June 2013 Clinical Laboratory News: Volume 39, Number 6
Does the New CLIA Guidance Mean Big Changes?
By Bill Malone
Laboratory professionals work in one of the most highly regulated environments in healthcare. Everything from specimen integrity to result reporting fits into a continuum that has to meet strict quality standards under CLIA. As a result, suggesting even a small change to one part of a lab’s process can be unsettling, especially when labs already have little room to maneuver—be it due to time, budget, or staff constraints.
Now, new guidance from the Centers for Medicare and Medicaid Services (CMS) aims to clarify the CLIA rules for an area that seems routine, but one in which many labs have been getting it wrong—assessing the competency of personnel who perform testing. During an April 17 AACC webinar with CMS Division of Laboratories Director Judy Yost, MT(ASCP), questions from laboratory professionals poured in, highlighting the confusion on this topic. Surprisingly, many labs get tripped up on the basics, like which staff members should be assessed by whom and how often.
“Competency assessment is critical to ensure that the personnel in the laboratory are meeting their duties under CLIA,” Yost said. “Really what that means is that the individuals in the laboratory are providing high quality testing. Performing routine competency assessments is an important way labs can avoid errors that could lead to patient harm.” But while the CLIA regulations for competency assessment have not changed, the often vague language in the regulations has led to an increasing number of inquiries that spiked over the past several years, Yost said. Accreditation organizations also noticed a high number of citations for this area, which prompted CMS to prepare a new guidance with more detailed explanation.
Defining Roles and Responsibilities
So where are labs having trouble? Based on CMS surveys and reports from accrediting organizations, labs are failing to follow some of the ground rules for competency assessment, not due to negligence, but from confusion over the nuances of the regulation. Under CLIA, anyone performing testing must have his or her competency assessed annually, and during the first year a person works in the lab, every 6 months. The new CMS guidance emphasizes that competency assessment is not the same as a performance evaluation. Rather, the legal requirements for competency assessment mirror the responsibilities of each person’s role in the lab as defined by regulation: laboratory director, clinical consultant, technical consultant, technical supervisor, general supervisor, and testing personnel.
Although some of these roles can have a long list of responsibilities based on how much the lab director delegates, labs often miss the minimal requirements for anyone who performs testing. CLIA defines six elements of competency assessment for anyone who actually performs testing, and all six must be documented for each person, each year (See Box, below).
Competency Assessment Basics
Six Areas Define Minimum Requirements
Under CLIA regulations, all phases of testing should be reflected in a lab’s competency assessment program. A new CMS guidance defines competency as the ability of personnel to apply their skill, knowledge, and experience to perform their duties correctly. Laboratory directors, consultants, supervisors, and managers must be assessed on their administrative duties in addition to performing testing. However, the experience of CMS and accrediting organizations points to the basics of competency assessment as the area where most labs run into trouble. CLIA regulations break down competency assessment for performing testing into six areas, each of which must be completed for each person, each test, each year.
- Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing.
- Monitoring the recording and reporting of test results.
- Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
- Direct observations of performance of instrument maintenance and function checks.
- Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.
- Assessment of problem solving skills.
CMS’s new brochure on competency assessment, “What Do I Need to Do to Assess Personnel Competency?” is available online.
In addition, not just anyone can perform the assessments. Depending on whether the lab performs high- or moderate-complexity testing, only those individuals who meet the regulatory qualifications of a technical supervisor, technical consultant, or general supervisor may perform an assessment.
Accrediting organizations, such as the Joint Commission, have also spotted trouble. “Competency assessment is one of our most frequently cited areas for lack of compliances,” noted John Gibson, MT(ASCP), DLM, associate director of the Standards Interpretation Group at The Joint Commission, in an interview with CLN. “In 2012, 39 percent of labs were cited for non-compliance. In many cases, we’re seeing that not all six of the competency assessment criteria are being utilized, and the required frequency of six months during the first year and annual thereafter falls short in some laboratories. We’ve also noted that frequently the individual performing the competency assessment does not really have the required qualifications.”
Deb Hagen-Moe, a frequent presenter on competency assessment at lab management meetings, said she always receives a lot of anxious questions on this topic. Hagen-Moe is an education coordinator in the department of laboratory medicine and pathology at Mayo Clinic in Rochester, Minn. “I think this is a challenge because the regulations have to be written broadly, since laboratories come in a variety of sizes and complexities,” she said. “I hear a lot of comments like, ‘I’m not quite sure how to interpret those regulations. I’m afraid I’ll do it wrong and I don’t want to risk a citation,’ or even, ‘how do I get started?’”
Often labs get confused about who can delegate to whom. The important point to remember is that the task must be delegated in writing, and only to someone who has the required level of education and experience. “We’ve had situations where we found that people were delegating this to almost anyone, and that was a little bit too risky for us,” Yost told CLN. “However, most labs have personnel who have the education and experience to qualify for a position as a technical supervisor or consultant but don’t necessarily have that title. Delegating assessments to these personnel can give the lab more flexibility, while still holding the assessments to a high standard.” For example, in a high-complexity lab, a technical supervisor may delegate to a general supervisor, or to someone at least meeting the minimum qualifications for a general supervisor (See Sidebar, below).
Who Can Perform Competency Assessments?
Labs Must Delegate Carefully
A common pitfall for labs is the question of who can actually perform a competency assessment under the regulations. In a moderately complex laboratory, the person performing the competency assessment must be qualified as a technical consultant. This means at least a bachelor’s degree and 2 years of laboratory training or experience with non-waived testing. The experience should be in the designated specialty or subspecialty in which the testing takes place.
In a highly complex laboratory, he or she must qualify as a technical supervisor, with a bachelor’s degree and 4 years’ training or experience in high-complexity testing. However, a technical supervisor may delegate the responsibility for competency assessments, in writing, to a general supervisor. Minimum qualifications for a general supervisor are an associate degree and 2 years’ of high complexity testing training or expertise. For technologists who’ve been working in the lab longer, the regulation makes an exception for those previously qualified as a general supervisor under federal regulations on or before Feb. 28, 1992.
Personnel who perform point-of-care testing must also have their competency assessed. In this case, trained nurses may perform the assessment, but they must still meet the regulatory qualifications—at least a bachelor’s degree and 2 years’ of training or experience with non-waived testing. In addition, the laboratory director must delegate this task to a nurse in writing beforehand.
The requirement for an annual competency assessment applies to everyone who actually performs testing, Yost emphasized, including pathologists and doctoral-level personnel. On the other hand, personnel who only perform waived testing or whose work in the lab only involves pre- or post-analytical processes are not required to undergo assessment under CLIA, although some accrediting organizations may require it.
The Question of Test Systems
Under CLIA regulations, all six elements of competency assessment must be completed for every test a person performs, not just testing in general. In order to make competency assessment less burdensome, labs will naturally want to consolidate the assessment of multiple steps or analytes. However, they can easily run afoul of CLIA regulations if they go too far, Yost warned. “If you have several analytes that are based on the same testing platform, labs can certainly combine them as part of competency assessment,” Yost said. “But that means one compact device or test system; the regulation does not give labs the leeway to go further than that.”
CMS’s new guidance on competency assessment recommends labs focus on whether there are unique procedures for the test. If so, the test will require a separate assessment of competency. “As long as there are no unique aspects, problems, or procedures associated with any test on the testing platform, all tests performed simultaneously on the same testing platform may be combined,” the document states. “However, any test with unique aspects, problems, or procedures within the same testing platform should be assessed separately to ensure that staff maintain their competency to report test results promptly, accurately, and proficiently.”
According to Yost, the regulation’s definition of a test system draws a clear line between different analytes on the same platform versus lumping together broader categories such as serology or immunology. CLIA defines a test system as “the instructions and all of the instrumentation, equipment, reagents, and supplies needed to perform an assay or examination and generate test results.”
Another way to look at consolidating testing is grouping tests based on platforms, according to Gibson from The Joint Commission. “We see an instrument as a single platform of testing—for example, a hematology analyzer or chemistry analyzer,” Gibson explained. “All of the tests that are being performed on that analyzer are on a single platform, and labs can assess competence across the board for all the analytes on the instrument unless a specific test has some unique step or process. That simplifies things tremendously.”
This question of assessing competency for every test—but not necessarily every analyte—comes to the fore with next-generation sequencing, which may explore many different genes. This is an area where CMS plans to produce further guidance for labs. Meanwhile, competency assessment should tackle reasonable goals, Yost commented. “We realize that it doesn’t make sense to require every single possible analyte in this case,” she said. “Further guidance is coming for labs, but in the meantime, labs are safe if they do what they think is best.”
Hear directly from CMS Division of Laboratories Director Judy Yost, MT(ASCP), answering labs’ questions about competency assessment. A recording of the April 17 AACC webinar is available for download or on CD from the AACC store website.
Don’t Reinvent the Wheel
Having a thoughtful system in place for competency assessment will help labs stay in compliance. However, a competency assessment plan need not create a lot of new work. It should be integrated into what laboratory professionals already do every day—performing tests, reviewing results, checking maintenance on instruments—and simply capture and document these routine events. “Unfortunately, instead of using the quality processes that they already have in place, we often see labs trying to create something completely new from scratch,” said Stacy Olea, MT(ASCP), a field director in surveyor management and development for The Joint Commission. “But if you actually look at the six elements under CLIA, laboratorians are doing all of those on a regular basis.”
For example, one of the requirements is reviewing intermediate test results or worksheets and quality control records. “Usually you have a supervisor of the department who reviews quality control on a regular basis, so you’re already doing that piece as part of your existing lab quality program,” Olea explained. “What labs need to do is take that documentation and include it in competency assessment.”
Similarly, many everyday tasks fall under the rubric of problem-solving skills. For example, an unusual number of delta flags may prompt a technologist to go back and investigate a possible instrument error. “The technologists working the bench are doing this problem-solving on a day-to-day basis,” Olea said. “But instead of just fixing the problem and moving on, the person could document the problem-solving that they did, and submit that as part of their competency assessment program.”
Yost also clarified that the annual requirement does not mean that labs have to perform all of their assessments at the same time each year. “Don’t do it all in one day,” Yost said. “I recently received a question from a supervisor who said she did a lot of observation of testing, but didn’t always see everyone through the entire testing process. I said, ‘I bet you do over the course of a year, though, don’t you?’ So she was already doing it, and didn’t realize she was covered. Often it’s just a matter of documentation—making sure you have a checklist or spreadsheet to record all of this.”
Gibson echoed this idea. “Too frequently managers feel that competency assessment is a snapshot in time, when you actually have a year to gather the data that’s used to determine the competence of your staff,” Gibson said. “It makes a lot more sense to gather that data as a continuum. The direct observation of testing, the monitoring of the recording, review of intermittent results, and so on, does not have to happen at one point. It happens on an ongoing basis, and most of it happens in the routine supervisory review process.”
Planning, Teamwork, and Efficiency
If labs follow the rules carefully about who can perform assessments, they can share responsibility and avoid overwhelming one person, according to experts. “One of the pitfalls we see is the lab manager or the supervisor trying to run the competency assessment program all by him or herself—doing all six elements for every test for every person,” Olea said. “The key is to involve the testing personnel: they’re the ones who know when they’re doing maintenance, testing, or problem solving. At some level, all of the staff of the laboratory have to be accountable.” Olea recommends giving each person a binder or folder so that when they accomplish one of the elements of their assessment for a test, they can proactively gather documentation.
Creating a schedule for which elements will be assessed, and by whom, can save time and keep documentation organized, said Hagen-Moe. “I often recommend that labs make sure their staff knows that they’re responsible for getting this done within a certain timeframe. It can’t only be the responsibility of the laboratory director to chase everyone around: set out the expectations and make your staff accountable.”
Overall, a standardized approach across the organization can help make sure that regulatory requirements are met while setting clear expectations for staff. Hagen-Moe recommends that laboratory directors and managers sit down with representatives from each area of the lab and design a process together, along with clear policies and procedures. “You want to avoid everyone producing variations on the same thing,” she said.
Laboratory directors and managers should also explain why competency assessment is important in the first place, Hagen-Moe emphasized. “I think it’s really important to explain to your staff that competency is not just a compliance issue. The goal is that we’re doing quality work: we want to provide the highest quality test results that we can, and to do that we’re doing quality checks on our staff,” she said. “Don’t take it as something punitive—we do quality checks on the instruments, we do quality checks on the process, so we’re going to do a quality check on you to make sure we’re providing our patients with accurate test results.”