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Problem Management Scenario # 3

Problem Management Scenario # 3. September 17,2005. Scenario # 3 A. A patient has <200 ANC 35 days post matched sibling PBPC transplant. The program defines this as a ‘Failure to Engraft’. Dr. Decisive asks the lab if there was something ‘wrong’ with the stem cell product. What do you do?.

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Problem Management Scenario # 3

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  1. Problem Management Scenario # 3 September 17,2005

  2. Scenario # 3 A • A patient has <200 ANC 35 days post matched sibling PBPC transplant. • The program defines this as a ‘Failure to Engraft’. • Dr. Decisive asks the lab if there was something ‘wrong’ with the stem cell product. • What do you do?

  3. General Approach • What type of product is involved? • 361 matched sibling PBPC • Is this a complaint?

  4. Complaint? • No, not according to GTP definition since it is not related to communicable disease. • However, even though this is not a GTP Complaint, an investigation should be performed.

  5. Investigation • Review: • Product record (calculations and processing as per SOP) • Recent transplant engraftment data to determine if there is a trend towards slow/no engraftment • Data from other products collected from patients with the same disease to compare this product’s CD34 and/or cell dose to the other products.

  6. Follow-Up • The investigation should be summarized. • If deviations were discovered they should be handled as per the Deviation Reporting SOP.

  7. Scenario # 3 B • Dr Decisive stops Tina Tech (CTL) in the hall and states that his patient had a fever for 2 days post infusion of ex vivo expanded cord blood cells. • Tina states, “OK, I’ll tell someone.” Two days later she tells another tech, who reports this to the supervisor. • What should you do?

  8. General Approach • What type of product is involved? • 351 ex vivo expanded cells • Is this a complaint?

  9. Complaint? • Yes (211.198), document in complaint file. • Any oral or written complaint regarding possible failure of the product to meet any of its specifications. • Written complaint record should include: Product/patient ID, name of complainant, nature of complaint, and reply to complaint.

  10. Investigation • Review: • Product record • Sterility samples obtained as per SOP? • Process deviations occurred? • Equipment issues/malfunctions? • Reagents were in-date? • Infusion record • Did a reaction occur during the infusion?

  11. Investigation Continued • Review patient blood culture results. • Contact Micro Lab to confirm product sterility results & request a review of their QC/equipment data. • Consider retesting remaining product aliquot. • Contact Infection Control to determine if this is an isolated case.

  12. Follow-Up • Retrain staff on the definition of complaint; report immediately • The investigation results should be summarized. • If deviations were discovered they should be handled as per the Deviation Reporting SOP. • The IND Sponsor should be notified.

  13. Scenario # 3 C • Debbie Disgruntled, a former lab employee, sends an email to the newspaper and alleges ‘poor practices’ in the lab. • The reporter takes no action, but forwards the message to Hospital Administration, who sends it onto you. • What do you do?

  14. General Approach • What type of products are involved? • 351 and 361 products • Is this a complaint?

  15. Complaint? • ‘Poor Practice’…could relate to potential transmission of communicable disease and failure to meet product specifications. • Yes, document in complaint file. • Written complaint record should include: Product/patient ID (N/A), name of complainant, nature of complaint, and reply to complaint.

  16. Investigation • Investigate specific allegations and current practices regarding cGTPs and potential for transmission of communicable diseases. • For 351 products, have QC Unit determine whether an investigation is required under 21 CFR 211.192. • Consider hiring a contractor for an external audit of the laboratory. • Contact hospital Risk Management for guidance.

  17. Follow-Up • The investigation results should be summarized. • If deviations were discovered they should be handled as per the Deviation Reporting SOP.

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