Change in Sputum Acceptability Criteria

University of Virginia Health System Medical Laboratories “Quality You Expect, Service You Deserve”

LABORATORY MEDICINE UPDATE

October 5, 2009

Influenza Update

Because a novel strain of Influenza (H1N1) was reported in Mexico and the US this spring, the Medical Laboratories changed testing platforms in order to reliably detect this strain. The new PCR test was implemented on 6-29-09. Since then, a total of 260 flu screens have been ordered and performed. Of those, 22 have been positive by PCR for Influenza A, with most reported in July. These were presumed to be novel H1N1, since that was the circulating strain according to the state laboratory and CDC.

At Present PCR is performed once per day with results available by approximately 1500 hours. Only Inpatient, ED and Employee Health samples are tested by this method at this time. As the prevalence of influenza increases in the community, and at the discretion of the Clinical Microbiology Laboratory and Hospital Epidemiology, performance frequency of the Influenza A&B PCR will be changed to twice daily.

Plans for the Future Unless there is a significant change in the local prevalence of flu, the Clinical Microbiology Laboratory will resume rapid antigen testing on Nov. 1, 2009. Rapid antigen tests will be performed upon receipt of the specimen in the laboratory. Those reported as negative will automatically reflex to PCR testing for Influenza A&B.

A PCR-based test for Influenza A subtyping will be made available concurrently with rapid antigen testing. Subtyping should only be considered for the following patient groups: 1. Pregnant patients 2. Highly immunocompromised patients (solid organ transplant recipients; HIV+) 3. Patients likely to be admitted to the hospital

The molecular subtyping assay will detect novel H1N1 (swine origin), human H1 (seasonal) and Human H3. If your patient is among the populations listed above and you want subtyping performed, please request “subtype” in the special request field when ordering in CareCast or MIS. The subtyping PCR will be performed once daily.

In order for the laboratory to provide the best results possible, the specimen submitted for a flu screen MUST be a swab in VTM (viral transport media). The laboratory can provide collection kits upon request by calling 2-0460.

of 3 C. difficile results in CareCast and MIS

Ordering clinicians have sometimes been unable to find results of C. difficile testing in the above computer systems.

Because this test is now performed in the Molecular Diagnostics Laboratory (by PCR), the results are located in CareCast (Centricity) under Laboratory Results, Molecular Diagnostics tab. In MIS the results are in the row ALL LABS excluding Microbiology.

RSV testing

As of Oct. 1, 2009 the laboratory has begun using a new rapid antigen kit for RSV (Respiratory Syncytial Virus). The test will be performed upon receipt in the laboratory with results available within 2 hours. The sample submitted must be nasal wash or aspirate. The test is FDA approved only for children 18 and younger. If RSV is suspected in an adult 19 years or older, a full respiratory culture should be ordered.

A comment will be attached to all negative or inconclusive rapid antigen test results: Confirmation of negative or inconclusive results available upon request. If the result of the test is negative and RSV is highly suspected, please call the laboratory at 2-0460 and request a full respiratory culture.

FDA Safety Alert Concerning Glucose Meters

On August 13, 2009, the FDA issued a second safety alert regarding select glucose monitoring technology and medications containing maltose, galactose, and xylose. The hand-held (Point of Care) meters in use throughout UVa are among the instruments affected. Specific drugs on the formulary that contain maltose, galactose, and xylose are: hepatitis B immune globulin (HepaGamB®), tositumomab (Bexxar®), and abatacept (Orencia®). Additionally, select immune globulins, specifically Octagam 5%, and RH immune globulin (WinRho®) contain one or more of these compounds.

The specific concern is that Point-of-Care glucose measurements in the 48 hours after administration of these drugs will be falsely elevated, masking hypoglycemia or presenting as a false-hyperglycemia.

The Laboratory is evaluating a different technology for the Point of Care program, but this will be a long-term solution. In the interim, whenever any of the above compounds are ordered through MIS, a cautionary statement will appear reminding the provider that glucose determinations should only be made using a blood gas analyzer or a Core Laboratory method for 48 hours after drug administration. This same message will appear on the nursing PTP and on the dispensed product.

of 3 In outpatient settings, patients are unlikely to know if they have received the above drugs or others not on our formulary that increase measured glucose. Thus normal or high results in patients suspected of being hypoglycemic should be checked by a laboratory method.

Equally important is patient education. The Pharmacy will be distributing information with any home-use glucose meters they dispense. Longer term, they may change the meter they distribute.

Below are two links, the first to the FDA notification and the second with information for patients. If you have any questions, please contact the Clinical Chemistry Director on-call (pic 1267) or the Director of Point of Care Testing (pic 3200). http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm177189.htm