THE FOOD AND DRUG ADMINISTRATION (FDA) UPDATES
Contents
1. JULY AUGUST 10 A COLA Information Resource Center 800 981 9883 www cola org www LabUniversity org www COLAcentral com COLA Information Resource Center 800 981 9883 www cola org www LabUniversity org www COLAcentral com JULY AUGUST 10 E It doesn t matter if the product insert is updated We ve always done the test this way and it s always worked Don t worry about following the timing on the dipstick chart Just look for a color change I didn t know that was supposed to run daily QC but I was told it was okay because it s only been a couple weeks since it was last run It s never a good idea to break rules take short cuts or ignore protocol Not only is patient care compromised but there can be monetary complications as well Your lab may not be fined as much as a national organization like the Red Cross but you could be forced to cease testing or close your doors which could be just as costly FDA FINES AMERICAN RED CROSS S16 MILLION FOR PRIOR FAILURES TO MEET BLOOD SAFETY LAWS For Immediate Release June 17 2010 Consumer Inquiries 888 INFO FDA The FDA announced today that the American Red Cross has been fined 16 million for prior failures to comply with Federal laws and regulations related to the collection and manufacture of blood products Despite the compliance failures the FDA found no evidence that the Red Cross violations endangered any patients and the blood2. the hepatitis C virus HCV for individuals 15 years and older The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis HCV is transmitted through exposure to infected blood which for example can occur during intravenous drug use The virus can also be transferred from an infected mother to her child Hepatitis C can lead to liver inflammation and dysfunction and over time to liver disease and liver cancer OraQuick is a test strip and does not require an instrument for diagnosis It takes about 20 minutes to obtain results from the test Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures said Jeffrey Shuren M D J D director of the FDA s Center for Devices and Radiological Health Getting faster treatment is an important public health step to control this dangerous disease OraQuick is not approved for HCV screening of the general population According to the U S Centers for Disease Control and Prevention there are approximately 3 2 million people in the United States chronically infected with HCV continued on page 2 COLA 9881 Broken Land Parkway Suite 200 Columbia MD 21046 1195 www cola org www LabUniversity org www COLAcentral com JULY AUGUST 10 E FROM THE CHA
3. 800 981 9883 This publication may be obtained through enrollment in a COLA accreditation program or by subscription for 48 per year ALL RIGHTS RESERVED Reproduction in whole or in part without written permission is prohibited Q COLA Information Resource Center 800 981 9883 www cola org www LabUniversity org www COLAcentral com Q JULY AUGUST 10 E THE FOOD AND DRUG ADMINISTRATION FDA UPDATES continued from page 2 the diagnostic setting detect HIV antibodies only Although direct detection of the virus itself by nucleic acid testing is available it is not widely used in diagnostic settings HIV is the virus that can lead to acquired immune deficiency syndrome or AIDS HIV damages a person s body by destroying specific blood cells called CD4 T cells which are crucial to helping the body fight diseases Two types of HIV have been identified HIV 1 and HIV 2 HIV 1 is responsible for most HIV infections throughout the world HIV 2 is found primarily in West Africa however cases of HIV 2 infection have been reported In North America and Europe The Centers for Disease Control and Prevention report that approximately 18 million people in the United States are tested for HIV each year Most recent CDC estimates are that there are about 56 000 new HIV infections in the United States each year In addition there are more than 1 million people living with HIV in the United States according to CDC The appro
4. AFP Chair COLA Board of Directors COLA Information Resource Center 800 981 9883 www cola org www LabUniversity org www COLAcentral com THE FOOD AND DRUG ADMINISTRATION FDA UPDATES continued from page 1 and each year about 17 000 people are newly infected Chronic HCV infection is a leading reason for a liver transplant in the United States and HCV is associated with an estimated 12 000 deaths annually Approximately 75 to 85 percent of people who become infected with the hepatitis C virus develop chronic infection OraQuick is manufactured by Bethlehem PA based OraSure Technologies Inc For more information e FDA Medical Devices http www fda gov MedicalDevices default ntm e NIH Hepatitis C http health nih gov topic HepatitisC Article reprinted from http www fda gov NewsEvents Newsroom PressAnnouncements ucm217318 htm See website for more information FDA Approves First Diagnostic Assay to detect both HIV Antigen and Antibodies For Immediate Release June 21 2010 Consumer Inquiries 888 INFO FDA Test advances ability to detect HIV infection earlier The U S Food and Drug Administration today approved the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus HIV This assay is approved for use as an aid in the diagnosis of HIV 1 HIV 2 infection in adults including pregnant women It is also the first assay for use as an aid in the diagnosis of HIV 1 HIV 2 infection in child
5. Health Care HealthWare Harvest the Power NON PROFIT ORG U S POSTAGE Lab Accreditation Through Education PAI D PERMIT 273 9881 Broken Land Parkway Suite 200 ANNAPOLIS MD Columbia MD 21046 1195 www cola org www COLAcentral com PAID SUBSCRIPTION COLAcentra CENTRAL TO YOUR WORK CENTRAL TO YOUR LAB Introducing COLAcentral It s the personalized web portal from COLA that puts you in control of your lab and your life
6. IR Just as the fireworks burst in the air over the July 4th weekend innovations are bursting on the scene of laboratory medicine So this seemed like the appropriate time to share a few of these advances with you This issue of nsights includes press releases from the FDA regarding approval of new test assays that might prove useful in your laboratory and recall notices about automatic external defibrillators AED Although AEDs are not confined to laboratory use we felt we had to include this information as a precautionary measure to avoid potential serious adverse events An article about a novel approach to decreasing hospital acquired nosocomial infections reinforces the patient safety theme from the last edition of Insights We ll continue to highlight lab medicine innovations at our next Symposium Join us in Scottsdale AZ in September Finally the notice of fines imposed upon the American Red Cross Blood Services stresses the importance of identifying investigating resolving and documenting problems within the lab as they occur For help addressing problems as they occur you could refer to any installment of the recently concluded series which focused on Occurrence Management As always our goal Is to help you provide quality care to your patients Please share your questions and comments with us so that we can share your knowledge with the rest of the COLA community VA on Verlin K Janzen MD FA
7. Insights is now avaiable online at www COLAcentral com and www COLA org JULY AUGUST 10 THE FOOD AND DRUG ADMINISTRATION FDA UPDATES From http www fda gov ForConsumers ByAudience ForPatientAdvocates HIVandAIDSActivities default htm The Food and Drug Administration FDA is a regulatory agency that enforces the Food Drug and Cosmetic Act and the Public Health Service Act assuring that drugs and biologics are safe and effective for their intended uses and properly labeled FDA s activities helo protect all consumers in the United States regulating some trillion dollars worth of products The FDA sets standards for and monitors e all prescription and non prescription drugs e all blood products vaccines and tissues for transplantation e all medical devices and equipment and all radiation emitting devices e all animal drugs and feed e nearly all domestic and imported foods except for meat and poultry e and all cosmetics Because of this the FDA plays a major role in the personal and professional lives of all medical laboratory professionals The following articles highlight a few examples of this impact Lab Accreditation Through Education 4 FDA Approves Rapid Test for Antibodies to Hepatitis C Virus For Immediate Release June 25 2010 Consumer Inquiries 888 INFO FDA The U S Food and Drug Administration today announced approval of the first rapid blood test for antibodies to
8. ay Friday FDA Comments The following are Defibtech s immediate recommendations e Determine if your battery pack is affected by this correction by following the steps on the company website e f your battery pack is affected by this correction keep your DDU 100 series AED and battery in service until you have received your battery pack update card from Defibtech and have updated your battery pack Make sure that you have a replacement battery pack available and arrange for a backup AED if you do not have a replacement battery pack available e f during a rescue your AED cancels shock and shuts down with a service code 1003 replace the battery pack and proceed with the rescue If this condition occurs the AED containing an affected DBP 2800 battery pack will announce Shock Cancelled Service Code 1003 Powering Off e f your battery pack is not affected by this correction keep your DDU 100 series AED and battery in service and maintain it in accordance with the User Manual Article reprinted from http www fda gov MedicalDevices Safety RecallsCorrectionsRemovals ListofRecalls ucm215407 htm See website for more information Physio Control Inc LIFEPAK 20 and LIFEPAK 20e External Defibrillator Monitors Recall Class Class Date Recall Initiated May 27 2010 Product s LIFEPAK 20 and LIFEPAK 20e External Defibrillator Monitors To view the Physio Control notification and instructions to search f
9. e as well as the invention of sterile or anti bacterial covers for both See the following sites for more information 1 http www prnewswire com news releases ama weighs infec tion hazard posed by medical clothing 96784634 html 2 http www ama assn org amednews 2010 06 28 prsn0628 htm 3 http www ama assn org amednews 2010 06 07 biscO607 htm Correction n the May Jun 10 edition of Insights there was an inadvertent omission in the Occurrence Management article According to CLIA requirements the test report date is another key element that must be included on the final test report Please note The collection date the testing date and the test report date are all required as part of a complete test record A listing of all elements required by CLIA to be on the test report can be found in subpart K sec 493 1291 at the following link http wwwn cdc gov clia regs subpart_k aSpx 493 1291 lt r ua D 9 4 D At Orchard we focus ROI discussions on reda Ei eio ors impre productivity and increasing revenue So with an Orchard aw lab information system you can improve your lab s b a huge investment of time and money Orchard u automation ICD 9 screening rules based technolo EMR and reference laboratory integration to simpli workflow and help you increase your lab s yield Call demonstration of how our LIS can help you produce n mg r Harvest the power of rules based 800 856 1948 Harvest the pa
10. eline AED Semi automatic External Defibrillators Recall Class Class Date Recall Initiated May 21 2010 Product s DBP 2800 Battery Pack for the Defibtech ReviveR AED and Lifeline AED semi automatic external defibrillators Affects only DBP 2800 battery packs distributed prior to June 4 2007 and used with the ReviveR AED and Lifeline AED devices Affected battery pack serial numbers range e Between 202001005 and 202005916 or e Between 206001001 and 206009871 In a letter to customers dated May 20 2010 Defibtech States that the company is mailing to all affected customers a battery pack update data card that will allow customers to update device software to correct the problem while allowing the devices to remain in their locations To view the Defiotech notification and instructions on determining whether a battery pack is affected visit http www defibtech com BatteryFA usa htm Reason for Recall If the AED is used with an affected battery pack the AED may falsely detect an error condition cancel charge and not provide therapy Recalling Firm Defiobtech LLC 741 Boston Post Road Suite 201 Guilford Connecticut 06483 3921 continued on page 4 JULY AUGUST 10 A THE FOOD AND DRUG ADMINISTRATION FDA UPDATES continued from page 3 Public Contact Defibtech Technical Support at techsupport defibtech com or call 1 877 453 4507 or 1 203 453 4507 8 30 A M to 5 00 P M Eastern Time Mond
11. ions presented by experts from Q CMS and the field e CLIA Validation Surveys e CLIA Hot Topics EHRs and Personnel Qualification Issues e The Impact of ARRA HITECH Stimulus EMR EHR Initiatives and Meaningful Use on Laboratories gt TWO new Clinical sessions presented by Toni Clinton Vice President Sonic Healthcare e Vitamin D Analyte of the Moment e POCT Issues and Answers gt PLUS new sessions of particular interest to those in COLA labs e COLA Top 10 Citations Part 1 amp Part 2 e COLAcentral Training AND sessions focused on improving your work environment so hot we had to bring them back e Want Quality Outcomes Empowered People are the Most Important Asset e Improve Quality by Improving Communication Even With Difficult People e Improve Quality by Improving Your Leadership Skills araara sett eee eee see slisete saaten atista Calibration verification linearity testing has a new address Yes it s that easy 1 Open 2 Dispense 3 Run Insights is now avaiable online at www COLAcentral com and www COLA org SYMPOSIUM FOR CLINICAL LABORATORIES a celebration of DUCATION The University of Wisconsin School COLA Spring 2010 Symposium of Medicine and Public Health and COLA thank the following companies for their financial support of the Symposium for Clinical Laboratories Thank you OrchardSoftware MEDICA Ante AUDIT _ charset Products For
12. or affected devices by serial number visit http www physio control notices com notice_home aspx pid 95 The serial number is located on the underside of the device and contains only numbers COLA Information Resource Center 800 981 9883 www cola org www LabUniversity org www COLAcentral com Approximately 42 943 devices were distributed worldwide between September 16 2002 and September 27 2007 These devices were manufactured from July 31 2002 to September 19 2007 Recalling Firm Physio Control Inc 11811 Willows Road NE Redmond Washington 98052 2003 Reason for Recall A failure on the power supply assembly can result in either No DC power or No DC or AC power A failure of DC battery power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC battery power and no AC line power is available Public Contact Physio Control Technical Support at rs sealifepaksupport usa medtronic com or call 1 800 442 1142 Monday Friday between 6 00 A M and 4 00 P M Pacific Time FDA Comments The firm began mailing notification letters to affected customers on May 26 2010 All affected power supplies will be updated Customers are advised to keep the defibrillators in service and follow recommended daily Operator Checklist steps while service updates are scheduled Useful Links e LIFEPAK 20 and LIFEPAK 20e daily Operator Checklist http www physio control notice
13. ren as young as two years old The highly sensitive assay is intended to be used as an aid in the diagnosis of HIV 1 HIV 2 infection including acute or primary HIV 1 infection Since it actually detects the HIV 1 virus specifically the p24 antigen in addition to antibodies to HIV the ARCHITECT HIV Ag Ab Combo assay can be used to diagnose HIV infection prior to the emergence of antibodies Most tests used today in continued on page 3 COLA INSIGHTS COLAissponsored by the American Academy of Family Physicians AAFP the American Medical Association AMA the American Osteopathic Association AOA and the American College of Physicians ACP and is endorsed by 29 national and state medical organizations Letters to the editor are welcome ADVERTISING POLICY COLA accepts advertising requests for inclusion in it s publications All advertisements are subject to review and approval by COLA COLA reserves the right to reject or cancel any advertisement that Is not in keeping with COLA s standards as a national accreditation organization and it s publication standards COLA and it s publications do not and will not endorse directly or indirectly any advertiser s products or services If you would like to discuss advertising opportunities please contact COLA at 410 381 6581 ext 368 COLA 2010 COLA INSIGHTS is published periodically by COLA 9881 Broken Land Parkway Suite 200 Columbia MD 21046 1195 COLA INFORMATION RESOURCE CENTER
14. s their clothing can become contaminated Hours later that bacteria can still be alive and passed on through incidental contact with other patients The article mentioned recent studies done at the University of Maryland and Virginia Commonwealth University but the American Medical Association AMA feels more studies should be conducted According to a report issued by the AMA Board of Trustees better hygiene not dress codes appears to provide the greatest hope in reducing hospital acquired infections The AMA report encourages more research and validation of the research JULY AUGUST 10 E results before advocating changes in dress code policies It also reaffirms existing AMA policy urging the adoption of hand washing as an important patient safety priority Whether or not clothing is a major means of transmission of nosocomial infection steps have already been taken to combat this form of bacterial spread The PR Newswire article mentions the creation of lab coats and scrubs embedded with Tri Active an FDA approved silver based antimicrobial compound that can kill resistant micro organisms such as MRSA E coli and Salmonella An alternative approach mentioned in an article on the AMA website is clothing that when washed in bleach maintains the chlorine until the next wash continually working to kill bacteria This article also mentions other possible transmission vehicles the stethoscope and cell phon
15. s com S fnmiysaq5bi 1tkemwnfmmgy55 resources aspx pid 95 Article reprinted from http www fda gov MedicalDevices Safety RecallsCorrectionsRemovals ListofRecalls ucm217933 htm See website for more information Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA s MedWatch Adverse Event Reporting program either online by regular mail or by FAX Useful Links MedWatch The FDA Safety Information and Adverse Event Reporting Program http www fda gov Safety MedWatch default htm continued on page 5 Q Q COLA Information Resource Center 800 981 9883 www cola org www LabUniversity org www COLAcentral com Q Q INCREASING PATIENT SAFETY BY DECREASING HOSPITAL ACQUIRED INFECTIONS A recent article released by PR Newswire documented how infections may be spread via lab coats and scrubs worn by medical personnel Lab coats or scrubs can be the source of some serious bacterial hazards like MRSA said Charles P Gerba PhD a professor of Environmental Microbiology in the Department of Microbiology and Immunology at the University of Arizona When doctors or nurses lean over the beds of patients who are carrying organism
16. supply is believed to be safe Multiple layers of safeguards are in place to protect and enhance the safety of blood products However these types of violations decrease the assurance that blood products manufactured by the American Red Cross will continue to be safe and have the potential to compromise the safety of the blood supply The FDA assessed fines totaling 16 18 million 9 79 million for violations related to mismanagement of certain blood products and 6 39 million for Good Manufacturing Practice violations Blood products include red cells plasma and platelets The FDA is encouraged by recent efforts made by the Red Cross leadership and will work closely with them to achieve full compliance The FDA is hopeful these fines will encourage the Red Cross to act more quickly to take the actions necessary to address and correct the issues that have contributed to these violations In October 2009 the agency notified the American Red Cross that FDA inspections conducted during fiscal years 2008 and 2009 revealed violations that included failure to identify problems that occur during manufacturing and failure to adequately investigate identified problems The fines announced today were assessed under an amended 2003 consent decree that outlines requirements for the American Red Cross to ensure safety of the nation s blood supply The original 1993 decree was amended In 2003 to allow the FDA to impose significant fines for fail
17. ure to comply with agency regulations and provisions designed to ensure the safety of the nation s blood supply Since 2003 the American Red Cross has made progress addressing some of its quality issues including Standardizing procedures upgrading its National Testing Laboratories and increasing oversight of the organization However to fully comply with federal regulations and consent decree provisions the American Red Cross must make swift additional progress on all of the issues the FDA has identified The agency has previously sent 12 similar letters to the American Red Cross and imposed a total of more than 21 million in fines under terms of the amended 2003 consent decree The American Red Cross is one of several organizations that is responsible for the nation s blood supply For more information http www fda gov AboutFDA CentersOffices ORA ORAElectronicReadingRoom ucm189699 htm Article reprinted from http www fda gov NewsEvents Newsroom PressAnnouncements ucm216156 htm See website for more information Q the ICAL Septem r 2 for gt FOUR new sessions presented by quality guru Luci Berte President Laboratories Made Better PC e Having a Global Laboratory Perspective An ISO 15189 Update e Ensuring Accreditation Success with Laboratory Audits e Nonconforming Event Management Learning From Our Mistakes e Management Review for Laboratory Improvement gt THREE new regulatory sess
18. val of this assay represents an advancement in our ability to better diagnose HIV infection in diagnostic settings where nucleic acid testing to detect the virus itself is not routinely used said Karen Midthun M D acting director of FDA s Center for Biologics Evaluation and Research It provides for more sensitive detection of recent HIV infections compared with antibody tests alone The ARCHITECT HIV Ag Ao Combo assay is not intended to be used for routine screening of blood donors However it is approved as a donor screening assay for HIV 1 HIV 2 infection in urgent situations where licensed blood donor screening tests are unavailable or their use is impractical The ARCHITECT HIV Ag Ab Combo assay will be used in clinical laboratories and in public health laboratories and is the first assay approved in the United States to detect HIV antigen and antibodies simultaneously The ARCHITECT HIV Ag Ab Combo assay is manufactured by Abbott Laboratories Abbott Park IL For more information e HIV Testing http www fda gov ForConsumers ByAudience ForPatientAdvocates HIVandAlDSActivities ucm117922 htm e HIV and AIDS Activities http www fda gov ForConsumers ByAudience ForPatientAdvocates HIVandAlDSActivities default htm Article reprinted from http www fda gov NewsEvents Newsroom PressAnnouncements ucm216375 htm See website for more information Defibtech LLC DBP 2800 Battery Pack for ReviveR AED and Lif
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