CSL Plasma Center Operations Overview

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Questions and Answers

What is your location's center code?

089

What are some examples of controlled forms that are posted in your location?

Emergency procedure, center area cleaning checklists, and hand washing instructions.

What are some examples of uncontrolled documents that are posted in your location?

An example is an evacuation plan and the review process includes management reviewing the UD's no less than annually for accuracy, relevance, and indicate approval with date and initials.

Explain your location's donor recruitment area.

Must identify and post a map/list of zip codes indicating the DRA used by the center. Signup and view all the answers

What constitutes an unacceptable address?

Unacceptable addresses include homeless shelters, hotels for transients, or transient camps. Signup and view all the answers

State where the Center Emergency Contact List is posted.

Where it can be easily seen and found during an emergency situation. Signup and view all the answers

State the medical coverage requirements for processing donors.

Review of medical history and conducting a physical examination. Signup and view all the answers

Explain the purpose of SOPs and Work Instructions and where they can be found in your location.

The purpose of an SOP is that it outlines processes and procedures while a WI provides the action steps to a procedure in order to perform it correctly. Signup and view all the answers

Describe the 3 colored signs that are posted where supplies are stored, explaining what they each mean.

Red: Quarantined, Yellow: Not in use, Green: In use. Signup and view all the answers

What are some examples of biohazard waste items?

Plasma units/samples, blood, and sharp containers. Signup and view all the answers

What must happen when a donor posted is revised?

It must be reviewed first before it is posted. Signup and view all the answers

What are the roles and responsibilities of the center personnel as it pertains to the Quality Program?

They work together with the Assistant Manager and the Associate Director of Operations and Quality to ensure that the center works in a state of compliance with all written procedures, state, federal, and international regulations as applicable. Signup and view all the answers

What are the 3 main objectives of the CSL Plasma Center and explain how they are accomplished?

<ol> <li>Assure the quality is built into the system, not inspected in but done by the quality of the procedures, caliber of our employees, and the effectiveness of the training program. 2. Assure quality systems are regularly monitored to ensure continued effectiveness by the IQASR, audits, trending reports and meetings by QT and MR. 3. Continually improve and enhance quality systems by IQASR, corporate audits, and recommendations from QT's.</li> </ol> Signup and view all the answers

What is the role of the Assistant Manager of Quality?

They are accountable for QA functions with additional responsibilities of training and development. Signup and view all the answers

What is the role of the Compliance Specialist Alternate?

They monitor the center to ensure overall compliance with CSL Procedures. Signup and view all the answers

What is eProgesa and what are some examples of information stored/recorded in the system?

It's a software system that allows donors to self-register and perform the self-administered health history, assessment and evaluation of donor sustainability, information related to unit status, and manage unit distribution. Signup and view all the answers

What are the requirements to reset a password?

Click center administration, click users, click change password, enter current password, enter new password, re-enter new password, and then confirm. Signup and view all the answers

When is it acceptable to shift/tab to correct an entry?

To correct a data error on the previous field. Signup and view all the answers

What is the plasma color that indicates a cell loss?

Pink Signup and view all the answers

What are the donor safety precautions that should be monitored?

No chewing gum, no eating, no drinking, no sunglasses, and no sleeping. Signup and view all the answers

What are the PCS2 aspects that should be monitored?

If it displays a value greater than 250 mls and if it displays the AC amount as less than 250 mls. Signup and view all the answers

What is the donor to staff ratio?

It cannot be less than 1:6. Signup and view all the answers

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Study Notes

CSL Plasma Center Overview

Center code for your location is 089.
Donor recruitment area must be identified with a map of relevant zip codes.

Document Control

Controlled forms include emergency procedures, cleaning checklists, and hand washing instructions.
Uncontrolled documents, like evacuation plans, need annual reviews for accuracy, relevance, and approval documentation.

Address Policies

Unacceptable donor addresses comprise homeless shelters, transient hotels, and camps.

Emergency Preparedness

Center Emergency Contact List should be clearly visible during emergencies.

Medical Processing Requirements

Donor processing includes reviewing medical history and conducting physical examinations.

Standard Operating Procedures (SOPs)

SOPs outline overall processes, while Work Instructions (WIs) detail specific actions for proper execution.

Signage and Waste Management

Color-coded signs indicate supply status:
- Red: Quarantined
- Yellow: Not in use
- Green: In use
Biohazard waste items include plasma units, blood, and sharp containers.

Document Revisions

Any revised donor documents must undergo a review before being posted.

Quality Program Roles

Personnel collaborate with the Assistant Manager and Associate Director to ensure compliance with procedures and regulations.

Quality Objectives

Quality assurance is integrated into systems via procedures and trained personnel.
Continuous monitoring is conducted through audits and reports.
Quality improvement efforts include feedback from quality teams and audits.

Assistant Manager and Compliance Roles

The Assistant Manager of Quality oversees QA functions and focuses on training.
Compliance Specialist Alternate ensures the center adheres to compliance standards.

eProgesa System

eProgesa is a software platform for donor registration and health history management, including unit status and distribution tracking.

Password Management

Password resets require navigating to center administration, selecting user options, and securely changing the password.

Data Entry Protocols

Shifting/tabbing is allowed for correcting previous data entry errors.

Plasma Characteristics

Pink plasma color indicates cell loss, requiring further investigation.

Donor Safety Precautions

Strict guidelines are in place: no chewing gum, eating, drinking, sunglasses, or sleeping allowed during the donation process.

Monitoring Standards

PCS2 should be monitored for specific values, with action taken if exceeding 250 mls or displaying low AC amounts.

Staff-to-Donor Ratio

The center maintains a minimum donor to staff ratio of 1:6 to ensure proper management and safety.

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