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POLS adjusting to life under CLIA.

IN AN IMPLEMENTATION process marked by more fits than starts, the Clinical Laboratory Improvement Amendments of 1988 (CLIA) '88) continue to undergo fine-tuning that requires close monitoring by the entire lab industry.

Although the Department of Health and Human Services spent much of the year asserting there would be no major regulatory changes, Secretary Louis Sullivan, M.D., did announce a number of revisions during the fall. And it's still considered likely that HHS will publish a set of "final final" CLIA regulations by the end of the year.

For openers, HHS determined that claims for lab tests would continue to be paid "without regard to CLIA registration" until Dec. 1, 1992. The 90-day phase-in was made necessary by the Government's inability to process all the certificates requested by labs as of Aug. 31.

On Sept. 1, the department also announced that testing personnel engaged in high-complexity testing and employed as of that date would be allowed to continue working night shifts in the absence of on-site supervision--provided that the work performed during those times is checked within 24 hours.

Officials said they intended to "reevaluate this requirement and at the same time prevent disruption of laboratories, especially those in rural areas." The change was made partly in response to small hospitals' concerns that the supervisory requirement would effectively prevent many individuals with years of experience from performing these tests.

Among other moves, HHS said workplace drug testing will not come under CLIA jurisdiction, at least until concerns over a potential chilling effect on such programs can be evaluated. Further, it was announced that sanctions will not be imposed for the first citation of unsuccessful proficiency testing during the first PT cycle of three consecutive events unless there is an immediate threat to public health.

Some of the most controversial changes--which some observers are calling preferential treatment--apply specifically to physicians' office laboratories (POLs). Notably, sources confirm that the new CLIA Advisory Committee has recommended that HHS consider a new waived test category under the regs' test complexity classifications. The category would encompass certain procedures, particularly some microscopy procedures, commonly performed by POLs. The panel's recommendation was under advisement within HHS at this writing.

Physicians' office labs will also be spared from unannounced inspections, unless a problem is suspected or a complaint lodged. It's unclear, however, whether other labs will gain the same exemption. CLIA regulations are generally interpreted as calling for unannounced inspections. But HHS surveyor guidelines give inspectors discretionary authority to allow any lab site to three days' advance notice prior to routine survey.

Also helpful to POLs, the Health Care Financing Administration (HCFA) will begin inspections with the approximately 12,000 labs previously regulated under CLIA 1967. The delay will mean most POLs won't face inspection until some time next year. Privately accredited labs will not be inspected until all "deemed status" applications are approved or denied.

It is perhaps no coincidence that these changes were made after an appeal to the Bush Administration from physicians, particularly representatives of the American Medical Association and the American Academy of Family Physicians. In a meeting with the Administration's Council on Competitiveness, the representatives told officials that CLIA would disrupt of physician practices and that patients' access to services might suffer because doctors might drop out of clinical testing.

Whatever pressures were brought to bear, the changes regarding POLs raised charges that HHS was unfairly giving physicians special treatment. Responses rumored to be under consideration including hearings to be called by House Commerce Committee Chairman John Dingell (D-Mich.), a vocal critic of HCFA's handling of CLIA, and an oversight study by the HHS Inspector General's office.

In the meantime, there is little evidence that CLIA is forcing physicians out of lab testing in droves. At last count, some 135,000 lab sites had registered with HCFA. J. Stephen Kroger, M.D., chief executive officer of the Commission on Office Laboratory Accreditation (COLA), says the proportion of POLs in that number is speculative, as HCFA does not yet have a breakdown. He notes, however: "If the statistic is accurate that there are 100,000 or so office labs, and 12,000 labs were previously regulated, then it would appear physicians are not deserting their laboratories."

Physicians, Kroger believes, are just beginning to cope with CLIA, having previously been occupied with the resource-based relative value scale, OSHA regulations on transmission of bloodborne pathogens, and self-referral limitations. He adds that "one of the reasons they haven't taken CLIA on right away is that there have been so many delays" in implementation.

COLA is one of several groups with applications pending for deemed status accrediting power. Kroger indicated that COLA anticipates approval by Jan. 1. But even that won't be soon enough to eliminate the confusion that has been created among POLs. "One of the difficulties we've experienced with the implementation process is that HCFA is pushing ahead with the application for survey before they have approved any accrediting organizations," Kroger explains.

That application, HCFA form 116, has thus added another level of uncertainty by asking labs whether they are accredited by a body that hasn't been recognized with deemed status. That has led some labs to question the advisability of spending the time, effort, and expense of going through private accreditation.

In reality, says Kroger, "What HCFA is saying is that if labs are currently approved by an accrediting organization, or plan to be, then they should mark the form accordingly." And, he points out, "Any laboratory that chooses to list accreditation on HCFA 116 will not be billed by HCFA for a period of nine months to a year. Even if a lab is not currently accredited, but intends to be, they can choose that option and have time to sign up and go through the process."

COLA, which Kroger says is the primary group that accredits POLs, has altered its survey and accreditation process in light of CLIA's focus on biennial inspections. Before, the process relied heavily on a self-assessment mechanism along with other performance measures. Now the self-assessment is used primarily as an educational tool that aids preparation for the on-site inspection.

POLs coming into conformance with various CLIA requirements will face different challenges. "Each area potentially can be a problem; it depends on the sophistication of the individual lab," Kroger says. For example, he notes that many laboratories, not just POLs, have difficulty with sufficiently detailed record keeping. But that can be improved, he says, by designing forms better and accenting the importance of collecting information.

As to other challenges, Kroger notes, "Labs need to practice proficiency testing before they're graded. I think that's why HCFA is phasing it in: to give them an opportunity to participate in two or three test events prior to being graded."

Kroger believes CLIA's quality control requirements are reasonably straightforward, and that POLs that follow manufacturer directions won't have any problem.

He observes, however, that to some extent CLIA '88 "reorients the concept of quality assurance from what people used to think about." In today's context, Kroger says QA involves "looking back over laboratory processes and assuring yourself that they are actually working."

Kroger is a member of the CLIA Advisory Committee, which held its first meeting Oct. 28 and 29. The blue-ribbon panel is charged with making recommendations to the Government about CLIA standards.

"For a group of 20 individuals who had never worked together before, I think we got a surprising amount of work done," Kroger says. He was particularly encouraged that there was no evidence of significant "partisan positions," and he predicts it will be a "very active committee."
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Title Annotation:physicians' office laboratories; Clinical Laboratory Improvement Amendements of 1988
Author:Albertson, David
Publication:Medical Laboratory Observer
Date:Dec 1, 1992
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