For accredited biobanks, a path to CLIA equivalence

Biobanks affiliated with CAP-accredited laboratories should already be familiar with the BAP checklist content, Dr. Branton says. Freestanding biobanks that haven’t had exposure to clinical lab inspections, on the other hand, may benefit by having a staff member spend time in a hospital laboratory or participate in a biorepository inspection.

Dr. McCall cautions that a few requirements such as those for digital image analysis could catch biorepositories off guard if they aren’t cognizant of the additions. “But I don’t see that any of them would be problematic or particularly challenging. It’s just that they’re different and biobanks need a little bit of time to become aware of the changes.”

On the other hand, documentation has been a “common challenge for biorepositories that are new to the overall accreditation process,” Dr. McCall says, “particularly regarding overarching quality management plans, for example, or documentation of personnel training and competency.” Dr. Branton agrees: “A lot of biobanks get into trouble not so much because they’re not doing things correctly, but because they’re not capturing and documenting correctly.”

The Biorepository Accreditation Program grew more rapidly than committee members initially believed it would, says Dr. Branton.

“What we’ve experienced in the program is sometimes called the iceberg effect,” Dr. McCall says. “That is, it’s very difficult to get a handle on the actual number of biorepositories in the United States.” Initially, BAP Committee members believed the program would address the needs of a small, vocal community of biobanks. “But it’s become apparent there are many, many biorepositories that are just not visible to us.”

Some of these, she speculates, are offshoots of individual research or disease-specific collections. Others likely formed in response to increased demand in the biomedical research industry more recently, after the BAP was developed. “We suspect there’s an even bigger market for biorepository accreditation, and a growing market,” she says.

CLIA equivalence, however, “is something we didn’t even think about seven years ago” when the program was established, says Dr. Branton. “And that’s just one example of how rapidly this area is evolving.”

Prior to there being a path to CLIA equivalence for biorepositories, “the laboratory medical director always had the ability to set internal policies,” Dr. McCall says. “As a committee, we were aware of clinical labs whose medical directors simply created internal policies” allowing samples from CAP-accredited biorepositories back into the lab for clinical testing. But, she notes, “this type of internal policy could be more limited in that it might not allow samples to come back from small investigator academic laboratories.” And some laboratory medical directors may have been hesitant to make those calls, Dr. McCall says, despite having jurisdiction to do so.

The biobank director who initially brought the need for CLIA equivalence to the committee’s attention eventually gained accreditation under the Laboratory Accreditation Program, Dr. Branton says. “Even though they were a biobank,” he explains, “they reconstituted themselves for inspection purposes as a clinical laboratory so they could get CLIA certification.”

“I think directors of CLIA-certified diagnostic testing laboratories will probably, as the word gets out about this new alignment, feel more comfortable with BAP-accredited and CLIA-compliant biorepositories and accepting samples back for clinical care,” says Dr. McCall.

But the need to transfer samples between biobanks and clinical laboratories isn’t the only reason for the new focus on CLIA equivalence in biobanking, Dr. McCall says. For one thing, as pathology labs see increasing clinical workload and declining reimbursement, supporting research in addition to care has become prohibitively expensive for many clinical laboratories. “There’s a need for clinical research projects to be rerouted through a pathology-associated biorepository or research support lab separate from the clinical laboratory,” she says.

When that happens, “CLIA certification of the biorepository can provide assurance to the research sponsor or the FDA that samples used in the research were acquired, processed, and stored in a manner that protects their integrity and supports the overall validity of the research downstream.”

In addition, federal granting agencies have started to recognize CLIA equivalence as a standard that can be applied to biorepositories, so that language began to appear in requests for applications for grants. “When the NIH put out the All of Us biobanking RFA, they used language indicating that the applicant biorepository must be CLIA equivalent or CLIA compliant, even though there was really no mechanism to measure that,” Dr. McCall says. “Since the BAP already existed, and we were already so very close to what we thought the NIH meant by CLIA compliant and CLIA equivalent, we saw the opportunity to finish that alignment and formalize the CLIA equivalence of our accreditation program for biobanks.”

CAP-accredited biorepositories, Dr. McCall adds, may “benefit in their ability to seek federal grants or provide documentation in support of their quality practices for clinical trial support.”

With patient specimens moving freely “from one side of the house to the other,” as Dr. Branton puts it, the division between biorepositories and clinical diagnostic laboratories appears to be shrinking.

Says Dr. McCall, it’s always been a “two-way street.” In other words, clinical laboratories have also acted, to a certain extent, as biorepositories. Surgical pathology labs maintain leftover tissue specimens, and molecular diagnostics labs often save leftover extracted DNA for later use in patient care. “They’ve been in the business of storing samples,” she says. The BAP borrowed much of its material from the Laboratory Accreditation Program to begin with, “so there was already a high degree of alignment.”

Something the committee didn’t anticipate, however, was that several BAP requirements—freezer monitoring and quality of temperature stabilization, for example—ended up being stricter than the equivalent Laboratory Accreditation Program requirements.

“I think that was a bit satisfying to the committee, that perhaps we had something biorepository-specific we could offer to the clinical labs that would help them better maintain their specimens,” she says. 

Charna Albert is CAP TODAY associate contributing editor.