Readers respond: collegial atmosphere challenged.

In reference to the MLO's Washington Report, "What HR 686 means to American patients," November 2006, p. 56, while I agree that there can never be too much oversight to ensure that each and every patient in the American healthcare system receives the best care possible, I am concerned that this bill as introduced by Representative Cummings is another "feel-good" measure that attempts to treat symptoms rather than causes.

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If you will recall, CLIA started out with a double purpose--first, to ensure that PAP smears were reviewed and reported correctly (in many cases, cytotechs were reading too many, perhaps hundreds, of smears in a day and missing the cytological changes indicative of cancer or pre-cancer, and some pathologists who were supposed to review all positives and 10% of the negatives were not exercising that review); and second, to ensure that physician operated labs (POLs) were being brought into the realm of QC and QA that hospitals had already entered because of CAP, JCAHO, FDA, and the rest of the alphabet soup of regulatory agencies. While CLIA has now been modified to encompass more, if not all, labs regardless of their level, for several years, because of politics, POLs were essentially excused from the most stringent and important aspects of CLIA, and hospitals simply had one more set of rules to follow--and these rules did not necessarily correspond to CAP, FDA, or JCAHO regulations.

Yes, whistleblowers need to be protected. But the blanket condemnation of "the collegial composition of inspection oversight" and the "focus on so-called 'education' over imposing sanctions" shows that Rep. Cummings or his staffers, have never faced an English major with a checklist as I once did during an FDA blood-bank inspection. The CAP--and other inspection and regulatory agencies--has an obligation to ensure that the labs it inspects meet all of the requirements and regulations under which a laboratory operates, be they CLIA, state, JCAHO, or any other agency for which CAP has deemed status. If there is a problem, especially if there is a hint of conflict of interest, then the regional director has a responsibility not to assign that pathologist to inspect that hospital. On the other hand, the most valuable portion of any of the many CAP inspections that I have undergone is the sharing of information in a "collegial" atmosphere.

Our labs perform thousands of tests each year. There are going to be errors for which the lab, its personnel, and its directors need to [be] brought to account. On the other hand, pointing out these errors in a way that future errors can be prevented is at least as important.

--Charles G. Millstein, MBA, MT(ASCP) Laboratory Manager

Memphis and Shelby County Health Department

Memphis, TN

Editor's Note: MLO has contacted Representative Elijah Cummings (D-MD) for a response to Mr. Millstein's letter.