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Hi everybody this is Dr A and we are doing a video on quality assurance and were going over some basic principles, so quality outcomes are of the utmost importance in the clinical laboratory, this is because lab results affect patients lives diagnostic laboratory test results play a decisive role in decision making related to individual patient care, public health policy, and research decisions, the clinical value of a lab test result involves balancing the benefit of that test against any harm that it may cause so what kind of harm? harm can be caused by ordering an inappropriate test, not ordering the appropriate test, not using an appropriate test results properly, delaying or missing test results from an appropriate test, or reporting an incorrect or an inaccurate test result all those things can cause harm to the patient because it can cause a misdiagnosis or treatments that arent necessary, and the treatment sometimes themselves can cause harm, so its very important to have some quality management in the lab, so quality management works at the organizational level to implement an overall quality policy there are formalized systems that document processes, procedures, and responsibilities for achieving these quality policies and objectives so the key components to providing high quality lab results include an educated laboratory and specimen collection staff, appropriate validated testing methods, properly functioning instruments quality assurance and quality control processes that are in place, and peer referenced proficiency testing, I have some videos on quality control and some videos on proficiency testing and that for you to review if you need to, quality management then encompasses both quality assurance and quality control, to achieve a 99% level of quality means that you accept a 1% error rate it is most important that lab specimens be properly identified and collected because if you do not have a properly identified and collected specimen, then everything that goes downstream is going to be an error, or can cause even harm to the patient, special patient preparation for some specimen collections might need to be done along with proper transportation too, and handling in the laboratory before the actual analytical assay happens, and all of that is very important quality assessment ensures that we have reliable test results, valid results can be reported only when the pre-analytical quality control has been ascertained, quality control is done in the lab at least on a daily basis, sometimes even more often depending on the instrument, so lets talk a little bit about CLIA, so that is a law that was enacted in 1988, it is called the clinical laboratory improvement amendment, and it established a minimum threshold for all aspects of clinical lab testing and in there, there was the introduction of routine quality control in the clinical lab and that was a major advance in improving the accuracy and reliability of clinical lab tests, errors that occur during the analytical phase of testing, within the clinical lab are now really rare so lets talk a little bit about the voluntary accrediting organizations, so we have the joint commission, it was formerly known as the joint commission on accreditation of health care organizations, often referred to as JACHO even though its the initials are actually JCAHO we flip the A and the C and call it JACHO the joint commission requires hospital laboratories to be accredited by the joint commission itself or by the commission on office laboratory accreditation COLA or the college of American Pathologists CAP per the joint commission, a periodic performance review will be required for the laboratory accreditation program and that periodic performance review is a formal standards evaluation tool that is intended to support the continuous compliance of the laboratory and its being added to this accreditation process at the request of the accredited laboratories, so its a tool that we can use to see what are they going to be inspected on and how you have to make sure that they are in compliance so that they can maintain their accreditation the ISO 15189 standards in clinical laboratory so ISO is the international organization for standardization and it is the worlds largest developer and publisher of international standards it is a non-governmental organization that forms a bridge between the public and the private sectors the benefit of ISO 15189 is the use of a comprehensive and highly structured approach for quality management that allows laboratory to use tools such as six sigma, I will have a video on six sigma coming up too and gap analysis, the assessors look carefully at where the laboratory does not meet the ISO standards and then this analysis reveals what facets of the day-to-day operations might need to be improved CAP15189 is a voluntary non-regulated accreditation to the ISO 15189 2007 standard so CAP15189 requires a steadfast commitment to the laboratory management system in all interacting departments it does not replace CAPs CLIA based laboratory accreditation program but rather complements the CAP accreditation and other quality systems by optimizing the processes to improve patient care to strengthen the deployment of quality standards to reduce errors in risk and to control costs a little bit more on quality assessment, so external standards have been set to ensure the quality of lab results reported through QA as imposed by CLIA88 and as administered by CMS, which is the Centers for Medicare and Medicaid Services, a clinical lab must be certified by CMS or by a private certifying agency, or by a CMS approved state regulatory agency, if theyre not then they cannot get funding from, you know, reimbursement for lab tests from CMS and CMS is one of the biggest reimbursements of lab tests, included in the CLIA88 provisions are requirements for QC and QA, for the use of proficiency testing, and, of course, certain levels of personnel to perform and supervise the work in the laboratory, so how educated do you have to be to do certain tests, and to report those results out, once certified, the lab is scheduled for regular inspections to determine compliance with federal regulations, including CLIA88, most labs are inspected about every other year and its a very serious matter and one that they are very careful with a little bit on error analysis, so error analysis can include active and latent errors so active errors include failing to identify a patient before phlebotomy, missing a blood vessel during phlebotomy, errors with anticoagulants in collection tubes, so collecting the wrong tube erros with transportation systems, such as the pneumatic tube system, errors with data entry, and errors with instruments or computers, such as ignoring an instrument flag the latent errors include staffing problems, such as chronic shortages, which then can cause staff to take shortcuts and cause other types of errors to happen, information technology problems such as no interface with technology, or problems with the technology interfaces, equipment malfunctions such as old error-prone analyzers, good labs are replacing analyzers every so many years to keep up with their technology, and because just analyzers run down, the work environment, such as your the expectation of multitasking, a poor lab layout, a disconnect between the lab and the patients policy and procedures, such as the relabeling of mislabeled or unlabeled tubes, and lab requisition variations, teamwork factors such as poor communication between shifts and departmental silos, so departments that dont talk to each other, like if chemistry doesnt talk to hematology etc, or even sometimes a poor communication between the lab and outside lab entities such as doctors and nurses, and then management organization problems such as when profit is a goal, ignoring patient safety, and a de-emphasis on incident reports and interventions based on analysis so, how to improve? so, ways to improve overall errors include at least three strategies, so formal patient safety training, including a discussion of the disconnect between lab personnel and the patients, again, so everybodys goal in the lab should always be patient safety, which includes the reporting of accurate test results, enhanced communication between patients and lab staff and providers that are directly caring for the patients, and then quality improvement projects that involve patient outcomes data and feedback of the data to the laboratory staff with an analysis of the consequences of high quality or low quality work, so again, if the lab staff is making some errors then its good for them to know how this is impacting patient care so that they can find the appropriate solutions to keep patient care to high-quality standards so where are the errors? so, there are three phases of testing, this is the pre-analytical also known as the pre-examination phase and that is the phase that encompasses the order of tests and specimen collection and delivery to the lab and checking it in, theres the analytical phase which then is the actual performing of the test, and then theres the post-analytical phase or the post-examination phase where its the reporting of the test results back into the patients chart or electronic record, so most laboratory errors are related to the pre-analytical phase or the post-analytical phases of testing rather than the analytical phase, so specimen and related errors continue to be a major problem, so its because theres the human component to it, its something that we cannot automate, we have to have an interaction between individuals to get a specimen collected and so the pre-analytical phase of testing is particularly error-prone mainly because it is especially susceptible to human error, the post-analytical has less error because weve had a lot of interfaces with computers and things that are automated but simply typing in the wrong results or typing in results on the wrong patient or something like that could, you know, be an example of a post-analytical error some non-analytical factors in quality assessment we have to make sure we have qualified personnel good established laboratory policies and a lab procedure manual thats accessible by the employees and its easy to read and understand test requisitioning, so thats going to be usually outside of the lab, ordering the right tests, etc, proper patient identification, specimen procurement and labeling proper procedures for specimen collection and storage, specimen transportation and processing preventative maintenance of the equipment, because a well-maintained analyzer breaks down less than one that is not well maintained, and selecting the appropriate methodology when a test is brought in house, because, you know, not all methodologies are the same, and so finding the right one for the lab and the population is really important so lastly, Im going to look at accuracy, in reporting results and documentation so the introduction of computer interface online reporting is useful in communicating information correctly and efficiently, no more paper writing, now everythings been computerized from the order entry all the way through the reporting of results, and because of that, now we have systems in place to monitor individual patient results, one of those is called a delta check, and the delta check looks at the difference between a patients present result and their previous results and if it exceeds a specific cutoff value then its flagged and thats the delta check and the tech has to review it, the ongoing process of making certain that the correct laboratory result is reported for the right patient in a timely manner at the correct cost is known as continuous quality improvement or CQI, CLIA regulations mandate that any problem or situation that might affect the outcome of a test result be recorded and reported, all such incidents must be documented in writing including the changes proposed and their implementation and the follow-up monitored lab computer systems and electronic information processing will expedite record-keeping and thats been really pushed with the electronic health record incentives, where everything is being put on computers, but also linked together where all these systems are communicating and now even the patients have access to lab results and lab reports through apps and access to programs like mychart, so QA programs also require documentation and computer record-keeping capability exists in this effort and so there are programs that can manage lab quality and quality assurance with the quality control and all of that together, so its good to take advantage of that, so anyway, so that wraps up our little video on quality assurance and Ill have one more on lean and six sigma coming up, so thank you for your attention
Dr. As Clinical Lab Videos: Quality Assurance - QA Testing