Published on: December 2, 2005

CAP response to Los Angeles Times article

NORTHFIELD, IL (Dec. 2, 2005) — Today's Los Angeles Times article on the quality of laboratory testing in the United States makes significant omissions of fact, which provides a distorted and misleading view of the College of American Pathologists' Laboratory Accreditation Program.

Many of the story's allegations regarding the quality of laboratory testing have been subject to exhaustive investigation by the College and by state and federal authorities. Nevertheless, the article, while repeating the allegations regarding several institutions, ignores many of the official findings of these authorities based on inspections of the institutions. Examples follow.

• The CAP went to extraordinary lengths to protect the identities of the complainants in the Magee case. Prior to contacting the CAP, the complainants made repeated and unsuccessful attempts to resolve their complaints internally. In consultation with the complainants, the CAP conducted an announced inspection of Magee on Oct. 31, 2001, so as not to tip off Magee officials that its inspection was prompted by whistleblower complaints. Further, the College consulted with the complainants and fully advised them of this course of action, and they concurred with the CAP decision. The College never divulged to Magee the identities of the whistleblowers. The College provided the Times reporter this information directly, but he chose not to include it.
• Multiple regulatory and private accrediting entities, including the Commonwealth of Pennsylvania and the federal Centers for Medicare and Medicaid Services (CMS), conducted inspections of the Magee laboratory and investigated the complainants' allegations. All concluded that the claims were unsubstantiated-information known to the reporter, but not included in the Dec. 2 Times article.
• The article also failed to note the Oct. 4, 2005, findings of an eight-member inspection team that responded to a September 2005 complaint alleging "quality problems in the performance of gynecologic cytology tests (Pap smears) in the Cytology section of the clinical laboratory, falsification of certain Pap smear quality control results, and that the laboratory had a high error rate in the reporting of Pap smear results." Based on the findings of the inspection team, which included CMS, Pennsylvania Department of Health, JCAHO and CAP inspectors, CMS concluded that "the allegations in the complaint were unsubstantiated."
• There have been at least seven onsite inspections of the Magee laboratory by multiple oversight entities since October 2001. In April 2004, a four-page CMS report on a survey of 1,405 gynecologic cases and 1,481 laboratory slides sampled from 1999 to 2003 found no evidence of widespread quality problems in the performance of Pap tests at the institution. None of these relevant facts was cited in the Times article.
• In addition, in June 2004, the judge presiding over the lawsuit filed by Drs. McCarty and Silver specifically dismissed allegations asserting "negligent mismanagement" and "negligent supervision" of the laboratory.

• The CAP inspected the Yakima hospital laboratory referenced by the article in January 2004 and cited a number of deficiencies. Accreditation was granted once these deficiencies were corrected to comply with CAP accreditation standards. The reporter, through inference and without factual basis, leaps to the conclusion that the issues identified by emergency room physicians in May 2005 must have been missed or ignored by the CAP when it inspected the lab in 2004, 14 months earlier.
• Contrary to the implication that this case shows flaws in the current regulatory process for laboratory oversight, it, in fact, illustrates how all oversight entities-private, state and federal-work effectively to respond to complaints and force corrective action. The College responded expeditiously to the emergency physicians' complaints, conducted an unannounced complaint inspection and, upon identifying deficiencies, placed the laboratory on probation.

• With respect to the Mayo Clinic, the story suggests that Mayo won accreditation through the influence of Dr. Burgart's position on the CAP Surgical Pathology Committee. However, the Surgical Pathology Committee has no authority over accreditation decisions for Mayo or any other laboratory, and the CAP told the reporter this fact directly.
• The College consistently cited Mayo's unique specimen processing method as a deficiency over multiple inspections. The College evaluated Mayo's response to the cited deficiencies and never granted Mayo a waiver or an exemption. Mayo provided patient outcome studies that showed their unique method provides an excellent diagnosis for patients. Upon careful consideration in each accreditation cycle, the CAP granted accreditation to Mayo. Because this was a recurring issue, the CAP consulted with CMS about the Mayo specimen processing method to determine equivalence with federal standards. The College understands that CMS is still reviewing the Mayo method and, until the agency renders a final decision, the CAP will not recognize this method as meeting its standards.

  In summary, the story's multiple omissions of relevant and current facts present a distorted portrayal of the regulatory oversight process and, in particular, the College's role with respect to the cases cited.