Introduction to individualized quality control plan iqcp the new qc policy from cms. Iqcp for the microscan microbial identification system. The regulations included the qc required for certain microbiology reagents. We arent having issues with any part of this machine. The information is then gathered and formatted into many vital reports, including epidemiology and statistical reports. Jane has been active in volunteering nationwide for cap inspections. Click the button below to complete the form and download our iqcp resources for thermo scientific microbiology products. Introduction to iqcp kathy nucifora, mph, mtascp cola, accreditation division director description. Include copies of these requirements in your iqcp materials. Microscan database to search for common solutions, questions and answers compiled by microscan support engineers. Individualized quality control plan first coast idcm.
The wellestablished method for manual microorganism identification to the species level, biomerieuxs api identification products are test kits for identification of gram positive and gram negative bacteria and yeast. Users can participate in online presentations and seek expert advice. The iqcp has been a long time coming, says susan sharp, phd, director of regional microbiology and molecular infectious disease laboratories for kaiser permanente in portland, ore. Iqcp example for commercial antimicrobial susceptibilty. Iqcp stands for individualized quality control plan and is an alternative option provided by clia for a qc testing plan for nonwaived tests systems.
Department of microbiology clinical laboratory manual table of contents the following procedure and protocol manuals are provided for our microbiology laboratory and are available as an educational reference for other laboratories. Iqcp resources are available for thermo scientific products in each of the following categories. The laboratory has identified all tests using an iqcp and completed the caps forms for laboratories using an individualized quality control plan. Oct 07, 2015 laboratories will no longer be able to use equivalent qc eqc or the clinical and laboratory standards institute clsi standards alone for quality control of their microbiology systems. The new option is called individualized quality control plan iqcp, and it embraces the concept of risk assessment to determine the right. As integrated, endtoend offerings, they help enhance testing while streamlining workflows to improve outcomes and reduce overall.
List of individualized quality control plans and the individualized quality control plan summary. Iqcp and commercial microbiology identification systems. So most every microbiology lab will want to look into iqcp for media qc and for ast qc. Until recently, few guidelines for using malditof ms in clinical microbiology existed. This document library is provided to allow customers easy access to productrelated support documents and resources. Sensitivity testing eg vitek, microscan, etests, disk diffusion testing. Join us for this free webinar that will clear the air and show you a simple, costeffective approach to developing your iqcp. A partnership of the advocate and aurora health care system. Clinical microbiology laboratories recognized eqc as an effective program and adopted eqc successfully.
Clias new iqcp requirements are in effect, or are they. For people who work in microbiology labs, what software do. Microbiology media and reagents used for microbial identification and susceptibility testing may implement an iqcp as defined in the checklist. With less than 9 months to go, iqcp is still clouded in mystery. Iqcp support documents literature request thermo fisher.
As a trusted supplier of a broad range of high quality media and diagnostic products used in clinical, industrial, research, and academic laboratories, and backed by a team of service experts, we are dedicated to microbiology. Laboratories will no longer be able to use equivalent qc eqc or the clinical and laboratory standards institute clsi standards alone for quality control of their microbiology systems. Bhally, 1, 2 susan henciak, 2 and diane flayhart 2. Iqcp is coming january 2016, contd from page 1 ing agency for their requirements. Look for any risks associated with this system that have been identified in the manufacturers performance data located in the pi. Iqcp is an allinclusive approach to assuring quality. Bd phoenix automated identification and susceptibility. The cap requires the completion of the following forms if an iqcp is in use by the laboratory. The cap laboratory accreditation program has been approved by the centers for. Quality assurance issues in the tb lab mike loeffelholz, phd, abmm department of pathology. She also has volunteered on clsi poct04a3 point of care ivd testing and qms03 training and competence assessment documents.
Microbiology for identification and susceptibility testing are eligible for iqcp. Include these data in your iqcp materials, or identify. Microscan walkaway plus microbiology system beckman coulter. For your convenience we have also attached the iqcp example from asm for exempt media. Its just a small microbiology lab that currently records everything on paper, and theres quite few mutants as well. Experience the benefits of nextgeneration microbiology mid to highvolume laboratories may benefit by. Maldi tof ms quality control in clinical microbiology. Bd life sciences integrated diagnostic solutions maintains an extensive portfolio of microbiology solutions designed to make your laboratory run more efficiently and effectively. This pi is located in the microbiology laboratorys pi files. The individualized quality control plan iqcp is the clinical laboratory improvement amendments clia quality control qc procedure for.
Package insert pi contains system performance data and describes testing principle and procedure, qc recommendations, and limitations. The reagent drawer rather than a door is a big success. Associate professor, oregon health and sciences university, department of pathology. Iqcp resources and documentation are now at your fingertips. January 1, 2016 effective date for iqcp implementation january 1, 2016 marks the implementation of the centers for medicare and medicaid services cms new qc option, the individual quality control plan iqcp. Biofire filmarray product support documents biofire. Clias new iqcp requirements are in effect, or are they implementing laboratory risk management now to ensure success jack zakowski, phd, facb director, scientific affairs and professional relations beckman coulter, inc. The following types of microbiology testing are eligible for iqcp. You can also visit the microscan download center to. The iqcp movement will allow us hospitals to move toward an isolike approach that places a focus on process and outcomes, and allows healthcare facilities to individually develop their own means of ensuring quality results.
Review your initial verification studies and any subsequent studies and historical qc data to help define your iqcp. Cola has a software product that helps to develop iqcp s. Software hardware transmission of data to lis result reporting. It also enables workflow efficiency by utilizing automated nephelometry, which results in a. Regional microbiology and molecular infectious diseases laboratories. Its a work horse and it is a machine we love and rely so heavily on. Individualized quality control plan iqcp how to complete a risk assessment june 2015 an interview with susan e. Contact your washington state department of health, laboratory quality assurance lqa surveyor if you have questions or need assistance. Iqcp is an allinclusive approach to quality based on risk.
Iqcp provides a framework for laboratories to customize a qc program by assessing. Iqcp will have a more profound effect on clinical microbiology than some other areas of the lab that already run positive and negative controls every day they run tests, says susan sharp, phd, presidentelect of the american society for microbiology and a member of the cap microbiology resource committee. Informing laboratories about the iqcp option that contains significant detail about the program. The clinical and laboratory standards institute clsi recently published the m52 standard that requires that an iqcp be written if the laboratory is performing streamlined qc with their commercial microbiology system. While many systems claim sampletoanswer capabilities, only the eplex system is able to integrate the entire process from ordertoreport to better realize the patient and laboratory benefits of rapid, multiplex molecular diagnostics.
Evaluation of the bd phoenix automated microbiology system for identification and antimicrobial susceptibility testing of enterobacteriaceae karen c. Microbiology checklist, molecular microbiology section. Bd phoenix automated identification and susceptibility testing system. The bd phoenix automated identification and susceptibility testing system provides rapid, accurate and reliable detection of known and emerging antimicrobial resistance. Technical ive spent the last two months almost exclusively trying to make our qc processes and package inserts actually match up.
Individualized quality control college of american pathologists. The iqcp option applies to a variety of nonwaived microbiology tests, but it may be most useful for testing that has been performed following the clsi microbiology guidelines for reduced qc testing, including antimicrobial susceptibility testing, commercial identification systems, and culture media. One laboratorys experience with the methods for the. Introduction to individualized quality control plan iqcp. In many laboratories, the microbiology section uses iqcp to a greater extent than any other department. Once we get approval, then every tech at any computer terminal will have access to the walkaways software. Representatives from american society for microbiology asm, college of american pathologists cap, and clinical and laboratory standards institute clsi have jointly prepared materials you can use as a guide in development of an ast iqcp in your laboratory for a commercial automated ast. Jane is currently directing a cross functional iqcp team to provide iqcp. Guideline and helpful tools for implementation laboratory. Include a copy of your manufacturer s package insert pi in your iqcp materials. Individualized quality control plan iqcp examples susan e.
Microbiology tests that do not need an iqcp 121415. Iqcp1 is an allinclusive approach to assuring quality. Jane is currently directing a cross functional iqcp team to provide iqcp support materials for alere products. The surveyors have shared information at the end of mts surveys when iqcp will affect the laboratory. Fullcourt collaboration in transition to iqcp cap today. It includes many practices that your laboratory already uses to ensure quality testing beyond requiring that a certain number of qc materials be tested at a designated frequency. With single database management of up to 8 instruments per computer, the biofire filmarray 2. This is based in part on information included in clsi ep23a laboratory quality control based on risk management and cdccms developing an iqcp, a stepbystep. Iqcp and commercial microbiology identification systems by susan walker department of healthlqa t he centers for medicare and medicaid services cms is implementing a new voluntary quality control model based on risk management called individualized quality control plan iqcp that is to be used for tests and test systems that do not follow clia. Individualized quality control plan iqcp powerpoint template. Iqcp eligibility determination pdf, 55 kb iqcp in microbiology pdf, 154 kb iqcp.
Is there a plan by cms to educate laboratories regarding the iqcp for microbiology. Iqcp is coming january 2016 washington state department. Our customizable labpro alert ex software automates detection of atypical results for quick reporting and directs staff to the most appropriate action, based on customized institutional procedures. Apiweb is rapid and easy to use key in the biochemical or numerical profile of the strip to obtain the organism identification.
Thermo fisher scientific has assembled various tools, references and links to help you address the cms requirement for iqcp implementation. Microbiology id systems streamline qc iqcp example pdf, 489 kb word, 2 mb. Table 3 lists microbiology tests that would not require an iqcp. Software rules will flag most potential errors results are to be checked by tech daily. The guidance and concepts for iqcp are a formal representation and compilation of many of the activities currently undertaken in laboratories to ensure quality test results for patients. The implementation of iqcp in clinical microbiology laboratories will most certainly be an added burden, the benefits of which are currently unknown.
The individualized quality control plan coming soon to clinical. Microbiology testing performed using media, identification systems, and. The individual quality control plan iqcp cms new qc option for test sites inspected for clia compliance. Sep 11, 2015 do the new iqcp requirements have you down. Iqcp does not apply to some types of testing for which daily qc is not performed and where the clia. Since a large number of clinical microbiology laboratories have adopted malditofms as a primary method, labs absolutely need to implement sufficient quality control qc practices to ensure they report accurate identifications. The individualized quality control plan iqcp is the clinical laboratory improvement amendments clia quality control qc procedure for an alternate qc option allowed by 42cfr493. Observa is an information management system that stores the test data generated by the vitek 2 or vitek 2 compact.
And there are good ways to do that through an iqcp. The guidance and concepts for iqcp are a formal representation and compilation of many things laboratories already do to ensure quality test results. The individual quality control plan iqcp cms new qc option for test sites inspected for clia compliance january 1, 2016 effective date for iqcp implementation january 1, 2016 marks the implementation of the centers for medicare and medicaid. Apiweb is a software product containing all of the api databases for a reliable automated interpretation of api strip results when used on any compatible pc workstation.
Evaluation of the bd phoenix automated microbiology system. Iqcp can be applied to all nonwaived testing performed, including existing and new test systems. November 2017 webinar iqcp assessment example formword, 637 kb prepare your laboratory for inspection instructions for completing the individualized quality control plans form pdf, 158 kb. The iqcp option offers your laboratory flexibility for meeting regulatory qc requirements appropriate for the testing you perform and when you add a new test.
Cms is publishing guidance for a new, more meaningful alternate qc option that will replace eqc. Molecularbased infectious disease testing and direct antigen testing performed using nonwaived instruments or devices that have internal control processes. Create a culture of more efficient microbiology testing. Individualized quality control plan iqcp powerpoint.
For this first foray into iqcp and accreditation requirements, the laboratory accreditation program supported the two areas of microbiology. T he iqcp arose from a sense that the old eqc program was inadequate, says christopher lehman, md, a member of the cap standards and checklists committees. Optional labpro connect software allows you to consolidate data from multiple testing systems on epidemiology reports right in your laboratory office. Many laboratories are struggling to understand how to comply with the new guidelines. The following represents one example of how you might organize your iqcp for a commercial antimicrobial susceptibility testing system. Department of microbiology clinical laboratory manual. The microscan walkaway plus system includes labpro information manager software designed to simplify workflow and minimize technologist interaction. The cap has resources for individualized quality control plan iqcp.
This is based in part on information included in clsi ep23a laboratory quality ontrol ased on risk management and dms developing an iqp, a stepby. You will see several updates to our certificates of analysis and product inserts rolled out by the end of september 2015 to help support your iqcp efforts. As integrated, endtoend offerings, they help enhance testing while streamlining. Id systems m50 streamline, including yeast id systems. Clinical microbiology laboratories have an opportunity to replace. Apr 22, 2015 all labs running eqc must either revert back to the us clia minimums or develop and switch to an individual quality control plan iqcp. A partnership of the advocate and aurora health care system iqcp guidelines and template for getting started linda c.
1584 1659 1388 89 860 1648 1449 1165 325 481 249 491 931 1029 127 753 889 986 1428 1432 252 1628 408 510 1159 851 235 359 1025 1062 318 208 645 468 396 707 594 433 949 1424 1106 1414 1102 963 966 582