Total Quality Management in Blood Banks: A Case Study Analysis

This case study examines the challenges faced by a newly promoted Center Quality Manager (CQM) in a blood bank setting, focusing on issues such as inadequate staffing, lack of coordination between the general manager and quality assurance, deviations from standard operating procedures (SOPs), and mislabeling of products. The analysis identifies key concerns, including the lack of experience in leading personnel, insufficient staff training, high error rates, and non-compliance with established protocols. To address these issues, the study proposes a comprehensive strategy based on general provisions such as organization and personnel management, plant and facility improvements, production and process controls, finished product controls, laboratory controls, and meticulous record-keeping. The strategies emphasize adherence to current good manufacturing practices (GMP), proper equipment maintenance and calibration, sterilization requirements, and the systematic management of suppliers and reagents. The study concludes that implementing these measures will enhance the quality, safety, and compliance of blood bank operations, ensuring the production of safe and effective blood products.

Total quality management
TOTAL QUALITY MANAGEMENT
Name
Department:
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Date

Assumptions
 Blood banks and transfusion services
 Blood and blood components
Introduction
 On the analysis of the case study, the following concerns are imminent.
 Even though Carl has experience as quality control technician, he has no significant
experience in leading or managing other personnel, though he enthusiastically looks
forward to the task.
 Lack of enough staff and trained ones is another primary concern in the improving
the quality of the company.

 Zero correlation between the general manager and quality assurance department.
 Carl notices significant trends in the high error rate, but manager overlooks the
claim suggesting that the process will revert ones the employees are retained.
 Another challenge is DIT not practicing proper standard operating procedures:
trained in screening donors and determining the donor suitability
 Has not been asking all the medical history question of regularly donating donors as
required by the SOP.
 Carl questions the why DIT did not follow the due process; the manager says that
the process will result in time wastage and disruption of events.

 company lacks sufficient staffs.
 vacancy of assistant managers who oversees the policies and regulations are vacant.
 the position of the operations supervisors who manages the donor suitability and
overall medical history is vacant also.
 Another controversial issue is labeling of the products.
 Compliance audit in which the company scores 5.
 breakdown of donor identification and labeling of the plasma bottle.
 Secondly, the current trend of deviation records could be attributed due to
mislabeling. The strategies can be followed to counter the above concerns:

General provisions
 Organization and personnel
 Plant and facilities
 Productions and process controls
 Finished products controls
 Laboratory controls
 Records and reports
 Controls illustrate having responsibility for maintaining the continued safety,
potency, purity, and compliance with applicable products and establishment
standard, and accordance with the current good manufacturing practices.

Organization and workers
 sufficient in number, education, experiences, training or amalgamation to ensure the
products are safe, potent, pure, active and maintaining distinctiveness.
Plants and facilities
 Hygienic and tidy
 Appropriate size, construction, location to enable maintenance, washing, and
operations
 Details related to space: donor privacy, exposure of equipment
 Space to store in an logical manner secluded products discrete from the complete
products (Chryssolouris 2013, pp. 33).

Equipment
 The type of equipment: used in the collection, processing, compatibility, testing,
storage, and distribution (Chryssolouris 2013, pp.35).
 Clean and orderly
 Observed, standardized and calibrated on a schedule as prescribed in the standard
operating procedures
 Use it as it was intended.
 CFR provides a few examples of types of equipment

According to the CFR
 Apparatus performance checks at well-defined frequent such as comparing against a
thermometer each day of using
 Calibration at a definite frequency such as everyone months.
 However, the manufacture’s manual supersede CFR requirement (Chryssolouris
2013, pp. 39).

Additional sterilization requirement
 Materials used for assortment
 Discarding of unclean materials
 The efficiency of the sterilization process shall be no less than that accomplished by
an attained temperature of 121.5C maintained for 20 minutes by saturated steam or
by a reached temperature kept at 100C with dry heat (Klein and Anstee 2014,
pp. 17).

Suppliers and reagents
 Stores safely and systematic
 Exteriors that come in contact with products should be pyrogenic-free, disinfected
 Inspect the containers that will hold blood.
Reagents
 If the reagents do not have an end, they must be stored such that they are used FIFO
(first in first out)
 Use them according to the manufacturer instructions
 Use dispensable when possible for items that come into contact with blood.

Standard operating procedures
 It gives exemptions for clinical investigation
 Shows what workers should remember in the products requirements
 Remind the staff on what to maintain and follow all steps
 Provides outline

SOP needed
 Donor suitability
 Approaches for donor qualification-acceptable standards
 Planning of phlebotomy site
 Tracking all products to the donor
 Collections trials
 Analysis and replication testing of products
 Pre-transfusion testing counting recipient credentials
 Examination of donor and recipients responses
 Storage controls and temperatures

QC procedure
 Equipment maintenance and calibration: procedures and schedules
 Labeling
 Pheresis- to guarantee re-infusing of donor’s cells
 Preparing plasma including separation, pooling, labeling, and storage
 Scrutinize prior aids
 Review of records
 Investigation of discrepancies
 Expiration dates
 Tracking methods for blood from donor to final disposition,

Good news
 An organization can use currents SOPs such as the manuals of an organization as
long as particular procedures are consistent with and at least as stringent as the
requirement contained in either American national red cross, American association
of blood banks.

Conclusion
 Good manufacturing practice (GMP) is a structure of quality assurance intended at
warranting that produces are steadily manufactured to a quality suitable for the
planned use. It is thus concerned with the quality control and manufacturing
processes and actions.
 Labels indicating status should only be attached by someone authorized by the
quality control. Such names shall be of a form or nature which averts confusion
with any same tags.

 All containers equipment holding intermediate products shall be labeled
appropriately to identify the material and stage of processing. Before applying the
label, all unsuitable tags previous applied shall be removed entirely or crossed.
 Personnel are essential in the day to day running of the business. Therefore, the
company should employee more workers, train, and retains experienced workers to
avoid a turnover.

References
Chryssolouris, G., 2013. Manufacturing systems: theory and practice.
Springer Science & Business Media, pp.32-48.
Klein, H.G. and Anstee, D.J., 2014. Mollison's blood transfusion in clinical
medicine. John Wiley & Sons, pp. 15-25.