Office throat cultures may be less available. (due to standards for specimen collection set by the Clinical Laboratory Improvements Amendment)(the Journal of the American Medical Association, January 19, 1994)

Most health care consumers are probably not aware of some of the regulatory changes in medical practice that have been taking place. One of them has to do with the functioning of both commercial laboratories and those in private offices. In 1988, Congress passed the Clinical Laboratory Improvements Amendment (CLIA). By doing so, they spelled out the specific methods and regulations to which all laboratories must adhere or face shut-down. The purpose, of course, was to decrease inaccuracies in laboratory diagnoses that had been surfacing over the years. In general, this is a good idea and will most likely produce an improvement in the quality of health care in this country.

One area that will significantly be affected by CLIA will be the performance of throat cultures in the private office setting. An article in the Journal of the American Medical Association (JAMA) reviews the findings of a survey of pediatricians who perform throat cultures in their offices and how CLIA might affect their continued performance of these tests.

The article first discusses the general role of doing throat cultures to diagnose strep throat. It emphasized how the only accurate way to make the diagnosis of strep throat is by throat culture. Trying to diagnose by the clinical appearance of the patient and the throat is fraught with inaccuracies. Even in the best of hands, a doctor will be correct only 50% of the time when trying to tell by appearance which throat is a strep throat. In other words, you might as well flip a coin. In spite of this, however, a certain number of physicians routinely attempt to make the diagnosis without the aid of a throat culture. It's therefore very important for parents to obtain throat cultures for their children when the possibility of strep is present.

Having said this, however, it's important to make sure that throat cultures are being done accurately. This is where CLIA comes in. It reviews the specifics of doing this test and outlines in detail how physicians should conduct this procedure in their office. One of the discrepancies that has been found since CLIA has been instituted is the lack of proper "controls" in the physicians' offices. A control is a quality assurance test. A test sample known to be either positive or negative for strep is analyzed every day in the physician's office. If the results are not correct, measures must be taken to review procedures and correct any deficiencies before performing any further tests that day. It's been found that few pediatricians who do throat cultures in their office perform daily controls. Now, however, if a physician wishes to continue doing lab procedures, he must perform daily controls. This is all well and good. It will improve ...