TECHNICAL SERVICES Trouble-Shooting And Performance Review FISCAL YEAR 2012

Prepared March, 2011

Mid-South Blood Services Upper Ouachita Region 5432 West Elm Street Little Rock, Arkansas 72204
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Table of Contents I. II. III. IV. V. Executive Summary Department Overview Strengths, Weaknesses, Opportunities, and Threats Goals and Objectives Summary

Page 3 4 4 5 6

I.

Executive Summary

The Mid-South Blood Services Technical Services Department consists of several functional areas located in the main facility at Little Rock, Arkansas. The areas are designated as Reference Laboratory, Quality Control Laboratory, Component Manufacturing Laboratory, and Quarantine and Labeling. They work together as a collective unit to process blood or blood products and provide clinical services to our hospital customers. Technical Services is commonly referred to as the Laboratory. The Technical Services Trouble-Shooting and Performance Review for fiscal year 2012 will focus on assessing quality products and services to our internal as well as external customers and training of existing staff to remain compliant to reduce our deviations and make our areas more efficient and quality focused. By taking a proactive approach to improving quality and efficiency, Technical Services of the Mid-South Blood Services will remain a leader in providing safe blood products and related healthcare services.

II.

Departmental Overview

Component Manufacturing/Sample Management: This area provides almost seven-day, twenty-four-hour coverage for the performance of component processing and sample management. Responsibilities include making sure that timelines are met for the production of leukoreduced red cells by the in-line and sterile connection method, buffy coats, fresh frozen plasma, and recovered plasma for further manufacturing. Donor sample tubes are packed and prepared for shipment. Sample management must meet Hospital Services courier or Little Rock airline schedules to initiate the process of obtaining test results from the National Testing Laboratory and the National Genome Testing Laboratory in St. Louis, MO. This department assists in the continuous monitoring of the BACT/Alert system that is used for bacterial detection for apherisis collections. Quarantine and Labeling: Quarantine and Labeling area coordinates the activities of Component Manufacturing to ensure that blood products are released to Hospital Services in a timely manner in order to meet the needs of our customers. This section also addresses special customer needs related to CMV negative, sickle tested, and leuko-reduced products. Quarantine and Labeling performs all activities associated with interpreting test results, placing components in the correct disposition based on these results, labeling components, and plasma fractionation, meeting a weekly shipping schedule for the further manufacture of plasma into injectable and non-injectable plasma products. This department also assists in the continuous monitoring of the BACT/Alert system that is used for bacterial detection for apheresis collections. Reference Laboratory: The Reference Laboratory performs basic and extensive red cell serology for all hospitals served by Mid-South Blood Services. Consultation services are provided twenty-four hours a day through a rotated on-call process. Reference Laboratory staff are trained in component manufacturing and quarantine and labeling activities in order to facilitate the emergency release of granulocyte products (Buffy Coats or Granulocyte apheresis) and the routine release of platelets apheresis units. The Reference laboratory freezes and deglycerolizes blood.

Quality Control Laboratory: Quality Control Laboratory is responsible for tracking, trending and monitoring component quality and equipment performance and would control all Technical Services quality control activities, assuring continued compliance with the quality control BSDs. This laboratory is also responsible for coordinating all our proficiency testing and performs testing on 100% of our apheresis products through instrument analysis as well as determining the quality of products by microscopic analysis. This department also has the challenge of testing 100% of our apheresis products of bacterial detection. A major task for this department will be the adding a statistical process control system which will be used to assist in tracking and trending of quality control data.

III. Strengths:

Strengths, Weaknesses, Opportunities and Threats:

Dedicated management staff are driven for the success of the operation Supervisory staffing requirements are met throughout the department Reference Laboratory is customer focused and well respected by customer base Department responds well to the challenges of ARC national policy changes Line staff is willing to go the extra mile to ensure departmental goals and objectives Plasma yields are among Areas highest Weaknesses: Communication with other departments needs improvement General staffing concerns for 24 hour/day, 7 days/week in Reference Lab Supervisory Review Scarcity of qualified reference medical technologist/medical technologist for hire in Little Rock area Need for Technical Support area in the department that would be used to assist in document control, SPC, and training new staff Opportunities: Communication between areas within the Department Overall work quality and productivity of general staff High amount of discards during the manufacturing process

Threats: Difficulty of hiring medical technologists due to qualification requirements and competition from local hospitals Inability of the department to emphasize that administrative tasks are as important as operational tasks (i.e. timeliness of reports, forms, compliance statements)

IV.

Goals and Objectives

Continue to operate in compliance, as reflected by zero FDA, QRA or AABB observations Have zero lost products

Maximize production Maintain expenses at or below budget Generate revenue wherever possible 1) Better Compliance for Department Technical Services plans to lower the number of problems and have better compliance within the department. We intend to do this by better training and instilling a quality-first attitude. Ensuring that supervisors are adequately self-reporting problems will show that the department catches problems prior to outside review by Quality Control or any other auditing body. This includes emphasizing to each supervisor the importance of meeting timelines for projects and training and BSL implementation. Technical Services will focus on all administrative tasks in order to maintain timelines. 2) Create Technical Support Department It has been observed by the TS manager that regions within our division have technical support departments that oversee document control, change control, training, problem management, and BSL implementation. This area will be used to guarantee timelines is met and will remove some tedious tasks from operations. 3) Control Statistical Process This area will complete the validation of Microsoft Excel for statistical process of control of QC data. 4) Analyze Market for Medical Technologists The laboratory manager and the human resources manager will coordinate a local job market analysis targeting medical technologists. The goals of the proposal are to hire qualified, experienced staff and reduce medical technologist turnover.

5) Initiate 24 hour/day, 7 days/week Supervisory Review for Reference Lab Due to mandates from our National organization, we will be initiating a plan to provide supervisory reviews prior to release of blood products from Reference Lab. This will present a challenge due to the fact that only the TS manager and Reference Lab supervisor provide this type of review. 6) Decrease the Number of Disposal of Blood Components This goal is to reduce the number of discards that are incurred during the manufacturing process. Management will stress to the staff good manufacturing practices to lessen the possibility of errors and focus during the manufacturing process. Also, with the initiation of Triglyceride testing we anticipate less discards due to unsuitable samples 7) Participation in the PALL RC2D Blood Collection Set Trial In an effort to improve productivity and compliance and maintain the regions plasma yields, Technical Services plans to implement the trial of PALL RC2D blood collection set which will prevent the need to filter our blood using a sterile connecting device and a sterile dockable filter set. This will also assist in maintaining compliance and will lessen the possibility of sterile docking errors.

V.

Summary

A continued focus on improving quality blood products and providing exceptional customer service is essential for the Technical Services Department to help the Upper Ouachita region achieve the Mid-South Blood Services vision of being a financially viable provider of quality blood products and health care services. The means for measuring the success of the various goals are either already in place, such as the deviation and customer contact system, or will be developed to monitor the progress. We trust that quality and customer drive will be enhanced this year by recognizing and influencing opportunities for improvement.