"Lab Industry Briefs"

Victorville Community Hospital, Quest Diagnostics, ASCP, MIME

ASCP ACQUIRES MIME’S CYTOLOGY TRAINING AND PROFICIENCY TESTING

IT WAS A BIG BREAK for pathologists and cytotechnologists involved in Pap testing. In a deal announced at the end of February, the American Society for Clinical Pathology (ASCP) has acquired “the complete cytology product line of the Midwest Institute for Medical Education (MIME).”

This eases some of the problems caused by the requirement of the Centers for Medicare and Medicaid Services (CMS) that, during 2006, all cytotechnologists and all pathologists examining gynecologic preparations must participate in an approved proficiency testing (PT) program.

At the time CMS announced the PT requirement, it also declared that only two PT programs were approved. One is operated by the Maryland State Department of Health and the other is operated by MIME. The decision to give MIME a near-exclusive lock on cytology PT training was controversial within the laboratory industry.

Since that decision became public, many laboratorians have criticized CMS for limiting approved PT programs to just two sources: a state health agency and MIME. There have also been criticisms about the fundamental need for a federally-administrated proficiency testing program in cytology, as well the design of the program as mandated.

However, there is another dimension to this story which was under- played. Informed sources asked how and why MIME came to be selected by CMS over other more-qualified providers of laboratory PT training. CMS has never answered those questions, nor has it taken steps to dispel accusations that favoritism or inside connections played a key role in the selection of MIME as the near-exclusive source of all cytology PT training done in the United States.

In fact, the questions about MIME are legitimate. Ongoing investigations by THE DARK REPORT in recent months have uncovered several facts that call into question the original decision by CMS to make MIME the primary source of cytology PT programs.

That’s because MIME was a new enterprise. It was established in recent years by Diagnostic Cytology Laboratories, Inc. (DCL) of Indianapolis, Indiana. This is a cytology testing laboratory that has had its share of financial problems during the past five years.

Between 2002 and 2004, numerous federal tax liens and state tax warrants were filed against DCL and cleared as payment was received. During these same years, MIME was operated as a subsidiary of DCL. It was eventually split off into a separate company before CMS selected MIME to be the primary source for cytology proficiency testing.

Given this background, and given the fact that MIME had never operated a PT program of large size and scope, it certainly raises important questions about the process CMS used to select a cytology PT vendor and whether personal influence played a role in the selection of MIME.

Further, the fact that ASCP has acquired MIME’s complete cytology product line at this time is likely to be directly linked to MIME’s lack of capital and expertise to operate a large scale, national cytology PT program.

Thus, it is a positive development that ASCP will assume MIME’s role in federal cytology proficiency testing. However, MIME’s exit from the scene will not quiet those critics of cytology PT as it is currently constituted. These criticisms are directed toward the relevance of current cytology PT requirements and whether they appropriately reflect current technologies and clinical standards of care involving cytology.

HOSPITAL LAB LOSES MEDICARE LICENSE IN VICTORVILLE, CALIF.

FALLOUT CONTINUES FROM THE SERIOUS PROBLEMS discovered at the laboratory of Maryland General Hospital in Baltimore, Maryland in the winter of 2004. Government regulators are taking more decisive action when laboratory deficiencies are uncovered.

In recent months, several labs have been the targets of regulatory action. In Victorville, California, the Centers for Medicare and Medicaid Services (CMS) has suspended payments to the laboratory at Victor Valley Community Hospital.

CMS took enforcement action after determining that the hospital laboratory had failed surveys, particularly in bacteriology. At one point, for a five- day period, the lab was deemed in “immediate jeopardy,” an indication that the agency considered the health of patients was at risk.

Medicare payments to the laboratory were terminated on October 5, 2005. Since that date, fines of $3,000 per day have accrued and now total over $426,000. Hospital administration has filed a written appeal with a California administrative law judge. Hospital officials also emphatically
state that patient care has not been put in jeopardy.

No resolution has been made public. Discussions are ongoing between CMS and administrators at Victor Valley Medical Center.

In Maryland, the State Department of Health has increased its scrutiny of laboratories following the widely-publicized failures of the laboratory at Maryland General Hospital. Last fall, health officials in Maryland cited a laboratory facility of Quest Diagnostics Incorporated in Southwest Baltimore for a number of deficiencies. During inspections of the Quest Diagnostics laboratory by state health officials on October 22, 2004, April 18, 2005, and September 19, 2005, it was determined that the laboratory was reporting inaccurate test results for several assays. These included tests for thyroid-stimulating hormone and testosterone, among others.

In a week-long follow-up inspection in February, state officials also determined that the automated chemistry department at the Quest laboratory was understaffed and lacked the number of employees needed to allow time for proper documentation of quality control and other essential steps. The lab was cited for this situation. None of the incidents identified by healthcare inspectors was considered to have been life-threatening to patients affected by the problems.

THE DARK REPORT sees these two enforcement actions against laboratories as signals that regulatory scrutiny of laboratory operations will be increasing. Given the bad publicity following the MGH laboratory debacle, government laboratory regulators are on notice that the media will pounce on any juicy story that lab inspectors were “asleep at the switch.” To forestall such situations, lab regulators will be quicker to formally cite laboratories where deficiencies are discovered.

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