Spectra Optia Apheresis System Bone Marrow Processing Instructor Handbook

CONTENTS 1.

Spectra Optia Apheresis System Bone Marrow Processing (BMP) Procedure Training Checklist

2.

Spectra Optia Apheresis System BMP Training Presentation

3.

Spectra Optia Apheresis System IDL Set Diagram

4.

Spectra Optia Apheresis System BMP Accessory Set Diagram

5.

Spectra Optia Apheresis System BMP Flow Path and Interface

6.

Spectra Optia Apheresis System BMP Quiz Answers

7.

Spectra Optia Apheresis System SOP: BMP Procedure

8.

Spectra Optia Apheresis System Sample Validation: BMP Procedure

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Spectra Optia Apheresis System Bone Marrow Processing (BMP) Procedure Training Checklist Student

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Instructor

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Date(s) Institution NOTE: This document serves only as a record that a training session was provided on the date(s) noted. A checkmark next to a topic in the list below indicates that the instructor discussed the topic during the training session. The signatures above indicate that the student was present when the instructor discussed the topic. This document cannot be used to confirm that the student is trained, or as a certificate of competency. Instructor: Indicate all materials used during this session, including the version number, if applicable.

Equipment

Version

Spectra Optia Apheresis System Spectra Optia System IDL Set Spectra Optia System BMP Accessory Set

Training Tools and Materials

Part Number

Spectra Optia System Essentials Guide Spectra Optia System BMP Procedure Guide Spectra Optia System BMP Procedure Training Presentation (handout version) Spectra Optia System BMP Laminated Flow Path Spectra Optia System Channel Loading Guidelines

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Spectra Optia System BMP Training Checklist

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Topics 1. Confirm that the student has completed the Essential Principles Training Checklist.

Introduction 1. Explain the parts and use of the IDL set. 2. Explain the use of the components of the BMP accessory set. 3. Explain the basic principles of the procedure, including the BMP flow path. 4. Explain how the automated interface management system (AIM) controls the collection.

Preparing to Perform Procedure 1. Explain the options for transferring the bone marrow into the BMP bag: •

Via the spikes

•

Via the luer connectors

2. Explain the configuration parameters on the BMP configuration screen. 3. Demonstrate configuring the system for plasma collection. Describe the options for connecting the accessory plasma bag. 4. Demonstrate how to load the IDL set in the proper sequence using the Essentials Guide, the Channel Loading Guidelines, and the instructions on the screen. •

Demonstrate how to load the channel; discuss the critical elements to look for (notch at the base of the locking pin is visible, centrifuge collar position, optical reference is visible, and the connector sits flush with the groove in the channel)

•

Explain the importance of inspecting the tubing for kinks before loading the set, and avoiding kinking, or otherwise obstructing fluid flow, after loading the set

5. Discuss data entry and the importance of entering accurate BM data. 6. Discuss the values on the run values screen: •

Bone Marrow Volume (BMV) processed (mL)

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BM cycles

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Inlet flow rate

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Collect flow rate

7. Review the correct sequence for connecting the BMP bag to the IDL set and priming the inlet line.

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Topics

Monitoring the Run 1. Discuss the run states: •

Diverting prime saline

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Filling channel

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Establishing initial interface

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Collecting MNC

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Re-establishing interface

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Collecting plasma (optional)

2. Explain the information on the main run screen and how to change procedure parameters. 3. Explain the information on the collection status screen and the options available on this screen: •

Collection preference: trend graph, image, value, graphic

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Collect into Bag, and Return to BMP Bag buttons

4. Discuss what to look for in the connector: •

Collect port

•

Interface

5. Explain how to assess the collect line appearance.

Completing the Run 1. Discuss the run targets attained screen and explain how to do the following: •

Extend the run

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Collect plasma

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Proceed to rinseback and disconnect

2. Explain the importance of periodically mixing the contents of the BMP bag during the run. 3. Discuss sealing and removing the plasma and collection bags before starting rinseback. 4. Explain each value on the procedure summary screen.

Making Changes 1. Discuss values for BM data you may update and why. 2. Explain how to use the information on the alarm history screen. 3. Demonstrate how to access procedure reports and review the information on the report. 4. Review the information and functions on the collection status screen.

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Topics 5. Demonstrate how to use the strobe. 6. Explain how the appearance of the run values screen changes if you change a run value. 7. Demonstrate how to initiate plasma collection during the run using the options screen. 8. Review how to use the values on the run targets screen to change a target or review the current status of the run.

Troubleshooting 1. Discuss how to respond to the warning: “The RBC volume in the BMP bag is less than the minimum required volume of 125 mL.” 2. Explain why the contents in the collect line may look light. 3. Explain why the contents in the collect line may look dark. 4. Discuss how to determine if there is a clump or clot at the collect port and how to eliminate it. 5. Discuss the alarms: •

“Centrifuge pressure exceeded limit”

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“Return pressure was too high”

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“AIM system did not detect interface”

6. Briefly discuss using Semi-Automatic mode (refer to the BMP Procedure Guide): •

AIM system is enabled

•

AIM system is disabled

Comments:

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Training Presentation

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Training Presentation

• This presentation is designed to help train Spectra Optia system operators to perform a bone marrow processing procedure. • Before beginning this training, please complete the Spectra Optia system Essential Principles training and read the Spectra Optia Apheresis System Bone Marrow Processing (BMP) Procedure Guide. • The procedure guides supersede all information in this presentation, including the speaker’s notes. The trainer is responsible for understanding the operation of the Spectra Optia system and for ensuring the proper training of users. Prior to performing a procedure using the Spectra Optia system, the user must read and understand the information in the Spectra Optia Apheresis System Essentials Guide and the applicable procedure guide.

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The bone marrow processing procedure requires the use of the IDL Set and the standard filler. This is unique to BMP procedures. Use the tubing set diagram to highlight the following components: 1. Replace line: Used to carry replacement fluid from the replacement fluid container to the reservoir. In BMP procedures, this line is used to connect a plasma bag for plasma collection. • Frangible connector: The tubing must be bent back and forth to completely break the frangible connector and open the fluid pathway. 2. Collection bag: • Spike port to accommodate the addition of bags. • The two sample bulbs allow sampling of the collected product during or after the procedure. Lines to the bulbs should be sealed before the bulb is removed to help maintain the functionally closed system. • Additional anticoagulant (AC) can be injected into the collection bag through the sterile barrier filter. 3. Connector: Serves as the site of blood separation, as well as the site where the separated blood components exit the channel. 4. Cassette: Contributes to the ease of loading the tubing set. 5. Colored spikes and tubing: Allows quick and easy identification of the lines so that the AC container and the saline container are spiked with the correct spikes. • The sterile barrier filters on the lines help maintain the functionally closed system. 6. AC check valve: Prevents the free-flow of AC through the tubing when the cassette is in the raised position (not used in BMP procedures). 7. Colored clamps: Aid in quickly identifying the clamps on the inlet and the return lines. 8. Diversion bag: Used to capture a skin plug after performing a peripheral venipuncture, or used to collect a blood sample. The diversion bag may be sealed and removed if it will not be used.

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• This diagram displays the flow path of the different fluids through the cassette of the IDL Set. • You should know the flow path of the different fluids and blood components during the procedure. Note: The AC line and the RBC detector are not used in the BMP procedure.

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1. The bone marrow (anticoagulated) is continuously pumped through the set. 2. The inlet pump pumps the bone marrow through the inlet line into the channel. The buffy coat is separated from the RBC and plasma in the connector. • The RBC are continuously pushed through the RBC line and to the reservoir. 3. The AIM system controls the plasma pump flow rate. Plasma is pumped to the reservoir or to the plasma bag. 4. The collect pump pumps the buffy coat from the channel into the collection bag. At the beginning of the procedure the collect valve is in the return position. As soon as cells are detected in the collect port, the collect valve moves to the collect position and the cells are pumped into the collection bag.

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• Separation of the bone marrow occurs in the channel. Based on the specific gravity of the cells, centrifugal force separates the buffy coat from the RBC in the connector. • The collect pump pumps the cells from the connector into the collection bag. • Plasma is pumped from the connector to the reservoir. • The RBC are continuously pushed out of the connector to the reservoir. • The operator can set the collection preference to collect light or dark from the buffy coat. The AIM system controls the collection according to that setting. 1. The AIM system monitors the concentration of cells, or swirl of the blood, in the collect port. The AIM system controls the plasma pump flow rate to manage the interface position by monitoring the concentration of cells in the collect port. 2. When the AIM system detects cells in the collect port the system moves the collect valve to the collect position. Note: If the operator moves the collect valve from the collect position to the return position at any point during the run, the operator must subsequently move the valve back to the collect position to resume collecting cells. The system will no longer automatically control the position of the valve. While the collect valve is in the return position the system operates in Caution status.

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Collection Preference: • There is no unit of measure for this number. This number is used for comparison purposes only. • This is a fine control to set the depth at which the cells are collected from within the buffy coat layer. • It determines the concentration of cells that flow through the collect port. This affects how light or how dark the collection will be. • This has a default setting, but may be changed during the run to meet the unique conditions of each procedure. Notes: A higher collection preference results in a collection from higher within the buffy coat, resulting in: • A lower concentration of cells flowing through the collect port. • The contents of the collect line looking lighter. A lower collection preference results in a collection from lower within the buffy coat, resulting in: • A higher concentration of cells flowing through the collect port. • The contents of the collect line looking darker. If you enter a low number, the system pumps more RBC into the collection bag along with the MNC.

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The BMP Accessory Set is used to facilitate the flow of the bone marrow into and out of the Spectra Optia system. The set includes the following components: 1. BMP bag: Holds the bone marrow during the processing procedure. 2. Plasma bag: Optional bag for plasma collection (if plasma will be used in laboratory processing): • Ports: Provide insertion points for the spikes on the replace line of the tubing set. • Line: Used to connect the plasma bag to the replace line of the tubing set if a sterile connection method is used. • Clamp (blue): Used to clamp the line to the bag. 3. Return line: Used to carry fluid from the tubing set reservoir to the BMP bag. 4. Administration line: Used to transfer bone marrow into the accessory set; this includes: • Spikes: Used to spike the transfer bag. • Clamps: Used to clamp the lines to the spikes. • Filter (200 micron): Used for additional filtration of the bone marrow, if desired. 5. Luer connector assembly: Used to transfer bone marrow from the transfer bag(s) into the accessory set. 6. Inlet line: Used to carry the bone marrow from the BMP bag to the tubing set channel for processing. 7. Sample bulb assembly: Allows sampling of the bone marrow before or during the procedure; this includes: • Sample bulb with sampling port: Used to obtain a sample of the bone marrow. • Clamp (white): Used to clamp the line to the sample bulb.

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All devices in the facility should be configured the same way and should be configured according to the facility’s standard operating procedures.

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Before the bone marrow can be processed on the Spectra Optia system, it must be properly prepared for processing. • Filtering: The bone marrow should be filtered to remove bone chips, debris, or clots. Follow your facility’s Standard Operating Procedure (SOP) for filtering the bone marrow. • Anticoagulant addition: Add ACD-A to the bone marrow at a ratio of 1:10. This may be done in the operating room immediately following the bone marrow harvest. • The bone marrow is then transferred to the BMP bag via the administration line of the BMP bag, using either the spikes or the luer connectors. Note: ACD-A must be added to the bone marrow prior to processing. Therefore, no AC will be used during a BMP procedure. For more detailed instructions, refer to the BMP Procedure Guide.

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• Transfer the bone marrow into the BMP bag. This may be done via the spikes or via the luer connectors. • You will need to determine the total volume and hematocrit of the bone marrow prior to processing. The hematocrit is most accurate when taken from a pooled bone marrow (if more than one bag of bone marrow is transferred to the BMP bag). Note: A minimum of 125 mL of RBC is required for the BMP procedure (for appropriate cell separation). If the RBC volume is less than 125mL, you will need to add patient-compatible, leukoreduced, irradiated, CMV-negative RBC to the bone marrow before processing. Note: For detailed instructions on connecting and transferring the bone marrow, refer to the BMP Procedure Guide.

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• You may access the BMP-specific configuration screens after you select the BMP procedure. • On this screen you can configure procedure-specific parameters that the system uses to calculate the initial run values for the procedure. • You may change these values on the run screens to optimize each procedure. • You must touch Confirm to save the settings. • Collect plasma: If you intend to collect plasma during all (or most) BMP procedures, you can configure the system to collect plasma by selecting Yes. The Spectra Optia system will determine the optimal plasma volume to collect based on the bone marrow volume and hematocrit. This setting can be changed by the operator during the run. • Inlet flow rate (mL/min): Inlet pump flow rate. Rate represents the maximum inlet pump flow rate at the start of the run. • Pressure alarm limit (mmHg): The limit at which an inlet pressure alarm or a return pressure alarm occurs. These are the only settings you can change on this screen during the run.

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