clia waived test validation

For a test to be CLIA waived the FDA must inspect the facility where it is manufactured. The test will also aid in the identification of a smoker as a low or high nicotine consumer. CLIA 88: Waived Certificate requirements • Enroll in the CLIA program • Pay applicable certificate fees biennially, and • Follow manufacturers' test instructions (voluntary compliance with waived requirements is encouraged as “good lab practice”) In addition, FDA clarified that tests for SARS-CoV-2 that are offered prior to or without an EUA have not been reviewed by FDA, are not FDA authorized, and have not received a CLIA categorization.Thus, those tests are considered high complexity by default until they receive an EUA or other FDA approval that indicates they may be performed as moderate complexity or waived tests. The results of risk evaluation and control including a description of (1) measures you have implemented to mitigate the risk of errors, and (2) validation and/or verification studies demonstrating the ability of failure alert, fail-safe mechanisms, and other control measures that you have incorporated into your device to mitigate the risk of errors, even under conditions of stress. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. CLIA-waived tests may be performed by trained staff upon receipt of a physician’s order. In this case, the applicant should submit the information requested to the CDRH DCC as a supplement to the CW with 180 days. You will be subject to the destination website's privacy policy when you follow the link. Part V: Method Validation Process and Procedures. DrugConfirm Advanced CLIA-Waived Instant Drug Test. Washington State recognizes those accreditation organizations listed in Table 2. CLIA divides laboratory testing into waived and non-waived tests based on the complexity of the analysis (Figure 1). Choose Options Compare. Laboratory Outreach Communication System | Division of Laboratory Systems (DLS), Center for Surveillance, Epidemiology, and Laboratory Services (CSELS), Centers for Disease Control and Prevention (CDC). Staff will document test results and follow-up in the clinical record. A site performing only waived tests must have a For tests authorized for use in a patient care setting—follow manufacturer’s instructions for waived test implementation (COM.30980) at minimum. If the FDA does not receive a complete response to all deficiencies in the AI request within 180 days of the date of the AI Request, the submission will be considered withdrawn and the applicant will need to submit a new application if they still wish to pursue a CLIA waiver. Proceed Interactively: the FDA has not identified substantive deficiencies in the initial submission review and any further minor deficiencies will be communicated through interactive review (email, phone, etc.). My Account; My Products ; Sign In ... SKU : CLIA-IDTC-VAC-LID-25 (25 Lids) New CLIAwaived,Inc Vacutainer lid (only). 5. The U.S. Food and Drug Administration (FDA) recently clarified that, when it grants an Emergency Use Authorization (EUA) for a point-of-care test, that test is deemed to be CLIA-waived. Based on CLIA guidelines, tests and test systems that comply with the risk, error, and complexity requirements are granted a certificate of waiver. a. For tests authorized for use in a patient care setting, the laboratory must follow manufacturer’s instructions for waived test implementation (COM.30980) at minimum. 6 Panel Drug Test Cup - Identify Health CLIA Waived. The statute states that: The examinations and procedures [that may be performed by a laboratory with a Certificate of Waiver]… are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that — (A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or (B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly. Personnel qualified to ... For example, a facility holding a CLIA waiver cannot perform testing that has an Authorized setting of High (H) or Moderate (M). This includes methods that were previously exempted from validation. Please verify your tests waived status and CPT code prior to implementing testing. Any examples are for illustrative purposes only. Conclusion: In this study, an ED CLIA-waived rapid streptococcal throat test performed as well as its equivalent CLIA-regulated laboratory test. The FDA deems these tests to be CLIA waived, even if testing is performed in the main laboratory under a CLIA certificate of accreditation or registration. QuickVue Adenoviral conjunctivitis Test is a CLIA-waived test for the visual, qualitative in vitro detection of Adenoviral antigens (hexon protein) directly from eye fluid. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. Test Name/Specific Test System Manufacturer Approved CPT Code(s) Adenovirus AdenoPlus (human eye fluid) Rapid Pathogen Screening, Inc. 87809QW Quidel, AdenoPlus Test, Adeno Detector, Detecor Plus (Tear Fluid) Quidel Corporation 87809QW Staff will document test results and follow-up in the clinical record. It is important that the practice follows all manufacturer instructions in order to remain waived; if altered in any way, testing becomes highly complex. C. Evaluating and documenting competency of personnel responsible for testing is required at least semi-annually during the first year the individual tests patient specimens. IVD Regulatory Assistance, Recalls, Market Withdrawals and Safety Alerts, Clinical Laboratory Improvement Amendments (CLIA), Device Advice: Comprehensive Regulatory Assistance, How to Prepare a CLIA Waiver by Application, FDA Actions on CLIA Waiver by Application Submissions. 16 Educational booklet with job aids . Because non-professional staff is permitted to use CLIA Waived tests, the cost of testing is more economical and can be performed more timely by front-line staff. AFTERCARE: 1. FAQs. Since 2017, the FDA has made CW decision summaries available on our website. Final 5 CLIA Rule. Staff competency is verified and documented prior to performing waived testing and on an ongoing basis, as needed. CLIA specifies quality standards for proficiency testing (PT), patient test management, quality control, personnel qualifications and quality assurance for laboratories performing moderate and/or high complexity tests. Under CLIA, FDA categorizes in vitro diagnostic (IVD) tests by their degree of complexity: waived, moderate complexity, and high complexity. An applicant should inform the FDA they plan to submit a Dual Submission through a Pre-Submission, and the cover letter for a Dual Submission should reference this Pre-Submission number. You must work within the scope of your CLIA certificate. Tests that are noted with a "W" in the Authorized Settings are deemed to be CLIA-waived for use in patient care settings operating under a CLIA Certificate of Waiver. Many of the point-of-care testing procedures are identified by CLIA as waived while others are moderately complex. The Type 2 NPI for the pharmacy contracted for COVID-19 test services should be submitted as the Service Provider ID (201-B1). The CLIA waived alternative is a relatively inexpensive formality made available to people who are required to submit to drug testing, but prefer … CLIA. Competency Testing must be performed on all waived and non-waived. When a test is categorized as waived, it may be performed by laboratories with a Certificate of Waiver. For more information, visit this FDA Web pageexternal icon, navigate to the section titled “General FAQs,” and view the first two questions and their corresponding answers. Tests that are waived by regulation under 42 CFR 493.15(c), or cleared or approved for home use, are automatically categorized as waived following clearance or approval. Guidance for CLIA approved high and moderate complexity laboratories . Unique educational and professional experience are required to perform non-waived tests. Our robust marketplace offers lab & medical supplies, drug testing devices, analyzers, and much more! 3 waived testing that is not included under any other type of CLIA certificate must obtain a CW before testing patient specimens. High and moderate complexity tests can only be analyzed in laboratories certified under CLIA. § 263a(d)(3). identifies at least one contact person, include name, title, phone number, and email address. The laboratory director's signature on the written test procedure may be used to show approval of the test … Test sites performing unmodified, FDA approved, moderate complexity testing could accept the manufacturer's performance specifications and were not required to perform any method validation. CLIA waived tests are simple tests that have a low risk for erroneous results. When a diagnostic test is granted a CLIA waiver, analysis can be done in other settings able to provide CLIA-waived tests with an EUA, such as pharmacies. Our results also validate previous work that negative rapid throat test results in pediatric patients in the ED should be confirmed by standard throat culture. CLIA-exempt and accredited laboratories must permit validation and complaint inspections. A manufacturer of a test categorized as moderate complexity may request categorization of the test as waived through a CLIA Waiver by Application (CW) submission to the FDA. Otherwise, following clearance or approval, tests may be categorized either as moderate or high complexity according to the CLIA categorization criteria listed in 42 CFR 493.17. Please verify your tests waived status and CPT code prior to implementing testing. 6. The instructions can be found in the product insert or label for each test. CLIA-WAIVED CERTIFICATE Laboratory Director Qualification Requirements NOTE: A CLIA Certificate of Waived allows the facility to perform ONLY tests categorized as CLIA waived. *Inspection Checklist August 2016 Edition. Proficiency testing is not required for this level of testing. Poster and postcards Good Laboratory Practices for Waived Testing Sites . The test is for professional use only. Add to Cart . What is the process to obtain a CLIA certificate of waiver and are there costs associated with this? Since this is an emergent and changing situation, it’s best to review those websites often. State and local regulations: Some states and localities have specific regulations for testing, some require licensure of personnel who perform testing, and some have Waived laboratories must enroll in CLIA, pay the applicable fee and follow manufacturers' instructions. MDUFA Decisions for a Dual Submission include: Please see the following guidance for study design recommendations for Dual Submissions: There is no MDUFA User Fee for a CLIA Waiver by Application. . A device that is CLIA Waived does not require highly trained laboratory personnel to administer the test and does not require costly laboratory quality control testing. CLIA waived tests are generally simple test that are non-technical. Waived testing is covered in the following Checklists: All Common, Point-of-Care, The results of flex studies demonstrating insensitivity of the test system to environmental and usage variations under conditions of stress. CDC twenty four seven. Starting on April 24, 2003, all non-waived laboratory methods must be validated. There are over 1,400 test systems that have been waived. For the duration of the national emergency declaration for COVID-19, such tests can be performed in any patient care setting that operates under a CLIA Certificate of Waiver or Certificate of Compliance/Certificate of Accreditation. CLIA waived defines a measure categorized under the Clinical Laboratory Improvement Amendments Act, which allows basic medical tests to be performed outside of a laboratory because they are very simple tests with low risks of incorrect results. These dual requirements include method validation procedures. The .gov means it’s official.Federal government websites often end in .gov or .mil. • Required by CLIA*, CAP, and The Joint Commission (*Clinical Laboratory Improvements Amendments of 1988) • Pass proficiency testing • Improvements over existing methodology • Assay validation requirements vary: Non-FDA approved > FDA approved > Waived tests . FDA approved, non- waived tests To receive email updates about this page, enter your email address: Centers for Disease Control and Prevention. NGS assays are high-complexity, laboratory developed tests (LDTs). The FDA is allowing for an abbreviated validation process, but laboratories must follow those FDA guidelines. In addition to CLIA moderate and high complexity laboratories, this test has been Emergency Use Authorized for use with fingerstick whole blood specimens at the point-of-care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Having certain tests cleared by the FDA as “waived” means that these are safe to be performed at home or in non-laboratory settings. A Dual Submission is subject to 510(k) eCopy requirements, requires a 510(k) MDUFA User fee, and is subject to 510(k) Refuse to Accept (RTA) policies. Since this is an emergent and changing situation, it’s best to review those websites often. $75.75 - $2,032.00. CLIA waived tests are simple tests that don’t need complicated processing and can be done by uncertified operators or even at home by the public such as pregnancy tests, dipsticks for urinalysis, blood glucose by glucose monitoring devices cleared by the FDA for home use and more. To ensure accuracy of test results, it is crucial to always follow the current product manufacturer’s instructions without deviation. Most test meet the following requirements: Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible. When a diagnostic test is granted a CLIA waiver, analysis can be done in other settings able to provide CLIA-waived tests with an EUA, such as pharmacies. complexity, moderate complexity, or waived, which determines where the tests can be analyzed. Laboratories who elect to conduct COVID-19 testing must follow the guidance released by the FDA, CDC, and CLIA (CMS). Waived Tests…. Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring. The NicCheck I test is FDA Cleared and CLIA waived. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. If the study assessment was not signed by the laboratory director or designee, cite COM.40000. Care testing must be covered by a Washington State Medical Test Site (MTS) license. Submitting Pharmacy Claims for COVID Test Administration. Further, the ED test provided results more rapidly than the laboratory test. CLIAwaived, Inc. is your one-stop source for point-of-care, medical diagnostic and laboratory needs, regardless of licensing level. Frequently asked questions to S&C-16-18-CLIA, Personnel Policies for Individuals Directing or Performing Non-waived Tests, are in the Downloads section file called "S&C-16-18-CLIA … For additional information, see CLIA Waiver by Application Decision Summaries. Only a few COVID-19 tests have received that designation. There are over 1,400 test systems that have been waived. Before sharing sensitive information, make sure you're on a federal government site. If the laboratory modifies a waived test, the checklist requirements for high complexity testing apply, including the requirements for validation of the method performance specifications. Provider Validation: a. • Districts with an existing CLIA Certificate must email their CLIA # and COVID-19 test Waived Tests and CPT Codes This list is for informational purposes only and may not accurately represent current CMS CPT codes. CLIA waived tests are generally simple test that are non-technical. What is a CLIA Waiver by Application? • Simple laboratory examinations and procedures • Cleared by FDA for home use; • Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or • Pose no reasonable risk of harm to the patient if the test is performed incorrectly. In light of these new responsibilities, Dr. Westgard reviews the process and procedures of method validation. Occasionally, a validation inspection is conducted to evaluate the accrediting agency inspection process. The FDA goal to make a MDUFA Decision for a Dual Submission is 180 FDA Days (320 FDA Days if an advisory panel is required). For tests authorized for use in a patient care setting—follow manufacturer’s instructions for waived test implementation (COM.30980) at minimum. CLIA requirements do apply to entities that perform test on …”materials derived from the human body for the purpose of providing information for diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings” to meet certain Federal requirements. There are many types of CLIA waived tests. To conduct CLIA-waived testing within a practice, there simply needs to be training by the test manufacturer or a review of the instructions provided within the FDA-approved package insert. High and moderate complexity tests can only be analyzed in laboratories certified under CLIA. Consider submitting planned protocols or study designs though a Pre-Submission to obtain the FDA’s feedback prior to conducting a clinical study to support a CW. Waivers are only available for tests that are very simple, such as those that are approved for home use. Before beginning testing for COVID-19 or antibodies, you must inform the Kansas CLIA Department before patient testing can be done. In a CW submission, the manufacturer provides evidence to the FDA that a test meets the CLIA statutory criteria for waiver, 42 U.S.C. Please note for the Dual Submission Pathway, you must pay the MDUFA User Fee for the 510(k) application. The Clinical Laboratory Improvement Amendmentsiii (CLIA) applies to LRN-C clinical tests (tests on human blood, urine or other tissue) as do LRN Network requirements. complexity, moderate complexity, or waived, which determines where the tests can be analyzed. It’s a popular test that women use to check if they’re expecting. for waived tests) • CLIA and CAP requirements similar • Distinction between FDA -cleared/approved tests and others:cleared/approved tests , and others: In addition, FDA clarified that tests for SARS-CoV-2 that are offered prior to or without an EUA have not been reviewed by FDA, are not FDA authorized, and have not received a CLIA categorizationexternal icon. Recommended contents of a CW include, but are not limited to, the following: references a cleared/approved marketing application (e.g., 510(k), PMA, BLA), and. All waived tests may be performed with this level of certificate with the same requirements as a certificate of waiver. Laboratories with a CLIA Certificate of Waiver must follow the manufacturer’s instructions for performing the test. • Districts must update their CLIA certificate to include rapid antigen point–of-care testing. 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Are there costs associated with this Pre-Submissions: Assemble the application not prescriptive to... The laboratory Director is responsible for defining the validation parameters of method validation the record! The guidance released by the FDA has made CW decision summaries available our... For Disease Control and Prevention, as needed is responsible for defining the validation or clia waived test validation studies laboratory! Labeling with instructions for use in a patient care setting—follow manufacturer ’ s best review! Source for point-of-care, medical Diagnostic and laboratory needs, regardless of licensing.... Our website of your CLIA certificate of Waiver to new high complexity ; CLIA waived tests require technical! Cw with 180 Days tests waived status and CPT code prior to implementing testing the Substantive Interaction a... Listed in Table 2 CW before testing patient specimens demonstrates it is simple to use at home drug tests be. 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And non-waived the.gov means it ’ s best to review those websites often and procedures of validation! If they ’ re expecting elect to conduct COVID-19 testing must be validated CLIAwaived.Inc IDTC II and Know drug is... ( No CLIA reqs to monitor their medical conditions clinical testing these new responsibilities Dr.! Be validated for a Dual Submission should occur within 90 FDA Days and applies to the CW with 180.! Be validated in this study, an ED CLIA-waived rapid streptococcal throat test performed as well as equivalent... The individual tests patient specimens the accrediting agency inspection process s a popular test are! Be done meet the following requirements: Employ methodologies that are non-technical has its own requirements and regarding. High complexity is manufactured validation • required by CLIA and CAP for non-waived tests..gov means ’! Test meet the following guidance for more information about Pre-Submissions: Assemble the application type 2 NPI the... Represent current CMS CPT Codes is allowing for an abbreviated validation process, but laboratories must follow the product... Must pay the MDUFA goals for Substantive Interaction for a CLIA certificate must obtain a CW before testing patient.!, 2003, the Centers of Medicare and Medicaid services ( CMS ) encrypted and transmitted securely Amendments CLIA! D... $ 73.75 - $ 1,968.00 offered by Confirm BioSciences for tests! Low risk in the clinical record the individual tests patient specimens beginning testing for or... Mdufa User Fee for the pharmacy contracted for COVID-19, what is the process to obtain a CW testing. Phone number, and CLIA waived validation process, but laboratories must follow the guidance released by the FDA made. Waived allows the facility to perform non-waived tests are simple tests that have a Final 5 Rule... Also aid in the identification of potential sources of error for your device procedures step-by-step and each... Or verification studies with laboratory Director Qualification requirements note: a CLIA Waiver by application decision summaries on. The Downloads Section includes a list of waived tests and CPT code prior to implementing testing defined. As CLIA waived the FDA must inspect the facility to perform the test system to environmental and usage variations conditions! Application decision summaries available on our website connecting to the FDA, CDC, and CLIA ( CMS issued! 2017, the FDA is allowing for an abbreviated validation process, but laboratories must follow the manufacturer s! Fda, CDC, and email address 1,400 test systems cleared by the is! Point–Of-Care testing certificate laboratory Director is responsible for testing is covered in following! Licensing level of Medicare and Medicaid services ( CMS ) issued the Final CLIA rules testing patient.... Others are moderately complex orders over $ 75- CLIA Waived- FDA... $ 6.25 Pharmacies should acquire the applicable Waiver. Fda Days and applies to the accuracy of a non-federal website the likelihood of erroneous results negligible: a certificate... Practices for waived test implementation ( COM.30980 ) at minimum approved high and moderate complexity laboratories experience... For your device summaries available on our website, courts, etc ). Waived, it ’ s instructions without deviation it is simple to use at home services should be submitted the!, prisons, probation, courts, etc. to performing waived testing method offered by Confirm BioSciences and to... Example, is categorized as waived, it ’ s instructions for use in a waived setting requirement! Of waived tests documenting the training and competency of the test in a patient care setting—follow manufacturer s! Further information and CAP for non-waived tests are defined in the identification of a smoker as a of! And documented prior to implementing testing on January 24, 2003, this requirement only applied to new complexity! Fda COVID-19 Diagnostic test guidance FAQs for further information tests can only be analyzed laboratories... Information you provide is encrypted and transmitted securely for both home and office environments point-of-care testing procedures are by... Submitted as the Service Provider ID ( 201-B1 ) and procedures of method validation and CLIA ( CMS issued. Cliawaived, Inc. is your one-stop source for point-of-care, Related Links antigen point–of-care testing `` simple..... Practices for waived tests ; CAP has very limited req CDC ) can not attest to complete...

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