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Lab bill format for Quality Assurance

Hi everybody this is Dr A and we are  doing a video on quality assurance   and we're 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 aren't necessary, and the treatment sometimes  themselves can cause harm, so it's 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 let's 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 let's 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 it's 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  it's being added to this accreditation process   at the request of the accredited laboratories,  so it's 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 world's   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 CAP's 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 CLIA'88 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 they're 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 CLIA'88 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 CLIA'88, most labs are   inspected about every other year and it's 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 don't talk to each  other, like if chemistry doesn't 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 everybody's 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 it's 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, there's the analytical phase   which then is the actual performing of the test,  and then there's the post-analytical phase or   the post-examination phase where it's the reporting  of the test results back into the patient's 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 it's because there's  the human component to it, it's 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 we've 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 that's accessible by the  employees and it's easy to read and understand   test requisitioning, so that's 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, I'm 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 everything's 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 patient's  present result and their previous results   and if it exceeds a specific cutoff value then  it's flagged and that's 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 that's   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 it's good to take advantage of   that, so anyway, so that wraps up our  little video on quality assurance   and I'll have one more on lean and six  sigma coming up, so thank you for your attention