CEO SUMMARY: Quietly published in the March 25 issue of the Federal Register was a notice that CMS had granted deeming authority for CLIA to the American Association for Laboratory Accreditation (A2LA). This action gives laboratories in the United States a new choice to meet the accreditation requirements of CLIA. Founded in 1978, A2LA is itself recognized as compliant with ISO 17011 and has offered ISO 15189 accreditation services to clinical labs for more than a decade.
THERE’S A NEW PLAYER in CLIA accreditation! Last month, CMS named the American Association for Laboratory Accreditation (A2LA) in Frederick, Maryland, as an accreditation organization for clinical laboratories under CLIA for all specialty and subspecialty areas.
This significant announcement was made quietly and was published in the Federal Register on March 25. CMS wrote that, “We have determined that the A2LA meets or exceeds the applicable CLIA requirements.” The deeming authority is for four years, CMS said.
A2LA now joins a handful of organizations that have deemed status that allows them to accredit labs and inspect the labs in CLIA’s stead. This is also the first time in two decades that CMS has granted deemed status to a new organization for CLIA requirements.
“A2LA submitted its application for deemed status to CMS in January 2012, along with several boxes of supporting documents,” stated Roxanne Robinson, A2LA’s Vice President, COO, and Manager for Medical Accreditation Programs. “CMS was rigorous in assessing our capabilities, particularly as they related to the CLIA requirements addressing complaints, corrective action, and proficiency testing.”
A2LA expects quick engagement with clinical laboratories. “We have a number of labs that have indicated their interest in using our services once CMS granted us deemed status,” noted Robinson. “Thus, within the next 90 days we expect to have completed our first inspections and assessments of laboratories for CLIA accreditation purposes.
Three Options for Labs
“A2LA has three options,” she continued. “Option 1 is CLIA accreditation only and this service is priced competitively compared to existing CLIA deeming authorities.
“Option two is ISO 15189 accreditation only, a service we have offered to labs here in the United States for years,” noted Robinson. “ISO 15189 accreditation can be earned independent of CLIA accreditation requirements.
“Option three is what we call ‘Platinum Choice,’” she said. “In one assessment, with one team of assessors, a lab can accredit to CLIA requirements at the same time that it accredits to ISO 15189. In addition to the regular CLIA fees, a surcharge of just $2,500 per year would be added for the ISO 15189 accreditation.
“Platinum Choice gives labs a benefit that they have not had before,” emphasized Robinson. “In one assessment cycle, they can earn accreditation to both CLIA and ISO 15189 and what this means is that the laboratory test results they produce will be accepted throughout the United States (under CLIA) and in any of 80+ countries worldwide (under ISO 15189).
“We have to be clear,” she added, “that the accreditation under CLIA would be done with regard to the standards from CMS and the accreditation to 15189 would be under ISO (meaning the International Organization for Standardization).
Tested Once, Fully Accepted
“What is different is that this dual accreditation helps labs meet a goal we have here at A2LA,” continued Robinson, “which is to help testing labs handle specimens and be able to say: ‘Tested once—accepted every- where!’
“Global acceptance of medical lab test results is happening because there is more cross-border movement of medical lab specimens, along with rapid growth in clinical trials testing,” she said. “That makes this dual accreditation strategy a worthwhile advantage for labs that want to access these specimens and pursue these opportunities.
“Take this same point up one notch,” observed Robinson. “With the dual accreditation to both CLIA and ISO 15189, A2LA helps a laboratory not only say: ‘tested once—accepted everywhere;’ but, now, for the first time, the lab can also say, ‘accredited once—accepted everywhere.’”
In practical terms, the addition of A2LA as a deeming authority gives medical laboratory directors and lab administrators a new choice when it comes time for their lab to meet CLIA requirements. Several traits set A2LA apart from existing deeming authorities.
Accreditation of Labs
First, A2LA has deep experience in the field of accreditation. It is dedicated to the formal recognition of competent testing and calibration laboratories, inspection bodies, proficiency testing providers, and reference material producers. It has served laboratories in a large number of industries since its founding in 1978 as a non-profit, public service membership society.
Second, A2LA can accredit clinical laboratories in the United States to the requirements of ISO 15189 and, because A2LA is a member organization of the International Laboratory Accreditation Collaboration (ILAC), the lab test results produced by that laboratory will be accepted in any other country worldwide that is a signatory to ILAC.
Third, A2LA becomes the only organization with CLIA deemed status here in the United States that is, itself, recognized as compliant with ISO 17011: Conformity assessment–General requirements for accreditation bodies accrediting conformity assessment bodies. Accreditation to ISO 17011 is a requirement for an accrediting organization to be a member of ILAC.
Fourth, A2LA has broad authority under its deemed status for CLIA. This is also true of the four other groups that have deemed status for CLIA. They are: COLA, College of American Pathologists (CAP), The Joint Commission (TJC), and the Healthcare Facilities Accreditation Program (HFAP) offered through the American Osteopathic Association.
“Other accrediting agencies are niche accreditors and have deeming status specific to such disciplines as cytology and blood banking,” Robinson said. “It’s important to note A2LA now has deemed status for every specialty covered by the CLIA law.”
Some lab directors and lab administrators may question why a CLIA-accredited laboratory would also want to earn accreditation to ISO 15189. “When you examine the advantages and disadvantages of both CLIA and 15189, you see that it is quite a good marriage to be accredited to both standards,” observed Robinson.
“CLIA is strong in some areas where ISO 15189 is not as strong, and the opposite is true as well. ISO 15189 is strong in areas where CLIA is not as strong,” she said. “That’s a message we want to get out to clinical labs.
“Having both accreditations can strengthen the management operations of a clinical laboratory,” continued Robinson. “To date, just a handful of labs in the United States have seen the advantages of pursuing a standard beyond CLIA accreditation. Today, about 40 labs are accredited to ISO 15189 in this country.”
“Another significant benefit is the adoption of the quality management system (QMS) that is at the core of ISO 15189,” stated Larnell Simpson, A2LA’s Director of Marketing and Medical Affairs. “Once a laboratory implements the QMS of ISO 15189 and establishes the operational culture needed to sustain it, the lab gains added capabilities to continuously improve quality while managing costs. This will be a critical success factor going forward as labs find themselves serving integrated care organizations and being paid differently.”
Dual Accreditation Option
Now that the decision by CMS officials to grant deeming status to A2LA is official, it will be interesting to see how many medical laboratories will actively use A2LA for either or both accreditations to CLIA and to ISO 15189.
CMS and Quality Management Systems: Still an Uncertain Path toward Acceptance
AROUND THE WORLD, the quality management system (QMS) known as ISO 9001 has gained wide acceptance. Already in use by tens of thousands of manufacturers, distributors, and service organizations, it is now poised to achieve wider acceptance by hospitals, physicians, and clinical labs globally— despite slow acceptance in the United States.
The QMS of ISO 9001 forms the foundation of ISO 15189 Medical Laboratories, as it does for all the other ISO standards. Here in this country, CMS officials have been slower to warm up to the potential of the QMS of ISO 9001 to underpin both the accreditation process for health providers, as well as to contribute to improved quality, patient safety, and lower overall costs of care.
One reason for this is that the accreditation standards used by the federal Medicare program were originally established in the 1960s and 1970s, following Medicare’s creation in 1966. Thus, much of the management principles contained in these standards are now five decades old. Moreover, to change any of these requirements requires both Congressional action and a multi-year rulemaking process.
Meanwhile, over that same 50 years, new management techniques and methods have emerged and undergone continual refinement. Today, rooted in the quality management work done by W. Edwards Deming, Joseph Juran, Taiichi Ohno and others, we have the tools of Lean, Six Sigma, continuous improvement, and system of prevention, to name just a few.
Thus, THE DARK REPORT considered it progress when, in October 2008, CMS granted deeming status to Det Norske Veritas (DNV) for Medicare accreditation of hospitals. DNV’s value proposition was that it could not only help the hospital meet its Medicare Conditions of Participation (COP), but the hospital could also earn certification to ISO 9001 at the same time. (See TDR, June 8, 2009 and December 14, 2009.)
Since that date, DNV has become the accrediting agency for several hundred hospitals in the United States. This shows there is interest among hospital administrators to pursue the advantages that come from implementing the QMS of ISO 9001.
Granted Deemed Status
Now comes the news that, as of last month, CMS has granted deemed status to the American Association of Laboratory Accreditation (A2LA) for accrediting clinical laboratories to the requirements of CLIA. Given that A2LA is itself recognized as compliant with ISO 17011 and already accredits medical laboratories to ISO 15189, this must be seen as another forward step by CMS officials to be supportive of the QMS embodied in ISO 15189.
By the way, these developments did not go unnoticed by other agencies with deemed status. In 2012, The Joint Commission announced the launch of its own program to help hospitals certify to ISO 9001 and several other ISOs. The College of American Pathologists initiated its ISO 15189 accreditation service in 2008.
For previous coverage on the subject of QMS and the accreditation requirements of ISO 15189, these earlier issues of THE DARK REPORT will be helpful: October 12, 2009; November 23, 2009; and April 6, 2010.
A2LA Outlines Standards for Its CLIA Assessors
ONE AREA OF CONCERN for clinical laboratories pursuing CLIA accreditation with an assessment organization is the ability and the experience of the organization’s assessors.
The assessors used by American Association for Laboratory Accreditation (A2LA) in Frederick, Maryland, are paid professionals and are not allowed to consult for the laboratories where they perform assessments as part of the accreditation process.
A2LA requires all of its assessors to meet two primary criteria. First, they must have at least 10 years of bench experience in which they were actually performing tests.
Second, the individuals must have several years experience as a laboratory supervisor. “This is the baseline before A2LA will consider an individual for any role as an assessor,” noted Roxanne Robinson, A2LA’s Vice President and COO. “We use a rigorous process to evaluate and prepare our assessors.
“First, their experience and credentials are reviewed,” she said. “Each assessor is then designated to work in certain areas, based on their skills.
“Next, they undergo five days of on-site training and are required to pass an examination,” continued Robinson. “We also review their interpersonal skills to ensure that they are fair and unbiased. In some areas, such as pathology and cytology, we select only individuals who are board certified and are medical doctors.
“The next step is to evaluate them on assessments in a technical role,” she explained. “During their qualifying as a technical assessor, we send our seasoned assessors along with them to ensure that they are conforming to A2LA standards and CLIA or ISO requirements. Once they are approved as assessors, every three years, we go in the field with them to review their skills.”