An estimated 70 percent of health care decisions are based on laboratory test results. To ensure that all test results are as accurate as possible, the performing laboratory is required to follow certain protocols and practices outlined by the federal government, including those related to laboratory quality.
Some laboratories struggle with quality assessments because they don’t fully understand the benefit and impact these reviews can have on patient care. This article will break down quality assessments in simple terms to get you started on the right track.
Clinical Laboratory Improvement Act (CLIA) 42 CFR 493 laboratory requirements state that each laboratory issued a certificate must maintain a quality assurance and quality control program adequate and appropriate for the validity and reliability of the laboratory examinations.1 Updates made to CLIA in 2003 describe a quality systems approach to laboratory operations in which all the procedures, processes, policies, and resources in place to achieve high quality laboratory testing are bundled together and defined as quality systems.1
Accreditation agencies such as the Commission on Office Laboratory Accreditation (COLA) and the College of American Pathologists (CAP) define their requirements for quality with more detail. Quality assessment (QA), as defined by COLA, is a “planned, ongoing review process that observes and evaluates the quality of all laboratory-related processes and activities.”2 Quality management (QM), the quality program required by CAP, is designed to improve patient service through established activities and mechanisms to monitor and evaluate quality.
Performance of QA (COLA) requires careful observation and examination of the tasks that are performed every day. Data about these tasks are gathered over time and reviewed, with a focus on detecting patterns of events in an in-depth analysis and evaluation. A QA is more than just a routine check of activities to assess if they were performed correctly; it should assess how all activities are performed and how they can be improved.
CAP requires quality management to be a dynamic process which will be reviewed annually and updated as necessary. The goals of a QM program include the assessment that all the services provided by the laboratory and areas of the laboratory contribute to the overall delivery of excellent medical care.3
For the purposes of this article, the terms quality assessment, quality assurance, and quality management will be used interchangeably.
Performing quality assessments
When performing quality assessments, the laboratory processes requiring evaluation can be broken down into four sections: the pre-analytical, analytical, and post-analytical phases of testing, plus general laboratory actions not related directly to daily specimen testing.
The pre-analytical phase is the period before the samples are tested. It includes test ordering, specimen collection and labeling, and the transport, storage, and processing of the samples. Evaluation of quality in the pre-analytical period may be difficult because specimens are often collected outside the laboratory performing the testing. Detailed specimen collection and transportation instructions are critical. Specimens received outside of the specified collection and transportation instructions must be rejected and documented. Specimens that are incorrectly labeled should not be processed and the original collection site should be notified immediately. In order to improve quality in the pre-analytical phase, a strong educational component is needed to follow up on all rejected specimens. Documentation of these educational opportunities should be part of the quality assessment.
The analytical phase includes actions such as equipment calibration and maintenance, quality control, test performance, and result review and interpretation. Problems with any of these actions can have a negative impact on the quality of the result. Tight control of the quality of these processes can be maintained with supervisory oversight. In addition, many analyzers have lock-out features prohibiting test performance when calibration, maintenance, and quality control are not performed.
The post-analytical phase includes result reporting, corrected reports, record retention, and specimen retention (if applicable). Result reporting often refers to the time it takes for a test to be performed and results to be charted, also known as turnaround time. In hospital laboratories, turnaround time for STAT testing is high priority. However, in many physician office laboratories, turnaround time is less relevant because testing is performed immediately after collection. Selecting quality measures pertinent to your laboratory’s quality measures should be a key focus when developing and reviewing QA.
|Required Competency||How to Assess|
|Test performance||Direct observation|
|Test recording and reporting||Review records|
|Quality control, proficiency testing, and maintenance recording||Review records|
|Instrument maintenance||Direct observation|
|Blind sample testing||Proficiency testing|
|Problem solving skills||Review relevant documentation|
|*Competency assessments must cover these six categories|
In addition to the testing phases, general laboratory actions are also a critical part of quality in the laboratory. Assessment of personnel competency must be performed six months after new employees are trained, one year after training, and annually thereafter. Documentation of competency is required. Proficiency testing records and results should be reviewed, and all corrective actions must be documented. All data interfaces must be validated before being placed into action. Interfaces should also be checked when updates or enhancements are installed and periodically in between. Additional factors such as safety, communication, and receipt of complaints should also be documented and investigated.
Quality review meetings
QA review meetings are an integral part of the quality assessment. During these meetings, QA is reviewed and discussed. When QA measures do not meet the expected threshold for acceptability, a plan of correction should be reviewed. Reviewing these measures and the associated plan of correction within a group provides an opportunity for others to offer suggestions and ideas to help improve the quality. Many actions within the laboratory cross from one department to another. Sharing information and ideas across the laboratory disciplines will help produce a positive outcome for the entire laboratory.
Evaluating all laboratory activities for a short period (e.g. monthly) is not enough to tell how the laboratory operates on an ongoing basis. Quality assessments should detect errors over a period of time (e.g. three, six, and nine-month intervals). These timeframes allow implementation of corrective actions that not only solve the initial problem but also prevent the errors from repeating. The laboratory can also review key areas more frequently and implement a method to catch errors before they happen.
When problems are found, ongoing observation should continue. A QA review should concentrate on the recurrent issues. Comparing performance over time should reveal if changes in staffing, workload, or other factors influence the problem. Ultimately, identifying the root cause of the problem will allow the laboratory to uncover what is really wrong. Since the quality program is designed to improve patient care, the program should continuously identify and monitor potential problems or concerns that may interfere with optimal services.
Currently selected quality monitors should be reviewed periodically. If the data indicate that the laboratory repeatedly meets or exceeds the performance benchmark, a new quality monitor should be selected, or the benchmark should be re-evaluated. Quality monitors do not only pertain to correction of errors; they should also be designed to lead to improvement of laboratory services.
Typically, the laboratory director delegates quality measures to the laboratory supervisory team or an individual assigned directly for these monitors. COLA suggests all laboratory technical and non-technical staff be included in the discussions about quality monitors. These staff members should have a full understanding of the processes performed during each phase of the workflow. They may have insight into problems that arise and should be able to offer suggestions for opportunities for improvement.
Ultimately, whether the laboratory has a CLIA certificate of compliance or is accredited by COLA or CAP, the purpose is the same. The laboratory should evaluate all phases of testing—pre-analytic, analytic and post-analytic, as well as general laboratory actions—to ensure the highest quality of laboratory work and patient care.
1. Code of Federal Regulations: Title 42, Public Health, Chapter IV, Centers for Medicare and Medicaid Services, Department of Health and Human Services, Subchapter G, Standards and Certification, Part 493—Laboratory Requirements
2. Quality Assurance in the Laboratory, COLA Lab Guide 70, revised 5/99.
3. CAP Accreditation Program. “General Laboratory Checklist.”08/21/2018. www.CAP.org