If the test is classified as waived complexity, no further action is required, provided that the laboratory has followed checklist requirements for implementation of waived tests (COM.30980). The service requires full cookie support in order to view this website. (New May 16, 2023), What does my laboratory need to do if the COVID-19 EUA that we are performing obtains FDA clearance and the EUA is revoked? Reference CAP accreditation checklist requirements: COM.30600, COM.30675. Store reagents and controls properly to minimize target DNA/RNA contamination and degradation. IQCP can be performed on SARS-CoV-2 assays with EUA to assist A wipe or swipe test can be done by: A positive result from a wipe test indicates environmental contamination. Subsequent CAP changes, if applicable, are not reflected in this eAlert. Results of testing must be considered in the context of the individuals clinical and other information. Convalescent plasma transfusions were given for other viral infections, including influenza and the coronavirus infections Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). The IQCP procedure is located in the guidance for 493.1256(d) found in the State Operations Manual, Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (PDF). Manage rapidly evolving changes in laboratory medicine and technology, Exchange ideas and best practices among pathology and laboratory medicine peers, Offer professional development and learning opportunities for laboratory staff, On-site inspections occur every two years using, Participating laboratories can access the checklists through, Peer-based inspection model uses teams of practicing professionals qualified through a. In the revised standards, all references to EQC have been removed. These Fact Sheets were updated with the February 4, 2021 letter of authorization to reflect the current patient eligibility, and earlier versions should no longer be used. The extent of the study is left to the discretion of the laboratory director. Until then, use of investigational CCP is permitted from prior stocks. Annual checklist updates incorporate the latest best practices. We will also share information on CAP resources available to help you prepare an IQCP. Our complimentary educational resources help laboratories prepare for accreditation, maintain compliance, and provide high-quality service. For testing procedures with a high likelihood to generate aerosols or droplets, use either a certified Class II Biological Safety Cabinet (BSC) or additional precautions to provide a barrier between the specimen and personnel. Evaluate if anything has changed in the testing process (eg, intended use, test system, reagents, procedure) or if it is simply a change of label. It is currently unknown if, or how, accrediting organizations (for example, CAP) or states that have additional requirements will accept IQCP. Participants of the CAP accreditation programs may download the checklists from the CAP website (cap.org) by logging into e-LAB Solutions Suite. Units of CCP are transfused to a patient with COVID-19 infection as a source of passive immunity. (Updated May 16, 2023), Is my laboratory still required to report COVID-19 test information and data elements to the state or local public health authorities? No, the enforcement discretion described in the CMS Memorandum QSO-23-15-CLIA GENERAL: WHAT IS IQCP AND WHY DO WE NEED IT? lock Why? Although IQCP has not historically been applicable to tests with Emergency Use Authorization (EUA), CMS updated this in 2020 for the COVID-19 public health emergency. Inspectors will review the records and determine if the action taken by the laboratory was adequate. It is helpful to include the manufacturers recommendations for QC to assure the QCP is not less than what is recommended. Subsequent international inspections are announced. Whichever option is selected laboratories are not permitted to establish quality control procedures that are less https://extranet.who.int/pqweb/sites/default/files/documents/230207_EUL_SARS-CoV-2_Approved_IVDs.pdf. (Updated March 24, 2023), Is CCP safe and effective for treating COVID-19? But as a service to CAP-accredited labsand with the aim of keeping panic at baythe CAP has marshaled an array of resources to ease laboratories transition to IQCP. Laboratories may consider modifying this template to support their practice. All content on this website, including dictionary, thesaurus, literature, geography, and other reference data is for informational purposes only. American Society for Microbiology ("ASM") is committed to maintaining your The laboratory must follow the manufacturers instructions for inclusion of a disclaimer on the patient report, as applicable. For laboratories not subject to US regulations, this same information applies to tests authorized through the FDAs EUA process and the World Health Organization Emergency Use Listing (EUL): https://extranet.who.int/pqweb/sites/default/files/documents/230207_EUL_SARS-CoV-2_Approved_IVDs.pdf. The scope of the work falls within the primary sites certificate. Use our database to search for CAP-accredited laboratories. QCP must ensure accuracy and precision of the test/assay. The primary laboratorys test reports indicate the remote site location where the testing is performed. Examples of Nonwaived Rapid Direct Tests with Built-in Internal Controls Eligible for IQCP, Either Implement an IQCP or Follow CMS/CAP Default. The CAP does not mandate the use of a specific disclaimer statement for EUA assays. If using IQCP, a laboratory should establish a plan to monitor the effectiveness of the QC plan. Acronym. It was not until mid-2015 and after laboratories began to fully appreciate the consequences of not adopting IQCP as an alternative to the CMS CLIA default of performing QC on each day of patient testing. or Request Information Submit a fee estimate form to receive more information about cost and next steps to become CAP accredited. .gov They are available in different checklist types and formatting options, including: Master contains ALL of the requirements and instructions available in PDF, Word/XML or Excel formats ( This process is automatic. Each batch of media, and each lot number and shipment of antifungal agent(s) before, or concurrent with, initial use, using an appropriate control organism(s), Each week tests are performed, laboratory must use appropriate control organism(s) to check the procedure. An asymptomatic individual may be suspected of COVID-19 for various reasons, such as known exposure or working in a high-risk environment. So where are we now with IQCP? The guidance does not apply to pathologists who have already obtained CLIA certificates for their home site or other locations separate from the primary testing site. An IQCP includes many practices that your laboratory already engages in to ensure quality testing, not just the frequency and number of QC materials. To comply with federal regulations and the CAPs current collaborative agreement with The Joint Commission (TJC), the following inspection notification process will be used for these laboratories: Laboratories that have already been notified of a scheduled inspection date occurring after May 11th will have the inspection occur as scheduled. This information should not be considered complete, up to date, and is not intended to be used in place of a visit, consultation, or advice of a legal, medical, or any other professional. Determine the complexity of the test. The primary laboratory maintains a list of staff working remotely. What is IQCP? 166, 02-03-17 (PDF), CLIA Brochure - CLIA Individualized Quality Control Plan Introduction July 2013 (PDF), CLIA Brochure - CLIA IQCP, Considerations When Deciding to Develop an IQCP - November 2014 (PDF), CLIA Brochure - CLIA IQCP, What is an IQCP? In addition, the Occupational Safety and Health Administration (OSHA) published a document Guidance on Preparing Workplaces for COVID-19, which provides guidance for defining the level of employee risk and steps to be taken to reduce the level of risk and protect workers. Also, do we also need to compare the antigen tests with our molecular tests twice a year? Quantitative tests - two controls at different concentrations each day of patient testing, except for . Any questions about IQCP should be forwarded to LabExcellence@cms.hhs.gov. A new panel is a separately manufactured device and is considered a new test. Use of a specimen collection device or sample type not included in the manufacturers IFU is considered a modification and requires validation of the applicable test performance specifications (accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference intervals, and any other performance characteristics required for test performance). The CMS Memorandum QSO-23-15-CLIA issued May 11, 2023, states that as of the end of the public health emergency (PHE), laboratories are required to follow the manufacturers instructions for intended use for SARS-CoV-2 testing. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/sars-cov2-testing-strategies.html. Additional information can be found on the CDC website. Heres how you know. ASM's Clinical and Public Health Microbiology Committee, clinmicro@asmusa.org, 1752 N St. NW While still following the manufacturers QC frequency recommendations, EQC allowed laboratories to decrease external QC while saving dollars in laboratory supplies and labor.1 Although EQC was adopted by many laboratories, over time it proved to have technological limitations. The CMS memorandum further clarifies that they will not consider it a modification of the manufacturers instructions for use when the IFU states that is intended for individuals suspected of COVID-19 by their healthcare provider, and the test is ordered by a healthcare provider for asymptomatic patients. The temporary site complies with other applicable federal and state laws, including the Health Insurance Portability and Accountability Act (HIPAA). Manage rapidly evolving changes in laboratory medicine and technology. MIC.11017 QC Confirmation of Acceptability Phase II Dampening a sterile swab in sterile saline, Swabbing the area around the testing instrument. means youve safely connected to the .gov website. Laboratories using different nonwaived instruments to detect the same analyte must compare them against each other at least twice a year for comparability of results. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. CAP IQCP forms not completed or used as a substitute for the QCP or risk assessment 4. Reference CAP accreditation checklist requirements: GEN.74100 and MIC.19840. This exception is allowed under the Business and Professions Code 1206.7. Patients who recovered from COVID-19 infection proven by a positive diagnostic test and were subsequently vaccinated can donate CCP within six months after symptom resolution. Reference CAP accreditation checklist requirements: GEN.54750. Now, the CAP Laboratory Accreditation Program has integrated IQCP requirements into the 2015 edition of the All Common Checklist, which at CAP TODAY press time was scheduled for release at the end of July. www.mlo-online.com is using a security service for protection against online attacks. Yes, the CAP requires laboratories to have written procedures to monitor for the presence of false positive results (eg, due to nucleic acid contamination) for all molecular microbiology tests. Please note this page is iterative and we are adding more questions as we receive and answer them. If so, and if it is likely to be of interest to others in laboratories, send it to CAP TODAYs Q&A column (srice@cap.org) or complete our online form. issued May 11, 2023, does not extend to glass slides. Public Health Emergency Updates for CAP Customers (Updated May 16, 2023), What are the requirements for verifying the test method performance specifications for an emergency use authorization (EUA) test kit for COVID-19? CQIP. For a brief historical review, the Centers for Medicare and Medicaid Services (CMS) in 1967 created the Clinical Laboratory Improvement Act of 1967 (CLIA 67) to regulate laboratories that performed Medicare billing and/or engaged in interstate commerce. 5. Laboratories must be appropriately licensed to perform testing when required by law. Laboratories must review manufacturers package inserts, relevant policies/procedures, QC, corrected reports, physician complaints, personnel training and competency records, PT results, and temperature records, to name a few.3,4Table 4 is an example of a helpful checklist that may be utilized, especially when writing more than 1 IQCP. (New February 23, 2021), How can health care providers (HCPs) and patients get information about CCP under the EUA? External QC may not be performed less frequently than defined in the manufacturers instructions. (Updated May 16, 2023) Is an EUA assay considered a laboratory-developed test (LDT)? The laboratory should be able to provide records to inspectors explaining any gaps or delays, as well as the actions that were taken to communicate with vendors and to ensure the quality of the affected instrument/equipment. During the PHE, the CAP heard concerns from some laboratories about difficulties getting service vendors to complete scheduled maintenance for different types of equipment, such as chemistry analyzers, pipettes, and hoods. Every lab accredited by the CAP has the expertise to do a risk assessment, Dr. Gerald Hoeltge says. Individuals suspected of COVID-19 infection may be symptomatic, pre-symptomatic, or asymptomatic. Top-ranked hospitals prefer our program. The Joint Commission Accreditation Laboratory. (Updated February 23, 2021), Archives of Pathology & Laboratory Medicine, Public Health Emergency Updates for CAP Customers, Transition Plan for Medical Devices Issued Emergency User Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). Three other quality control changes that took effect January 1, 2016, and dramatically affect quality control requirements for antimicrobial susceptibility testing, identification test systems, and exempt culture media will also be explained. If any modifications are made to the EUA assay, the modifications must be validated by the laboratory and the assay becomes subject to requirements for modified FDA-cleared/approved tests. If a test is non-waived and eligible per the guidance, and the lab wishes to reduce QC below the CLIA default QC (typically two levels per day), and the manufacturer has no recommendation or a recommendation that is less than CLIA default, then an IQCP must be performed and in place starting January . IQCP was based on principles contained in EP23-A, but the two are not 100 percent identical. Enable CGP with flexibility and scalability in-house. 6. alternative CLIA quality control (QC) option that will provide for equivalent quality testing for 42 CFR 493.1250. Now, the CAP Laboratory Accreditation Program has integrated IQCP requirements into the 2015 edition of the All Common Checklist, which at CAP TODAY press time was scheduled for release at the end of July. Sign up to get the latest information about your choice of CMS topics. www.mlo-online.com is using a security service for protection against online attacks. Memorandum Summary IQCP: The Centers for Medicare & Medicaid Services (CMS) is implementing a new quality control option for laboratories based on risk management. (Updated May 16, 2023), Does the CAP require any type of monitoring for false positive results for molecular-based COVID-19 testing? They are subject to All Common Checklist requirements for test method verification of nonwaived testing. https://acronyms.thefreedictionary.com/CQIP, "We do it as a value-added manufacturing process." CCP is an investigational product and must be administered under an emergency use authorization (EUA) or an investigational new drug (IND) authorization. In many cases, previous quality control and/or proficiency testing results may be used to complete records of verification. Once the RA has been completed, a grid or table format is created and populated with each of the 5 components, followed by all the risks related to that component, frequency of occurrence, impact of harm, an assessment of the risks acceptability, and what policies or procedures are in place to mitigate the risk (Table 6). Persons who received vaccine and never had known SARS-CoV-2 infection cannot donate CCP. Table 7 is an example of a helpful tool to document the continuous monthly monitoring of the various areas of each IQCP. instructions or CAP Checklist requirements, whichever is more stringent. Source of Answer: CLSI/CAP/ASM Clinical Microbiology IQCP WG Q. Guidelines and tools are provided that can assist laboratories in determining what is eligible for IQCP and how to design an IQCP program. Reference CAP accreditation checklist requirements: COM.40250 and COM.40350. Antifungal susceptibility tests (disk, strip or MIC method), Each day tests are performed, laboratory must use the appropriate control organism(s) to check the procedure. The CAP's Laboratory Accreditation Program is unlike any other. Clinical dosing may first consider starting with one unit of COVID-19 convalescent plasma (about 200 mL), with administration of additional convalescent plasma units based on the prescribing physicians medical judgment and the patients clinical response. (Updated February 23, 2021), When will CCP be available under the terms of the EUA? The purpose of the RA is to review the entire testing process, from the preanalytic to the analytic to the post analytic, and assess where an error might occur and, if it goes unnoticed, cause harm to the patient. The CAP requires that laboratories performing external QC less frequently than the default CLIA frequency develop and implement an IQCP for COVID-19 test methods with an internal quality control process; however, it is not required during the COVID-19 health care emergency. In addition, only the CAP offers specialty inspectors for key, high-complexity disciplines. The FDA has now authorized several antigen, molecular, and over-the-counter tests for use in asymptomatic individuals. If a test is waived, an IQCP is not required. Example of Risk Assessment Grid with 1 Component and Related Risks, After the RA is complete, the QCP is written, detailing the number of QCs to be tested, and their types, frequency, and criteria for acceptability. After May 31, 2021, all CCP must conform to EUA high-titer requirements. The CAP has developed an eligibility determination tool to assist in the determination of eligibility of a test system for a CAP IQCP. Wayne, PA: Clinical and Laboratory Standards Institute; Clinical Labboratory Improvement Act of 1967, Clinical Laboratory Improvement Amendments of 1988, Clinical Laboratory and Standards Institute, Centers for Medicare and Medicaid Services, Oxford University Press is a department of the University of Oxford. website belongs to an official government organization in the United States. CLSI Supplement M100, Clinical and Laboratory Standards Institute, Quality Control For Commercially Prepared Microbiological Culture Media, Quality Control for Commercial Microbial Identification Systems; Approved Guideline. No, an EUA assay is not considered a laboratory-developed test (LDT). CCP has not been approved by the FDA and its safety and efficacy are still under review. Some blood centers are electing to have a brief deferral period in case of side effects from the vaccine. The new IQCP option gives laboratories the flexibility to determine the appropriate tool(s) for their test system and environment. It is important to educate staff on the importance of keeping the work area clean and disinfected, following established protocols for specimen processing and handling throughout the testing process, and on proper handling and disposal of specimens and testing materials. (Updated February 23, 2021), How does COVID-19 vaccination affect eligibility for routine blood donation? Archives of Pathology & Laboratory Medicine, international laboratories seeking CAP accreditation, Browser and Operating System Requirements, Maintain accuracy of test results and ensure accurate patient diagnosis. requirements of IQCP. Does the QCP need to be modified? The lab must then document and be able to demonstrate QA is being performed. If a facility is restricting visitors within the institution for any reason, the CAP recommends that inspectors comply with the facilitys visitor policies at the time of the inspection. 4. No IQCP in place and EQC still in use 2. Secure .gov websites use HTTPSA The revised CMS standards allow laboratories the option of adhering to the defined default for QC frequency or implementing the newly defined IQCP for eligible nonwaived tests.8 Additionally, the College of American Pathologists (CAP) has incorporated new checklist questions and revised previous checklist questions as of July 28, 2015, to comply with the new CMS standards.9. For tests authorized for use in a patient care setting, the laboratory must follow manufacturers instructions for waived test implementation (COM.30980) at minimum. Continuous Quality Improvement Process. (New May 16, 2023), How does the end of the COVID-19 public health emergency (PHE) affect my laboratorys CAP inspections? The revised CMS QC regulations have drastically changed laboratory standards with regards to the frequency of performance for external QC as of January 1, 2016. In cases where an EUA is revoked due to the manufacturer obtaining FDA approval or clearance, your laboratory should take the following steps: For more information, please review the following article in the Journal of Clinical Microbiology: Considerations from the College of American Pathologists for implementation of an assay for SARS-CoV-2 testing after a change in regulatory status. The new Individualized Quality Control Plan (IQCP) option that became effective January 1, 2016, will be explained. The decision to order a test for an individual suspected of COVID-19 is at the discretion of the health care provider or individual authorized to order a test. If your laboratory confirms that there is no change to the test other than the labeling, the laboratory director should review the initial test method verification study (for nonwaived tests) to confirm its adequacy. Reference CAP accreditation checklist requirements: GEN.20374, GEN.41316. Will our laboratory be cited with a deficiency during our next inspection? So what exactly does that mean? (Updated May 16, 2023), Are any disclaimers required when reporting a COVID-19 EUA assay? CLSI document M50-A, American Society for Clinical Pathology, 2016. The All Common Checklist contains the requirements for IQCP, including RiskAssessment, Quality Control Plan, and Quality Assessment Monitoring.
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