotype, DNA index, FISH, karyotype, and MRD.
Average shipment time from participating hospitals to central laboratory X-Chart
Target: < 48 hours
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Time (in hours)
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METHODS
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UCL
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37.8
CL
30
30.5
LCL
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23.3
20 15 10 5
Theory of change • Aim: To reduce to zero the number of critical errors in samples sent through the Bridge Project to the centralized laboratory.
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Month of participation
Process measure
Percentage of labeling errors in ALL samples shipped to the centralized laboratory P-Chart
35% 30% 25%
UCL
20% 15%
11.9%
CL
10% 5%
2.1% 48
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0% 1
We utilized the Model for Improvement1: defined aim, theory of change, a family of measures, and iteration for improvement through Plan-Do-Study-Act (PDSA) cycles. Patient samples (children aged 0-18 years old) were shipped from the treatment facility to the central laboratory. Upon arrival, the laboratory evaluated the samples against 14-item criteria (9 critical and 5 non-critical based on their impact on sample viability/reliability) and collected de-identified information in a database. Participating institutions ran and documented PDSA cycles to decrease the number of errors.
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Percentage
Day 84
Percentage of total errors (critical and non-critical) in ALL samples shipped to the centralized laboratory P-Chart
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• •Morphology (BMA +/- biopsy) •Full MRD
18%
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•Morphology (BMA +/- biopsy) •Full MRD only in case of morrow M2 or M3
Process measure
20%
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Day 29
1
Month of participation
3
•N/A
0.0%
Target: 0% critical errors
0%
48
2%
2
•MRD Lite
4.0%
4%
1
Day 15
LCL
6%
Percentage
•Morphology (BMA +/- biopsy) •Immunophenotype •DNA index •Karyotype •FISH: BCR-ABL, MLL-AF4, •CDKN2A, TLX1, TLX3, TRA/D
9.0%
8%
Strain T
•Morphology (BMA +/- biopsy) •Immunophenotype •DNA index •Karyotype •FISH: BCR-ABL, ETV6RUNX1, MLL-AF4, EA2PBX1, iAMP21
CL
10%
Consensus derived Diagnostic panel for the Bridge Project Strain B
UCL
14% Percentage
In addition to securing access to a comprehensive diagnostic panel, the Bridge Project aims to standardize ALL sample procurement, processing and shipment within participating hospitals. All samples are shipped and processed in a centralized Laboratory (Hospital Infantil Teletón de Oncología) in Mexico.
Diagnosis
Percentage of critical errors in ALL samples shipped to the centralized laboratory P-Chart
20%
Month of Participation
Process measure
70%
Percentage of volume errors in ALL samples shipped to the centralized laboratory P-Chart
60%
Percentage
50%
UCL
40% 30%
CL
20%
Acknowledgments Bibliography
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0% Month of participation
Most common errors (Median)
Pareto Chart
• Measurement strategy examples: 1. Outcome: % events with zero critical errors 2. Process: % events that arrive w/in <48hrs 3. Balance: % satisfaction among clinicians
11.8%
10%
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• Driver Diagram: 1. Access to equipment and supplies 2. Process standardization and reliability 3. Meeting for norms and regulations 4. Efficient data management 5. Communication and teamwork
18% 16% 14% 12% 10% 8% 6% 4% 2% 0%
CONCLUSIONS
15.0%
4.0%
3.0%
3.0%
3.0% 0.0%
0.0%
Hematology/Oncology leaders and clinical research coordinators and laboratory staff of participant hospitals. Administrative staff from Casa de la Amistad para Niños con Cáncer. Special gratitude to Erika Casillas Toral, Elianneth Rey, Verónica Espinosa and the Mexico in Alliance with St. Jude team. 1Institute for Healthcare Improvement. (2023). Model of Improvement. Retrieved from
https://www.ihi.org/resources/Pages/HowtoImprove/default.aspx
Our results show that centralization of specialized diagnostic services is feasible, can effectively build local capacity, standardize the process of sample procurement, packaging, and shipment, and increase access to a standardized diagnostic panel for children with suspected ALL. A replica of the model across other specialized laboratories in Mexico is underway. Contact information
mas-puenteALL@stjude.org