Quality Assurance in the Laboratory

Every clinical laboratory is required to have a qaulity assurance program. What is QA? What is its purpose? Why bother with the tedious documentation?The following is a brief description of how to answer this questions and implementing QA.

Qaulity assurance is an all-encompassing program that monitors and assures improvement of every step in the process of ordering, performing and resulting of a laboratory test. Most clinical laboratory divide qaulity assurance into three phases: pre-analytical, analytical, and post-analytical.Quality Assurance begins with the pre-analytical phase. The pre-analytical phase includes specimen selection,collection, and transportation to the laboratory. All sections of the laboratory must supply clinicians with the appropriate collection devices, transport devices and enough information to select the correct specimen and collect it correctly.
Specimen integrity must be maintained throughout transportation. A specimen rejection policy which clearly states what is and is not accepted should be established, enforced, and followed. This policy should be aggressively circulated to the physicians and other clients.

Quality Control

The second phase of quality assurance, the analytical phase, includes the tests and media, reagents, and equipment needed to perform the tests. An integral part of the analytical phase is quality control. Quality Control is the process with which a laboratory assures its customers that results are accurate, reliable and reproducible.Once the specimen is collected labelling correctly is of impportance. All collection devices and medias should be labeled correctly with its type and name, when it was made or prepared, when it was received, an expiration date, and an in-service date. All media or reagents prepared on-site must be subjected to QC testing: a positive control, a negative control and observation of sterility must be run simultaneously. When purchased from a vendor medias and reagents may or may not need to be subjected to QC testing according to Clinical and Laboratory Standard Institute(CLSI) of the United States document M22-A3(5). Uppon receipt, exempt media or reagent needs only to be checked for appearance, color, hydration, and lack of physical damage. Lot numbers for media and reagent, whether quality control was performed or not, must be documented.
CLSI publishes guidelines for the quality control of stains and reagents. In general, qualitative tests requires both a positive and negative control, and quantitative results requires a negative control and two positive controls of different titers, levels or amounts. Quality contnrol must be performed on each shipment regardless whether it is the same lot number or different. Most supplies directly related to and used in testing must be labeled with type or name, expiration date, date of receipt, and date placed into service.

Many automated instruments require QC testing and documentation. Automated instrumentation usually is synonymous with more QC. Documentation of reagent lot numbers, instrument maintenance(daily, weekly, monthly, etc.), and results of QC testing are important not only because the QC is required, but most of all for detecting adverse or clinically relevant trends.
When QC results are within range, and instruments are working as expected, all that is necessary is for QC information to be recorded as usual. However, when QC result are out of range, technologists need access to a policy which states what must be done to bring QC results back in range. The problem and details of its resolution must be documented. Documentation enables the management team to follow both consistent and intermittent problems and trends. It also aids in communication between coworkers, shifts, and/or departments.

The final phase of QA is the post-analytical phase. The post-analytical phase is the point at which the clinician receives and interprets the result of a test. The technologists must ensure that the results seen by the physicians are clear and concise. A concise, clear, easy to understand and standard format of reporting results must be issued, enforced and implemented in all sections of the laboratory to ensure uniformity and consistency.

Personnel is a key element of QA. Without a competent personnel to perform the tests, the quality of even the best QC program would be less than optimal. Therefore QA must not only include the pre-analytical, analytical and post-analytical, but also of the personnel involve in the performance of the test. Trainings, competency testing, continuing education and profeciency testing of all personnel involve in the laboratory must be in place.

Policies and procedural manuals also plays a key role in QA. This policies and procedures aims in guiding and assisting laboratory personnels in troubleshooting any adverse problems in the performance of a laboratory test. What should be done if QC fails? What positive results are critical and requires notification to the doctor? These questions and critical situations is found and answered in the written policies and procedures of a laboratory.

The last important component of quality assurance is quality improvement, i.e., how are we doing, and how can we improve it, what tests do we perform and why, and is the information we provide clinically relevant? After needed tests are identified, verification and validation of these test are necessary.

Quality control, personnel, procedures, record keeping, and quality improvement are the fundamental component of quality assurance. Quality control is a program which ensures media and reagents are working properly. Appropriately trained personnel assure that the policies and procedures are effective and results are reliable. Quality improvement monitors the overall effectiveness of the program.

This excerpt is taken from the Article written by Barabara DeBurger, MT(ASCP), Lead Technologist; and Joel E. Mortensen, PhD, MLT(AMT), Director of the Diagnostic Infectious Disease Testing Laboratory, Cincinnati Children's Hospital and Medical Center, Cincinnati,OH. Published in "American Medical Technologists Journal of Continuing Education"Vol.8 January 2006 Number1.