Observatory
News/ Trends/ Analysis
CDC reports first HIV transmission from blood transfusion since 2002. In June 2008, a man donated whole blood at a blood center in Missouri. His donation was screened for HIV; tests were negative. Components from this donation were infused into two recipients (packed red blood cells and fresh frozen plasma). When the man donated blood again in November 2008, his blood tested positive for HIV. A lookback investigation revealed blood products from his first donation were transfused to two patients. In July 2008, one unit of packed red blood cells from the donor was transfused into a patient during cardiac surgery. This patient died two days later from cardiac disease. In August 2008, one unit of fresh frozen plasma from the donor was transfused into a patient receiving a kidney transplant. The recipient later tested positive for HIV. Lab tests conducted by the Centers for Disease Control and Prevention (CDC) confirm that the donor’s 2008 donation was the source of the recipient’s HIV infection.
Before both blood donations, the blood donor told healthcare workers that he did not have any risk factors for HIV. In a follow-up interview, the donor reported he was married but had sex with both men and women outside of his marriage, including just before his June 2008 donation. Health investigators determined that the man had donated blood during the window of time before HIV infection can be detected though screening. The Oct. 22 issue of Morbidity and Mortality Weekly Report (MMWR) details this case at www.cdc.gov/mmwr/pdf/wk/mm5941.pdf.
Few veterans receive HIV test. A new study from the Infectious Disease Society of America found that the Veterans Affairs health system, which is responsible for providing healthcare for 67 million Americans, rarely offers HIV testing to its patients, MedPage Today reports. Of the 5.7 million outpatients seen in the VA health system in 2009, only 9.2% had ever been tested for HIV — and a mere 2.5% of VA outpatients were tested for HIV in 2009 — researchers reported at the annual meeting of the Infectious Diseases Society of America. In the District of Columbia where HIV infection prevalence is 1,402.4/100,000, only about 21.6% of VA outpatients have ever been tested for HIV. In New York, where the prevalence of HIV is 777.4/100,000, just 11.8% of people in the VA health system have ever been tested for HIV. In places where HIV prevalence is low, such as Utah with a prevalence of 105.2/100,000, just 2.7% of outpatients in the VA facilities there have been tested for HIV.
Cholera cases in Haiti on the rise. Haiti is facing a potential cholera epidemic that has sickened nearly 5,000 people and caused more than 300 deaths as of Oct. 29. The Pan American Health Organization (PAHO) says cholera treatment centers are being built to help handle the surge in cases. The PAHO also reports that the disease is reaching new parts of the country, and the main contamination sources are water, food, and dead bodies. The CDC laboratory has confirmed the
Vibrio cholerae O1 isolate as serotype Ogawa, biotype El Tor. Cholera epidemics have not been reported previously in Haiti, and the population is highly susceptible to the disease, according to the CDC.
S Hvittingfoss outbreak in Illinois final report. The Illinois Department of Public Health has issued its final report on the
Salmonella outbreak that sickened nearly 200 people between late April 2010 and June 2010. The organism Salmonella Hvittingfoss is rare, with only 44 cases reported in the United States in a typical year. A total of 109 cases were confirmed in Illinois, with at least 90 additional probable or suspected cases. The source of the outbreak is believed to have been consumption of foods from Subway restaurants in Illinois, and the organism S Hvittingfoss was most likely contained on or in produce, although it was not possible to link a single specific food item to the illness.
MRSA in Maine lobstering village. Health officials in Maine suspect that lobster-fishing activities have contributed to a methicillin-resistant Staphylococcus aureus (MRSA) outbreak that has affected about 30 people in the island fishing community of Vinalhaven over the past two years, the Associated Press reports. Maine’s state epidemiologist says there is no indication that MRSA is linked to lobsters but that multiple small hand traumas that occur in activities, such as hauling lobster traps and cutting bait. Some fishermen and other island residents have been treated multiple times, but no deaths have been reported.
Virus linked to monkey epidemic infects human. Researchers say a never-before-detected strain of virus that killed more than one-third of a monkey colony at a U.S. lab appears to have jumped from the animals to sicken a human, HealthDay News reports. A scientist who worked with the animals appears to have caught the virus while investigating an outbreak of illness among a colony of Titi monkeys at the California National Primate Research Center in Davis. The scientist recovered in a month. Among the monkeys, the virus was highly contagious and deadly: Of 55 monkeys at the center, 23 (about 40%) became seriously ill with upper respiratory symptoms that progressed to pneumonia and an inflammation of the liver. Nineteen monkeys (about 83% of those infected) died. Researchers later determined the cause of the illness was a new adenovirus strain that had never before been identified.
CLSI method evaluation software. The Clinical and Laboratory Standards Institute’s (CLSI) new method-evaluation software for clinical laboratories, StatisPro, can be used to establish and verify the performance of lab test methods by performing the statistical analysis necessary to demonstrate compliance with regulatory and accreditation requirements. It can produce reports on analytical accuracy, precision, linearity, limit of detection and quantitation, and reference intervals based on the most up-to-date CLSI guidelines, which is helpful for evaluating performance parameters when introducing a new method or new reagents and when replacing instrumentation. It can also be useful after maintenance or when QC data indicate the need for further evaluation. Learn more at www.StatisPro.org.
Top 10 reasons for laboratory citations. COLA offers this list of the 10 most frequently cited reasons for laboratory citations by its surveyors. The results are based on accreditation surveys conducted to meet U.S. CLIA and state regulatory requirements between 2008 and 2010.
- No procedure for the FDA voluntary reporting of device-related adverse events.
- Materials used as controls not verified by repetitive testing to meet manufacturer’s established parameters for mean and standard deviation.
- Specimens not labeled with a unique patient identifier composed of two individual identifiers, and the source of the specimen (when appropriate).
- Calibration verification not performed according to the manufacturer’s instructions including the number, type and concentration of materials to be used; use of materials at low, medium, and high values within the reportable range as determined by the laboratory; acceptable limits for calibration verification, once every six months or more often, if required by laboratory procedures.
- Manufacturer’s instructions for the use of reagents, controls, and kits not followed.
- One or more laboratory employees not adequately fulfilling the responsibilities for position(s) held.
- For each quantitative test performed, quality-control data is not prepared and plotted with each testing event, or statistical indices are not calculated to permit the laboratory to assess continued accuracy and precision of the method.
- Personnel record does not contain documentation of person’s education and experience to qualify him for the position he holds in the laboratory.
- Laboratory does not have documented education of its personnel in the FDA procedure for voluntary reporting of device-related injuries and/or malfunctions.
- Laboratory director or qualified designee does not regularly review the quality-control data with laboratory personnel.
Unique strain of antibiotic-resistant Klebsiella in U.S. The CDC reports that a certain antibiotic-resistant strain of Klebsiella pneumoniae has been identified for the first time in the United States. An American who was hospitalized in Greece returned to the U.S. with a “carbapenem-resistant Klebsiella pneumoniae strain that produced a Verona integron-encoded metallo-beta-lactamase carbapenemase not reported previously among Enterobacteriaceae in the United States,” according to a Sept. 21 MMWR report. The CDC recommends vigilance and says all healthcare facilities should have procedures to rapidly recognize and report resistant Klebsiella cases to infection-prevention personnel.
New test offers fast diagnosis of drug-resistant TB. A new test can accurately diagnose drug-resistant tuberculosis (TB) in as little as two hours, researchers report in a study published Sept. 1 in the New England Journal of Medicine. The best test — growing the bacteria in a lab dish from a mucus sample — takes a week or more, so the most common approach is to look for bacteria in a sample under a microscope, which misses many cases and tells nothing about drug resistance. The new test uses a machine that amplifies the DNA in the sample and checks for bacterial genes. The process takes less than two hours. Researchers used the test on 1,730 patients with suspected TB in Peru, Azerbaijan, South Africa, and India. The test identified 98% of all confirmed TB cases and 98% of cases resistant to rifampin. It correctly identified nearly three-quarters of TB cases that were mistakenly declared negative from the microscope exam, and it accurately ruled out TB in 99% of people who did not have it. Further study is under way to see if the test can reveal multidrug-resistant strains.
Testing urine protein helps slow CKD. Measuring urine protein in black patients with chronic kidney disease (CKD) related to high blood pressure may help physicians slow the disease progression in some patients, according to researchers at Johns Hopkins University School of Medicine in Maryland. A study published in the Sept. 2 New England Journal of Medicine found that lowering blood pressure below recommended goals delayed end-stage renal disease (ESRD) in black patients with a baseline urinary protein-to-creatinine ratio greater than 0.22. No benefit of aggressively decreasing blood pressure was seen in patients whose protein-to-creatinine ratio was 0.22 or less. CKD is 15% more prevalent among black individuals than white, and about 30% of new ESRD cases are attributed to high blood pressure, according to the study.
