Question and Answer Session

March 8, 2005 Presentation:
Developing a Patient Safety Culture in the Clinical Laboratory

Transcript

Our topic this month is Developing a Patient Safety Culture in Developing a Patient Safety Culture in the Clinical Laboratory the Clinical Laboratory

This month's expert is Michael Astion, MD, PhD. View the presentation and direct your questions to our experts.

AACC would like to thank Bayer HealthCare Diagnostics for making this program possible.


Talk more about the reduction in cognitive errors by good supervision. Washington, DC

Michael Astion, MD, PhD: Cognitive errors are usually due to lack of knowledge. An example might be a tech who consistently misidentifies a particular rare red blood cell morphology on a peripheral blood smear. The approaches that might work for this problem are 1) more education or 2)more supervision For more supervision, what you can envision is that no technologist should be reporting out some kind of very rare result, without having it seen by a more experienced set of eyes. A good rule of thumb is that if it is the first time you are reporting out a rare result, it would be best to have more experienced staff look at it first. Similarly, if it is the first time you are processing a certain kind of specimen, it would be best to get help. This approach can actually be put into policy and procedure. For example, "Reporting of positive _______ cultures, requires supervisor review before reporting."


From an actuarial POV, people die. In hospitals, where there are lots of sick people, more people die. Is there a chance that some of the death outcomes were unavoidable, regardless of medical error? Also, from a strictly hospital business POV, we’re in the business of not just risk assessment, but also risk/cost assessment. I certainly don’t want to discount patient health, and many of your solutions should be implemented in day-to-say hospital procedures, but is it possible that excessive (unwise?) application of safety measures could lead to diminishing returns on our efforts and unnecessarily strain resources? Boston, Mass.

Michael Astion, MD, PhD: This is a complex question. It is true that it is hard to score the bad outcomes related to lab errors. It is uncommon that a lab error unambiguously leads to patient injury. It happens, but it is not that common. For example, occasionally a miscommunicated coagulation result directly leads to incorrect warfarin dosing and a bleeding event. More commonly, you have to estimate the contribution of the lab error to the patient's condition. Although it is hard to score the outcome, it is not impossible. We have used a checklist of outcomes that can usually be scored with reasonable accuracy. Regarding your question about the cost/benefit of patient safety interventions. My argument is as follows. Labs should collect patient outcomes information for laboratory errors so that they can prioritize QI projects. The error-reduction projects that get the highest priority are those that involved reducing errors known to harm patients. The errors that are most likely to harm patients in one institution may not be the ones most likely to harm patients in another institution. You need to do the work in your institution.


What is some information on dry ice, for a project?
Rochester, NY

Michael Astion, MD, PhD: I do not understand this question. Can you be more specific, and perhaps a little more wordy?


Where can I find written regulations for the operation of biohazard hood in the Microbiology Dept? Which cultures must be set up in the hood. How long after using the hood should it be left on to ensure safe environment?
Los Angeles CA

Michael Astion, MD, PhD: This expert access is about laboratory errors and patient safety and not about work safety issues confronting laboratory staff.


You mention the use of delta checking. We have not used delta checking much because of the low sensitivity and specificity of the process. My feeling is that a false alarm in far greater frequency that a true alarm de-sensitizes one to the rare true alarms. Comments?
San Jose, CA

Michael Astion, MD, PhD: You are correct that error detection processes will not be useful if they produce too many false alarms relative to true alarms. When using alarms (or flags) of any type, you are always faced with a classic signal to noise problem. There is an inherent tradeoff between the sensitivity and the specificity of error detection. For a given error detection method: As the sensitivity of the error detection method goes up, the specificity goes down. Conversely, as the sensivity goes down, the specificity goes up. If you have set your delta limits for a particular test so that it is detecting too many false positives, you should use more restrictive (i.e. less sensitive, more specific) limits.


What do you mean:Pacient safety culture ?
Topo¾èany,Slovakia

Michael Astion, MD, PhD: The Merriam-Webster dictionary defines culture as " the set of shared attitudes, values, goals, and practices that characterizes a company or organization." Organizations with an adequate patient safety culture are those whose shared values and practices are oriented toward understanding and minimizing the medical errors that are mostly likely to harm patients.


1. How would you define a patient safety culture in the clinical laboratory? 2. Does the patient safety culture include only the errors in laboratory testing or also inlude the confidnetiality of the information of the patient test results? 3. What are possible errors in lab testing and how these could be minimized? And what are the procedure needed to start quality improvement and sustain the improvement? 4. Please state in details the mothods for obtaining patient outcomes and also detail methods for developing a culture of patient safety.
ICDDRB, Dhaka, Bangladesh, SE Asia

Michael Astion, MD, PhD: 1. The Merriam-Webster dictionary defines culture as " the set of shared attitudes, values, goals, and practices that characterizes a company or organization." Organizations with an adequate patient safety culture are those whose shared values and practices are oriented toward understanding and minimizing the medical errors that are mostly likely to harm patients. 2. Patient confidentiality is important but it is not a patient safety issue because violations of patient confidentiality rarely lead to increased morbidity or mortality. 3. Depending on whose taxonomy you use, there are 10 - 20 steps in the laboratory testing process, and each of these steps has multiple components. There are failure points in each of the components. Different laboratories have different vulnerabilities. Each lab has to determine where they are weakest, and when they are most likely to harm patients. 4. For a particular laboratory error, the best method for determining patient safety outcomes is to call the physician or nurse taking care of the patient who was potentially affected and ask them to describe the clinical implication of the error. A checklist can be helpful in when questioning caregivers. Here is one we use: ___Redraw or recollection of specimen ____ Outpatient admitted to hospital because of incident ___ Inpatient hospital stay prolonged or increased level of care required (e.g., transfer to an ICU, use of telemetry need for an invasive procedure) ___ Patient received treatment or change in treatment that would not otherwise have been required (e.g., received potassium because of spurious hypokalemia; received medication dose change that was unnecessary) ___ Patient failed to received treatment or change in treatment that would otherwise have been required (e.g., did not receive potassium because hypokalemia not communicated; failed to receive medication dosage change) ___ Patient had transient morbidity* (i.e., resolved by time of discharge; for outpatients, resolved within days – a week) ___ Patient had morbidity* lasting beyond hospital discharge or longer than one week ___ Patient death associated with the incident Interviewing caregivers is not perfect because caregivers tend to minimize the harm caused by errors. However, interviewing is a better method than using the medical record, where under-reporting of errors and their impact is the rule rather than the exception.


Do you think that a Continuing Education Program which major goal would be integrate, motivate and educate the employees to work as a team, understanding how responsible everyone must be when working in the health care could help us? (Sorry about my english mystakes)
Piracicaba, SP, BRAZIL

Michael Astion, MD, PhD: Continuing education is useful in two regards: 1) some (but not most) errors are knowledge-based, and continuing education can provide this knowledge, and 2) continuing education that teaches people to look at errors from a systems perspective can help them design meaningful interventions to decrease laboratory errors. However, continuing education oriented toward improving teamwork is necessary but not sufficient. Most of the errors that harm patients are due to systems problems. When a system is broken or suboptimal, you cannot educate your way out of it. Let me give you a concrete example. Let's say management refuses to purchase and implment an interface between an automated chemistry analyzer and the laboratory information system. In this case, technologists are forced to hand enter lots of data into the LIS. No matter how good the technologist, they are occasionally going to make data entry errors. They are going to be more likely to make these errors when they are distracted as can occur when the laboratory is very busy. There is no amount of continuing education that will significantly and permanently lower the rate of data entry errors by the technologist. What is needed is a "systems fix", which in this case is the computer interface between the analyzer and the LIS. That "systems fix" will dramatically and permanently reduce the rate of data entry errors because it will dramatically increase the amount of data entry.


What is meant by patient safety? Does it refer to accurate results or confidentiality?
Mt Holly NJ

Michael Astion, MD, PhD: Patient safety refers to minimizing medical errors that physically harm patients. So in this sense, patient safety certainly encompasses accurate results. It generally does not encompass confidentiality since violations of confidentiality rarely increase morbidity or mortality.


When is it appropriate to allow nursing to relabel, or label an unlabeled specimen. For example, recently the lab received a 24 hr specimen with no label on it. Our outstanding specimen report indicated that we were pending receipt of 24 hr specimens on 2 different patients. When the floor was called, the nurse in charge of one of the patients indicated that he had just taken a specimen to the lab. Should we allow for nursing to label a specimen in cases like this?
McAllen, Texas

Michael Astion, MD, PhD: Relabeling is a dangerous practice and should rarely be allowed. The only time it is permissible is if BOTH of the following 2 conditions are met: 1)Recollection of the specimen would significantly harm the patient. 2)The specimen can reasonably be identified by the caregiver who collected and submitted it. Relabeling of routinely collected blood and urine collection should almost never be allowed. However, for invasively collected specimens like biopsies, cerebrospinal fluid, and other similar specimens, this may be necessary. For example, if a patient has an open brain biopsy, and the specimen is unlabeled, relabeling should be allowed if there is no confusion about the specimen in the laboratory. Frequently, this is the only specimen of that type (brain biopsy) in the lab, so the identity of it can be reasonably established.


When you encounter a staff member not being safe, how do you handle it as a manager? As a fellow co-worker? Is discipline involved? How is staff encouraged to follow the rules? For example, not wearing gloves when handling vacutainer tubes. Or not wearing lab coats when performing testing?
Peoria, Illinois

Michael Astion, MD, PhD: This question involves worker safety and not patient safety, and is outside the scope of this session.


What do you think of front end automation and how it can help with laboratory errors?
huntington, WV

Michael Astion, MD, PhD: Automation, in general, and front end automation specifically, can reduce laboratory errors provided that the automation is chosen and implemented carefully. Front end automation projects are complex and require a significant amount of resources to plan and implement. It is essential to commit the resources before starting any large scale automation project. It is also useful to visit and talk with other sites that have implemented the automation you are interested in implementing. You can learn quite a bit from their experience.


1. What is your recommendation for analyzing hemolysed samples? The guidelines always have exceptions to the rule for rejection of the sample but patients are put at risk when results from hemolyzed specimens are interpreted without consideration of the effect of the hemolysis.
Halifax, Nova Scotia

Michael Astion, MD, PhD: On the surface, what you are saying is true: A hemolyzed specimen can produce inaccurate results that could potentially harm the patient. However, there is actually quite a bit of complexity to this issue. For example, hemolysis does not affect the measurement of every analyte. So certainly it is best to put out results on analytes that are not effected by hemolysis. In addition, to illustrate an important point, let's do this thought experiment. Let's say that, in the presence of severe hemolysis, the measurement of a certain analytes is off by 20 - 30%. However, if the result for that analyte is dramatically high, it still would be high, even if the result was 20% - 30% from the actual value. So you still might have a result that is usable by a physician in an emergency if no other specimen was available. In the end, you make a hemolysis policy that covers most of the clinical situations in your institution, and then you take dramatic (e.g. STAT) cases on a case by case basis.


Thanks for an interesting presentation - A comment: I don't think "latent" error, which I have heard before, is a good term (slide 11). Latent implies hidden yet these errors are detectable. They are causes for more severe errors - you call these "active" errors, which is also a questionable term - as the latent errors are also "active". FMEAs and especially fault trees show the cause-effect relationship between a cascading series of errors.
Sherborn, MA

Michael Astion, MD, PhD: Thanks for your suggestions. The terms "latent" and "active" are not mine, but are commonly used in the literature about errors. The main point is that we often look at the surface, and not at what lies beneath. Thus, we punish the person who committed the data entry error, even though data entry could have largely been eliminated by an instrument-LIS interface. FMEAs are very useful in clinical laboratory work, and it seems like you might be an expert in using them. I recently read about at FMEA at a peer University medical center that significantly reduced errors in patient identification and specimen collection, and I was suitably impressed.


Would a quality management sistem like ISO, if propoerly focused, achieve the goal of improving patient safety?
Belo Horizonte, MG, Brazil

Michael Astion, MD, PhD: ISO, like other quality management systems, tends to reduce errors and rework, and therefore would be likely to improve patient safety.


How do we handle patient safety when it conflicts with another issue, like HIPAA? We had an incident with an employee where her condition was a threat to patient safety and the tech who reported it was fired for violating HIPAA.
Espanola NM

Michael Astion, MD, PhD: Obviously, this is a very tough issue, and there is no one answer. The case you present shows that there is sometimes a tradeoff between patient safety and privacy/confidentiality. This is a philosophical problem, and has to be confronted on a case by case basis. When we face these problems, we try to involve both senior management and the compliance officer in coming to a decision about how to handle it. Risk management may also need to be notified or involved in the discussions.


As a laboratory consultant, I have a number of POL clients who struggle with point of care testing (such as coag -- INR testing); in that, the lab is responsible for the compliance records, but the nurses and MA's operate the instrumentation. The operators are not keen on performing the required QC and accompanying documentation. Keeping a good working rapport between the lab and the nurses is such a constant challenge. Do you have any suggestions or insight on this?
San Antonio, Texas

Michael Astion, MD, PhD: I have seen two approaches to this problem. The first is what you might call "Point of Care police". This is when the laboratory (or occasionally another group) is actually given authority over all point of care locations, including POLs in the healthcare system. By authority, I mean that top management in a particular healthcare organization backs the lab's efforts regarding training, competency assessment, QC, and other types of monitoring. Essentially, MAs, nurses, and physicians in the system must comply with the rules set forth by the laboratory, or the noncomplying location will not be able to perform testing. The good news about this approach is that it works. The bad news about the policing approach is that it seems to be restricted to large healthcare systems, and even most of those of do not use this approach. I see this in my own experience. For example, the University of Washington (where I work) makes a Provider Performed Microcopy Procedure (PPMP) competency assessment product, consisting of two exams per year for each of 8 PPMPs. We have about 120 clients in the U.S. for this product and they are nearly all healthcare systems where authority has been given to the laboratory to administer the POC testing program including overseeing POC testing at POLs. However, our own University system barely uses the product because the lab does not have authority over POC testing, and without this authority we cannot convince most POL and other POC testing locations to use the product. That brings me to the second approach to the problem, which -in contrast to the "Point of Care police"- might be called "Point of Care helper". That is the situation our laboratory is in, and it appears to be the situation you are referring to. I wish there was a glorious, simple solution. The plain fact is that the solution is frequent communication between the lab and nursing/M.A./P.A. staff. A combination of scheduled meetings and frequent feedback. For example, we meet quarterly with the staff of the POLs in our healthcare system to discuss a variety of quality issues (e.g. mislabeling, suboptimal specimens, point of care testing...) related to laboratory services. In addition, we provide feedback when QC data (that they are suppose to provide) is late. Even better than this negative feedback, is some positive feedback when a particular location is compliant with the POC program! This really motivates the location to continue their excellent work.


The state of California is now requiring the certification of all previously non-certificated personnel performing phlebotomy. This requires extensive training and testing per position. The ancillary nursing positions as nurse assistant are less than overwhelmingly accepting of this new mandate. In addition the recruitment of minimal paid personnel to phlebotomy positions is made more difficult in that many candidates are unwilling to go through the increased and continuous recertification process. Are you familiar with this and other such state programs and do you believe that patient safety is increased by continued certification?
San Bernardino, CA

Michael Astion, MD, PhD: A: At the bottom of this response I am pasting a short article that I recently wrote regarding trends in patient identification, and specimen collection. I include it because certification and other forms of standardization are an irrevocable trend. This article appeared in Issue 2 (September 2004) of "Laboratory Errors and Patient Safety" (www.laboratoryerrors.org), a new newsletter which is a collaboration of multiple medical centers and industry. Overall, the short answer to your question is that: 1) I believe that certification will improve patient safety 2) To my knowledge, there is so far no published evidence that certification improves patient safety. So why do I believe that certification is a good thing? The reason is that many, if not most, laboratory errors are preanalytic and associated with the specimen collection. If one looks at organizations that are particularly good at specimen collection, you will find that they have minimized the number of policies and procedures related to specimen collection, and minimized the number of staff, and the types of staff collecting specimens. The most dramatic example of this that I know of is the Mayo Clinic, where laboratory specialists collect all patient specimens, and this is for both hospitalized and ambulatory patients. This even includes the intensive care unit. Specimen collection is so important that it deserves dedicated, specialized staff, when this is feasible. Unfortunately, it may not be feasible for every healthcare location. ----------------- Future trends in patient identification and specimen collection: automation and standardization. Besides implementation of the first national patient safety goal, which specifies the use of two identifiers in actively identifying patients, how will the practice of patient identification and specimen collection evolve over the next decade? Through interviews with laboratory directors and industry experts, LEPS has identified several trends in patient identification and specimen collection that should mature over the next 10 years. These trends can be broadly categorized as automation and standardization. Specifically, the trends include: 1. Automated systems that integrate barcoding of patient identification wrist-bands with proper specimen collection procedure. 2. Computerized physician order entry (CPOE) 3. Standardization of specimen collection procedures within each healthcare organization. 4. Certification of phlebotomists 5. Complete replacement of glass blood tubes by plastic tubes Automated systems for patient identification and specimen collection are technically challenging and not trivial to implement, but preliminary results from the first implementations are promising. One system on the market is the BD.id system from Becton-Dickinson (Franklin Lakes, NJ; www.bd.com/bdid/). The system uses barcoding technology and rule-based algorithms to assure that correct patient is drawn, and the appropriate tubes and specimen volumes are collected. The phlebotomist, or other healthcare professional, uses a hand-held device to scan their barcoded badge to identify themselves as the specimen collector, and to scan the patient's wrist-band to identify the patient and bring up the patient's orders from the laboratory information system (LIS). (The system does not eliminate the need for the patient to actively identify themselves.) Using a number of error-proofing features, the system then guides the phlebotomist through the correct order of draw, and prints barcodes on a bedside printer. The barcodes -which identify the phlebotomist, the patient, the collection date and time, and the tests ordered - are then placed on specimen containers in front of the patient. The main driving force behind CPOE is reduction in errors related to ordering medication. However, there is also an obvious benefit to laboratory services. In CPOE, physicians order tests from the computer system without writing orders on a chart or paper requisition. This decreases errors in the test order by eliminating errors related to poor physician handwriting, and by eliminating the manual entry of data from the paper requisition into the LIS. CPOE decreases errors in specimen collection since errors in the test order lead directly to collection errors including failure to obtain a specimen, and incorrect specimen containers and volumes. CPOE is currently listed as one of the top three patient safety practices by the Leapfrog Group (www.leapfroggroup.org/safety.htm), an influential group of more than 100 public and private organizations that provide health care benefits. Standardization of specimen collection procedures reduces errors by simplifying, optimizing, and reducing the number of different collection procedures followed in a healthcare organization. As discussed in the Shirley Weber (Kansas University) interview in this issue of the newsletter, standardization requires enhanced cooperation between the laboratory and other healthcare professionals, especially nurses. Standardization of specimen collection procedures is also being driven by laboratory automation. For example, there are now several preanalytic automation systems on the market, which automatically centrifuge, decap, and aliquot blood specimens after they are received in the laboratory. These systems work with a limited number of different size blood tubes. Fewer tube types will eventually lead to less confusion in specimen collection. Certification of phlebotomists, which is already mandated in California, is another aspect of standardization. Other states, and individual healthcare organizations are likely to follow California's lead and either require phlebotomy certification, or offer incentives for obtaining it. Certification ensures that a phlebotomist meets a minimal set of qualifications, and this is likely to reduce error in the specimen collection process. In summary, automation and standardization are the key trends in patient identification and specimen collection over the next decade, and these trends will certainly improve patient safety.


Did you collect any data related to the cost impact of laboratory error in any of the incidents studied? eg. extended hospital stays, delay in treament/incorrect treatment-any idea what the cost to the healthcare facility/laboratory is associated with these incidents?
Winnipeg, Canada

Michael Astion, MD, PhD: In the studies described in the presentation, patient outcomes were calculated but the costs were not. I can tell you that sometimes the costs are modest, as in the case of redraws caused by mislabeling, or an extra (unnecessary) dose of a relatively inexpensive drug. In other cases, there were repeat surgical procedures, and these are obviously very expensive. Obviously, the average cost will be driven much higher if there any errors that involved serious loss of life or limb. There are patients who have sued and won millions of dollars related to false diagnosis caused by problems in laboratory testing. I have not seen very much published data regarding the real cost of redraws. I have heard estimates ranging from 100$ - 700$ per redraw when all the redraws from a particular institution are aggregated and the aggregate data is analyzed. The aggregate data will include individual cases that have minimal cost associated with them (e.g. tech time and some materials) and cases that might have very high costs associated with them (e.g. harm caused by an incident which also involved the need for a redraw).


Would you address how the new JCAHO requirement of having 2 patient identifiers for POCT can be accomplished with instruments like glucose monitors and i-stats? We've been told that the i-stat cartridge should be labeled in some way, that a single ID number entered in the analyzer is not adequate.
Rockford, IL

Michael Astion, MD, PhD: This is a tough question and you need to work with your hospital and laboratory administration to interpret the JCAHO requirements in a consistent, logical way. The JCAHO requirements are an important step forward in patient safety, and for routine laboratory testing, it is essential that they be followed. However, a number of institutions, facing the problem you describe, have made the logical interpretation that the JCAHO rules do not apply to much of POC testing because the JCAHO rule is intended to minimize errors associated with the various handoffs associated with an individual specimen. For example, the two identifiers helps eliminate confusion in the handoff between a hospital unit where the blood was collected, and the laboratory that processes and analyzes the specimen. For most POCT, there is no handoff, so the JCAHO requirement does not fit. If blood is going right from the patient's finger into an instrument, there is no handoff, so the more stringent JCAHO requirement adds complexity but no value. Having said that, however, I want to make sure not to go overboard. Many locations perform POCT poorly. I have had discussions with colleagues at various institutions who describe nurses performing what essentially amounts to batch testing on POC instruments. In this case, specimens could get quite confused, and the JCAHO requirement is a real necessity. So in summary, when POCT is "ideally" performed on a single specimen at a time, right at the bedside, some institutions come to the logical conclusion that the JCAHO requirement should not apply. However, when POCT is (unfortunately) performed in "batch mode", the JCAHO requirement may be the only thing that saves the patient from harm.


Nurses are so very stressed out from lean staffing, mega amounts of paperwork and of course patient care. Why does anyone think that nurses will perform all the minutiae that is so important in the procurement and proper labeling of patient specimens? They always look for short cuts and this is where problems arise. Samples are not labeled at the bedside and checked thoroughly. Simple as that. The excuse is almost always the same when there is an error: "Got interrupted, was busy, patient was crashing, the labels were on the wrong chart, another nurse was helping me; she labeled the tubes"... Nobody should be drawing and labeling patient samples when they have 100 other tasks on their mind. Mistakes will occur no matter what type of strict disciplinary policies an institution has. Don't you think it would be better for institutions to stop focusing on such bottom line productivity when patient safety is involved? Even the phlebotomists are under the gun to do so many sticks per hour. Everyone is always rushing at top speed to get the job done. There is something wrong with this picture. JCAHO initiatives are good, but the problems are still very basic and mislabelings and wrong treatments will continue to occur. Do you think that procurement of blood samples for the laboratory should be performed by phlebotomy teams (and of course line draws by a nurse)?
Ft. Lauderdale, Fl.

Michael Astion, MD, PhD: I am in agreement with most of your thoughts regarding specimen collection. Most laboratory errors are preanalytic and associated with the specimen collection. If one looks at organizations that are particularly good at specimen collection, you will find that they have minimized the number of policies and procedures related to specimen collection, and minimized the number of staff, and the types of staff collecting specimens. The most dramatic example of this that I know of is the Mayo Clinic, where laboratory specialists collect all patient specimens, and this is for both hospitalized and ambulatory patients. This even includes the intensive care unit. Specimen collection is so important that it deserves dedicated, specialized staff, when this is feasible. Unfortunately, it may not be feasible for every healthcare location. For locations that use both centralized and decentralized phlebotomy, the key is collaboration between laboratory and nursing/M.A./P.A. staff. If you want to see a full discussion on this topic go to: http://www.laboratoryerrors.org/leps.pdf


How to address the problem of interferrence.for e.g. in a stat specimen not obviously hemolysed or lipemic, if CK-MB(say67 U/L) comes equal to total CK(say66 U/L) or INR suddenly shooting up from 2.5-3.0 to 6/7 on same regualr dose?
Manchester, CT

Michael Astion, MD, PhD: A: These have to be taken on a case by case basis, and your response will depend on how much expertise you have available. For example in the case of CK-MB, the result is clearly not possible, and it is reasonable to append a text message to the result, stating that the result suggests an interference or other technical problem. In this case, I would recommend ordering Troponin, as the interference may not effect a different analyte. The same reasoning, that I just applied to the troponin case, would apply to any case where you had strong reason to believe there was a problem. I think it is OK to append a text message to the result for these cases. The strength of the message will depend on the strength of the evidence. In many cases of interferences, you simply do not know if there is an interference. Interferences can cause subtle increases or decreases in a measurement, and for these cases, the clinician just has to use their best judgment, which comes from comparing the laboratory result to the rest of the clinical picture. If a laboratory result is out of line with the clinical picture, the clinician has a number of options including ignoring the result, repeating the result, or ordering other tests to clarify the situation. Many clinicians will consult with a pathologist when facing these difficult situations.


If you have an LIS, is it necessary to "read back" critical laboratory results?
Towson, Maryland

Michael Astion, MD, PhD: It is necessary to readback results whenever there is an oral communication of results. A recent study of communication errors in three hospitals showed an error rate of 3.5% for the initial oral communication of lab test results by phone, and also showed that all the errors were corrected by having the care provider read back the result (Reference 1 below). The JCAHO considers read back to be an essential measure to reduce communication errors and has incorporated read back into the 2004 and 2005 patient safety goals. 1.Barenfanger J, Sautter RL, Lang DL. et al. Improving patient safety by repeating (read-back) telephone reports of critical information. Am J Clin Path. 2004; 121: 801 - 803.


What is the imprtance of the "read back" policy when it comes to verbal or phone orders and also giving out reports?
Houston, Tx

Michael Astion, MD, PhD: It is necessary to readback results whenever there is an oral communication of results. A recent study of communication errors in three hospitals showed an error rate of 3.5% for the initial oral communication of lab test results by phone, and also showed that all the errors were corrected by having the care provider read back the result (Reference 1 below). The JCAHO considers read back to be an essential measure to reduce communication errors and has incorporated read back into the 2004 and 2005 patient safety goals. The same reasoning and results apply to verbal orders. 1.Barenfanger J, Sautter RL, Lang DL. et al. Improving patient safety by repeating (read-back) telephone reports of critical information. Am J Clin Path. 2004; 121: 801 - 803.


What is the legitimate role of the laboratorian in ensuring lab tests are used safely ie. abnormal results/delta changes (TDM, coagulation, lytes etc) are addressed and so on?
Chattanooga, TN

Michael Astion, MD, PhD: This is a tough question, requiring a longer answer than I have time for here. However, here are some rules of thumb you might find helpful. The role of the laboratorian will depend on the expertise of the laboratorian. For example, I don't expect a laboratorian with little expertise in microbiology to audit the interpretation of laboratory tests by physicians who specialize in infectious disease. However, if you have a strong expertise in an area, for example cardiac enzymes, it is an appropriate part of QA to audit the utilization and interpretation of laboratory tests and discuss your findings with clinical colleagues. It is certainly the legitimate role of all laboratorians to create a high quality laboratory. A high quality laboratory helps with patient safety in innumerable ways. For example: - critical values policy that fits the institution properly - policies that prevent the reporting of physiologically "impossible" results - policies that decrease the likelihood of communication errors, etc A good place to start is to help your institution meet the JCAHO goals for patient safety for clinical laboratory services. Obviously, this is just a starting point.


I've heard the assertion that autoverification of lab results increases patient safety because most normal lab results do not need manual verification, which can lull the tech to the point that he/she may overlook a result that truly requires manual intervention. Yet many labs seem apprehensive about implementing autoverification due to uncertainty about the parameters that should be used. Are there any published guidelines on how to implement autoverification in a way that will maximize patient safety?
Trenton, NJ

Michael Astion, MD, PhD: I am copying an interview that I did with Drs. Mario Plebani and Linda Sandhaus regarding autoverification. It was published in the 4th issue of "Laboratory Errors and Patient Safety" (www.laboratoryerrors.org), which is a newsletter that I edit. This covers most of the issues you raise. I favor autoverification, if it is carefully implemented, but there is currently no peer-reviewed data showing that improves patient safety. --- Question and Answer: Autovalidation LEPS interviewed experts from two institutions to understand some of the key issues in autovalidation. For a European perspective we interviewed Dr. Mario Plebani and Dr. Maria Laura Chiozza from the University Hospital of Padova, Italy. For a U.S. perspective, we interviewed Dr. Linda Sandhaus, who is a laboratory director at University Hospitals of Cleveland. LEPS: What is meant by "validation" and "autovalidation"? Plebani and Chiozza: These terms have been adequately defined by a number of others1, 2. A working definition of validation is the process of confirming that a test result is accurate. Results that fail validation are potentially questionable and may require that the laboratory perform retesting or notify a care provider that there is a potential problem with the test result. The terms autovalidation and autoverification are used interchangeably. A reasonable definition of either term is "a set of computer-based rules that accomplishes what expert laboratory personnel would do if they had manually verified test results". In practice, no validation techniques, including autovalidation techniques, are error-free. In addition, there is an unavoidable trade-off between the sensitivity and specificity of detecting an error in a test result. As rules are made more permissive to increase the sensitivity (less false negatives) of error detection, there is often a decrease in the specificity (more false positives) of error detection. LEPS: What are the problems with manual validation of results? Isn't it a time-tested method? Plebani and Chiozza: Manual test validation takes a great deal of time, and this sometimes delays the release of results. Manual test validation also suffers from a high variability between individuals performing validation. This is made worse by inconsistencies throughout the day. For example, some laboratory staff members fatigue as the day progresses and therefore tend produce lower quality validation toward the end of the day. All of these problems are compounded by the challenging issue of developing objective methods to determine personnel competency regarding validation of results. Sandhaus: The amount of time that manual validation takes should not be underestimated. In a busy hospital hematology laboratory, it can take several hours per day. One reason is that automated CBC data are complex, and require that, for each sample, the technologist make decisions about which parameters can be validated and which ones need additional evaluation. Knowledge and experience in laboratory hematology are required to perform this task efficiently and competently, and not all laboratories have enough technologists with the required expertise. An additional problem in hematology is that during the manual validation process, the results are presented in an abbreviated format in which graphic displays and other visual cues to abnormalities are not visible to the technologist performing the validation. LEPS: Can automation, in the form of autovalidation, help? Plebani and Chiozza: Autovalidation, has the potential, through standardization of validation methods, to decrease inter-individual variability, decrease the amount of time spent on validation, and decrease errors in the validation process. Autovalidation is better suited for routine clinical chemistry and hematology tests and less useful for esoteric immunoassays, molecular biology assays, and for laboratory tests which have interpretations attached, as is often the case for protein electrophoresis and flow cytometry. Sandhaus: Autovalidation in hematology can help reduce variability among technologists in application of the validation rules and improve turn-around times. However, there are so many rules for validation of abnormal CBC results, that autovalidation systems must be designed and programmed very carefully to incorporate every decision level in the manual process. This is a difficult and time-consuming task. We recently implemented an autovalidation system in our hematology laboratory, and we are still discovering and troubleshooting pitfalls in our rules and programming glitches. LEPS: What systems are you using, and how are they performing? Plebani and Chiozza. We use VALAB3 a commercially available rule-based system for chemistry and hematology. The system is installed on a personal computer and it reviews clinical laboratory reports coming from the laboratory information system. VALAB considers many pieces of information when validating test results including delta checks, extreme limiting values of the test, correlation between different test results, patient age, ambulatory or hospitalized patient, ordering department, urgency of request, and the medical specialty of the requester. In addition, VALAB incorporates statistical quality control as part of the overall validation process. This is noteworthy since some experts, like James Westgard4, have pointed out that ignoring QC is a weakness of some autovalidation techniques. In 1999, VALAB was introduced in the Department of Laboratory Medicine of the University-Hospital of Padova. Since then we have used this validation system for screening about 17,9000 tests per day on 2,300 patients. This has enabled an 80% reduction in visual inspection by laboratory specialists, who now focus on more appropriate cases. Sandhaus: We are using a rule-based system that uses a personal computer network that is interfaced between the automated analyzer and the LIS. Autovalidation is only one of the features of this system, which is actually a comprehensive hematology information system. This system has not been trivial to implement and required many months of planning and preparation. The biggest problem was not programming the rules, but rather the programming issues related to the hierarchical scheme for partial validation of results. About 50% of automated hematology results are now autovalidated. We have been able to create rules that permit autovalidation on in-patient samples that have consistently abnormal results through the use of time-limited delta-checks in the autovalidation rules. We continue to monitor if the rules are doing what they are intended to do, and revise them as needed. LEPS: Would your solution work at other institutions? Plebani and Chiozza: Yes. VALAB is popular in Europe. Like any autovalidation method, VALAB has limitations in terms of specificity and sensitivity of error detection. Unlike many other autovalidation methods, VALAB's performance characteristics have been published in the peer-reviewed literature3,5. Sandhaus: Autovalidation can work in almost any hematology laboratory, but the rules should take into consideration the analyzer’s capabilities, the available technical expertise, the LIS features, and the patient population. For example, our set of rules would not be appropriate for a small community hospital or a commercial laboratory that primarily serves physician office practices. We wanted a highly sophisticated system that would allow autoverification of some abnormal results as well as normal results. A much simpler system could accomplish autoverification of normal results, and may be more appropriate for other laboratory situations. LEPS: Does autovalidation improve patient safety? Plebani and Chiozza: It has not been rigorously scientifically proven that validation systems allow clinical laboratories to reduce errors, and improve patient safety and outcomes. This is due to difficulties in designing and performing longitudinal studies that allow identification of real errors and a comparison with historical error rates. However, from a practical standpoint, the implementation of autovalidation systems should be considered an effective form of error reduction. This is because it is clear that there are significant operational limitations of both internal quality control and manual test validation. It is logical to assume that a well-designed and tested autovalidation system, like the one we have chosen, improves the quality of laboratory services. Sandhaus: This would be difficult to measure. However, we can say that it greatly reduces the time spent on validation of results, and makes these results available faster to clinicians who can act on them. For example, our turnaround times for autovalidated samples to the Emergency Department are now down to a few minutes, and it is likely that this improves patient safety. References 1) Burnett D. A practical guide to accreditation in laboratory medicine. London, ACB Venture Publications, 2002. 2) Auxter-Parham S. Taking autoverification to the next level: new tools make it easier to increase efficiency. Clin Lab News 2003; 29 (11): 6-7. 3) Valdiguié PM, Rogari E, Philippe H. VALAB: expert system for validation of biochemical data. Clin Chem. 1992; 38: 83-7. 4) Westgard JO. Taking autoverification to the next level. Is that up or down? http://www.westgard.com/essay57.htm 5) Oosterhuis WP, Ulenkate HJLM, Goldschmidt HMJ. Evaluation of LabRespond, a new automated validation system for clinical laboratory test results. Clin Chem. 2000; 46: 1811-7.


I would be interested in your thoughts on autoverification and any possible role the process may have in patient safety.
Laurinburg, NC

Michael Astion, MD, PhD: I am copying an interview that I did with Drs. Mario Plebani and Linda Sandhaus regarding autoverification. It was published in the 4th issue of "Laboratory Errors and Patient Safety" (www.laboratoryerrors.org), which is a newsletter that I edit. This covers most of the issues you are interested in. I favor autoverification, if it is carefully implemented, but there is currently no peer-reviewed data showing that it improves patient safety. --- Question and Answer: Autovalidation LEPS interviewed experts from two institutions to understand some of the key issues in autovalidation. For a European perspective we interviewed Dr. Mario Plebani and Dr. Maria Laura Chiozza from the University Hospital of Padova, Italy. For a U.S. perspective, we interviewed Dr. Linda Sandhaus, who is a laboratory director at University Hospitals of Cleveland. LEPS: What is meant by "validation" and "autovalidation"? Plebani and Chiozza: These terms have been adequately defined by a number of others1, 2. A working definition of validation is the process of confirming that a test result is accurate. Results that fail validation are potentially questionable and may require that the laboratory perform retesting or notify a care provider that there is a potential problem with the test result. The terms autovalidation and autoverification are used interchangeably. A reasonable definition of either term is "a set of computer-based rules that accomplishes what expert laboratory personnel would do if they had manually verified test results". In practice, no validation techniques, including autovalidation techniques, are error-free. In addition, there is an unavoidable trade-off between the sensitivity and specificity of detecting an error in a test result. As rules are made more permissive to increase the sensitivity (less false negatives) of error detection, there is often a decrease in the specificity (more false positives) of error detection. LEPS: What are the problems with manual validation of results? Isn't it a time-tested method? Plebani and Chiozza: Manual test validation takes a great deal of time, and this sometimes delays the release of results. Manual test validation also suffers from a high variability between individuals performing validation. This is made worse by inconsistencies throughout the day. For example, some laboratory staff members fatigue as the day progresses and therefore tend produce lower quality validation toward the end of the day. All of these problems are compounded by the challenging issue of developing objective methods to determine personnel competency regarding validation of results. Sandhaus: The amount of time that manual validation takes should not be underestimated. In a busy hospital hematology laboratory, it can take several hours per day. One reason is that automated CBC data are complex, and require that, for each sample, the technologist make decisions about which parameters can be validated and which ones need additional evaluation. Knowledge and experience in laboratory hematology are required to perform this task efficiently and competently, and not all laboratories have enough technologists with the required expertise. An additional problem in hematology is that during the manual validation process, the results are presented in an abbreviated format in which graphic displays and other visual cues to abnormalities are not visible to the technologist performing the validation. LEPS: Can automation, in the form of autovalidation, help? Plebani and Chiozza: Autovalidation, has the potential, through standardization of validation methods, to decrease inter-individual variability, decrease the amount of time spent on validation, and decrease errors in the validation process. Autovalidation is better suited for routine clinical chemistry and hematology tests and less useful for esoteric immunoassays, molecular biology assays, and for laboratory tests which have interpretations attached, as is often the case for protein electrophoresis and flow cytometry. Sandhaus: Autovalidation in hematology can help reduce variability among technologists in application of the validation rules and improve turn-around times. However, there are so many rules for validation of abnormal CBC results, that autovalidation systems must be designed and programmed very carefully to incorporate every decision level in the manual process. This is a difficult and time-consuming task. We recently implemented an autovalidation system in our hematology laboratory, and we are still discovering and troubleshooting pitfalls in our rules and programming glitches. LEPS: What systems are you using, and how are they performing? Plebani and Chiozza. We use VALAB3 a commercially available rule-based system for chemistry and hematology. The system is installed on a personal computer and it reviews clinical laboratory reports coming from the laboratory information system. VALAB considers many pieces of information when validating test results including delta checks, extreme limiting values of the test, correlation between different test results, patient age, ambulatory or hospitalized patient, ordering department, urgency of request, and the medical specialty of the requester. In addition, VALAB incorporates statistical quality control as part of the overall validation process. This is noteworthy since some experts, like James Westgard4, have pointed out that ignoring QC is a weakness of some autovalidation techniques. In 1999, VALAB was introduced in the Department of Laboratory Medicine of the University-Hospital of Padova. Since then we have used this validation system for screening about 17,9000 tests per day on 2,300 patients. This has enabled an 80% reduction in visual inspection by laboratory specialists, who now focus on more appropriate cases. Sandhaus: We are using a rule-based system that uses a personal computer network that is interfaced between the automated analyzer and the LIS. Autovalidation is only one of the features of this system, which is actually a comprehensive hematology information system. This system has not been trivial to implement and required many months of planning and preparation. The biggest problem was not programming the rules, but rather the programming issues related to the hierarchical scheme for partial validation of results. About 50% of automated hematology results are now autovalidated. We have been able to create rules that permit autovalidation on in-patient samples that have consistently abnormal results through the use of time-limited delta-checks in the autovalidation rules. We continue to monitor if the rules are doing what they are intended to do, and revise them as needed. LEPS: Would your solution work at other institutions? Plebani and Chiozza: Yes. VALAB is popular in Europe. Like any autovalidation method, VALAB has limitations in terms of specificity and sensitivity of error detection. Unlike many other autovalidation methods, VALAB's performance characteristics have been published in the peer-reviewed literature3,5. Sandhaus: Autovalidation can work in almost any hematology laboratory, but the rules should take into consideration the analyzer’s capabilities, the available technical expertise, the LIS features, and the patient population. For example, our set of rules would not be appropriate for a small community hospital or a commercial laboratory that primarily serves physician office practices. We wanted a highly sophisticated system that would allow autoverification of some abnormal results as well as normal results. A much simpler system could accomplish autoverification of normal results, and may be more appropriate for other laboratory situations. LEPS: Does autovalidation improve patient safety? Plebani and Chiozza: It has not been rigorously scientifically proven that validation systems allow clinical laboratories to reduce errors, and improve patient safety and outcomes. This is due to difficulties in designing and performing longitudinal studies that allow identification of real errors and a comparison with historical error rates. However, from a practical standpoint, the implementation of autovalidation systems should be considered an effective form of error reduction. This is because it is clear that there are significant operational limitations of both internal quality control and manual test validation. It is logical to assume that a well-designed and tested autovalidation system, like the one we have chosen, improves the quality of laboratory services. Sandhaus: This would be difficult to measure. However, we can say that it greatly reduces the time spent on validation of results, and makes these results available faster to clinicians who can act on them. For example, our turnaround times for autovalidated samples to the Emergency Department are now down to a few minutes, and it is likely that this improves patient safety. References 1) Burnett D. A practical guide to accreditation in laboratory medicine. London, ACB Venture Publications, 2002. 2) Auxter-Parham S. Taking autoverification to the next level: new tools make it easier to increase efficiency. Clin Lab News 2003; 29 (11): 6-7. 3) Valdiguié PM, Rogari E, Philippe H. VALAB: expert system for validation of biochemical data. Clin Chem. 1992; 38: 83-7. 4) Westgard JO. Taking autoverification to the next level. Is that up or down? http://www.westgard.com/essay57.htm 5) Oosterhuis WP, Ulenkate HJLM, Goldschmidt HMJ. Evaluation of LabRespond, a new automated validation system for clinical laboratory test results. Clin Chem. 2000; 46: 1811-7.


What are examples of the two best patient identifiers? Our facility uses name and DOB because they wanted to use one policy that would apply to both ambulatory and acute care settings. Our policy states that some depts may require a third identifier- which for the laboratory is medical record number. Any comments on use of DOB as a patient identifier?
Rochester, New York

Michael Astion, MD, PhD: The most commmonly used identifiers are Patient Name and Hospital ID number. Many facilities are using ID numbers and ID bracelets, even for outpatients. There is nothing wrong with using DOB as an identifier. It is acceptable, and although it is not unique, its combination with name or Hospital ID number is reasonable.


Could you be more specific regarding some of the patient outcome data that you are currently collecting?
Toronto, Canada

Michael Astion, MD, PhD: For a particular laboratory error, the best method for determining patient safety outcomes is to call the physician or nurse taking care of the patient who was potentially affected and ask them to describe the clinical implication of the error. A checklist can be helpful in when questioning caregivers. Here is one we use (feel free to modify it for your own use): ___Redraw or recollection of specimen ____ Outpatient admitted to hospital because of incident ___ Inpatient hospital stay prolonged or increased level of care required (e.g., transfer to an ICU, use of telemetry need for an invasive procedure) ___ Patient received treatment or change in treatment that would not otherwise have been required (e.g., received potassium because of spurious hypokalemia; received medication dose change that was unnecessary) ___ Patient failed to received treatment or change in treatment that would otherwise have been required (e.g., did not receive potassium because hypokalemia not communicated; failed to receive medication dosage change) ___ Patient had transient morbidity* (i.e., resolved by time of discharge; for outpatients, resolved within days – a week) ___ Patient had morbidity* lasting beyond hospital discharge or longer than one week ___ Patient death associated with the incident


Do you have data regarding the impact on patient if the sample is mislabeled?
Wilmington, DE

Michael Astion, MD, PhD: I am not aware of published, peer-reviewed data regarding this issue. However, through personal experience and conversations with colleagues, I am aware of many cases where patients were harmed by mislabeling. If you go to www.laboratoryerrors.org and click on the sample issue, you will see an excellent composite case related to mislabeling in the hospital. It is on page 10 of that newsletter.


One of our Quality Plan goals for 2005 is to begin the process of developing an "open non-punitive" work environment. Would you recommend a couple books that we could offer our managment staff as resource material? We would then follow-up with discussion groups.
Dayton,OH

Michael Astion, MD, PhD: I very strongly recommend: 1. Mark D. Patient safety and the "just culture": A primer for healthcare executives. April, 2001. http://www.mers-tm.net/support/Marx_Primer.pdf This is free on the web and is the best article I have ever read regarding this topic. I favor the term "just culture" rather than "blame-free" or "non-punitive". If you read this article you will understand why.


I agree that good supervision is key in reducing errors and creating a learning environment. What are your thoughts on supervisor to employee ratio for non-technical departments (phlebotomy and specimen processing).
Dayton,OH

Michael Astion, MD, PhD: Good supervision is important for several reasons. One of the most important is that good supervision can be used to prevent certain knowledge-based errors. For example, many laboratories have rules that require that supervisors review certain rare results before they are reported out. The proper supervisor to employee ratio for nontechnical staff depends on the environment you are working in. The more complex the environment, the more lower the ratio you need. I would not expect the same ratio in a relatively uncomplicated environment (e.g. like an outpatient draw center for relatively healthy ambulatory patients) and a complicated environment (e.g. a tertiary care hospital that sees very sick as well as ambulatory patients, and includes pediatric as well as adult patients). One size will not fit all.


When patient safety is compromised by inadequate staffing in face of an imposed hiring freeze what strategy(s) should be pursued?
Boise, ID

Michael Astion, MD, PhD: The best strategy here is to actually collect patient outcomes associated with the most egregious errors. Show these outcomes to top management. This might help them see that they are standing on dollars to pick up some dimes. In today's environment hospital management is faced with a tremendous amount of near-miss data. If you can show them that patient safety is actually being compromised, rather than theoretically being compromised, you may be able to make a resource breakthrough. The best place to look for actual impact is to look for errors associated with STAT testing or other testing performed in a critical care setting such as the ICU and the Emergency Room.


How can we get funding to help us initiate a patient safety improvement initiative after we have decided what to do, but have insufficient funding for staff and/or IT support?
Ft. Lauderdale, FL

Michael Astion, MD, PhD: One reasonable strategy is to actually collect patient outcomes associated with the most egregious errors. Show these outcomes to top management. This might help them see that it would be worth it to fund QI for patient safety. In today's environment hospital management is faced with a tremendous amount of near-miss data. If you can show them that patient safety is actually being compromised, rather than theoretically being compromised, you may be able to make a resource breakthrough. The best place to look for actual impact is to look for errors associated with STAT testing or other testing performed in a critical care setting such as the ICU and the Emergency Room.


I am having difficultyunderstanding the terms latent and active errors, can you please expand on these definitions and offer some examples or methods to distinguish between these types of errors?
Baltimore, MD

Michael Astion, MD, PhD: Think of the latent error as the "error behind the error". For example, the active error is that a person typed in a result incorrectly. The latent error might be that management could have eliminated the error entirely by having an instrument-LIS interface, so that results rarely had to be typed in. The active error might be a math error made by a tech related to a dilution. The latent errors might be that 1)management has forced the tech to multitask, because staffing is poor, and 2)management purchased an instrument with an inadequate dynamic range, so too many dilutions are required.


Most of the time, when an error is discovered internally in the lab, we make the necessary changes and inform the clinician. We do not question the clinicians on the outcome of the error unless they give us that information. In this case it is difficult to categorize a potential adverse event (near miss) from adverse event. What do you suggest, do we question the clinician?
Fort Belvoir, VA

Michael Astion, MD, PhD: For a particular laboratory error, the best method for determining patient safety outcomes is to call the physician or nurse taking care of the patient who was potentially affected and ask them to describe the clinical implication of the error. A checklist can be helpful in when questioning caregivers. Here is one we use (feel free to modify it for your own use): ___Redraw or recollection of specimen ____ Outpatient admitted to hospital because of incident ___ Inpatient hospital stay prolonged or increased level of care required (e.g., transfer to an ICU, use of telemetry need for an invasive procedure) ___ Patient received treatment or change in treatment that would not otherwise have been required (e.g., received potassium because of spurious hypokalemia; received medication dose change that was unnecessary) ___ Patient failed to received treatment or change in treatment that would otherwise have been required (e.g., did not receive potassium because hypokalemia not communicated; failed to receive medication dosage change) ___ Patient had transient morbidity* (i.e., resolved by time of discharge; for outpatients, resolved within days – a week) ___ Patient had morbidity* lasting beyond hospital discharge or longer than one week ___ Patient death associated with the incident


Do you know of a way to determine if it is the process or the people that are causing errors in patient identification or Laboratory erros?
Salem,NJ.

Michael Astion, MD, PhD: It is helpful to classify errors using a simple psychology model because it helps design interventions. Cognitive errors (also known as mistakes), are due to limited or lack of knowledge or poor judgment. (including purposeful disregard of policies and procedures). Examples of cognitive errors include: failure to properly interpret a common instrument flag, mistaking yeasts for host cells on a Gram stain, and calling in a critical value to a voice mail (against institutional policy). Cognitive errors are usually overcome by additional training or supervision. For example, a laboratory might invoke a policy that rare peripheral blood smear results must be reviewed by a supervisor before being reported. Non-cognitive errors, also known as (slips), are due to interruptions in a process that is relatively automatic. Examples of noncognitive errors include failure to enter information from a requisition into the LIS, data entry errors, mislabeling, and math errors. Non-cognitive errors are reduced by strategies for avoiding lapses in concentration. These strategies include automation, checklists, reducing phone calls or other interruptions, simplifying procedures, and increasing optimizing staffing. For example, interfacing instruments directly into the LIS is a good way to reduce post analytic data entry errors. Most noncognitive errors are process problems. Cognitive errors are frequently a mix of process and people problems. In general, it is best to assume that a problem is NOT a people problem. Before declaring that a problem is a people problem, look for all the process errors that might be making a person's job difficult or impossible.


In order to investigate patient outcomes, the support and involvement of Laboratory Pathologists seems critical. Do you have any suggestions about how motivate Pathologists to be involved in and coordinate efforts to get this information.
Tacoma Washington

Michael Astion, MD, PhD: Essentially, I do not think it is going to be possible to motivate most "contract" pathologists, who are not actually employees of the institution. This is because contract pathologists are most motivated to do the work they can bill for. However, in my experience, most pathologists, who work for the facility that wants to improve, will be motivated to perform patient safety QI projects, when they are shown some of the adverse events related to laboratory errors.


According to Plebani et al, 74% of preanalytical errors are detected because they are observed or suspected. In your experience, how many of these specimens are actually redrawn, and how many of these tests are cancelled?
Toronto, Canada

Michael Astion, MD, PhD: In the 3 or 4 studies that I have participated in, about half are redrawn and half are canceled. I would expect that different types of facilities would produce different results. One size will not fit all in this case.

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