Microbiologists Gear Up To Encourage Better Clinical Laboratory Standards

New federal rules for proficiency testing, personnel, and waived tests worry scientists in clinical laboratories WASHINGTON -- When the 90th annual meeting of the American Society for Microbiology convenes this week in Anaheim, Calif., the talk in the halls will almost certainly be about new federal regulations for clinical laboratories. Those proposed regulations, which implement the Clinical Laboratory Improvement Amendments of 1988, will affect tens of thousands of micro- biologists. The 1988 law, known as CLIA 88, remains one of the more hotly contested regulatory issues in the microbiology community. This law revises standards set more than 20 years ago for clinical laboratories. At that time, a complex, book-length set of regulations was developed to assess and maintain those standards, which were based primarily according to whether the laboratories were located in a hospital or here. CLIA 88 shifts the basis for regulation so that the rules are determined by the types of tests performed instead of where they are done. Some scientists worry that this shift, which also includes a deemphasis on personnel qualifications, could undermine quality control. This week the government begins reviewing comments submitted on the latest proposed regulations. CLIA 88 was created during a period when Congress was pushing for increased oversight but President Reagan was insisting on deregulation. So while Congress was still debating what would become CLIA 88, the Reagan administration sidestepped legislators by publishing the new oversight rules that are at the heart of the controversy. These proposed rules replace personnel standards with periodic checking on the accuracy of the testing as the primary assessment of qualifications. Some tests will be exempted from scrutiny altogether. Also, standards would be determined based on a laboratory's performance, rather than on whether or not it was located in a hospital. Clinical tests represent one of the most profitable sectors in the health care industry. And scientists want to preserve their professional pride by keeping the tests under their purview. On the other hand, there is a public mandate to cut costs. Physicians want to do more testing in their offices, and new diagnostic kits are making that possible. Microbiologists have worked hard these past two years presenting their case to regulators. In March, after more than a year's delay, new rules were proposed that they believe are a step in the right direction. But scientists say they worry that the regulations underplay the importance of well-trained experts in assuring high quality testing. The microbiologists are most concerned about three aspects of the regulations: standards for personnel, implementation of proficiency testing, and exemptions for certain tests. Those regulations, they say, raise the specter of a sacrifice of quality in the name of cost. For example, if regulations cease to require that personnel have specific qualifications, then labs may cut corners in staffing so as to beat out the competition. "The question is, What is the most effective way to provide patients with valid results?" says University of Virginia microbiologist Dieter Gr”schel. "The lab's primary cost is for personnel, and if you hire people who are less qualified in order to lower costs, that's not the answer." Adds John Smith, microbiology supervisor at HCA Wesley Medical Center in Wichita, Kans., "In microbiological tests, it's not a matter of putting a specimen in an instrument and reading out a number. Here, the employee is the instrument." The new regulations set personnel standards based in part on the complexity of tests, according to Rhonda Waylan, branch chief at the federal Health Care Financing Administration (HCFA). In the past, standards were set according to location. Consequently, rules for independent labs were different from rules for labs in hospitals. But the new rules may mean that, as equipment becomes more sophisticated, the machines will be regulated more closely than their operators. The federal government also plans to depend more on proficiency testing (PT) to assess a laboratory's quality than on the qualifications of the people doing the work. Under the current proposal, labs will be asked to test five specimens four times a year. Those scores must be 80 percent accurate to pass muster, according to HCFA regulations. Microbiologists fear that, as a result, scores will become the sole determinant of a lab's continued viability as opposed to a mix of criteria that includes the qualifications of people doing the tests. There are complaints that such an absolute number falsely implies that microbiology is an exact science. Labs are also afraid of being tested on specimens and procedures not routinely performed in their facilities. Others would prefer to see labs graded in relation to one another, not on some absolute scale. HCFA's Waylan refutes all these concerns, however, by noting that labs will be tested only on what they are already supposed to know. "Labs will not have to do any more on PT than they do on patient testing," says Waylan. "They will only be challenged in what they regularly do. This is a case where you tell us exactly what you do and we test you specifically on it." And, she adds, regulators understand that some tests are not exact. These new laws also exempt some tests from oversight and regulation. At issue is which ones should receive waivers. Each time a suggested list leaks out of the government, microbiologists grow wary. They say that the quality will decline if these tests are not done under regulatory purview - particularly if they are performed by individuals untrained in microbiology. But physicians argue that performing these tests in their office labs will increase a patient's access to care. The most recently leaked proposed waiver list includes two tests of particular concern to microbiologists. One diagnoses rheumatic fever. The other (according to the list) appears to test for gonorrhea. Obtaining an accurate reading on this gonorrhea test, called a gram stain, seems to be an acquired art. This notion is supported by a 1988 Temple University study that found an error rate of up to 40 percent in gram stain readings at physicians' office labs. Even so, 16 physicians' professional associations and two manufacturers have sent a letter to HCFA Administrator Gail Wilensky encouraging her to add more tests to the waiver list. In addition, the letter asked that HCFA view improved technology as a way to balance lowering personnel standards. There is little hope that the regulations will be made clearer soon. Oversight of clinical laboratories dates to the Medicare Act of 1965. Those rules covered only those laboratories seeking Medicare reimbursements. In 1967, the Clinical Lab Improvement Act (CLIA) was passed after negative publicity about quality control. This act extended the Medicare Act regulations to more laboratories. Amendments to the Medicare Act in the early 1980s made it clear that the regulations needed to be consolidated. At the same time, reports began to surface in the media about inaccurate Pap smears and faulty HIV test results. In response, Congress asked HCFA to revise regulations for all federally regulated labs. "But the Reagan White House was very eager to deregulate as much as possible," says Virginia's Grüschel. "And between this laissez-faire attitude about regulations and personnel and Congress' desire to fix the problem lay an obvious conflict," he recalls. While Congress debated the bill that became CLIA 88, the Reagan administration on August 5 published its own proposed rules in the Federal Register. Eighteen months later, on March 14, 1990, those rules were restated in the Register with some revisions. The comment period has just ended. Although scientists were pleased that the regulations reinstated some earlier personnel standards, they view the proposal as only an interim step. CLIA 88 alters dramatically how labs are to be regulated, and the government must still come up with final strategies to accomplish these changes. "This latest publication is just a part of the iceberg, not the whole thing," predicts Indiana University pathologist James Smith. A number of people remain very concerned about the submerged portion of the iceberg. They are frustrated that the government chose not to set up technical advisory committees, even though the regulations are very complex. Consequently, many societies, including ASM, are mobilizing their members to comment on the proposed procedures. ASM is hosting a round table at this week's meeting in Anaheim on the subject. It will include a discussion on "How Clinical Microbiologists Can Be Effective In Influencing the Regulatory Process for the Implementation of CLIA 88" (see accompanying story). For Waylan, one of the scheduled speakers, such discussions are an integral part of making the system work. "We know we need help in establishing these implementation processes. Once we publish [proposed regulations], it's up to the public to help us and comment on them. We need some assistance and - despite what people may think - we don't have a predetermined set of requirements in mind. This is something new for us, and we want very much to establish regulations that strike the balance between not overregulating and setting appropriate requirements." Theresa S. Herring is a freelance writer based in Silver Spring, Md.

Microbiologists Gear Up To Encourage Better Clinical Laboratory Standards

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