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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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Problem management scenario 3 l.jpg

Problem Management Scenario # 3

September 17,2005


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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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General Approach

  • What type of product is involved?

    • 361 matched sibling PBPC

  • Is this a complaint?


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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.


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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.


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Follow-Up

  • The investigation should be summarized.

    • If deviations were discovered they should be handled as per the Deviation Reporting SOP.


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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?


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General Approach

  • What type of product is involved?

    • 351 ex vivo expanded cells

  • Is this a complaint?


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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.


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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?


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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.


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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.


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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?


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General Approach

  • What type of products are involved?

    • 351 and 361 products

  • Is this a complaint?


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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.


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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.


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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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