IMPORTANT NOTICE - CDC LOCS:

Swine Flu

For the most recent H1N1 updates related to Healthcare and Laboratory settings go to: What's New on the CDC H1N1 Flu Site http://www.cdc.gov/h1n1flu/whatsnew.htm

12-18-09

CDC LOCS Update: Questions and Answers Regarding Respiratory Protection For Preventing 2009 H1N1 Influenza Among Healthcare Personnel to supplement previously released updated interim guidance on infection control measures to help prevent transmission of 2009 H1N1 influenza in healthcare facilities (reference CDC LOCS Update: Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel, sent on November 15, 2009).

These questions and answers (Qs & As) provide additional information intended to assist healthcare facilities in optimizing implementation of recommended respiratory protection practices in the context of shortages of respiratory protection equipment. The information contained in this document applies uniquely to the special circumstances of the current 2009 H1N1 pandemic during the fall and winter of 2009-2010, and will be updated as new information becomes available during the course of this influenza season.

What has been added?

The above-referenced Qs & As document was recently updated to include a discussion addressing the use of industrial N95 respirators when splashes or sprays of potentially infectious body fluids are anticipated.

Industrial N95 respirators are not designed to protect the face and eyes. For this reason, whenever industrial N95 respirators are used in settings where there is potential for splashes or sprays of potentially infectious body fluids, additional personal protective equipment is required. In the case of disposable N95 respirators, use of a face shield is required to assure against fluid penetration and for eye protection. When using half facepiece reusable elastomeric respirators, eye protection (goggles or a face shield) is required.

10-16-09

Updated Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel and two related Questions and Answers (Q&A) documents. The updated interim guidance is intended for healthcare personnel, including clinical laboratorians and others who may have direct contact with patients or contaminated material. The interim guidance describes a hierarchy of controls to prevent influenza transmission through elimination of potential exposures, engineering controls, administrative controls and personal protective equipment (PPE).

The information contained in the interim guidance document and accompanying Q&A* applies uniquely to the special circumstances of the current 2009 H1N1 pandemic during the fall and winter of 2009-2010, and will be updated as new information becomes available during the course of this influenza season.

* Questions and Answers about CDC�s Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel

Questions and Answers Regarding Respiratory Protection For Preventing 2009 H1N1 Influenza Among Healthcare Personnel are intended to supplement the updated interim guidance document by providing additional information to assist healthcare facilities in optimizing implementation of recommended respiratory protection practices in the context of shortages of respiratory protection equipment.

10-9-09

Interim Guidance for Influenza Surveillance: Prioritizing RT-PCR Testing in Laboratories.

This interim guidance describes the prioritization of patient samples to be tested by rRT-PCR for SURVEILLANCE purposes* and is intended for state and local health departments, hospitals, and clinicians participating in influenza surveillance activities.

* Prioritization of patient samples to be tested by rRT-PCR for SURVEILLANCE

� Patients presenting to healthcare providers participating in the US Outpatient Influenza-like Illness Surveillance Network (ILINet) who meet the surveillance case definition of influenza-like illness (ILI**).

� Hospitalized patients for whom influenza infection is clinically suspected despite a negative result on a rapid influenza diagnostic test.

� Patients whose deaths are believed to be influenza-associated.

� Other patient samples may be tested according to state and local regulations or guidance. Please check with your Public Health Laboratory.

** see interim guidance for ILI definition

IMPORTANT NOTE: This document does not contain recommendations for the prioritization of patient samples sent for clinical testing, which can be found under a separate guidance (Interim Recommendations for Clinical Use of Influenza Diagnostic Tests During the 2009-10 Influenza Season)

9-11-09 - New and Updated Interim Guidance and Links to Resources for Clinicians

H1N1 Flu (Swine Flu): Resources for State and Local Health Officials - http://www.cdc.gov/h1n1flu/statelocal/

2009 H1N1 Flu Situation Updates and FluView - http://www.cdc.gov/h1n1flu/

Locate all H1N1 Flu guidance documents - http://www.cdc.gov/h1n1flu/guidance/

Novel H1N1 Influenza: Resources for Clinicians - http://www.cdc.gov/h1n1flu/clinicians/

8-21-09 - MMWR - Use of Influenza A (H1N1) 2009 Monovalent Vaccine, Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009

The Centers for Disease Control and Prevention�s Laboratory Outreach and Communication System (LOCS) is providing a link to the August 21, 2009 (early release), Morbidity and Mortality Weekly Report article, "Use of Influenza A (H1N1) 2009 Monovalent Vaccine, Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009."

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0821a1.htm

This article includes important information that applies to laboratory workers who handle infectious materials; these individuals would fall into one of the five initial target groups for vaccination efforts. The groups identified in the MMWR article include pregnant women, persons who live with or provide care for infants aged <6 months, health-care and emergency medical services personnel (including laboratory workers who handle infectious materials), children and young adults aged 6 months--24 years, and persons aged 25--64 years who have medical conditions that put them at higher risk for influenza-related complications. Other highlights of the recommendations include establishment of priority for a subset of persons within the initial target groups in the event that initial vaccine availability is unable to meet demand and guidance on use of vaccine in other adult population groups as vaccine availability increases.

Vaccination and health-care providers should be alert to announcements and additional information from state and local health departments and CDC concerning vaccination against novel influenza A (H1N1) virus infection. Additional information is available from state and local health departments and from CDC's influenza website (http://www.cdc.gov/flu).

8-14-2009 - Interim Biosafety Guidance for All Individuals Handling Clinical Specimens or Isolates Containing 2009-H1N1 Influenza A Virus (Novel H1N1), as well as Vaccine Strains

This guidance is for all individuals who may perform diagnostic and research activities including rapid diagnostic testing at the point of care with 2009-H1N1 influenza A virus (Novel H1N1).

What has changed?

Revisions concerning required PPE and engineering and work practice controls are included as follows:

For those performing rapid immunoassay tests for influenza, splash protection is required.
For those performing more complex procedures (e.g., direct or indirect fluorescent antibody tests [DFA, IFA], culture, molecular assays), a Class II biosafety cabinet (BSC) in a biosafety level-2 (BSL-2) laboratory is required. Biosafety level-3 (BSL-3) practices are no longer required for viral isolation.

Updated nomenclature for the virus, now referred to as 2009-H1N1 Influenza A Virus (Novel H1N1), is incorporated throughout the guidance.

Link to guidance: http://www.cdc.gov/h1n1flu/guidelines_labworkers.htm

8-6-2009 - MMWR: Evaluation of Rapid Influenza Diagnostic Tests

Below is a link to the August 7, 2009, Morbidity and Mortality Weekly Report article, �Evaluation of Rapid Influenza Diagnostic Tests for Detection of Novel Influenza A (H1N1) Virus � United States, 2009.� The article describes the performance of three commercially available rapid influenza diagnostic tests (RIDTs) compared to real-time RT-PCR for their ability to detect the novel influenza A (H1N1) virus in respiratory specimens. Overall sensitivity for the novel influenza A (H1N1) virus ranged from 40-69%, meaning these infections may not be detected by RIDTs, especially if the amount of virus in a specimen is low. For this reason, decisions regarding treatment and further testing among patients with negative results from RIDT should be based upon clinician suspicion, underlying medical conditions, severity of illness, and risk for complications in those persons suspected of having the novel influenza A (H1N1) virus infection.

Link to MMWR: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5830a2.htm?s_cid=mm5830a2_e

7/29/09 - Interim Guidance for the Detection of Novel Influenza A Virus Using Rapid Influenza Diagnostic Tests

The Centers for Disease Control and Prevention�s Laboratory Outreach and Communication System (LOCS) is providing the following link to important interim guidance: Interim Guidance for the Detection of Novel Influenza A Virus Using Rapid Influenza Diagnostic Tests, which supersedes guidance (Use of Rapid Influenza Diagnostic Tests for Patients with Influenza-like Illness during the Novel H1N1 Influenza Virus (Swine Flu) Outbreak) previously posted to this web site on May 2, 2009.

The new interim guidance provides an overview of the sensitivities of rapid influenza diagnostic tests (RIDT) in detecting influenza A (H1N1) virus in order to help guide the reporting and interpretation of test results. This guidance is intended primarily for all individuals who may be processing or performing rapid influenza diagnostic testing on respiratory specimens from patients with suspected influenza A (H1N1) virus infection, including those in clinical practice settings. An Example of a Statement to Accompany Rapid Influenza Diagnostic Test Results and an algorithm to assist in the interpretation of RIDT results during periods when influenza viruses are circulating in the community are contained in this interim guidance. Guidance will be updated as needed based on new data.

Link to guidance: http://www.cdc.gov/h1n1flu/guidance/rapid_testing.htm

7/2/09 - Manuscript

The Centers for Disease Control and Prevention�s Laboratory Outreach and Communication System (LOCS) is providing a link to the manuscript, "Transmission and Pathogenesis of Swine-Origin 2009 A(H1N1) Influenza Viruses in Ferrets and Mice," that was published online, July 2, 2009, in Science. Results from these animal studies indicate that close contact is the most efficient means of transmission of this H1N1 virus. They further suggest an increased potential for lower respiratory and intestinal tract involvement with this infection. Similarly, human cases to date have indicated that a significant proportion of individuals infected with the H1N1 virus have exhibited gastrointestinal distress and vomiting.

http://wwwn.cdc.gov:80/DLS/LOCS/ViewUploadedDocument.aspx?DLS_Upload_Files_id=520

6-4-09 - Questions and Answers About CDC's Online Reporting

http://www.cdc.gov/h1n1flu/reportingqa.htm

Recently Posted or Updated Laboratory-Related Guidance Documents - 6/03/09

May 28, 2009 4:30 PM ET

Post-mortem Care and Safe Autopsy Procedures for Novel H1N1 Influenza

The guidance in this document reflects what we currently know about the novel influenza A (H1N1) virus. As additional information becomes available, the guidance may be updated.

May 27, 2009 6:30 PM ET

Interim Recommendations for Facemask and Respirator Use to Reduce Novel Influenza A (H1N1) Virus Transmission

This document provides updated interim guidance on the use of facemasks and respirators for decreasing the exposure to novel influenza A (H1N1) virus. This guidance replaces other CDC guidance on mask and/or respirator use that may be included in other CDC documents in regards to the outbreak of novel H1N1 virus. No change has been made to guidance on the use of facemasks and respirators for health care settings. This document includes guidance on facemask and respirator use for a wider range of settings than was included in previous documents and includes recommendations for those who are at increased risk of severe illness from infection with the novel H1N1 virus compared with those who are at lower risk of severe illness from influenza infection. Other CDC novel H1N1 guidance will be updated with the information contained in this document as soon as possible.

May 26, 2009 11:15 AM ET

An etiologic agent import permit from the United States Public Health Service is needed for importation into the United States of virus isolates and/or clinical samples associated with the novel influenza A (H1N1) virus outbreak. Guidance on the application for and use of an etiologic agent import permit can be found at DSAT Guidance on CDC Import Permits for Swine-Originated Flu

May 23, 2009 11:30 EST

Guidelines for the Submission of Tissue Specimens for the Pathologic Evaluation of Influenza Virus Infections

This guidance has been updated to refine the specimen sampling recommendations and to provide more detailed shipping instructions.

Guidance for Public Health Reporting of Test Results for Novel H1N1 Influenza - 5/12/09

The following information is directed to clinical laboratories and health centers that have the capacity to develop and/or perform testing for novel H1N1 influenza.

As testing for novel H1N1 flu moves from health departments to private testing locations, it is imperative that testing sites are informed regarding the guidelines for reporting test results for novel H1N1 flu to state health departments for epidemiologic surveillance purposes. The state health departments subsequently report to CDC. CDC Guidance for Laboratories can be found at http://www.cdc.gov/h1n1flu/lab/. Laboratories conducting testing for novel H1N1 flu should report results as required by their state and the state of the tested individual per normal surveillance protocol. Before intiating novel H1N1 testing, contact your state public health department to obtain their protocols for clinical and epidemiological data collection and specimen collection and transport.

Updates to the CDC Swine Flu Website - 4/29/09

CDC protocol of realtime RTPCR for swine influenza A(H1N1) - 4/28/09

Distribution of RT-PCR Primers and Probes for Detection of Swine Influenza A/H1N1 Virus

As a WHO Collaborating Center for Influenza, CDC is providing information and documents on its diagnostic protocols for detection and characterization of Swine Influenza, including: "CDC Realtime RTPCR (rRTPCR) Protocol for Detection and Characterization of Swine Influenza", "Protocol for Antiviral Susceptibility Testing by PyroSequencing", and "CDC Real-time RTPCR Swine H1 Assay ordering Instructions". These materials can be accessed at through the following links........
http://www.who.int/csr/resources/publications/swineflu/realtimeptpcr/en/index.html
http://www.who.int/csr/resources/publications/swineflu/pyrosequencing_protocol/en/index.html
http://www.who.int/csr/resources/publications/swineflu/sequencing_primers/en/index.html

The kits are to be sent overnight when practical. All kit requests must go to fluorder@cdc.gov. There is no charge for the kits, and kits will begin shipping on or about 05/01/2009. There are approximately 1000 reactions per kit including those used for controls. Any additional technical questions regarding the kits may be sent to flusupport@cddc.gov.

Interim Guidance on Specimen Collection and Processing for Patients with Suspected Swine Influenza A (H1N1) Virus Infection - 4/28/09

Guidance below can be accessed at: http://www.cdc.gov/swineflu/specimencollection.htm

Situation Update and Laboratory Guidance from CDC on Swine Flu - 4/27/2009

Investigation and Interim Recommendations:

Swine Influenza (H1N1)

CDC, in collaboration with public health officials in California and Texas, is investigating cases of febrile respiratory illness caused by swine influenza (H1N1) viruses. As of 11 AM (EDT) April 25, 2009, 8 laboratory confirmed cases of Swine Influenza infection have been confirmed in the United States. Four cases have been reported in San Diego County, California. Two cases have been reported in Imperial County California. Two cases have been reported in Guadalupe County, Texas. Of the 8 persons with available data, illness onsets occurred March 28-April 14, 2009. Age range was 7-54 y.o. Cases are 63% male. The viruses contain a unique combination of gene segments that have not been reported previously among swine or human influenza viruses in the U.S.or elsewhere. At this time, CDC recommends the use of oseltamivir or zanamivir for the treatment of infection with swine influenza viruses. The H1N1 viruses are resistant to amantadine and rimantadine but not to oseltamivir or zanamivir. It is not anticipated that the seasonal influenza vaccine will provide protection against the swine flu H1N1 viruses. CDC has also been working closely with public health officials in Mexico, Canada and the World Health Organization (WHO). Mexican public health authorities have reported increased levels of respiratory disease, including reports of severe pneumonia cases and deaths, in recent weeks. CDC is assisting public health authorities in Mexico by testing specimens and providing epidemiological support. As of 11:00 AM (EDT) April 25, 2009, 7 specimens from Mexico at CDC have tested positive for the same strain of swine influenza A (H1N1) as identified in U.S. cases. However, no clear data are available to assess the link between the increased disease reports in Mexico and the confirmation of swine influenza in a small number of specimens. WHO is monitoring international cases. Further information on international cases may be found at: http://www.who.int/csr/don/2009_04_24/en/index.html.

Clinicians should consider swine influenza infection in the differential diagnosis of patients with febrile respiratory illness and who 1) live in San Diego or Imperial counties, California, or Guadalupe County, Texas, or traveled to these counties or 2) who traveled recently to Mexico or were in contact with persons who had febrile respiratory illness and were in one of the three U.S. counties or Mexico during the 7 days preceding their illness onset.

Patients who meet these criteria should be tested for influenza, and specimens positive for influenza should be sent to public health laboratories for further characterization. Clinicians who suspect swine influenza virus infections in humans should obtain a nasopharyngeal swab from the patient, place the swab in a viral transport medium, refrigerate the specimen, and then contact their state or local health department to facilitate transport and timely diagnosis at a state public health laboratory. CDC requests that state public health laboratories promptly send all influenza A specimens that cannot be subtyped to the CDC, Influenza Division, Virus Surveillance and Diagnostics Branch Laboratory.

Persons with febrile respiratory illness should stay home from work or school to avoid spreading infections (including influenza and other respiratory illnesses) to others in their communities. In addition, frequent hand washing can lessen the spread of respiratory illness.

CDC has not recommended that people avoid travel to affected areas at this time. Recommendations found at http://wwwn.cdc.gov/travel/contentSwineFluUS.aspx will help travelers reduce risk of infection and stay healthy.

Swine Influenza A (H1N1) Virus Biosafety Guidelines for Laboratory Workers - 4/24/2009

The Swine Influenza A (H1N1) Virus Biosafety Guidelines for Laboratory Workers was issued by the Centers for Disease Control and Prevention (CDC) on April 24th, 2009, addressing biosafety for laboratory workers.

Other Sites of Interest