Quality Assurance

In QA Testing

Quality Assurance - read the full article about Quality Assurance 2021, QA Testing and Quality assurance from Dr. As Clinical Lab Videos on Qualified.One

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