Here are some helpful hints for searching test systems in the new Lab Central Connect database:

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Benedict Underwood
5 years ago
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1 Here are some helpful hints for searching test systems in the new Lab Central Connect database: The Lab Central Connect database uses the information from the FDA CLIA database. The information is derived from submissions by the vendor when the device is first licensed for use. It is the official categorization of complexity and specialty for CLIA regulatory purposes, which is why we use it. However, like any manually maintained information source, it has some gaps and occasionally you will need workarounds to enter your systems. Note that this system is only for FDA licensed tests. If you have Laboratory Developed Tests, LDTs, you should maintain a separate list of those for the surveyors to review. 1. Search by model name first without entering in a vendor name. Many devices have been acquired by new vendors since they were first licensed. It is not unusual to see a device that has three or four different vendors associated with the same device over time. For example, some Siemens devices were owned by Dade when licensed, Immucor by Gamma, etc. 2. Some reagents are approved for multiple platforms by the FDA at the same time. When this occurs, often only one platform is listed. For example, use the when entering toxicology for the other Architect models as it was the first approved and often the subsequent models are not listed by analyte in the FDA database. 3. The search will look for the exact name. For example, ITC is really International Technologies Corporation according to the FDA and Vitamin D is 25-hydroxyvitamin D. Acronyms should be spelled out. Punctuation is important, such as i-stat with a hyphen. 4. If looking for a specific analyte like d-dimer, try entering it into the method field. However, not all analytes can be searched this way based on how they are stored in the database. 5. Search by analyte to see what devices are licensed by this method and which most closely matches your device. 6. You can search by both the model name and the specialty at the same time to limit the search. 7. You may see the device without a specific analyte listed by it. This indicates a panel of multiple analytes. If you are only running one analyte in the panel, then select the specific analyte. Otherwise, it is faster to pick the panel and either check all or select from the panel components.

2 8. If the analyte or device was recently approved, allow time for the site to update. This occurs at least monthly. 9. Blood gases on the i-stat are listed by model. All other i-stat tests are listed by cartridge. The goals of entering the Test Systems into Lab Central are: 1. Informs the surveyors where to look for correlations 2. Provides a list of specialties for the CLIA certificate 3. Indicates the complexity level of the CLIA certificate If you cannot find the exact instrument, this will not be a survey finding. If this occurs: 1. Check the company s web site to see if the device is obsolete. If so, find a device that performs the same analytes, specialties and complexities. 2. Check if the device or the analytes are brand new. The database is updated monthly, so information that was recently entered into the FDA database may not yet be present. 3. If you cannot find an exact match, consider these options: a. If the device name is exact but an adjective doesn t match (such as Excelsior II versus Excelsior 2), look for the analyte, specialty and complexity. If those match, then this would be a suitable solution. b. If you cannot find the device, choose a similar device with the same analytes, specialties and complexity. If you have two devices doing the same thing, select a different system so the surveyors know to look for correlations. Remember - before Lab Central, all information was free-text with no information on specialty and complexities. The information you add will still be very helpful for surveyors on site. Manual additions for test systems The foundation of the Lab Central Connect tables is the official FDA CLIA database that assigns complexity and CLIA certificate specialty. Customers have found some test systems that are not in Lab Central Connect because the FDLA CLIA database is incomplete. We ve gotten many requests for an option to manage these situations. The result is that a Manual Addition tab has been added to the portal. By entering data under this tab, you choose the specialty and complexity, and then write in the name of the test system and test name. This option is useful for laboratory-developed tests and when the FDA CLIA database does not have the instrument listed.

3 What is the easiest way to add multiple analytes at once to an analyzer? Is there a bulk upload as there is for personnel? When you select the test platform, you can select multiple analytes as shown here:

Blood Banking Reagents We have noticed that labs are sometimes not entering their blood banking reagents into Test Systems.

4 Just check the boxes on the right under select for the analytes you wish to add. You can expand the page to show 50 analytes by choosing the page size at the bottom. This will allow you to add more analytes at one time. Blood Banking Reagents We have noticed that labs are sometimes not entering their blood banking reagents into Test Systems. This becomes obvious when we are matching the PT results to the organization's systems. If you are doing manual testing, the cells will be listed under your vendor and should be listed. Rule of thumb- if you have a specialty on your CLIA certificate, there should be a corresponding method in Test Systems.

5 Wet Mounts Need to enter a wet mount test method into Lab Central Connect? Enter wet mount in the method box, search, then you can select the best match for specialty and complexity. The search will return options to enter as bacteriology, parasitology, routine hematology or mycology. See screen shot below.