Quality Control, Quality Assurance, and Total Quality Management

Introduction

Quality is the key requirement for laboratory services. Constant quality and performance improvement is a management philosophy that is aimed at continuous improvement of the organization’s performance, satisfying customers’ expectations, and providing the best standards of care. Establishing quality is the responsibility of each employee within the hospital. Performance projects are designed to establish and monitor performance standards, enhance and maintain laboratory performance, and analyze data (1). Al Rahba hospital takes care of quality control by organizing a hierarchy of administration and setting high demands for internal and external quality control.

The Organizational Hierarchy of Quality Administration

At Al Rahba hospital, continuous quality improvement is practiced at the intermediate and executive management levels. Such an improvement promotes systematic advancement with the help of the following components:

1. quality control;
2. quality assurance;
3. continuous quality improvement:

   • organization;
   • personnel;
   • assessment;
   • process improvement;
4. quality system management;
5. quality cost management;
6. total quality management.

The Goals of Total Quality Management at Al Rahba Hospital

The Medical Laboratory Department at Al Rahba Hospital aims to eliminate the medical errors that might bring any harm to customers. Thus, the major goal of this department is to understand and record all processes, instruct employees to be proficient in adhering to these processes, determine the problematic ones, and enhance the ones that might bring any complications. The hospital’s total quality management plan is governed by the current College of American Pathologists Laboratory patient safety goals (2) that incorporate the following features:

• enhancing patient and sample recognition at specimen collection, investigating, and delivering the results;
• improving authentication and transmission of the information about life-threatening diseases and critical results;
• enhancing the prompt identification and correction of errors;
• improving the management of laboratory’s patient safety function within the hospital laboratories.

Quality Control in Al Rahba Laboratories

The function of quality control is to measure the actual operative procedural performance that is assessed through such indicators as precision and accuracy. There are two types of quality control at Al Rahba laboratories: internal and external (3).

Internal quality control (IQC) is the most commonly used type. Usually, it presupposes three levels: high, normal, and low. However, a laboratory needs to have at least two levels of control: high/low or normal/abnormal. The results received from such regulation are compared with the established control values. Every section of the laboratory takes care to perform IQC with regular frequency. The procedure of IQC incorporates the following steps:

• adhering to the manufacturer instructions mentioned on the package;
• taking actions when the results are within the provided range;
• double-checking the process of getting the material ready;
• verifying the lot number and expiration date and disposing of any materials or reagents that have expired.

External quality control (EQC) serves three purposes:

• it provides a measurement tool for guaranteeing that the laboratory data are accurate and useful;
• it establishes the regulatory agencies with credence that all laboratories are generating rigorous data;
• it guarantees that clinical trial volunteer specimens will be scrutinized in a system that provides reliable and precise data for establishing trial volunteer safety.

EQC programs in laboratories perform the following functions:

• handling proficiency test (PT) samples as routine patient ones;
• reacting to unacceptable PT outcomes;
• analyzing to find out the root cause of errors and to see whether patient results might have been impacted by these errors;
• taking corrective action to avert the same errors in the future.

Quality Assurance in the Workplace

Quality assurance (QA) at the hospital is aimed at measuring the effectiveness of clinical service processes concerning their respective path of flow through different indicators such as turnaround time and reporting about any inconsistencies. Each member of a laboratory team has responsibilities concerned with quality assurance:

• laboratory COS needs to ensure that relevant procedures are performed and the necessary resources are available;
• pathologist takes care of setting the quality standards to be accomplished and establishing the limits of performance for punitive actions;
• laboratory manager ensures the implementation of all appropriate QC procedures, reviews the results, and take care of corrective actions;
• senior technologists are responsible for the correspondence of all controls to the requirements;
• all technologists are accountable for the quality of their work (4, 5).

Examples of Measures, Potential Failures, and their Consequences

The most common types of measures at Al Rahba laboratories are the proficiency sample, measurand, and corrective action. Each of these and other kinds of measures may undergo failures that hurt the laboratory operations. To eliminate the negative results of any errors, corrective action has to be taken.

There are three major types of potential failures, each one containing several subtypes (3):

1. pre-analytical errors: specimen handling errors, problems with PT materials;
2. analytical errors: procedural/methodological problems, instrument/equipment issues, technical problems;
3. post-analytical errors: clerical errors, problems with PT evaluation.

The consequences of any of the mentioned problems are detrimental, since they may undermine the validity of test results and produce irrelevant outcomes.

Conclusion

Quality control and assurance are integral elements of the successful work of any laboratory. At Al Rahba hospital, all possible measures are taken to ensure that potential errors are eliminated, and patients receive the most precise results of testing. Each of the hospital’s employees realizes the utmost significance of conforming to the standards of quality and assurance of the best work.

References

1. Joint Commission International Accreditation. Standards for Hospitals. 10th ed.; 2014.
2. College of American Pathologists. Laboratory general checklist and all common checklist; 2011.
3. Health Authority of Abu Dhabi. JCI clinical lab standards; 2011.
4. CLSI Procedure. Using proficiency testing to improve the clinical laboratory. 2nd ed.; 27(8).
5. CLSI Procedure. Continuous quality improvement: integrating five key quality system components. 2nd ed.; 24(35).