October 2008
Feature Story

Anne Paxton

Over the next few months, the CAP Surveys and EXCEL proficiency testing program will usher in an array of new products to meet laboratories’ accreditation and quality improvement needs. The hallmarks for 2009: greater adaptability, more emphasis on mo­lecular testing, and a sharp focus on the Laboratory Accreditation Program theme, “Every patient deserves the gold standard.”

In molecular microbiology, among the most significant of the new products is a Survey for MRSA (methicillin-resistant Staphylococcus aureus) that increases the number of challenges from two to five. The first MRSA Survey was introduced only last year, making the 2009 Survey a rapid enhancement to the product line.

“What we offered last year was a two-challenge Survey to meet our laboratories’ needs quickly,” explains Corrine Cagney, MT(HEW), CAP product manager in proficiency testing marketing.

“This year, because of the Centers for Medicare and Medicaid Services’ ruling that it will not reimburse hospitals for expen­ses related to treating infections acquired in the hospital, a significant number of labs usually small to mid-size—that currently send their bacteriology or microbiology specimens to a reference lab are now bringing MRSA screen­ing in-house. They want to determine prior to admission to the hospital or the ICU or surgical unit whether the patient walked in the door with MRSA.”

The five-challenge test (MRS5) will meet CLIA and CAP laboratory accreditation requirements, Cagney says. The two-challenge test will continue to be available for hospitals that are subscribing to a bacteriology Survey and just want to verify they are doing the MRSA test correctly.

Hospitals that are not performing microbiology or bacteriology testing in-house are among the prime candidates for the MRS5 Survey, says Kathleen G. Beavis, MD, who chairs the CAP Microbiology Resource Committee. The College designed the MRS5 Survey to be used for molecular or culture-based testing.

Another new addition in 2009 is the stool pathogens Survey. “This is an innovative Survey,” says Dr. Beavis, who is acting medical director of pathology at Stroger Hospital of Cook County, Chicago. “It was designed for laboratories that test for Shiga toxin, rotavirus, norovirus, chlamydia, and adenoviruses 40 and 41, through nonculture methods either rapid testing or molecular methods that may or may not be done in the microbiology lab.”

The CAP contin­ues to strengthen its offerings in nucleic acid amplification as well, Dr. Beavis says. As a result of the reconfiguring and supplementing of the 2008 ID and IDV infectious disease panels, three new subscriptions are available: nucleic acid amplification, organisms (IDO); nucleic acid amplification, viruses (ID1); and nucleic acid amplification, respiratory (ID2).

The IDO Survey, for organisms, is newly configured in a way that refines the current ID Survey. The respiratory ID2 Survey is going to be especially popular, Dr. Beavis predicts. “Although it won’t meet all the requirements for procedures regulated for proficiency testing, what it can do is help provide labs that are detecting common respiratory viruses by molecular methods with an outside assessment.” Among the common viruses are influenza, respiratory syncytial virus, and the human metapneumovirus. “There is increased recognition of the role that human metapneumovirus plays in respiratory infections, and we wanted to keep our Surveys as current with laboratory practice,” she notes. (An additional module, called ID1T, is available for the JC and BK viruses associated with organ transplant.)

“We’re introducing both new analytes as well as new configurations to meet the needs of labs as more and more testing is put under molecular platforms,” Dr. Beavis says.

By adding challenges and reconfiguring the Surveys, the Surveys staff and CAP members continue to address more of what customers find they need in the marketplace. In Dr. Beavis’ view, the College has demonstrated in the past couple years that “we’re able to bring up Surveys quickly and able to respond quickly to changes in the practice of laboratory medicine.”

An important new Survey for transfusion medicine will be launched next year. After four years of development, the first proficiency test for bacterial detection in platelets will be released. “It was a bit more complicated than most proficiency tests,” says James P. AuBuchon, MD, advisor to the CAP Transfusion Medicine Resource Committee and president and CEO of the Puget Sound Blood Center, Seattle. “But it’s now been through a couple of rounds of pilot tests, and it will be simple for people to participate in.”

One of the main challenges was coming up with a format that would work for those labs that test com­ponents early in storage by a culture method, when bacterial counts are lower, as well as those that test at later stages. “What we are providing is a vial that may or may not contain bacteria,” Dr. AuBuchon explains. “Its contents are mixed into a liquid meant to simulate a platelet unit. The early culture labs can take their aliquot right then, while those testing platelets later in storage would save the mixture and test it later.”

“We still have not solved the problem of bacterial contamination of platelet units,” Dr. AuBuchon cautions. A recent Irish study reported in the journal Vox Sanguinis (Murphy WG, et al. 2008;95:13–19) followed up on units that had been cultured by the most sensitive method available. “They still showed the culture was detecting contaminants less than 30 percent of the time. That means seven out of 10 contaminated units were missed. And most blood-collection agencies in the U.S. don’t even use as sensitive a method as in the study.”

“So clearly we’ve got a long way to go to improve the safety of platelets for our recipients,” he says. “But this proficiency test is a step in the right direction. It allows laboratories to see whether they can at least detect bacteria in a standardized sample.”

In the chemistry area, the College is introducing a new Survey for lipoprotein- associated phospholipase, an inflammatory marker for risk of coronary artery and cerebrovascular diseases. The assay, a second-line test for patients at intermediate risk, is a bit more specific than C-reactive protein and provides complementary information, says William L. Roberts, MD, PhD, vice chair of the CAP Chemistry Resource Committee and medical director of the automated core laboratory at ARUP Laboratories, Salt Lake City.

The committee has been developing this Survey for the last year or so. “Originally the test was an ELISA, but recently the manufacturer, DiaDexus LLC, developed an immunoturbidiometric assay that can run on chemistry analyzers,” Dr. Roberts says. A number of articles in the literature confirm the clinical usefulness of the marker. As a result, “it’s become apparent that more labs are performing the test, which is why CAP was interested in offering proficiency testing for it.”

In the transition from an ELISA to the immunoturbidiometric assay, differences were noted in patient samples. “It’s not entirely clear what the cause of those differences was, but it may be dependent on sample collection and handling,” Dr. Roberts says, noting that the manufacturer has updated the package insert with specific directions on handling and processing.

The CAP Surveys catalog is now online in a virtual format, as well as in PDF files. Though it’s easier to print pages or entire chapters using the latter, Cagney says, “we’d really like to move our customers to use the virtual catalog, too, which is very progressive and includes an icon that actually ‘flips’ the pages.” The catalog can be accessed on the CAP Web site, through the Accreditation and Laboratory Improvement page, at http://www.cap.org/apps/cap.portal?_nfpb=true&_pageLabel=accreditation.