Readiness Tip # 7. Guidelines for Prophylactic Intravenous Immunoglobulin (IVIG) in Pediatric Hematopoietic Stem Cell Transplantation

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1 Readiness Tip # 7 Guidelines for Prophylactic Intravenous Immunoglobulin (IVIG) in Pediatric Hematopoietic Stem Cell Transplantation Who should receive IVIg? All immunodeficiency patients can receive IVIg every 3-4weeks post HSCT except those with phagocytic defect such as CGD and LAD. How frequent IgG level must be checked? On admission and monthly for recipients at high risk for infection such as: Allogeneic HCT from cord blood, matched unrelated or mismatched particularly with haploidentical donors Grade III IV acute GVHD or extensive chronic GVHD Extensive pre HCT immunosuppressive therapy (e.g. fludarabine, clofaribine) Prolonged pre-transplant neutropenia, or pre-transplant infection Post-HCT immunosuppressive therapy, in particular with corticosteroids, anti-thymocyte globulin and alemtuzumab Delayed neutrophil engraftment/non-engraftment Second HCT What IgG level required IVIg administration? If IgG level is <400mg/dl, IVIg shall be given as 500 mg/kg. Question 4: When IVIg should be started pre HSCT, if indicated? Should be initiated on day -1 to avoid risk for VOD 1 Reference: Guidelines for Prophylactic Intravenous Immunoglobulin in Pediatric Hematopoietic Stem Cell Transplantation, Internal Memo: PSCT-ONC: , 02 July 2012

2 Readiness Tip # 6 Hepatic Veno-Occlusive Disease (VOD): Diagnosis and Management What is the definition of VOD? It is the term used to designate the symptoms and signs that appear early after Hematopoietic Stem Cell Transplantation (HSCT) as a sequences of conditioning regimen related hepatic toxicity. It is characterized by jaundice, fluid retention and tender hepatomegaly appearing in the first days after HSCT. Classical VOD: it occurs several days after conditioning (from -1 to +21, there is presence of jaundice, hepatomegaly and/or right upper quadrant pain and weight gain. Late VOD: This shows the same clinical manifestations as classical VOD but develop late after HSCT. What is the first line therapy for symptomatic VOD? Restriction of salt and water intake ±diuretics Maintain intravascular volume and renal perfusion by means of albumin, plasma expanders and transfusions (Hematocrit>30%) What are the risk factors of VOD? See attached table. 1 Reference: Hepatic Veno-Occlusive Disease (VOD): Diagnosis and Management, IPP# MCO- MD-ONC , November 2012

3 Risk factors for Hepatic Veno Occlusive Disease (VOD) Risk Factors for VOD Transplant type Donor Type HLA compatibility Stem cell origin T-cell depletion (TCD) Diagnosis Status of the disease Conditioning: Intensity TBI Busulfan(Bu) Timing Lower risk<high risk Syngeneic or autologous<allogeneic Sibling<another relative<unrelated HLA match<any mismatch Peripheral blood<bone marrow With TCD<without TCD Non-malignant disease<malignant disease Remission<relapse Cy alone<cy+tbi<bvc (BCNU,VP,CY) Fractionated TBI<single dose Less than 12 Gy<more than 12 Gy Low dose rate <high dose rate IV Bu<adjusted oral Bu<non adjusted oral Bu Interval Cy-TBI 36 hours<12hours Younger<older/men<women Age/Sex Karnofsky index <lower than 90 ASAT/ALAT before HSCT Normal<high Transplant number First<second Previous hepatic irradiation No<yes Previous Mylotarg No<yes (incidence of VOD up to 64%) Status of the liver Norma<fibrosis<cirrhosis or infiltration CMV serology status Negative<positive Fever in conditioning Absent<present Hepatotoxic drugs Progestogens, ketoconazole, CSA, methotrexate, amphotericin B, vancomycin, acyclovir, IV Ig, Genetic Predisposing GSTM1 positive<gstm1 null genotype The most important risk factors are indicated in bold type 2 Reference: Hepatic Veno-Occlusive Disease (VOD): Diagnosis and Management, IPP# MCO- MD-ONC , November 2012

4 Readiness Tip # 5 Hematopoietic Progenitor Stem Cells- Tracking Forms Who is responsible for initiating the tracking forms? The form will be initiated by the department staff who is issuing and dispensing the product: 1. Fresh HPC-Apharesis product: form will be initialed by Apharesis nurse 2. Fresh HPC-Marrow product: form will be initialed by OR nurse 3. Frozen HPC product: form will be initialed by the collection facility based on product type except for HPC cord and products leftover, the form will be initiated by the Stem Cell Processing Lab What is the nursing responsibility regarding the tracking forms? 1. The nurse responsible for the infusion should return a copy of the form to the Stem Cell processing Lab and original to the patient s chart (Donor) if donor and recipient are on the same units at the same time of the product s infusion, otherwise the form shall be send to medical record for filing. 2. The nurse to ensure that physician was informed about any product s contamination and must date and sign in the required place The appropriate completion of the form: 1. The form is to travel from collection facility to the BMT Unit and must be signed at each 2. All required boxes shall be filled by the responsible personals 3. All boxes under ACTION DONE should be filled with date, time, and signature as needed Page 1 of 2

5 Materials: 1. Cryopreserved HPC Tracking - Transportation of Product (HPC Apheresis ) from the Apheresis Unit to BMT Unit via Processing Lab, From (05-32) 2. Fresh HPC Tracking - Transportation of Product(HPC Apheresis ) from the Apheresis Unit to BMT Unit via Processing Lab& Blood bank, Form (05-32) 3. Cryopreserved T-Cells Tracking- Transportation of Product (Donor T- cells) from the Apheresis Unit to BMT Clinic/Unit via Processing Lab, Form (05-32) 4. Fresh T-Cells Tracking- Transportation of Product ( Donor T cells) from the Apheresis Unit to BMT Clinic/Unit via Blood Bank, Form (05-32) 5. Fresh HPC Tracking - Transportation of Product(HP-Marrow) from the Operating Room to BMT Unit via Stem Cell Processing Lab and Blood Bank, Form (05-32) 6. Cryopreserved HPC Tracking- Transportation of Product (HPC Marrow) from Operating Room to BMT Unit via Processing Lab, Form (05-32) 7. Cryopreserved Hematopoietic Progenitor Stem Cells (HPC) Tracking Transportation of Product from the Stem Cell Processing Lab to BMT Unit, Form (11-32) Reference: Hematopoietic Progenitor Stem Cells- Tracking Forms MCO-MD-ONC Page 2 of 2

6 Readiness Tip # 4 Biological Hematopoietic Stem Cells/ Donor T-Cells Products Deviation- Reporting and Action Plan Define HPC/Donor T-Cells product deviation? It is the deviation from agreed standards, regulations or specifications that relate to the prevention of communicable disease transmission or cellular therapy product contamination, such as Bacterial, Viral and Fungal contamination. What is the difference between Planned and Unplanned Deviation? Planned Deviation: a pre planned amendment to an agreed practice/procedure. Unplanned Deviation: the result of non-compliance with an agreed practice/procedure that may result in a clinical incident. What is the indication of infusing a Hematopoietic Stem Cells/ Donor T- Cells Products with biological deviation? It will be used by the SCT Clinical Program only when the benefit outweighs the risk to the patients and no alternative is available. Question 4: What is the treatment for the microorganism involved? The treatment for the microorganism involved will be made on individual case by case basis. Question 5: In which situation the recipient/guardian shall sign a consent form explaining the infusion of the infected product? In the event of positive culture prior to HPC/Donor T-Cells infusion (planned deviation) Page 1 of 3

7 Question 6: List the procedure to follow in the event of microbial contamination product. A Clinical Incident (SRS) is required for unplanned deviation, to be initiated by the Stem Cell processing lab and to be followed accordingly. The transplant physician and the BMT coordinator are responsible to inform the stem cell processing lab and the collection facilities about the transplant from an infected product for planned deviation. The recipient/guardian shall be notified about the infusion of an infectious product planned deviation A care plan must be discussed with recipient/guardian and a care plan must be documented in the patient s medical record. All Staff are responsible for reporting any deviations to the SCT Quality Manger (QM) as soon as they become aware of them. Question 7: What is the role of The SCT Quality Manger in case of microbial contamination? The SCT Quality Manger (QM) is responsible for: Completing or/and advising staff to ensure that the necessary paper work has been completed. Reporting to the SCT Program Director on regular basis and provide an overview of all deviations and corrective actions outstanding. Maintaining details of all deviations relating to the SCT Program and for the implementation and review of corrective actions. Informing key individuals/departments of deviations. Investigating all unplanned deviation to identify the causes and the need for corrective/preventive actions. Discussing all planned deviations and identifying the need for any subsequent permanent amendments required to procedures A Deviation Form must be completed and signed off by SCT Quality Manager/Designee (Appendix ) Page 2 of 3

8 Reference: Biological Hematopoietic Stem Cells/ Donor T-Cells Products Deviation- Reporting and Action Plan, IPP# MCO-MD-ONC Page 3 of 3

9 Readiness Tip # 3 FACT-JACIE International Standards What is the purpose(s) of FACT-JACIE International Standards? These standards are designed to: Provide minimum guidelines for programs, facilities and individuals performing cell transplantation and therapy support services for such procedure. Promote quality medical and laboratory practice in HPSCT and other therapies using cellular products. To which phases of stem cell process, the FACT-JACIE International Standards are applied? They are applied to all phases of collection, processing, storage and administration of the cells that have derived from marrow or peripheral blood. What are the three types of FACT-JACIE International Standards? 1. Clinical Program Standards 2. Cellular Therapy Product Collection Standards 3. Cellular Therapy Product Processing Standards Reference: JACIE, International Standards for Cellular Therapy Product Collection, Processing and administration, 4 th edition, version 4.3, April 2011

10 Readiness Tip # 2 Circular Information for Cellular Therapy Products Define Circular Information for Cellular Therapy Products. It is referred to a Circular. This Circular is intended to provide general information to those who administered cellular therapy products and serves as an extension and enhancement of the label found on the cellular therapy product Is the Circular Information for Cellular Therapy Products available for the staff? Yes Describe how the Circular is accessible to staff members BMT Quality Shared Folder- SCT Quality Management at KFSH folder Hard copies within each SCT unit, clinic, Blood bank, and Stem Cell/Cord Blood Processing lab I Learn program- JACIE- under references Reference: Circular Information for the Use of Cellular Therapy Products, Revised November, 2009

11 Readiness Tip # 1 Progenitor Stem Cell transplants Nursing competencies What is the document used at KFSH to show that nurse have completed the generic, divisional and unit specific orientation competencies? The Competency Based Orientation Summary is used to document the completion of the generic, divisional and unit specific orientation competencies What tool can be used to determine competency for the unit specific courses/workshop and ongoing education? Competency based check-off can be used to determine competency for the unit specific courses/workshop and ongoing education How do nurses maintain their competencies? Once a nurse completes the check-off for a practice, she/he is considered competent unless proven otherwise. We do have skills review sessions that can be done yearly as part of the education plan, examples: new or update policy, new equipments, low volume, high risk skills and problem prone skills. Reference: ORIENTATION AND PRECEPTOR PROGRAM, IPP# MCO-NA-NAA