CEO SUMMARY: In seeking dual accreditation for CLIA and ISO 15189, Advanced Diagnostic Laboratory of San Antonio adapted existing processes to meet accreditor expectations. The result was stronger staff empowerment to suggest improvements in quality, combined with increased recognition of the clinical laboratory’s testing capabilities in global markets.
FOR CLINICAL LABORATORIES INTERESTED IN PURSUING BUSINESS in the global lab market, obtaining both U.S. and international accreditations can be advantageous. Why? Though meeting Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements is mandated for U.S. labs, those regulations mean less in other countries.
Instead, ISO 15189—Medical laboratories: Requirements for Quality and Competence, holds greater sway outside the American market. ISO standards are published by the International Organization for Standardization, based in Geneva, Switzerland.
Dual Lab Accreditation
Advanced Diagnostic Laboratory (ADL) in San Antonio accomplished both accreditations simultaneously through the deeming authority American Association for Laboratory Accreditation (A2LA) earlier this year. Tamara Kirby, Lab and Quality Manager at ADL, provided insights into the process of obtaining accreditations for the two standards during a presentation at April’s Executive War College Conference for Laboratory and Pathology Management. The session was titled, “Benefits and Key Lessons Learned after Accrediting Our Laboratory to Both CLIA and ISO 15189.”
“As we branch out into other testing, we’re partnering with companies in Europe on that testing,” Kirby noted. “Having the ISO 15189 accreditation—something that everyone understands outside the U.S.—has been beneficial.”
In broad strokes, in the United States, CLIA requires clinical laboratories and pathology groups to be certified to perform testing on human specimens. Meanwhile, ISO 15189 is the globally-accepted standard that specifies requirements for quality and competence in medical laboratories.
There are similarities between the two standards, but also notable differences in documentation and personnel needs.
“CLIA, having more of an analytical specific focus, mentions accuracy, reliability, and specific conditions that labs have to meet,” Kirby said. “ISO 15189 has a broad focus on quality: quality and competence for testing, having a management system, monitoring and evaluating the quality system, and then a focus on constant improvement.”
Across the world, ISO 15189 is increasingly becoming a widely-acknowledged accreditation for clinical labs. Because ADL provided global testing from the day it opened in July 2020, it needed ISO 15189 accreditation from the beginning.
For labs interested in pursuing dual accreditation to both CLIA and ISO 15189, Kirby suggested spending some time reviewing the two standards, becoming familiar with the specific lingo of each one, and identifying ways in which they can be consolidated instead of treating them as two separate entities.
“Previously, I worked in another lab that looked at CLIA and the ISO standard independently and had different procedures for both,” she noted. “It’s not a pleasant way to do it. It is very hard to keep up with them, and lab staff must deal with a lot of duplication. The more the lab can integrate the two standards, the better.”
Quality Improvement Tactics
Kirby referred to quality improvement as the “big kahuna” of ISO 15189. Other clinical laboratories that pursued ISO accreditation also mentioned this observation to The Dark Report. (See TDR, “Achieving CLIA, ISO 15189 at Same Time with A2LA,” Feb. 7, 2015.)
Under CLIA, labs must have written procedures for monitoring, assessing, and correcting any problems in the lab. The regulation also requires review and staff discussion of the effectiveness of any corrective actions.
However, ISO 15189 puts more emphasis on developing a system of prevention supported by continuous improvement. The standard requires internal audits, management reviews, quality management system evaluations, and risk assessments.
Kirby observed that quality monitoring requirements for both standards can be smoothly implemented into a laboratory’s existing culture. As a first step, it is important to discuss the organization’s goals with staff and reiterate why the lab will benefit from having both CLIA and ISO 15189 accreditations.
“Many of your lab’s existing procedures can be enhanced to cover both standards, so don’t feel the need to start over with existing procedures,” Kirby explained. “Look for ways to implement the processes into your lab’s current flow.
“Adding 15189 doesn’t have to be an overhaul,” she continued. “Your lab is already doing many quality processes. Think of your lab’s regular meetings and documentation that’s already in use. Then simply create tools to make it easier for your lab staff to remain on top of things.”
To ensure the dual accreditation process was seamless at ADL, the laboratory team held department and management meetings as needed. Tasks were combined and staff was encouraged to submit ideas and suggestions.
ADL also created a quarterly quality assessment tool that included many of the elements required by CLIA and ISO 15189. “Each quarter, we evaluate a different part of our quality system,” Kirby said. “This has become one of the best aspects of our meetings, as people bring ideas or concerns they have as they go about their jobs.
“We also do vendor evaluations as part of this process,” she added. “We review them each quarter. The next review for that particular vendor is then scheduled, usually between six and 12 months depending on how frequently we use that vendor.”
Evaluating the Lab’s Systems
ADL utilized existing meetings to help fulfill the management review requirements of the accreditations. The lab continues to have quarterly assessment meetings and designates one of those meetings each year as a full management review meeting.
“We simply adapted our existing meeting times to cover these new requirements,” Kirby said. “And just to clarify, we try to keep our meetings very concise and very productive because nobody wants to have meetings just to have meetings.”
Kirby added that the quarterly assessments typically last about an hour. Annual management reviews last from one to two hours. “Ultimately, your laboratory must decide how these requirements fit into what your lab is doing,” Kirby noted. “It’s important that these meetings are not simply to check off boxes, but something that’s going to serve your lab’s quality processes.”
Attributes of Quality Manager
Quality management with ISO 15189 has the requirement to have a laboratory quality manager, something CLIA does not mandate. However, CLIA and ISO 15189 do intersect in their directives for medical laboratories to employ a lab director.
When selecting someone to serve as the laboratory quality manager, Kirby proposed that labs look for the following attributes:
- Ability to control situations and not let situations control them.
- Knowledge of and experience in the clinical laboratory industry.
- Capacity to solve problems as they arise.
- Openness to listen to ideas and suggestions from other staff members.
ISO 15189 also requires labs to have a quality manual with a distinct hierarchy of policies that illustrate the lab’s procedures, descriptions of how tasks are to be performed, and documentation of what has been done. Kirby explained that writing ADL’s quality manual was the most time-consuming part of the process.
“We basically took the ISO 15189 standard and went through it step by step to write our quality manual alongside it,” Kirby said. “As we came to each step, we would write a procedure for it.”
Further, ISO 15189 requires the following: a risk assessment; evaluation of vendors and referral labs; management review; and job descriptions for the positions within the lab.
For personnel, CLIA has stringent guidelines regarding education and technical experience, while ISO 15189 has more general provisions. The two standards have different but complementary requirements regarding documents and records.
“Both standards give requirements for the content of procedures, but ISO 15189 also provides explicit directions on how to label documentation to include information such as title, page number, a unique identifier on each page, version numbers, and date of use,” Kirby said.
“Each standard also defines steps for record retention and documentation,” she added. “However, ISO 15189 provides a longer list of terms, including information such as supplier selection records, lab notebooks, quality control records, incident reports, and risk assessments.”
On the subject of purchasing and lab test referrals, CLIA includes provisions governing where items may be acquired and states that labs must use a CLIA-certified lab or an equivalent for test referrals. In contrast, ISO 15189 declares that labs must have a documented procedure on how to select and purchase services, equipment, reagents, and supplies.
ISO 15189 also includes a standard requiring labs to have an approved vendor list, along with procedures for selecting those vendors, then monitoring their performance. For lab referrals, ISO 15189 requires labs to have detailed procedures for selecting and evaluating outside labs and to execute periodic reviews of those external labs.
“ISO 15189 requires more substantial procedures and records for these processes, so this is a good example of how ISO 15189 enriches and adds details to CLIA,” Kirby explained. “Of course, that can also be looked at as more things to do, but as long as your lab team develops ways to work it into regular work processes, it does bring benefit in how your lab conducts business.”
Key Takeaways for Labs
Prime benefits that Kirby identified from the dual accreditation to both both CLIA and ISO 15189 include:
- Having global recognition for the quality of its testing and acceptance of its test results.
- Becoming preemptive in its processes.
- Obtaining a focus on what can be improved in the lab.
- Empowering staff to look for ways to make improvements.
- Encouraging employees to express their ideas and constructive suggestions.
Kirby also said that one of the greatest benefits to ADL’s ISO 15189 accreditation turned out to be the required risk assessments. “We are identifying concerns and addressing them before they become problems,” she declared. “More importantly, we are addressing these items before they become nonconforming events.
“We address things like lack of clarity in our procedures and inconsistencies in our processes, and we recognize areas of risk where there is not a current protection in place,” she explained. “This is why the risk assessment has become a very important part of our ongoing discussions in the lab.”
Kirby endorsed obtaining both CLIA and ISO 15189 certifications. Labs can take on the process without feeling overwhelmed. “Don’t fall prey to the idea that you have to have everything perfectly in place before you start the process,” Kirby suggested.
“It’s a learning process and—as ISO 15189 requires—it is an ongoing improvement of quality,” she concluded. “Overall, I believe this is a very achievable dual accreditation, and it can be very beneficial if your lab gives full attention to its implementation.”
Contact Tamara Kirby at firstname.lastname@example.org.
A2LA Dual Accreditation Recognized Worldwide
ADVANCED DIAGNOSTICS LABORATORY received its dual CLIA and ISO 15189 accreditation from deeming authority American Association for Laboratory Accreditation (A2LA). A2LA is a signatory to a mutual recognition agreement with the International Laboratory Accreditation Cooperation (ILAC). This means an A2LA accreditation is accepted by other ILAC-accredited labs worldwide.
The College of American Pathologists (CAP) also offers CLIA and CAP 15189 accreditations. Currently, CAP is not shown as a signatory on the websites of ILAC or the InterAmerican Accreditation Cooperation (IAAC).
Lab’s Testing Capabilities Enjoy International Reach
ADVANCED DIAGNOSTICS LABORATORY (ADL) OPENED IN JULY 2020 during the early stages of the SARS-CoV-2 pandemic with the intent of providing a broad range of testing services for doctor’s offices, hospitals, and clinics.
“When the lab initially opened, it did not plan on doing COVID-19 testing, but quickly pivoted to performing rapid antibody and PCR testing for both home collection and a drive-thru mobile site in San Antonio,” stated Tamara Kirby, Lab and Quality Manager at ADL.
By the end of 2020, ADL had performed COVID-19 testing on nearly 15,000 samples, and it completed approximately 65,000 of those tests in 2021. Most of its COVID-19 testing has been performed in the U.S., but the lab has also done travel testing in more than 20 other countries, including Australia, China, and Canada.
In Q4 2021, EKF Diagnostics, a global medical diagnostics company headquartered in Cardiff, Wales, U.K., purchased ADL. The acquisition positioned ADL to rapidly expand its testing capabilities nationally and globally.