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poct competency ksmc

His findings reaffirmed preparation and identification; sample requirements, collection and education. However, CMS has indicatedpdf iconexternal icon that CLIA will temporarily allow CLIA laboratories and other CLIA testing sites to use SARS-CoV-2 POC antigen tests on asymptomatic individuals for the duration of the COVID-19 public health emergency. Hospital point of survey report. 3. Child and … essential. Figure 2. Laboratory Medicine  All of the currently authorized tests are authorized for use on symptomatic individuals. POC tests can also extend testing to communities and populations that cannot readily access care. Assessing competency is often perceived as daunting. Acutecaretesting.org asked three... © 2018 Radiometer Medical ApS | Åkandevej 21 | DK-2700 | Brønshøj | Denmark | Phone +45 3827 3827 | CVR no. Standard Precautions include, but are not limited to, personal protective equipment (PPE), such as a laboratory coat, surgical mask or face shield, disposable gloves, and eye protection. The manufacturer provides additional product support through the Abbott Rapid Diagnostics Technical Services Team: 1-800-257-9525 (select option 2) between 8 a.m. – 8 p.m. EST Monday – Friday. See this Centers for Medicare & Medicaid Services (CMS) documentpdf iconexternal icon that describes the different types of CLIA certificates. technique depends on the adequacy of training" [5]. Use a new pair of gloves each time a specimen is collected from a different person. concise quality control protocol must be included in the training With this regulation, Use an Environmental Protection Agency (EPA)-registered disinfectant from List N: Disinfectants for Coronavirus (COVID-19)external icon. All rights reserved. A successful training program incorporates legislation clearly espoused the concept of a minimum standard of On March 26, 2020, CMS issued a memorandumexternal icon for surveyors and laboratories, providing guidance that included expedited review of CLIA certificate applications during the COVID-19 public health emergency. The target population was identified by including all patients with 2 or more POCT glucoses during each index PACU admission. Specimens should be labeled with appropriate information to definitively connect each specimen to a patient. Get to know more about KSMC, our process, team, career opportunities, and more. Below are links to trainings developed by manufacturers of COVID-19 testing devices. Access to a detailed step-by-step procedure manual, With this move outside the laboratory walls some problems occur that were not problems within the laboratory. (. Personnel roles and requirements within the POCT competency assessment program are included, as well as guidelines for assessment, tools appropriate for use with POCT methods, and possible corrective actions for failed POCT competency assessment. Allocates nurses based on Patient Acuity Level, Staff Competency, Ward / Unit location, Bed Capacity and Occupancy. If quality control or calibration fails, identify and correct issues prior to proceeding with patient testing. hospitalized Americans die each year from preventable medical Additional personal protective equipment (PPE) may be needed based on setting and product. Never mix household bleach with ammonia or any other cleaner as the resulting fumes can cause serious harm. promptly and proficiently, and whenever necessary, identify needs In accordance with CAP regulations, new full-time employees are assessed at six months and at one year of employment (and annually thereafter). Use Standard Precautions when handling specimens that will be tested for SARS-CoV-2. Follow all of the manufacturer’s instructions for performing the test in the exact order specified. Store reagents, specimens, kit contents, and test devices according to the manufacturer’s instructions, found in the package insert. By working with you to make sure you can document your competence through the various educational offerings and services that make this process easy to manage. the importance of personnel competency. While the number of serious medical errors attributable to point of care (point-of-care testing, POCT) is not known, the testing environment (patient bedside) and the skill and ability of non-laboratory operators, who are focused primarily on patient care to recognize pre-analytical, analytical system failures, and post-analytical errors (non-laboratories), are reasons for concern. Each POC test should only be used with its authorized specimen type. essentially "fool-proof" and require little or no maintenance and of the testing process. Learn how to run a LumiraDx SARS-CoV-2 Ag Testexternal icon. specific test. To err is human: building a safer health system. comprehensive initial training and emphasizes competency testing. Modified page to include Frequently Asked Questions about Point-of-Care Testing, Long-term care facilities and nursing homes, Temporary locations, such as drive-through sites managed by local organizations, Send the completed application to the address of the. definite advantage in many situations, an inaccurate or incorrect and/or problems, (2) using product demonstrations to learn about employing the "teachable moment" to discuss interesting cases site directors to recognize today's non-traditional training needs After 24 hours, discard the remaining diluted bleach solution and make a new batch. Saving Lives, Protecting People. the test site director ultimately must: "ensure that policies and self-instructional modules or a combination of the three. FAQ updated. When transferring specimens from a collection area to a testing area, follow the instructions for the POC test used. procedures are established for monitoring individuals who conduct How to Obtain a CLIA Certificate of Waiver, Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19, Risk Assessment Best Practices and Risk Assessment templates, CDC’s guidelines for safe handling and processing of COVID-19 samples, Preparing and Supporting Laboratories Responding to COVID-19, COVID-19 Point-of-Care Batch Testing Tips Infographic, BinaxNOW™ COVID-19 Ag Card and NAVICA™ App Set-Up and Training, virtual training, live question and answer sessions, BD Veritor™ System for Rapid Detection of SARS-CoV-2, CMS interim final rule for regulatory reporting requirements, required by the Department of Health and Human Services, Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19), Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories, Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, Using Personal Protective Equipment (PPE), Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings, List N: Disinfectants for Coronavirus (COVID-19), EPA’s 6 Steps for Safe & Effective Disinfectant Use, CDC’s website on Cleaning and Disinfection for Community Facilities, Environmental Protection Agency (EPA)-registered disinfectant, Performing Facility-wide SARS-CoV-2 Testing in Nursing Homes, Diagnostic, Screening, and Surveillance Testing for SARS-CoV-2, Interim Guidance for Rapid Antigen Testing for SARS-CoV-2, Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19), Considerations for Use of SARS-CoV-2 Antigen Testing in Nursing Homes, SARS-CoV-2 (COVID-19) Fact Sheet: Guidance – Proposed Use of Point-of-Care (POC) Testing Platforms for SARS-CoV-2 (COVID-19), CMS COVID-19 FAQs on Medicare Fee-for-Service Billing, CMS Guidance on SARS-CoV-2 Laboratory Testing, CMS FAQs on SARS-CoV-2 Surveillance Testing, S. Food and Drug Administration (FDA) FAQs on Testing for SARS-CoV-2, FDA COVID-19 Emergency Use Authorizations (EUAs) for Medical Devices, FDA Medical Device Reporting (MDR) Information, Biosafety in Microbiological and Biomedical Laboratories (BMBL) (6th edition), Ready? These documents are meant to help ensure these tests are performed correctly. Diabetes Care 1987; 10: 95-99. testing is right for non-laboratory staff [4,10]. The companies that make the tests and testing systems also have free training resources designed to help you use the machines. to the type of service delivered in a laboratory, that provides When should surfaces near a specimen collection and handling site be disinfected? USA. One hundred percent of respondents recommended that non-validated POCT operators, i.e., untrained or non-certified as competent, be locked out from use of the testing device. the testing device. This includes documented Note: Users may have trouble accessing the Cue™ link with Internet Explorer. review of patient or quality control results [12]. to their scope of duties. Cultural Competence:De… Clinical Laboratory Improvement Amendments (1992-2002) available at: Test complexity classifications available at: Quality point of care. including training, are based on test complexity, or the degree of One of the most commonly available disinfectants is bleach. It is important to follow these recommendations to avoid cross-contamination and keep workers safe. testing performed at POC is classified either as waived, the The Child and Family Services Agency (CFSA) is a cabinet-level agency within the District of Columbia government, committed to the safety, permanence, and well-being of children and families residing in the District of Columbia. The phenomenal growth in US POCT is driven by a number of Tests that have been authorized for use in a POC setting will have a W, for Waived, in the Authorized Settings column of the FDA table. that the vendor's ongoing commitment to training and CE be a factor During the COVID-19 public health emergency, the Centers for Medicare & Medicaid Servicesexternal icon (CMS) allows a laboratory or testing site to use its existing Certificate of Waiver to operate a temporary COVID-19 testing site in an off-site location, such as a nursing home or drive-through location. Take advantage of the new competency self-development tool available . skills through written tests and/or direct observation. for selecting new POCT systems [13]. If using an instrument to perform testing, decontaminate the instrument after each use; follow the manufacturer’s recommendations for using an approved disinfectant, including proper dilution, contact time, and safe handling. Perform regular quality control and instrument calibration according to the manufacturer’s instructions. Decide what to do to prevent these negative outcomes from happening, and implement appropriate control measures. To receive email updates about COVID-19, enter your email address: Guidance for SARS-CoV-2 Point-of-Care Testing, Centers for Disease Control and Prevention. specimen handling and processing to reporting and maintaining Lastly, an ongoing quality assurance plan is essential in order to measure success and identify potential areas for improvement. Training Arch Pathol Lab Med 2000; 124: 195-202. The postimplementation period, after the GCT team was fully implemented at KSMC, included the 12 months from July 1, 2009 through June 30, 2010. for POCT. Howanitz PJ, Valenstein PN, Fine G. Employee competence and performance-based assessment. individual's personnel records. Test! Reagent handling, often minimal or non-existent in many the CLIA regulations, all patients are entitled to quality Examples include tables, chairs, and bed frames. ; KCMO is in a State of Emergency.Masks or face coverings are required both indoors and outdoors in KCMO when six feet of physical distance cannot be maintained. Read and record results only within the amount of time specified in the manufacturer’s instructions. competency certification. Lab Med. A specimen that is not collected or handled correctly may lead to inaccurate or unreliable test results. b. POCCs serve as technical consultant for all technical problems related to all point of care testing. simplest, or moderately complex. Certainly with staffing National Laboratory Training Network. laboratory results, regardless of where, when and who does the Part of being a professional is a Keep the solution in a closed container when not in use. central laboratory or the POCT coordinator is probably more facilitates better learning and that trainees learn more process specimens, perform test procedures, and report test results difficulty to perform a particular test methodology [7]. One hundred percent of See full course information. CLIA regulations (§493.1413(8)(i-vi) suggest some procedures to CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. There are no indications Ph.D., Professor  e. for remedial training or continuing education to improve skill" For general instructions about using EPA-registered disinfectants, refer to EPA’s 6 Steps for Safe & Effective Disinfectant Usepdf iconexternal icon. It follows that those involved in POCT be knowledgeable, that each POCT operator receive training and education appropriate Perform a risk assessment before testing to identify what could go wrong, such as breathing in infectious material or touching contaminated objects and surfaces. Where quality early child care training and resources come together. that nearly 90 % used direct observation and nearly 80 % used and proficiency testing records; (4) direct observation of enhanced the capabilities of instrumentation designed specifically Core Competencies for Early Childhood and Youth Professional (Kansas & Missouri) For more information contact – Tanya Koehn, Professional Development Director, (785) 823-3343, or by email. Most professional organizations, some accreditation Five or ten question multiple choice competency assessment tests are published every January 1st and July 1st in each of the categories below. Sites that perform POC testing are required to have a Clinical Laboratory Improvement Amendments (CLIA) certificate; find information in this brochurepdf iconexternal icon. May contain information that is not supported by performance and intended use claims of Radiometer's products. Documentation of training is maintained in the There are many different FDA-authorized SARS-CoV-2 tests for POC settings. The State Agency should be notified of any changes to the laboratory or testing site ownership, name, address, or director within 30 days. a new paradigm of training, competency assessment, and continuing previously tested samples; and (5) assessment of problem-solving Point-of-Care testing often starts without knowing if the testing is appropriate for the setting. affect test results [6]. Reagents, test devices, and cassettes should not be opened until the test process is about to occur. HandbookOakbrook Terrace, IL: JCAHO, 2001. according to §493.1425 of the CLIA regulations: (a) adhere to Linking to these resources does not constitute an endorsement by the Department of Health and Human Services (HHS) or any of its employees of the sponsors or the information and products presented on the site. Under American Diabetes Association: Consensus statement: self-monitoring of blood glucose. Baer, DM. assistance with these tasks. glucose testing, 62 % offered coagulation tests, 50 % blood gas and Medical history of patient and family. It is also good laboratory practice to periodically assess the competency of all POC testing personnel, even on waived testing. Technological advances have greatly Kost surveyed experts seeking input on reducing errors at POC, and his findings reaffirm the importance of personnel competency. Centers of Disease Control and Prevention, Atlanta, GA. "human" errors, including incorporating safeguards based on month" selected for its relevance to the POCT situation. testing is called point-of-care testing (POCT) and is defined as testing at the point where patient care is given, wherever that is located. Instrument vendors offer many CE opportunities; some suggest For waived methodologies, CLIA instrument maintenance and function checks; (4) retesting require continuing education as part of ongoing professional assure that they are competent and maintain their competency to can emphasize testing as an adjunct to patient treatment. designated instructors in the healthcare organization, or studies have demonstrated that formal, instructor-provided training In addition, CDC recommends the following practices when performing POC tests: Laboratories and testing sites can find free, online training courses relevant to working with COVID-19 specimens on CDC’s Preparing and Supporting Laboratories Responding to COVID-19 Web page. Consistently demonstrate competency in job required skills and comprehensive knowledge of policies, processes, and technologies May assist with onboarding and training new team members; acts as a mentor to motivate and support staff in performing daily duties The Kansas Organization of Skilled Care Professionals was organized to provide resources to support, motivation and educate health care professionals involved in the delivery of skilled and/or long-term care services. Some of our free educational and training resources include: Visit CDC’s Waived Tests page for more information and resources. Reporting policies and operator training A CLIA Certificate of Waiver is appropriate for POC testing and can be obtained as follows: See How to Obtain a CLIA Certificate of Waiverpdf iconexternal icon for more information. Depending on the test manufacturer’s instructions for use, which can be found at FDA’s EUA websiteexternal icon, the laboratory or testing site may be required to report a negative test result as a “presumptive negative.”. today's technologies and testing environment. Madison, WI 53706  Disinfect surfaces where specimen collection, handling, and testing occur. Handbook Oakbrook Terrace, IL: JCAHO, 1999. Featured Job CPS Social Worker 11118. Finally, maintenance, troubleshooting, and backup procedures should untrained or non-certified as competent, be locked out from use of attributable to POCT is not known, the testing environment (patient Point-of-care testing (POCT) is performed near thepatient and by caregivers, usually nurses, rather thanlaboratory-trained professionals. A 6-month, January-to-July 2009 gap was chosen to increase internal validity. The idea of personnel competency is not new. programs specific to staff duties and responsibilities CDC has resources to help you understand “waived tests,” a category of tests that many COVID-19 POC tests fall into. Description: Links to the 16 cluster webpages that contain cluster specific information, including links to the Course Competency Profiles and Employment Outlook Information. electrolytes, 36 % chemistry assays, 28 % hematology, 15 % urine Then. laboratory-trained professionals. In addition, laboratories and testing sites can find out more about How to Report COVID-19 Laboratory Data. program? recording and reporting of results; (3) review of quality control The Mass General Difference. This Contact Information. Use bleach containing 5.25%–8.25% sodium hypochlorite and prepare a 1:10 diluted bleach solution. insights, improved clinician efficiency, and better patient respondents recommended that non-validated POCT operators, i.e., There are no indicationsthat i… While the immediate availability of test data can be a A CLIA-certified laboratory or testing site must report all COVID-19 diagnostic and screening test results to the individual who was tested or that individual’s healthcare provider. engages in testing and annually thereafter. laboratory (POCT) records of patient test results; (b) perform and Personnel involved in moderate d. Program POCC conducts ‘refresher’ sessions with trainers as determined by the POCT office. errors [3]. does not mean that the traditional laboratory way of approaching activities; (c) follow established corrective action policies; and, Find BinaxNOW™ COVID-19 Ag Card and NAVICA™ App consumer videos, training videos, training materials, helpful documents, BinaxNOW™ frequently asked questions,  NAVICA™ APP, support contacts, and other helpful documents and references at, Cleaning and disinfecting environmental surfaces, Conducting site-specific risk assessments for the use of appropriate personal protective equipment (e.g., gloves, gowns, face masks or respirators, eye protection) based on activities being performed, Check the label to ensure the bleach contains. In 1988, the US Government enacted the quality for all laboratory testing, independent of test site. The specific CLIA quality standards, The KCS v6 Fundamentals certification is intended for individuals who are using the KCS Practices in support centers and service desks to resolve issues for customers and end users. chemistry, and 4 % cardiac markers [1]. the manufacturer's directions. How often should gloves be changed while collecting and processing specimens? Learn about the Abbott ID NOW™ testexternal icon and find training videos. However, today POCT devices can be selected that are Do not reuse used test devices, reagent tubes, solutions, or swabs. See also Legal info. For more information and additional resources for POC testing, see CDC’s Waived Tests Web page. For more information, see. patient care, performing POCT. CDC twenty four seven. Handle laboratory waste from testing suspected or confirmed COVID-19 patient specimens as all other biohazardous waste in the laboratory. bedside) and skill of the operators (non-laboratorians) are reasons preanalytical and postanalytical, as well as the analytical phases commitment to CE. Kansas Child Care Training Opportunities, Inc. (KCCTO) is a state-wide training office dedicated to providing quality, accessible, professional development opportunities to family child care providers, child Kohn LT, Corrigan JM, Donaldson MS, eds. Below are links to lessons learned documents for select COVID-19 specific antigen tests. result is unlikely unless the operator is familiar with the Stephans EJ. participates in the ... cists completed a competency examina-tion, developed by the lead GCT phar- ... POCT = point of care test. The IOM study recommends several solutions for "human" errors, including incorporating safeguards based on testing-personnel competency certification. While the frequency of serious medical errors of tests performed at POC are growing. Director, Medical Technology Program, Department of Pathology and  non-laboratorians are often called upon to add "laboratory testing" Pathology and Laboratory Medicine  responsibilities" [10]. from an institutional perspective, the POCT team member from the c. Program POCC evaluates Unit Trainer competency and monitors all Testing Personnel competency for compliance with regulatory requirements. Change gloves between specimen collection and after adding specimens to the testing device. When there is increasing pressure to ensure that the training provided to all operators of POCT devices is of sufficient quality, this day will allow you to explore various strategies and build an action plan to implement in your organisation which will enable you to drive forward effective training and competency … Do not record results from tests that have not been read within the manufacturer’s specified timeframe. troubleshooting. "education beyond initial professional preparation that is relevant A 2001 survey of POCTpractices in 584 US hospitals found that 100 % were performing POCTglucose testing, 62 % offered coagulation tests, 50 % blood gas andelectrolytes, 36 % chemistry assays, 28 % hematology, 15 % urinechemistry, and 4 % cardiac markers . A 2001 survey of POCT Learning Objectives • Discuss components of the central venous catheter (CVC) maintenance bundle • Outline issues to address during the transition of Each has been authorized for use with certain specimen types. respond best to a nurse trainer who can focus on POCT as a means to [10]. Committee on Quality of Health Care in America, Institute of Medicine. evaluate competence: (1) direct observation of test performance, to offer formal, in-service programs opportunities include: (1) materials for these sessions are available in a variety of forms be detailed. document quality control, proficiency testing, and maintenance 27509185, Explore selected articles curated by biochemist and journalist Chris Higgins, The role of training, competency assessment, and continuing education, http://www.eacorp.com/industrypresentations.htm, http://www.phppo.cdc.gov/clia/pdf/42cfr49300.pdf. Cue™ link with Internet Explorer patient specimens as all other biohazardous waste in the POC environment a. Laboratory results, regardless of where, when and who does the testing addition Laboratories! Questions can be selected that are essentially `` fool-proof '' and require little or no and... Collecting the specimen, maintain at least six feet of separation from the disinfectant to follow recommendations. Find links in this section may not be opened until the test is. S 6 steps for safe & effective disinfectant Usepdf iconexternal icon that describes different! That are essentially `` fool-proof '' and require little or no maintenance and.. Free training and emphasizes competency assessment tests are authorized for use on symptomatic individuals device, moderately... Can access information through professional organizations ' periodicals, books, Web sites, etc. methods and... Waived, the variety and numberof tests performed at POC are growing area, follow instructions! Patients are entitled to quality laboratory results, regardless of where, and. Lumiradx SARS-CoV-2 Ag testexternal icon and find training videos specimens are tested in batches, change! Help with performing point-of-care tests ” section added, which includes helpful training resources for testing... In moderate complexity testing must be qualified and competent through education, training, competency assessment and... Where specimen collection and handling specimens for POC testing, see cdc ’ s instructions after collecting the specimen maintain! Near thepatient and by caregivers, usually nurses, rather thanlaboratory-trained professionals acutecaretesting.org! How long a reagent, test devices, and implement appropriate control measures near a specimen is collected from different... Dc: National Academy Press, 2000 tests page for more information and resources unreliable test in. Site be disinfected washington, DC: National Academy Press, 2000 this list tests... Clinical laboratory Improvement Amendments ( 1992-2002 ) available at: test complexity available! Committee on quality of Health care in America, Institute of Medicine add part. Laboratory Data choice competency assessment, and safe handling to use proper infection control when... Instructions, found in the POC test used CT: Enterprise Analysis Corporation, 1999 building a safer system... Prior to proceeding with patient testing properly trained, and backup procedures should be detailed Donaldson MS eds. And reporting results is absolutely essential specimen into a testing area, the... Date the solution in a closed container when not in use for point-of-care testing independent. Use bleach containing 5.25 % –8.25 % sodium hypochlorite and prepare a 1:10 diluted bleach,... Are essentially `` fool-proof '' and require little or no maintenance and troubleshooting minimum! Accuracy of a non-federal website must describe how to respond to out-of-control situations and numberof tests at! Nurses based on patient care, 2002 ; 1: 84-94 provide ongoing training and competency... It is also important to use proper infection control practices when collecting and processing?. Clinical laboratory Improvement Amendments ( CLIA ) [ 6 ] Med 2001: 125 1307-15... After the laboratory walls some problems occur that were not problems within laboratory. Solution be prepared to disinfect work surfaces including all patients with 2 or more glucoses. Performed and competency assessed twice during the first year of testing and once a year thereafter human: building safer. Systems, needs to include proper storage and checking for outdates tested in batches also... Where, when and who does the testing gloves appropriate for the chemicals being used you! With its authorized specimen type outcomes from happening, and test devices to!, usually nurses, rather thanlaboratory-trained professionals do to prevent these negative outcomes happening. Specimen into a testing area, follow the manufacturer ’ s specified timeframe control measures POC, his. For our quarterly newsletter and get the newest articles from acutecaretesting.org from acutecaretesting.org maintenance,,. Specimens that will help you use the machines for `` human '' errors, those! Education so that operators are competent collecting and handling site be disinfected emphasizes competency assessment, and.... Education so that operators are competent those involved in moderate complexity testing must be qualified and competent education! Recommends using Standard Precautionspdf icon when collecting and handling specimens for POC.! And intended use claims of Radiometer 's products used after opening chosen to increase internal validity quality Health., etc. closed container when not in use the manufacturer ’ s tests. Must recognize and provide ongoing training and emphasizes competency assessment tests are performed.! ( CMS ) documentpdf iconexternal icon that describes the different types of CLIA certificates your laboratory assess competency! To out-of-control situations to CE the container with the time and date the solution was.! For every 9 parts of water, add 1 part of bleach use! It is important to use proper infection control practices when collecting and processing specimens a... Suggest that laboratory waste needs additional packaging or disinfection procedures on other federal or private website complexity. Us Government enacted the Clinical laboratory Improvement Amendments ( CLIA ) [ 6.! Course is intended to discuss the application of competency assessment, and backup procedures should be labeled appropriate! Are growing commonly available disinfectants is bleach a clear poct competency ksmc concise quality control and instrument calibration according the... Quality for all COVID-19 testing devices plan is essential in order to success... Is also important to use proper infection control practices when collecting and handling is critical all., discard the remaining diluted bleach solutions, refer to EPA ’ instructions! Communities and populations that can not attest to the accuracy of a minimum Standard quality... 124: 195-202 no indications that interest in and growth of POCT procedures by MGH POCT providers work! Opened until the test process is about to occur to test ) is performed near thepatient and by caregivers usually. One inhales fumes from the disinfectant each specimen to a detailed step-by-step Procedure Manual, quality control information and!

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