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HCFA advances CLIA '88 implementation.

HCFA advances CLIA '88 implementation Federal officials have pushed ahead with the Clinical Laboratory Improvement Amendments of 1988 by issuing supplemental proposals on "deemed status" reviews and starting analysis of public comments on the initial proposed regulations.

In an 11th-hour move, the Health Care Financing Administration extended the deadline for comments on its main proposals from Aug. 20 to Sept. 21. Lab representatives had sought an additional 60 to 90 days to furnish their input, but, ironically, the volume of early responses was a factor in denying those requests.

A notice in late August said HCFA had already received some 10,000 comment letters, indicating the issues of concern "have likely already been articulated and are part of the public record."

On Aug. 20, HCFA issued additional CLIA regs on deemed status recognition of private and state accreditation programs.

By law, a lab can satisfy Federal requirements if it is licensed by an approved state agency or accredited by an approved private, nonprofit organization. These programs must, in turn, enforce standards that meet or exceed CLIA criteria. Lab inspection fees would be set by each program.

According to HCFA, the College of American Pathologists and New York State have the only accreditation/licensure programs whose labs currently are deemed to meet CLIA requirements. Once the new proposals are finalized, HCFA will review these programs to see if they still measure up, and determine whether other organizations merit similar recognition.

HCFA will apply the same set of performance requirements spelled out in its lab certification guidelines issued May 21. The rules will be uniform for private accreditation organizations and state licensure agencies since both seek to assure that labs meet health and safety laws. Individual labs that fall out of compliance with one of these programs could also be judged out of compliance with CLIA, pending a follow-up investigation by HCFA.

The agency is seeking comment on ways of proving that certain standards, although different from the Federal approach, are indeed just as stringent. Officials are trying to determine whether such a "crosswalk" would be administratively feasible.

HCFA will also assess a program's inspection process as part of the criteria for deemed status. Regulators will look at qualifications of the inspection team, comparability with HCFA procedures, continued monitoring efforts, and the ability to transmit reports by computer. The agency would periodically require facility-specific data such as proficiency testing scores and the names of any labs that have licenses or accreditation denied, suspended, withdrawn, or revoked.

Further, the rules would permit "validation inspections" of labs by HCFA or one of its agents. Labs could be inspected at random or in response to complaints about an organization's accrediting/licensing process. Random checks would be comprehensive at each facility, but complaint investigations would be limited to alleged noncompliance with specific CLIA conditions.

The agency was set to receive comments on the deemed status proposals through Oct. 19. A fourth piece of the puzzle, penalties for CLIA noncompliance, was expected to be released in September.

While HCFA has already given the lab industry much to think about, the industry has clearly responded in kind. Among the comments filed is a six-volume transcript of proceedings from the National Congress on CLIA '88, held Aug. 6-8 in Washington.

An executive summary that is now available from the National Committee for Clinical Laboratory Standards outlines 16 key findings reached by the 400 participants. Among them:

* There was a strong feeling that the concept of site-neutral regulation is basically flawed because the various testing sites covered have distinctly different operational and clinical needs that should be addressed. General agreement favored use of a multi-disciplinary committee to help craft specific regulatory language and implementation policy.

* Patients seeking services from physician offices and rural and inner-city hospitals would be adversely affected by the rules. The cost of quality control/quality assurance, personnel qualifications, and proficiency testing would force many providers out of operation and thus limit patient access.

* It would be sufficient for the general supervisor of a Level II lab to be "on call" rather than "on site" during all hours of testing. Attendees expressed concern that many smaller labs, including physician office, specialized testing, public health, and satellite labs, would have great difficulty finding personnel qualified under the proposals.

* Participants strongly agreed the regulations should explicitly encourage PT providers to use group means as an approach for setting target values when appropriate.

The executive summary also contains highlights of remarks by a team of officials representing the Federal government. The degree of their participation created a controversy when government attorneys initially advised that the representatives should limit their remarks to a recap of the May 21 proposals.

After negotiations with the host NCCLS, officials did elaborate on the bases and assumptions used to formulate the proposals. They did not, however, discuss the relative merits of alternatives.

Among the remarks, Wayne Smith, Ph.D., director of HCFA's Office of Survey and Certification, explained the criteria used in developing the proposals' three-level complexity model. Perhaps the most controversial aspect is the tests assigned to the "waivered" category as being low risk. Amplifying on the approach used, Dr. Smith said the category encompasses "tests that detect non-pathologic conditions, tests that are not the only indicator of underlying diseases, and tests where the results do not usually require immediate clinical intervention."

On other matters, Betty Addison, a health scientist with the Centers for Disease Control, conceded that requirements to rescreen the previous 500 slides of an individual who fails a PT event in cytology are very stringent, suggesting they would be the subject of additional review. She noted, however, that the twice-a-year personnel PT requirement is part of the CLIA legislation, giving regulators no flexibility in that regard. Still, it is expected there will be some different requirements in the proficiency testing of "cytoscreeners" and technical supervisors.

Responding to a question, HCFA laboratory specialist Rhonda Whalen was unable to give a definitive answer on how the agency will treat a large institution with multiple testing sites. She noted that a single-certificate approach has been applied to universities and large hospitals, but other officials said that could create problems when it comes to meting out penalties. It's considered likely the decisions will finally be made on an institution-by-institution basis.

Coalition opposes

competitive bidding

A coalition of 10 professional organizations is urging HCFA not to implement competitive bidding demonstration projects for lab services.

Congress last year failed to extend a moratorium that for several years had prevented HCFA from testing the system, which is designed to elicit lowest-cost test prices for Medicare. A provision in the Administration's proposed budget says Health and Human Services will give "serious consideration" to the plan next fiscal year.

A coalition letter to HCFA Administrator Gail Wilensky, Ph.D., said competitive bidding would substantially diminish lab services in demonstration areas. It cites the example of a contract awarded by the U.S. Air Force for Pap smears, where it is charged that the winning lab performed so negligently that 700,000 smears containing errors had to be impounded.

Coalition members further assert that the project is unnecessary because reimbursement reforms have successfully held the line on lab costs. The increases that have occurred, they say, are the result of more tests being ordered, not price hikes.

Prospects for action remain unclear. The contract with the firm that designed the project expired last year, and HCFA officials say it would take another year to revive the plan.

The coalition consists of the American Association of Bioanalysts, American Clinical Laboratory Association, American Group Practice Association, American Medical Association, American Medical Technologists, American Society of Clinical Pathologists, American Society of Internal Medicine, American Society for Medical Technology, College of American Pathologists, and the International Society for Clinical Laboratory Technology.
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Title Annotation:Health Care Financing Administration; Clinical Laboratory Improvement Amendments of 1988
Publication:Medical Laboratory Observer
Date:Oct 1, 1990
Previous Article:Breaking with tradition to relieve the shortage.
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