- Email: [email protected]
Engraftment and Outcomes Analysis
S350
Abstracts / Biol Blood Marrow Transplant 23 (2017) S18–S391
audits. Audits are used for process improvements and maintaining donor safety. Results are discussed amongst the Collection Medical Director, Program Medical Director and QM Coordinator and presented at a Quality Assurance Committee meeting. Recent results have initiated the need for process improvement plans. Methods: Between July 2015-June 2016, the UNC BMTCTP BMH team performed 15 collections. Document controlled forms were used to record key metrics, including lot numbers and expiration dates of the collection kit and the media solution components, anesthesia time, collection time, volume collected vs maximum amount allowed to be collected (20 ml/ kg), total nucleated cell (TNC) dose collected (goal > 2 x 108/ recipient kg) and requested goal, complications during the procedure, sterility and viability of collected product, and recipient engraftment. Nineteen metrics are validated with each collection. Goals for each metric were previously determined and used as measures of success. Results: We met our metric goals from for this period except for the following: achieving the requested TNC dose, the minimum collected TNC dose, and complications. In 87% of BMH, the requested TNC goal was not achieved with requests ranging from 3 - 10 x 108 TNC/recipient kg. Eighty percent of BMH did achieve a TNC dose of at least 2 x 108TNC/ recipient kg. Product viability ranged between 95 - 100%. Severe hypotension (SBP < 70) occurred in 27% of donors and occurred predominantly at the end of collection although the maximum volume threshold was not surpassed. In all cases, hypotension was reversible following intervention; no donor required hospital admission. All products were sterile and of the 4 related recipients, 100% engrafted. Discussion: Operating room process changes have been implemented with the pre-collection time out to assure that all team members are aware of the estimated collection volume and systolic blood pressure goal of >70. Further analysis of our results is underway to determine if other changes are necessary to improve cell dose collections. With the program’s increased use of haploidentical donors, we expect our harvest collection numbers to increase; thus, stressing the need to continually evaluate our processes to ensure donor safety and optimal cell dose collection.
486 Development of Care Pathway to Ensure Timely and Appropriate Re-Vaccination in Pediatric Survivors of Stem Cell Transplant (SCT) Jerry C. Cheng 1, Andrew Sy 2, Sylvia Reyes-Hatfield 3. 1 Pediatrics, Southern California Permanente Medical Group, Los Angeles, CA; 2 Pediatrics, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA; 3 Pediatrics, Kaiser Permanente, Los Angeles, CA Background: Patients undergoing hematopoietic stem cell transplants are known to have declining levels of antibodies to vaccine-preventable diseases. This is principally important in the pediatric population as exposure to vaccinepreventable diseases occur daily in daycare and school settings. For those eligible, re-vaccination provides a reprieve from use of IVIG and prophylactic antibiotics. However, in a community based setting, barriers to complete revaccination, such as, primary care providers’ reluctance, lack of patient compliance and parental hesitancy to vaccinate in current cultural climate, are present. Using the CDC recommended re-vaccination schedule, we report a communitybased model of re-vaccination utilizing the EPIC EMR and a case manager run database to deliver efficient population care management to address this care gap.
Methods: We performed a retrospective review of revaccination efforts in pediatric post-BMT survivors. Inclusion criteria were patients must be 0-18 year old, currently living and at least 2 years post stem cell transplant. Exclusion criteria were patients on high dose immunosuppressants or active chemotherapy or patients with documented active graft-versus host disease. Patients with incomplete vaccine profiles were called by an MD, appropriately counseled, their electronic medical records updated to reflect the need for revaccination and vaccination status tracked using a centralized database. Results: Initial rate for complete revaccination for all transplant recipients was 5%. Of the 57 total patients at least 2 years post BMT, 16 were post-autologous BMT (0% completed revaccination) and 41 patients were post-allogeneic BMT (7% completed revaccination). However ~30% of patients could complete re-vaccination with 1 visit. Four months after presenting this data our regional transplant coordinator and various PCPs, rates of complete revaccination increased by three fold to ~14% and almost four fold ~18% if those refusing only HPV are included. Two patients initially included were excluded after one relapsed and one transferred care to another institution. Conclusions: We propose that by employing a case manager database to notify families of re-vaccination and amending EMR problem lists, we can analyze those eligible for revaccination, equip primary care providers with re-vaccination schedules and ultimately improve revaccination rates in this at-risk population. Our rates of re-vaccination for patients post-autologous BMT are likely due to our practice of checking titers to verify immunization status prior to proceeding with re-vaccination. A vast majority are found to be nonimmune and highlights the need for all patients post-BMT to receive immunizations. At the time of this submission, we are in the process of addending EMR and contacting patients; full analysis of data to be completed in May of 2017.
487 Engraftment and Outcomes Analysis Elizabeth J. Williams 1, Michelle Hudspeth 2. 1 Blood and Marrow Transplant Program, Medical University of South Carolina, Charleston, SC; 2 Pediatric Hematology/Oncology, Medical University of South Carolina, Charleston, SC Background: Analysis of Engraftment and other outcomes in Blood and Marrow Transplant (BMT) patients is critical to generate evidence, detect trends, allow early intervention and track progress related to changes in treatment. Additionally, the outcomes data are closely reviewed by payors as the industry shifts the focus to quality metrics when determining transplant center certification status and reimbursement. The BME (bone marrow engraftment) Scorecard is a snapshot of BMT patients and their BME trends using a readily available Microsoft Access format. Methods: A BME scorecard (Figure 1) was introduced for quarterly review at the BMT Quality Management Meeting. The following metrics were determined to be most valuable when evaluating the trends in engraftment (reference FACT standards B4.7-10.0):
• • • • •
Diagnosis Type and Subtype of transplant Degree of HLA match Days to neutrophil engraftment (first of three consecutive lab values showing neutrophils ≥.5) Days to platelet engraftment (first day ≥20 after 7 days of platelet transfusion independence)
Abstracts / Biol Blood Marrow Transplant 23 (2017) S18–S391
S351
Figure 1.
• • •
Length of inpatient stay Stem Cell Dose expressed as CD34+ cells per kg, (target dose vs actual dose given) Survival at day 100
A key was created to identify the center’s expected baseline for days to neutrophil and platelet engraftment and was identified for each transplant type (e.g. autologous vs allogeneic and allogeneic related vs unrelated) and included on the scorecard. Patients whose engraftment times were outside of these target days were highlighted. Stem cell dose expressed as CD34+ cells per kg is an important factor in determining rate of and time to engraftment, so we correlated to CD34+ cell dose. Appendices were later added to the scorecard including: unrealized endpoints and quarterly mortality review. Results: The BME score card is a structured, readable snapshot of the transplant experience highlighting trends and providing critical information for clinical staff, regulators, administrators, and payors. Using an already available Microsoft Access platform allowed for data structuring, complex queries, automation of common events and database management with multiple users. Changes in practice made after reviewing trends on the engraftment score card included refining patient selection criteria, use of the HCT co-morbidity score, and patient discharge guidelines. The score card has greatly enhanced our ability to readily visualize the outcomes of our patients through pro-active review and enabled systematic evaluation and improvement of the quality of care.
NPS/PAS—ADVANCED PRACTICE PROFESSIONALS (FOR CLINICAL EDUCATION CONFERENCE)
488 Guidelines with Intent to Achieve Minimal Level of Sedation for Bone Marrow Aspirate and Biopsy Linda K. Baer 1, Brenda Cooper 2. 1 Adult Hematologic Malignancies & Stem Cell Transplant Section, Seidman Cancer Center, University Hospitals Cleveland Medical Center, Cleveland, OH; 2 Division of Hematology & Oncology, Seidman Cancer Center, University Hospitals Cleveland Medical Center; Case Wester Reserve University, Cleveland, OH Pain associated with bone marrow biopsy is not negligible. In addition to local anesthetic, a sedative and a narcotic have often been used to facilitate patient comfort resulting in a variable level of sedation. At our institution, a specific policy is in place when moderate or deep sedation is intended to facilitate the performance of a procedure. However, premedi-
cation with intent to achieve minimal sedation is not clearly defined. The purpose of this project was to establish guidelines for premedication for bone marrow biopsy. A search in PubMed/Embase databases resulted in 18 articles that revealed variable practices with local anesthetic along with systemic sedation prior to bone marrow biopsy. Although the majority of patients are able to undergo this procedure with local anesthetic alone, it may be necessary to discuss premedication with a sedative for treatment of anxiety or narcotic for treatment of pain. If local anesthetic is insufficient to complete this procedure, sedation with intent to achieve minimal sedation is recommended and appropriate for a bedside procedure. Some studies indicate no change in perception of pain with or without additional premedication. It is appropriate for the Advanced Practice Professional (APP) to evaluate the patient for use of minimal sedation. Minimal sedation is generally accomplished using one class of medications such as lorazepam, which is preferred, due to its short duration of action with anxiolytic, sedative, and amnesic properties. An alternative option is a short acting opioid narcotic. A new policy was created outlining minimal sedation procedure for bone marrow biopsy with a single agent to ensure safety and comfort. Additional monitoring under anesthesia is required for moderate to deep sedation. The APPs were instructed on this new policy. A 3-month follow up APP survey along with a chart audit of 20 patients is planned to confirm satisfaction and adherence.
QUALITY AND TRANSPLANT PROGRAM ADMINISTRATION (FOR ADMINISTRATIVE DIRECTOR SIG CONFERENCE)
489 Implementation of a Program Assessment Across a Network of 7 HCT Programs to Assess Risks Associated with Clinical Outcome Based on the 2015 Center for International Blood and Marrow Transplant Research (CIBMTR) Transplant Center-Specific Survival Report Rocky Billups 1, Laura Ione Brougher 2, Tonya Cox 2, Therese Dodd 3, Betsy Blunk 2, Charles F. LeMaistre 1. 1 Sarah Cannon, Nashville, TN; 2 Blood Cancer Network, Sarah Cannon, Denver, CO; 3 Global Quality and Education, Sarah Cannon, Nashville, TN Background: In 2006 the CIBMTR was awarded a contract from HRSA to administer the Stem Cell Therapeutic Outcomes Database of the C.W. Bill Young Cell Transplantation Program. A risk-adjusted one-year survival rate is calculated by CIBMTR for each center in the U.S., based on results
Abstracts / Biol Blood Marrow Transplant 23 (2017) S18–S391
audits. Audits are used for process improvements and maintaining donor safety. Results are discussed amongst the Collection Medical Director, Program Medical Director and QM Coordinator and presented at a Quality Assurance Committee meeting. Recent results have initiated the need for process improvement plans. Methods: Between July 2015-June 2016, the UNC BMTCTP BMH team performed 15 collections. Document controlled forms were used to record key metrics, including lot numbers and expiration dates of the collection kit and the media solution components, anesthesia time, collection time, volume collected vs maximum amount allowed to be collected (20 ml/ kg), total nucleated cell (TNC) dose collected (goal > 2 x 108/ recipient kg) and requested goal, complications during the procedure, sterility and viability of collected product, and recipient engraftment. Nineteen metrics are validated with each collection. Goals for each metric were previously determined and used as measures of success. Results: We met our metric goals from for this period except for the following: achieving the requested TNC dose, the minimum collected TNC dose, and complications. In 87% of BMH, the requested TNC goal was not achieved with requests ranging from 3 - 10 x 108 TNC/recipient kg. Eighty percent of BMH did achieve a TNC dose of at least 2 x 108TNC/ recipient kg. Product viability ranged between 95 - 100%. Severe hypotension (SBP < 70) occurred in 27% of donors and occurred predominantly at the end of collection although the maximum volume threshold was not surpassed. In all cases, hypotension was reversible following intervention; no donor required hospital admission. All products were sterile and of the 4 related recipients, 100% engrafted. Discussion: Operating room process changes have been implemented with the pre-collection time out to assure that all team members are aware of the estimated collection volume and systolic blood pressure goal of >70. Further analysis of our results is underway to determine if other changes are necessary to improve cell dose collections. With the program’s increased use of haploidentical donors, we expect our harvest collection numbers to increase; thus, stressing the need to continually evaluate our processes to ensure donor safety and optimal cell dose collection.
486 Development of Care Pathway to Ensure Timely and Appropriate Re-Vaccination in Pediatric Survivors of Stem Cell Transplant (SCT) Jerry C. Cheng 1, Andrew Sy 2, Sylvia Reyes-Hatfield 3. 1 Pediatrics, Southern California Permanente Medical Group, Los Angeles, CA; 2 Pediatrics, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA; 3 Pediatrics, Kaiser Permanente, Los Angeles, CA Background: Patients undergoing hematopoietic stem cell transplants are known to have declining levels of antibodies to vaccine-preventable diseases. This is principally important in the pediatric population as exposure to vaccinepreventable diseases occur daily in daycare and school settings. For those eligible, re-vaccination provides a reprieve from use of IVIG and prophylactic antibiotics. However, in a community based setting, barriers to complete revaccination, such as, primary care providers’ reluctance, lack of patient compliance and parental hesitancy to vaccinate in current cultural climate, are present. Using the CDC recommended re-vaccination schedule, we report a communitybased model of re-vaccination utilizing the EPIC EMR and a case manager run database to deliver efficient population care management to address this care gap.
Methods: We performed a retrospective review of revaccination efforts in pediatric post-BMT survivors. Inclusion criteria were patients must be 0-18 year old, currently living and at least 2 years post stem cell transplant. Exclusion criteria were patients on high dose immunosuppressants or active chemotherapy or patients with documented active graft-versus host disease. Patients with incomplete vaccine profiles were called by an MD, appropriately counseled, their electronic medical records updated to reflect the need for revaccination and vaccination status tracked using a centralized database. Results: Initial rate for complete revaccination for all transplant recipients was 5%. Of the 57 total patients at least 2 years post BMT, 16 were post-autologous BMT (0% completed revaccination) and 41 patients were post-allogeneic BMT (7% completed revaccination). However ~30% of patients could complete re-vaccination with 1 visit. Four months after presenting this data our regional transplant coordinator and various PCPs, rates of complete revaccination increased by three fold to ~14% and almost four fold ~18% if those refusing only HPV are included. Two patients initially included were excluded after one relapsed and one transferred care to another institution. Conclusions: We propose that by employing a case manager database to notify families of re-vaccination and amending EMR problem lists, we can analyze those eligible for revaccination, equip primary care providers with re-vaccination schedules and ultimately improve revaccination rates in this at-risk population. Our rates of re-vaccination for patients post-autologous BMT are likely due to our practice of checking titers to verify immunization status prior to proceeding with re-vaccination. A vast majority are found to be nonimmune and highlights the need for all patients post-BMT to receive immunizations. At the time of this submission, we are in the process of addending EMR and contacting patients; full analysis of data to be completed in May of 2017.
487 Engraftment and Outcomes Analysis Elizabeth J. Williams 1, Michelle Hudspeth 2. 1 Blood and Marrow Transplant Program, Medical University of South Carolina, Charleston, SC; 2 Pediatric Hematology/Oncology, Medical University of South Carolina, Charleston, SC Background: Analysis of Engraftment and other outcomes in Blood and Marrow Transplant (BMT) patients is critical to generate evidence, detect trends, allow early intervention and track progress related to changes in treatment. Additionally, the outcomes data are closely reviewed by payors as the industry shifts the focus to quality metrics when determining transplant center certification status and reimbursement. The BME (bone marrow engraftment) Scorecard is a snapshot of BMT patients and their BME trends using a readily available Microsoft Access format. Methods: A BME scorecard (Figure 1) was introduced for quarterly review at the BMT Quality Management Meeting. The following metrics were determined to be most valuable when evaluating the trends in engraftment (reference FACT standards B4.7-10.0):
• • • • •
Diagnosis Type and Subtype of transplant Degree of HLA match Days to neutrophil engraftment (first of three consecutive lab values showing neutrophils ≥.5) Days to platelet engraftment (first day ≥20 after 7 days of platelet transfusion independence)
Abstracts / Biol Blood Marrow Transplant 23 (2017) S18–S391
S351
Figure 1.
• • •
Length of inpatient stay Stem Cell Dose expressed as CD34+ cells per kg, (target dose vs actual dose given) Survival at day 100
A key was created to identify the center’s expected baseline for days to neutrophil and platelet engraftment and was identified for each transplant type (e.g. autologous vs allogeneic and allogeneic related vs unrelated) and included on the scorecard. Patients whose engraftment times were outside of these target days were highlighted. Stem cell dose expressed as CD34+ cells per kg is an important factor in determining rate of and time to engraftment, so we correlated to CD34+ cell dose. Appendices were later added to the scorecard including: unrealized endpoints and quarterly mortality review. Results: The BME score card is a structured, readable snapshot of the transplant experience highlighting trends and providing critical information for clinical staff, regulators, administrators, and payors. Using an already available Microsoft Access platform allowed for data structuring, complex queries, automation of common events and database management with multiple users. Changes in practice made after reviewing trends on the engraftment score card included refining patient selection criteria, use of the HCT co-morbidity score, and patient discharge guidelines. The score card has greatly enhanced our ability to readily visualize the outcomes of our patients through pro-active review and enabled systematic evaluation and improvement of the quality of care.
NPS/PAS—ADVANCED PRACTICE PROFESSIONALS (FOR CLINICAL EDUCATION CONFERENCE)
488 Guidelines with Intent to Achieve Minimal Level of Sedation for Bone Marrow Aspirate and Biopsy Linda K. Baer 1, Brenda Cooper 2. 1 Adult Hematologic Malignancies & Stem Cell Transplant Section, Seidman Cancer Center, University Hospitals Cleveland Medical Center, Cleveland, OH; 2 Division of Hematology & Oncology, Seidman Cancer Center, University Hospitals Cleveland Medical Center; Case Wester Reserve University, Cleveland, OH Pain associated with bone marrow biopsy is not negligible. In addition to local anesthetic, a sedative and a narcotic have often been used to facilitate patient comfort resulting in a variable level of sedation. At our institution, a specific policy is in place when moderate or deep sedation is intended to facilitate the performance of a procedure. However, premedi-
cation with intent to achieve minimal sedation is not clearly defined. The purpose of this project was to establish guidelines for premedication for bone marrow biopsy. A search in PubMed/Embase databases resulted in 18 articles that revealed variable practices with local anesthetic along with systemic sedation prior to bone marrow biopsy. Although the majority of patients are able to undergo this procedure with local anesthetic alone, it may be necessary to discuss premedication with a sedative for treatment of anxiety or narcotic for treatment of pain. If local anesthetic is insufficient to complete this procedure, sedation with intent to achieve minimal sedation is recommended and appropriate for a bedside procedure. Some studies indicate no change in perception of pain with or without additional premedication. It is appropriate for the Advanced Practice Professional (APP) to evaluate the patient for use of minimal sedation. Minimal sedation is generally accomplished using one class of medications such as lorazepam, which is preferred, due to its short duration of action with anxiolytic, sedative, and amnesic properties. An alternative option is a short acting opioid narcotic. A new policy was created outlining minimal sedation procedure for bone marrow biopsy with a single agent to ensure safety and comfort. Additional monitoring under anesthesia is required for moderate to deep sedation. The APPs were instructed on this new policy. A 3-month follow up APP survey along with a chart audit of 20 patients is planned to confirm satisfaction and adherence.
QUALITY AND TRANSPLANT PROGRAM ADMINISTRATION (FOR ADMINISTRATIVE DIRECTOR SIG CONFERENCE)
489 Implementation of a Program Assessment Across a Network of 7 HCT Programs to Assess Risks Associated with Clinical Outcome Based on the 2015 Center for International Blood and Marrow Transplant Research (CIBMTR) Transplant Center-Specific Survival Report Rocky Billups 1, Laura Ione Brougher 2, Tonya Cox 2, Therese Dodd 3, Betsy Blunk 2, Charles F. LeMaistre 1. 1 Sarah Cannon, Nashville, TN; 2 Blood Cancer Network, Sarah Cannon, Denver, CO; 3 Global Quality and Education, Sarah Cannon, Nashville, TN Background: In 2006 the CIBMTR was awarded a contract from HRSA to administer the Stem Cell Therapeutic Outcomes Database of the C.W. Bill Young Cell Transplantation Program. A risk-adjusted one-year survival rate is calculated by CIBMTR for each center in the U.S., based on results