Congress to open hearings on laboratory testing quality.

Congress to open hearings on laboratory testing quality

In the wake of numerous media broadsides charging spotty clinical lab performance, Congress will conduct hearings this month on the quality of lab testing.

The Senate Governmental Affairs Committee scheduled special oversight sessions for March 23 and 24 after several months of preliminary investigation. Leading members of the House have expressed interest in holding a similar review, although no dates had been set at press time.

The Senate panel will be considering the Federal Government's role in insuring quality testing and the Health Care Financing Administration's enforcement efforts under the 1967 Clinical Laboratory Improvement Act. Lawmakers will look at issues relating to inspections, proficiency testing, and physician office laboratories. No specific legislation has been introduced, although it is expected that committee members will use the hearings to determine whether a need for legislation exists.

Of late, laboratory associations have been busier with reimbursement issues than with press reports. The budget law approved last December will cut Medicare test payments approximately 8.3 per cent beginning next month. Many association officials, however, are now seeing a link between payments and quality concerns.

According to Mark Birenbaum, associate administrator of the American Association of Bioanalysts, "The hearings on quality control are very pertinent because they tie in with the legislators' attitudes on reimbursement. If they think labs are doing a poor job, they're likely to be much tougher on us during the next round of budget negotiations."

Although payments will not be a direct focus of the hearings, they are sure to surface in discussions of expenditures on quality control mechanisms.

During February, the AAB sponsored meetings in four cities in an effort to craft a lobbying strategy. On the eve of those meetings, Birenbaum explained: "We intend to discuss what has happened so far and attempt to determine the extent of industry concern about the budget cuts. We want to see if we can present a united front to legislators in that regard. If we don't band together, we will continue to be a target for the budget cutters."

Birenbaum noted that many smaller, more Medicare-dependent labs will be particularly hardpressed to absorb the impending reductions. He said many AAB members may be in severe financial trouble by the end of this year.

Some association officials believe that if Congress does anything on quality assurance in 1988, it will enact changes in the regulation of cytology procedures --an area with some widely publicized problems. HCFA has reportedly urged the Centers for Disease Control to move ahead with a cytology proficiency testing protocol that might be applied to Medicare certification. Last summer, the CDC floated a proposed uniform proficiency testing program to assess eight specialty areas, not including cytology.

In the meantime, the American Society of Clinical Pathologists has recommended independent industry action to assure quality in the performance and interpretation of Pap smears. The guidelines state:

Screening of a cervical/vaginal (Pap) smear should be performed in an accredited laboratory by certified cytotechnologists.

Reasonable limits on the daily volume of cytological smears examined and the hours worked by each cytotechnologist should be based on recommendations of professional organizations.

Cytology screening should be performed under the supervision of a certified pathologist or cytopathologist who has appropriate experience in the field.

The pathologist who directs the cytopathology laboratory should establish and administer an ongoing quality assurance program with standards recognized by national professional organizations.

Pap smear tests should be available to patients at a reasonable cost.

The strong financial incentives to perform low-quality or substandard Pap smears should be eliminated. Pap smear testing revenue should be used specifically for those lab services.

The Congressional hearings may also present an opportunity for laboratorians to address criticism about the reliability of AIDS testing. Last fall, the Office of Technology Assessment presented a study suggesting that HIV antibody tests are unreliable.

The report set off alarms in many quarters, including Capitol Hill, that people are being erroneously told they have been exposed to the AIDS virus. Lawmakers expressed concerns that AIDS testing is not properly regulated and that unqualified labs may have entered the business.

Industry leaders have already taken some steps to moderate those concerns. Herbert F. Polesky, M.D., chairman of the College of American Pathologists' transfusion-transmitted viruses committee, said the Government numbers "have been made to sound startling, but they actually are not. This is a matter of misplaced emphasis."

Polesky estimates the true error rate for false-positive confirmations from the Western blot assay is only about 2 per cent. He believes the Office of Technology Assessment went astray in examining test specificity and sensitivity in an extremely low-prevalence group of subjects. Using such a population virtually guarantees a high rate of false positives, according to Polesky.

The test may get a further vote of confidence at the Congressional hearings from a newer study by the Walter Reed Army Research Institute of Washington, D.C. That report states that screening of Army personnel during the past two years shows an error rate of 1 out of 135,000 instances, or 0.001 per cent.

HCFA may face a chilly reception in Congress for, among other things, taking so long with a report on possible physician office laboratory (POL) regulation.

The report was due nearly a year ago, but still had not been released at press time. Lawmakers scheduled an extension of Medicare standards to high-volume POLs as a last-minute addition to last fall's budget package. But it's unclear what the mood will be when this month's hearings convene. Product suppliers to the POL market are already pressing Congress to reverse its action.

HCFA may also be questioned about apparent plans to alter lab personnel standards. A regulatory agenda published last fall observes that hospital-based and independent labs face varying licensure requirements from state regulators, Medicare, and private accreditation groups.

The agency wrote, "Inconsistent standards create confusion regarding necessary credentials and performance standards." A proposal now being drafted "would identify common standards and propose other revisions to rules aimed at reducing direct and indirect costs of clinical laboratories and at increasing quality of output."

Reducing expenses may sound good, but many in the lab field are not pleased. The ASCP, for example, is concerned that HCFA plans to eliminate personnel standards below the lab director level.

In a letter to HCFA, ASCP President George C. Hoffman lauded efforts to reduce the cost of doing business with Medicare. But, he stated, "Elimination of personnel standards without further study appears entirely premature and potentially dangerous to Medicare beneficiaries' health."

The ASCP is attempting to build an industry coalition to oppose such a measure. The group will have to move quickly, however: HCFA reportedly plans to set the rulemaking process in motion sometime next month.

OSHA fine detailed

The Occupational Safety and Health Administration fined a Louisiana blood donor facility $650 for violating Centers for Disease Control AIDS prevention guidelines.

The fine, the first levied under new OSHA policy, was for not providing employees with protective gloves and not labeling trash bags that contained potentially contaminated blood waste products. The citations were made following an employee complaint to the agency. OSHA fines can range up to $10,000 for willful and repeated violations of the CDC standards.

In other AIDS-related news, a new survey of 100 departments in hospitals, nursing homes, blood banks, and other health institutions shows that 86 per cent of all facilities make gloves available to high-risk workers. However, only 65 per cent were found to offer gloves of sufficient protective quality, and only 57 per cent made gloves available in sizes to fit all workers properly.

Further, only 22 per cent of the facilities have standard operating procedures on AIDS prevention training and personal protective equipment. The survey was done by the Service Employees International Union, which represents some 300,000 health care workers, including 60,000 professional members such as lab technologists and blood center employees.