| Assuring Lab Quality During Public Health Emergencies |
How can laboratories assure quality during public health emergencies? It was a question pondered during the September 2009 meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). As more Americans experience fevers, sore throats, and body aches, many laboratories have been pressed to test for H1N1 influenza. Although the volume of confirmatory testing has dropped since the spring, the question of when to test remains.
CLIAC recommended that guidelines be issued to outline what, when and why testing should be performed during public health emergencies. The guidelines should also expand on actions physicians might take from the test results. CLIAC also suggested laboratories receive guidance on surge capacity challenges, anti-viral sensitivity testing, and limitations of non-PCR tests.
Other public health emergency recommendations include:
√ Availability of one standard panel of samples from the CDC;
√ Development of a tested list of national and state contacts for emergency communications;
√ If it becomes necessary to suspend quality oversight for clinical laboratories, such CLIA exemptions would only be made on a temporary, defined basis and must be announced by the government;
√ Consumers should be aware of the laboratory testing guidelines in order to temper demand and supply. |
| Forensic Science Follow-up |
 Reactions to the U.S. Supreme Court decision, in Melendez-Diaz v. Massachusetts, have, in some cases, been immediate and sweeping. As reported in last month’s RedLine, the Court held that sworn certificates from a state laboratory analyst may not be submitted as prima facie evidence since the defendant has the right to confront witnesses against him – and that includes laboratory technologists.
Virginia’s Governor Tim Kaine called a special session of the state’s General Assembly for August 19 to bring its laws into compliance with the recent ruling. According the Governor’s statement, the legislative action taken “offers some relief to Virginia’s forensic analysts, who may need additional time to schedule appearances for court testimony… (and) streamlines the procedure for requesting live testimony for prosecutors and members of the law enforcement community while appropriately preserving the intent of the court decision.”
News reports from Wisconsin, Massachusetts, and Pennsylvania also share varied reactions to the decision.
On September 9, 2009, the Senate Judiciary Committee held its second hearing on “Strengthening Forensic Science in the United States.” The Chairman of the Committee, Senator Patrick Leahy (D-VT), announced that the panel will soon discuss the reauthorization of the Innocence Protection Act and was holding this hearing to delve further into concerns over the prosecution of Todd Willingham, where forensic evidence may not have been scientifically sound. To view the webcast of the hearing, click here. |
| Did Congress Pass a Food Safety Bill? |
Yes. The U.S. House of Representatives passed the Food Safety Enhancement Act, HR 2749, by a vote of 283-142 on July 30, 2009. The legislation requires the Secretary of Health and Human Services to establish a food tracing system, issue science-based performance standards to minimize food-borne contaminants, and establish accreditation for food laboratories, among other issues.
Because of last minute legislative maneuvering, the House passage of this bill may appear confusing. The legislation was amended and passed out of the House Energy and Commerce Committee on June 17, 2009. After that time, the bill was placed on the suspension calendar of the full House of Representatives. In order to “suspend the rules” and pass the legislation, two-thirds of the Members voting are required to pass a bill. Suspensions may only be brought up on certain days and any other motions may not be entertained during a bill’s consideration (except for a motion to adjourn). Generally, bills addressed under suspension are considered non-controversial and pass easily by voice vote. On July 29, 2009, Representative John Dingell (D-MI) made a motion to suspend the rules for the food safety bill. A debate on the bill ensued. After the debate, a vote was taken. The tally was 280-150, just six votes short of the 2/3rds needed for passage. The bill failed under suspension.
However, the bill was not dead.
Later on the evening of July 29, the House Rules Committee was asked to provide a rule for the consideration of HR 2749. The subsequent rule would allow for the bill to be considered on the House floor. No amendments would be allowed and general debate was limited to one hour.
The next day, the House of Representatives again considered the food safety legislation. Representative Frank Lucas (R-OK) made a motion to send the bill back to Committee. This motion to “recommit” failed by a vote of 186-240. After the motion to recommit failed, the bill was cleared for a vote on final passage. This time the bill passed by a vote of 286-142.
The House legislation has been referred to the Senate Committee on Health, Education, Labor and Pensions for further consideration. |
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| Reports of Interest |
A report, Respiratory Protection for Healthcare Workers in the Workplace Against Novel H1N1 Influenza A, was released in September 2009 by the Institute of Medicine. Recommendations to use fit-tested N95 respirators and calls for additional research into transmission are outlined.
The Morbidity and Mortality Weekly Report issued the report, Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions, which provides guidelines for improving the quality and oversight of molecular genetic testing.
The Institute of Medicine released its workshop summary, The Public Health Effects of Food Deserts, explaining how limited access to healthy food choices impacts health. |
| Biochemical Genetic Testing Workgroup Underway |
| A biochemical genetic testing workgroup will provide input to the Clinical Laboratory Improvement Advisory Committee on good laboratory practices. The 26-member panel, chaired by Carol Greene, MD, has discussed the specific scope of biochemical genetic testing, identified testing process areas in need of guidance, and personnel competencies and qualifications. The workgroup held an orientation conference call in March 2009, and continues its deliberations. |
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