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Date: Thursday, March 28, 1996 FOR IMMEDIATE RELEASE Contact: HCFA Press Office(202) 690-6145
The Health Care Financing Administration has begun using a new flexible survey process which is in effect for some clinical laboratories with excellent performance records.
The self-evaluation procedure, called the Alternate Quality Assessment Survey, is designed to be used by certain laboratories for recertification purposes under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) in lieu of an on-site survey. HCFA has begun recertifying laboratories with exceptional past performance by allowing them to complete a self-survey questionnaire.
To supplement the new survey process, no laboratory will go longer than four years without an on-site survey. HCFA also will perform, every two years, random on-site surveys of a 5 percent sample of laboratories that are using the new survey process to verify its effectiveness.
"This flexible survey process supports last year's regulatory reform initiative by Vice President Gore to improve the CLIA program," said HCFA Administrator Bruce C. Vladeck. "It rewards labs with good performance by using a self-assessment format. We believe the new process will maintain quality for beneficiaries by better focusing our inspections and rewarding exceptional performance.
"By surveying 5 percent of the labs that use the new process, we will ensure that the excellent performers continue to deliver high-quality service," Vladeck said.
"The survey form contains questions that reflect an outcome-oriented, quality improvement type of assessment," Vladeck said. "The form's questions are patterned after the quality assurance requirement of the CLIA regulations."
CLIA sets uniform quality standards for clinical laboratories. The laboratories that conduct moderately or highly complex tests must be surveyed and recertified by HCFA every two years and must participate in proficiency testing. Until now, all surveys have been conducted on-site.
Currently, HCFA is responsible for implementing federal quality assurance standards for 152,000 laboratories. Of these laboratories, 59 percent are exempt from surveys because they do only simple tests. The remaining 41 percent are subject to routine surveys under CLIA.
Laboratories surveyed under the CLIA program and found to have exceptional performance -- that is, no deficiencies or only minor deficiencies and satisfactory proficiency testing -- are potential candidates for the Alternate Quality Assessment Survey.
Under the new survey process, a laboratory's completed self-assessment form and supplemental documentation are reviewed. If no problems are identified, the laboratory will be recertified for two years, the duration of the CLIA certification cycle.