Notification After the Fact

What does your lab do when you are notified about instrument/reagent problems after the fact? Let me give you two recent examples.

A vender sends a recall notice that goes back 6 months on one of their reagents. There has been a problem with a reagent for 6 months, but you are just now being notified. You look and determine that you have run 1000 tests on patients using that reagent during the problematic time period. What do you do?

Or another example, a reference laboratory changes their units of measure and you miss the notification. 23 patients had results come back from the reference lab and the values were entered into the computer with the incorrect units of measure and reference interval in place. The mistake is discovered on the 24th patient.

Laboratories work to have systems in place to prevent these scenarios. We try to carefully watch for changes from reference labs, and we hope that recall notices will not affect many patients. However, despite our best efforts, relatively large-scale lab errors like these happen. Laboratories need to have systems in place for dealing with these events. A few steps that are helpful when this happens include:

1) Determine whether the error is on-going
  a. Are immediate process changes necessary?
2) Fix the error so no new patients are affected
3) Determine the extent of the damage
  a. Often involves a Root Cause Analysis
  b. How many patients were affected
  c. How serious was the effect (changed treatment vs no effect at all)
  d. Do healthcare-providers need to be notified, and if so, who and how to notify
4) Notifications
  a. Healthcare-providers
  b. Hospital/laboratory Quality and/or Risk Departments
  c. Other clients
5) Documentation
6) Is there a way to turn this into an opportunity for improvement?

Occasionally an error can cause more headache than harm. For example, if you report a value of 35 mg/dL with a reference interval is 20 – 80 mg/dL, the result is normal. If the units of measure are supposed to be mg/L on both instead of mg/dL as reported, this is simply a clerical error because the result will still be normal if you change the units on measure on both the result and the reference interval. Unfortunately, it may still result in a corrected report on each patient, which depending on your system, may still flag your ordering physician. If you make this correction on a high volume test, a lot of irate physicians will be calling you regarding the number of corrected reports on their patients. Thus the error causes more headache than harm, but still requires that a procedure be in place to investigate and deal with it. All labs should have such a procedure.

 

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-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.

 

The Importance of Manual Urine Microscopy

Research presented today at the National Kidney Foundation spring clinical meeting indicates that manual microscopy surpasses automated analyzers when assessing kidney injury. The abstract is titled “Manual Microscopy: Not a Lost Art” and says, in part: “In this study, we examined if a significant difference exists between the reported ranges of granular and muddy brown casts using manual microscopy as compared to an automated urine analyzer in an acute kidney injury cohort.”

According to one of the abstract’s authors, Dr. Sharda, “What our research has been able to show so far is that the automated system under reported the value of granular casts in our patient cohort of acute kidney injury. The automated system still has utility as a screening test, but manual microscopy should be done in all cases of abnormal kidney function, as accurate quantification of casts could have some prognostic benefit to patients.”

The poster is available online. The authors are currently writing a paper on their research; their contact information is here.

So, What Does MLPW Mean to Me?

So, I’m going to continue the thread from my previous blog post next week since this is Medical Laboratory Professionals Week (or what we affectionately refer to as Lab Week). Coincidentally, for a public health-oriented person like me, Earth Day (April 22) is also during this week; globally, some celebrate the entire week as Earth Week. So, I encourage you to celebrate both.

Pathology can be a hidden or invisible profession to many, even more so on the lab side. Even though we are dependent on lab results to guide clinical care (at least 70% of clinical decisions are guided by lab results), it’s easy to forget that there are lab professionals and pathologists working assiduously, sometimes late into the night, behind the scenes to make sure we receive timely and accurate, lab results for our patients.

So, what exactly is Lab Week? It’s the time each year when we celebrate and recognize these lab professionals and pathologists, a time where we recognize them as more than nameless faces but as team members who vitally and equally contribute to patient care. Many hospitals and health care centers will highlight the work of those in their clinical labs with poster sessions and talks on relevant topics this week. Some will also cater Lab Week celebrations for their staff as a thank you for all their diligent work that often goes unrecognized or taken for granted during the rest of the year.

So, as we residents, what can we do? Well, first, we can get to know our lab professionals and this week in particular, personally thank them for all their hard work. I’m pretty sure it’ll bring a smile to their faces if you make a deliberate effort to recognize and say “thank you” this week. We can learn their names and get to know them on a personal level and not just when we need a test result or to troubleshoot a lab related issue.

I’m on pretty friendly terms with most of the lab techs from my clinical rotations. They have invited me to department holiday celebrations (even when I’m not on their rotation), gave great feedback about me to my rotation director/attending (trust me, they often do get to comment on how you perform during a CP rotation), and gave me a heads up to help me out of potentially difficult situations. I’ve learned a lot from them and they’re always happy when we show interest in their work. Plus, I never treat anyone in a formal hierarchical manner (no one calls me “Dr. Chung” but rather “Dr. Betty” or just by my first name). I acknowledge that there is always something that they teach me and that I believe that we are colleagues working together on a team…not that I am the doctor and they are not. And often, lab professionals will be the first to detect a potential patient clinical issue, even if they have limited patient history access, so I totally give them props when they help me out in this way. And having a good attitude with your lab staff, as I mentioned, can go a long way for both your learning and advancement on the rotation.

As residents, CP rotations are often when we have the opportunity (as opposed to surgpath) to take vacation time and many look at these rotations as unofficial boards study time. But spending physical time in the lab is still learning. And for me, I learn better by doing as opposed to sitting in a lecture or sitting at my desk reading a textbook. The lab regulatory policies and management issues (and even the basic science concepts) we need to know to pass boards, we can learn more efficiently if we spend actual time IN the lab working alongside our lab professionals on these very issues. In the lab, we can also serve as consultants for our referring physicians on the intricacies and appropriateness of specific lab tests and help with regulatory (CAP/CLIA) inspections – even if your rotation doesn’t specifically require this, you can still ask to be more involved – trust me, you’ll learn more this way (and it is boards studying).

So, how are you planning to celebrate Lab Week and acknowledge those in the clinical labs this week? While you’re at all, you can help contribute to Earth Day/Earth Week as well by committing yourself to being more environmentally conscious (don’t forget to recycle!) from this week forth.

 

Chung

Betty Chung, DO, MPH, MA is a second year resident physician at the University of Illinois Hospital and Health Sciences System in Chicago, IL.

Laboratory Professionals Week Celebrations Around the World

Happy Laboratory Professionals Week! Lab week is celebrated not only in the United States but around the world as well. As in the United States, labs get in on the fun on an individual level as they recognize their employees and the importance of the lab, and larger organizations organize celebrations and community outreach events.

In Cote d’Ivoire, located in West Africa, there is a week’s worth of activities and celebrations planned. The activities include ceremonies recognizing laboratory professionals throughout the country, demonstration sessions, and community outreach to the general public via radio broadcasts, information pamphlets, and text messages, among other activities. The official lab week ceremony will take place on April 22nd in the largest city of Cote d’Ivoire, Abidjan, at INFAS (the Institut National de Formation des Agents de Sante or the National Institute for Training of Health Workers). Speeches will be given by high ranking government officials, including the Minister of Health, as well as representatives of CDC-PEPFAR, and the Association Ivoirienne de Biologie Technique (l’AIBT), the national lab association.

In Tanzania, located in East Africa, the Tanzanian laboratory professionals association, Medical Laboratory Scientists Association of Tanzania (MeLSAT) has organized awareness raising activities and celebrations as well. Throughout the week they will provide community outreach by offering testing and educational information on HIV, diabetes, and high blood pressure. They will also be collecting blood donations for the national blood bank. The lab week closing celebration will be a parade in the town of Sumbawanga to celebrate laboratory professionals and their achievements and to raise awareness among the community.

What are you doing to celebrate in your neck of the woods?

 

Levy

-Marie Levy spent over five years working at American Society for Clinical Pathology in the Global Outreach department.

Are “Clerical Errors” Acceptable in Proficiency Testing?

Laboratories across the United States must complete Proficiency Testing (PT) and score a minimum of 80% score for all specialties (the exception is Transfusion Services, which requires a score of 100 percent). Occasionally, errors on PT could be attributed to “clerical error.” However, that should not be confused with “human unavoidable error.” Clerical errors in the clinical setting could bring serious harm to the patients and therefore, should be avoided and mitigated. Risk of patient safety within the three month period of the failed test event period should also be assessed after each unsuccessful PT event and education for personnel need to be conducted.

Once a supervisor or manager discovers their department has missed a PT survey because of clerical error, sometimes the only corrective action is to counsel the individual technologist, but no preventative action is taken. When that happens, there are no safeguards in place to keep the error from happening again; after all, these types of errors can happen to anyone, not just a specific employee. There should be an investigation for the root cause of the event. Review and assessment of the root cause analysis for the event could reveal that the technical personnel might have been rushed and didn’t double check the PT sample identity or result entry for the test. Could the clerical error been caused by unmanageable workloads, or sleep deprivation? Maybe the error was caused by general inattentiveness, such as failing to read instructions or mismanaging the samples. All of these examples highlight problems that are a great scope than “clerical error.”

Institutions must ensure their tests result are accurate and are free of any clerical/ transcription errors. These types of events should be reviewed by management with an appropriate preventive action/ mitigation to prevent it from occurring in the future.

Information on policies or practices are solely from my personal experience ONLY and have NO relation to my  affiliation with any regulatory or government agency.

satyadi

-Caroline Satyadi, MT(ASCP), SM, DLM, SLS, MBA, MS, CQA (ASQ) has been a laboratory management professional for over 25 years. She has worked with several different medical industries for CLIA/CMS, FDA/ICH/ISO, TJC/CAP/COLA/HFAP accreditation survey readiness.

Lab Week Fun

Since it’s National Medical Laboratory Professionals Week–aka Lab Week–we’d like to start off the week with a poll.

Happy Lab Week, everyone!

Edited 4/25/14 to add: Thanks for playing, everyone! The correct answer–which over 88 percent of you knew–is Saccharomyces cerevisiae.

Photo courtesy of Wikimedia Commons

 

Adventures in Grossing, Part I

So its no secret that I don’t feel that I’m the world’s best or fastest grosser. I didn’t read Lester or Westra (aka the grossing Bibles) as much as I should’ve first year and still have never finished either cover to cover. And the fact that we had surgpath fellows stand by our side and teach us how to gross initially was probably more of a crutch for me than I should’ve allowed it to be. I need to understand why I should gross a specimen a specific way because memorizing the steps does not work for me – because I forget the next time and because not every specimen is “perfect” and I may need to modify the general protocol.

But for the past two months, I’ve been at our program’s busiest surgpath site, a private practice in a community hospital setting that sees a whole lot of cancers. My first day definitely was not a good one. I had spent 10 hours traveling from USCAP back to my apartment and had gotten a mild migraine in between…so much so that I got off at my layover asking if I could take a later flight back. Unfortunately, the next flight would get me home close to 7 AM and it’s a 1-1.5 hour drive to this hospital for me during rush hour traffic. This site is close to the airport so I would’ve been better off going straight from there.

It was the perfect storm, both figuratively and literally. I was tired from travel and nursing the residual headache that always follows one of my migraines… it was snowing yet again…and this caused a few accidents…and for me to be late my first day at this site after I had missed the first two days of the rotation (which is generally a no-no). So my first impression was most definitely not a good one. Couple that with being assigned grossing duty for a moderately heavy day, not knowing where anything was or how things were supposed to be done at this site, not being able to access the EMR, and not knowing what my responsibilities were versus those of the tech assigned to stand by and assist me (at other sites, I had to do everything by myself), and its not surprising that I failed to impress my attending.

VoiceBrook (Medical Dragon dictation software), the bane of my existence right now, was not working and their staff kept calling since there was miscommunication about my appointment to re-train with VoiceBrook. On top of all of this, I didn’t get to do the compensatory rituals I usually do to feel less stressed about grossing – work up my patients/specimens ahead of time, read Lester and Westra, and triage my grossing day based on the OR schedule. I pretty much felt like a “robot” (a sick one at that) that went straight through the manual motions of continuous grossing until the time came to close the gross room.

The attendings at this site have very specific ideas of the “right way” to gross and their expectations varies from the other in terms of their views on these topics. It is very busy in terms of grossing, intraoperative consultations, and weekly tumor boards that the residents prepare and present. But this post is actually not to complain but to elaborate on a light bulb moment that I had today that I had subconsciously somewhat improved my speed and many of the gaps in my understanding of what to gross and how to do it. Sometimes, repetition can be a great teacher. Good communication with those you work with is key. And lastly, nothing beats a good mentor who is willing to work with you to address your weaknesses… so what were your light bulb moments during your most difficult rotation and how did you come to recognize them? I’ll continue next week with a little more on this topic but for now, its bedtime since I anticipate a busy grossing day tomorrow.

 

Chung

Betty Chung, DO, MPH, MA is a second year resident physician at the University of Illinois Hospital and Health Sciences System in Chicago, IL.