CEO SUMMARY: Laboratories in the United States are knowledgeable about the use of quality control (QC) and quality assurance (QA) programs. But QC and QA represent only two small parts of a comprehensive quality management system (QMS), says Lucia Berte, an expert in lab quality. One benefit for clinical laboratories using a QMS is that it can become easier to meet the requirements of multiple regulatory bodies. Use of the QMS will also help the laboratory respond more effectively to unannounced inspections.
GROWING NUMBERS OF CLINICAL LABORATORIES in the United States are adopting quality improvement programs in an effort to boost efficiency, reduce errors, and cut costs.
In fact, adoption of such methodologies as Lean and Six Sigma by clinical laboratories and pathology groups in this country is on its way to becoming the norm. However, pathologists and lab managers should recognize that an occasional Lean project does not mean the laboratory has implemented a quality management system (QMS).
Quality Management Systems
Lucia Berte, MA, MT (ASCP), a lab quality consultant and founder of Laboratories Made Better! in Broomfield, Colorado, believes these efforts are insufficient for labs seeking to compete successfully in the 21st century. In her view, clinical laboratories should be introducing a comprehensive quality management system (QMS) such as the type described in the international medical laboratory standard known as ISO 15189. Berte believes that, once in place, a QMS would be all a lab would need when seeking to comply with any requirement from any body setting quality standards, particularly here in the United States.
“Every laboratory professional working in the United States recognizes the wide range of published requirements, laws, and accreditation standards that must be met,” explained Berte. “What is problematic here in the United States is that clinical laboratories have multiple laboratory standards to meet. That is different than the situation in most other developed countries, which have a single standard for laboratory accreditation or licensing.
“In the United States, we have national agencies, such CMS, FDA, DOT, and OSHA with regulatory mandates; The Joint Commission with national hospital and laboratory accreditation requirements; and the AABB, CAP, and COLA with specific, detailed laboratory accreditation requirements,” she noted.
“Because of these myriad requirements, laboratory managers constantly search for the ‘better way,’” she observed. “It’s why there is interest in a simple, straightforward approach to quality management that encompasses and enfolds all these requirements into one integrated system. But few laboratory organizations in the United States currently have a comprehensive QMS.
More Than QC/QA
“Many labs have QC and QA, and they think that’s all they need,” she said. “But let’s be clear—neither QC not QA is quality management! How often do we hear technologists and administrators say, ‘QC/QA,’ as if it were one word? At best, quality control is an operational approach that seeks to answer one question: Is this test method working right now in this batch of samples? Period. That’s all you get from QC.
“Quality assurance is a little broader,” Berte added. “But it asks different process questions: What is the turnaround time from sample collection to receipt in the lab and from receipt in the lab to verification of results? How many lab reports have errors in them that need correction? How many of those lab errors adversely affect the patient? Those are examples of QA questions.
“When examined closely, the standards for CLIA, The Joint Commission, and CAP are based on QA,” Berte continued. “The bottom line is that these standards are not quality management systems.
Looking At Lean & Six Sigma
“In addition to QC and QA, we hear a lot about how Lean and Six Sigma projects are used to improve processes,” she said. “These are methodologies. They are not comprehensive QMS models. However, that’s not an indictment of Lean or Six Sigma—which are designed to support the improvement of workflow.”
For pathologists and lab administrators interested in exploring the benefits of a QMS for their clinical laboratory, one starting point is the definition of a quality management system. The web site www.businessdictionary.com defines a QMS as:
Quality Management System (QMS)— Collective policies, plans, practices, and the supporting infrastructure by which an organization aims to reduce and eventually eliminate non-conformance to specifications, standards, and customer expectations in the most cost effective and efficient manner.
The widely-accepted global standard by which all other quality management systems are judged is ISO 9001. Created by the International Standards Organization (ISO) in 1987, it is used worldwide in all industries and by both manufacturers and service organizations, including healthcare providers.
“ISO 9001 is designed to provide a quality improvement infrastructure,” Berte explained. “It is a QMS model that provides the building blocks of quality improvement to allow any company or organization to apply quality principles to any work process being performed.
“ISO 9001 exists to be a generic QMS model for any company in any field,” she said. “It provides the quality infrastructure while the technical requirements come from one’s own industry, whether it is aerospace, electronics, food, information technology, or healthcare.
“ISO 15189 derives the ISO 9001 QMS and is tailored specifically for medical laboratories,” said Berte. “Like ISO 9001, ISO 15189 incorporates QMS essentials, which include policies, processes, and procedures for every aspect of laboratory organization and operation. All the elements are addressed, such as equipment, suppliers, customers, documents and records, information management, and so on.
“Remember, a quality management system works because, everywhere you go, the building blocks of quality are the same,” she added. “They are generic and universal. Further, a QMS helps a laboratory look at the old things in a new way. Labs have plenty of experience with QC and QA. Now the time has come for labs to elevate their thinking and incorporate a quality management system.”
Based On ISO 9001
Berte, who worked on the international team responsible for developing ISO 15189, recommends that clinical laboratories in the United States consider adopting this QMS. “First, it is a system, which means a collection of approaches, ideas, and processes organized to act in a unified way. Second, it is designed to improve quality. Third, it is based on the process model of the mother of all quality management systems: ISO 9001.
“This is a one-time shift in mindset and organizational culture,” noted Berte. “When the laboratory builds policies, processes, and procedures for the path of workflow to meet requirements as the work is performed, these internal standards will become integral to the culture and that lab’s way of working. It is the reason why the QMS infrastructure will sustain the lab even when staff changes and when new leaders come on board.”
In the United States, as of this date only three laboratory organizations have earned accreditation under ISO 15189. They are Piedmont Medical Laboratory of Winchester, Virginia; Avera McKennan Health System Laboratories in Sioux Falls, South Dakota; and Blanchard Valley Hospital Laboratory of Findley, Ohio. (See TDRs, September 8, 2008, and August 31, 2009.)
These first mover laboratories report positive outcomes from their implementation of 15189. That is important evidence that this QMS delivers worthwhile benefits to laboratories.
In Canada, ISO 15189 is gaining acceptance by provincial health authorities as the best form for laboratory accreditation. In Ontario, more than 120 laboratories are now ISO 15189 accredited. Similarly, in recent years Quebec has opted to use ISO 15189 for laboratory accreditation in that province.
ISO 15189 as the basis for laboratory accreditation is also finding favor in numerous countries across the world. In most cases, these countries have never required their medical laboratories to be licensed or accredited. Thus, when policy-makers consider different options to achieve this outcome, ISO 15189 quickly surfaces as their first choice.
Raising The Competitive Bar
In North America (in Canada) and other continents around the globe, acceptance and use of ISO 15189 is likely to have two consequences in coming years. First, because growing numbers of laboratories use ISO 15189 as their quality management system of choice, this will raise the competitive bar for laboratory testing services, for a simple reason.
The longer a clinical lab operates under an effectively-implemented QMS, the more improvement in quality, productivity, and customer satisfaction it will achieve. Such continuous improvement will make the laboratory more competitive in the marketplace where it operates.
Second, as the number of countries using ISO 15189 as their basis for laboratory accreditation and licensure grows in future years, that will encourage the further globalization of laboratory testing services. After all, if labs in different countries are using the same analyzers, the same assays, and the same QMS, it makes it easier to document the level of their proficiency and quality. In turn, that makes it easier for nations to outsource their lab testing to other countries based on lowest cost, while having confidence that the quality of those laboratory services is as good or better than the quality of lab services from its domestic laboratories.
ISO 15189’s Value to American Labs
IN THE UNITED STATES, any laboratory that wants to implement ISO 15189 will still need to separately meet all the federal, state, and local requirements for accreditation, licensure, and quality.
That’s because, over the decades, the United States was one of the first developed nations to require clinical laboratories to meet accreditation and licensure requirements. As a result, the requirements of these accreditation and licensure standards were developed before ISO 9001 gained wide international acceptance as a quality management system (QMS).
Why QA and QC Are Different Than A Quality Management System (QMS)
QUALITY ASSURANCE (QA) AND QUALITY CONTROL (QC) SERVE DIFFERENT FUNCTIONS in a clinical laboratory—but neither are examples of a quality management system (QMS). Quality expert Lucia Berte of Laboratories Made Better! provided these brief definitions of QA, QC, and QMS, along with some examples or attributes of each.
Quality Control (QC)
Testing performed with samples of known values to verify that a given test method worked as intended so that patient results can be considered valid. Examples:
- Control reagents that are positive and negative—or reactive and nonreactive— for a qualitative analyte
- Control reagents with abnormally low, normal, and abnormally high quantitative values
Quality Management System (QMS)
Proactively designed management processes and procedures that build quality into the daily work processes. Includes:
- Document and record control
- Management plan for each piece of equipment
- Training in job tasks and initial competence assessment
- Ongoing competence assessment
- Complaint resolution process
- Nonconforming event reporting and analysis
- Internal auditing program
- Ongoing continual improvement
Quality Assurance (QA)
Measurements of aspects of pre-analytic, analytic, and post-analytic laboratory work processes to verify whether the process is performing as intended. Examples:
- Number of times patients do not have proper identification at time of sample collection
- Number of unacceptable samples received for testing/analysis
- Number of test orders with incomplete or incorrect information
- Number of unaccounted for (“lost”) samples
- Number of times QC controls did not give the correct values and reasons for same
- Number of times laboratory instrumentation was not functional and reasons for same
- Proficiency testing performance trends
- Elapsed time from sample receipt to verified results
- Number of laboratory reports with erroneous results