Authorization Information and Courses from MediaLab, Inc.

In order to determine where there is waste, the Lean system recommends taking a waste walk. The table below lists the types of waste that were discussed on the previous page and questions that you might ask as your team proceeds through a waste walk. You will probably not be able to get rid of all waste, but you can continually find ways to reduce it.Waste CategoryQuestionsDefect correctionAre you fixing errors in paperwork?Are you unable to process items because of illegible handwriting, errors, or other causes?OverproductionIs the laboratory producing more reports than needed?Is the laboratory printing, faxing, copying, and/or e-mailing more than is necessary?Are more tests or services being ordered or performed than required by the customer (eg, clinical staff) or for the patient?Excess motionAre you frequently searching for paper documents in cabinets and drawers?Are you regularly hand-carrying paperwork from one laboratory area to another, or one department to another?Excess movement of materialsDo you constantly need to locate and move a piece of equipment?Do you have temporary locations for supplies and equipment?WaitingIs there too much dependency on others to complete a task before you can begin a task?Are there delays in receiving information?Do patients wait for long periods of time before receiving care?Inventory Are files piling up? Is the laboratory purchasing excessive supplies of any kind?Are there obsolete items in the laboratory, eg, files,equipment, supplies, reagents?Excess processingIs the laboratory duplicating reports or information?Are you doing more work than is required for a particular process?Does the laboratory have unnecessary levels of authorization and approval?

A covered entity may use or disclose PHI, without getting an individual's authorization, in order to:Perform requested tests and treatments.Bill for the services performed.Perform essential operations, including quality assessment, accreditation, and compliance.Meet legal reporting requirements, including those mandated by public health departments, workers' compensation, law enforcement agencies, and the US Department of Health and Human Services. Other uses and disclosures require written authorization.

The privacy regulations give covered entities permission to use and disclose PHI for treatment, payment, and health care operations (TPO), without obtaining specific authorization.A covered entity may disclose PHI to other covered entities such as reference laboratories, and home care services, which are providing services to the primary covered entity.The service that the other covered entity is providing must fall within treatment, payment, or health care operations (TPO).If the service being provided does not fall within TPO, an authorization is generally required.An authorization form must state the specific disclosures of PHI to be made, what the information will be used for, and must be signed and dated by the patient.

The 2009 H1N1 influenza virus was first detected in the United States on April 15, 2009.The virus was a unique combination of influenza virus genes never previously identified in either animals or people; they were most closely related to swine-lineage H1N1 viruses (hence the designation of "swine influenza"). However, epidemiological investigations of initial human cases did not identify exposures to pigs and it became apparent that this new virus was circulating among humans and not among U.S. pig herds.By April 21, 2009, the Centers for Disease Control and Prevention (CDC) began working on development of a new vaccine effective against this new strain. On April 24, 2009, the CDC uploaded complete gene sequences of the 2009 H1N1 virus to a publicly accessible international influenza database. At the same time vaccine development was occurring, work was also being done at CDC to help laboratories more quickly identify the 2009 H1N1 virus in patient samples. A real time PCR assay developed by the CDC was cleared for use by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) on April 28, 2009.The development of an effective, rapidly performed molecular assay was critical, because a CDC evaluation of non-molecular rapid influenza assays indicated that while these tests were capable of detecting the novel H1N1 strain when present in high concentrations, the overall sensitivity was low. Positive results with these assays were useful, but negative results did not rule out infection with influenza.

A variety of tests are available for the detection of influenza A viruses, including the 2009 H1N1 strain. These tests include: rapid antigen tests, direct fluorescent antibody tests to detect the presence of virus in patient specimens, shell vial cell cultures, classical tube cell cultures, and reverse transcriptase PCR (RT-PCR), which detects influenza-specific viral genes. These tests differ in sensitivity, specificity, availability, and the ability to distinguish between different influenza strains and subtypes, such as influenza A 2009 H1N1.The rapid tests, such as the direct rapid antigen tests or immunofluorescence assays, have lower sensitivity and specificity compared to cell culture and the RT-PCR based tests. Rapid tests vary in their ability to detect the 2009 H1N1 virus. The range of sensitivity is 10% to 70% and none of the rapid tests that are currently available are specific for H1N1. However, results of rapid tests are available within 30 minutes to one hour so that a positive test will provide further information toward a diagnosis when it is coupled with a patient's symptoms. A few FDA-cleared RT-PCR kits are available for the detection of influenza A viruses. For the subtyping of influenza A viruses, such as Influenza A seasonal H3N2, and 2009 H1N1, the FDA has given the status of "Emergency Use Authorization" (EUA) to a few of the RT-PCR kits; currently available kits under this emergency status category include those made by the CDC, ELITech, Prodesse, Focus Diagnostics, and Roche. (http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm)State Departments of Health have been provided with RT-PCR kits from the CDC for the subtyping of influenza A viruses. This testing has also been FDA-reviewed and given the status of EUA. State and local health department guidelines determine which specimens should be submitted to public health laboratories for RT-PCR testing. In addition, several commercial reference laboratories, academic labs, and hospital labs have been able to perform influenza A subtyping for 2009 H1N1 under the same EUA status. Any laboratory that performs an EUA method would be required to perform an internal validation process.