QA program

An active program of surveillance of the quality of the immunostains produced must be defined. The primary elements of such a quality assurance (QA) program include procedures and policies for patient test management, quality control, proficiency testing, comparison of test results, relationship of clinical information to patient test results, personnel assessment, communications, complaint investigations, QA review with staff, and QA records. The documentation and review by the laboratory director of all QA procedures is imperative and cannot be overstressed. A brief explanation of each of the QA elements is as follows ... 

The quahty system should be documented in a QA program manual that outlines ah the quahty pohcies and procedures for the laboratory. This manual should be considered the handbook for ah employees. New employees should become famihar with the document so that they can use it to answer questions that may arise in their work. New or retrained employees should sign a form documenting that they have read and imderstood the manual. This form should be kept in the personnel files. 

Of course, appropriate QA programs are required not only to check each of the above three factors, but also to ensure that they are adequately combined. 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

Quality assurance (QA) is an essential part of analytical protocols. Each laboratory is required to detect and correct problems in analytical processes and to reduce errors to agreed-upon limits. To produce data that have acceptable quality, all laboratory members must follow established guidelines and protocols. Some of the essential elements that must be included in a QA program are as follows ... 

Audits must be performed on a scheduled basis to verify that all aspects of the QA program are operating sufficiently. 

To understand the approach taken in developing the QA program at DCLS, it is necessary to have a general overview of the organizational structure of the laboratory, and of the program itself. 

DCLS is the analytical regulatory laboratory for the State of Virginia, and is staffed by nearly 350 employees analyzing over a million samples a year. The laboratory consists of a Quality Assurance Section and the Bureaus of Chemistry, Forensic Science, Microbiological Science, and Technical and Logistic Support. The QA program is based on a Division QA Policy mandated by the Laboratory Director, and a Division QA Plan which establishes broad guidelines for more specific Bureau QA Plans. Each Bureau is divided into diverse analytical sections which operate under even more individualized QA plans that are patterned after the Bureau Plan. 

It should be noted that the basic elements of the DCLS QA Program closely parallel those set forth in the GLP regulations. Each of the major components of the GLPs is addressed in the BOC QA Plan. 

The DCLS QA Program evolved as a result of participation and input from all levels of personnel from the outset. The QA program in the Bureau of Chemistry was the first to be developed at DCLS, and serves as the prototype for QA programs in the other Bureaus, although each Bureau is expected to address its own unique functions in the preparation of a QA plan. 

The active participation of the entire staff in a QA program is essential. Responsibility for QA is therefore included in every employee s position description in the BOC. This emphasizes the importance of QA in the laboratory, and demonstrates an expectation of participation in the program. Individual performance standards addressing QA provide a mechanism for evaluating an employee s participation in the program, and rewards those demonstrating a positive attitude towards QA. This also helps establish positive role models for participation in the program. 

Currently the DCLS-BOC QA Program is entering into its second audit cycle. The Bureau and Section QA Plans are undergoing an annual review and update, with input from the entire staff. 

New Section Representatives have been appointed to serve on the Bureau QA Team. In this way bench scientists will have an opportunity to rotate into a more active role in the QA program. It is hoped that eventually most analysts will have served in this capacity. The DCLS QA Program is considered to be an active, dynamic process, undergoing review and change as needed, based on the support and input of all laboratory personnel. 

The importance of communication was evident throughout the development and implementation of the QA program at DCLS. A communication network between the QA unit and all levels of management and laboratory personnel is essential to the success of such a program. At DCLS, this communication network consists of regular Section, Bureau, and Division QA Team meetings, and quarterly reports from the individual Sections and the Bureaus to the QA Section and management, in addition to audit reports. 

The present paper discusses one contract laboratory s approach to setting up and operating a successful quality assurance program. The discussion focuses on the QA philosophy of the laboratory, the ingredients included in the QA program to help make it viable, and the responsibilities which both sponsor and contract laboratory must accept in order to optimize the contracting relationship and produce quality stud i es. 

Some Costs and Benefits of a Ulel 1-Operated QA Program... 

Let s look at the balance sheet of costs and benefits for a wel1-operated QA program. 

Finally, the ultimate benefit of a QA program which fosters a laboratory s commitment to excellence should be the production of high quality, scientific studies upon which reasoned, regulatory decisions can be based. 

B. Quality Assurance Program is the responsibility of a QA Officer who in turn is chairperson of a QA Committee. The elements of the QA Program are presented in the "Laboratory Quality Assurance Manual." August 1986. 

---