Pitfalls of Prolactin Biochemistry Assay

Laboratories occasionally get questions from clinicians about prolactin results, mainly to either rule out high-dose hook effect or assess interference from macroprolactin. In most laboratories, sandwich immunoassay is used to measure prolactin concentration and it is widely known that older generations of prolactin assays suffer from hook effect and interference from macroprolactin. In the presence of extremely high concentration of prolactin, antibodies can be saturated, resulting in falsely low results, which is known as high-dose hook effect. Multiple cases have been reported in patients with giant prolactinomas, that their prolactin results were measured as normal or moderately elevated. In order to rule out high-dose hook effect, clinicians normally request laboratories to perform appropriate dilutions for prolactin in patients with large pituitary tumors. Newer generation of prolactin assays have better performance in this aspect, and most assays nowadays have no hook effect up to concentrations of 10,000 ng/mL, claimed by manufactures.

Another pitfall of prolactin assay is the interference from macroprolactin. Macroprolactin is a complex of prolactin bound to immunoglobulin, and thought to be biologically inactive. In the presence of elevated macroprolactin, patient is asymptomatic. However, macroprolactin can be picked up by prolactin immunoassays to some extent, and results in misdiagnosis as hyperprolactinemia. Reports showed that 15-20% of cases with hyperprolactinemia was due to elevated macroprolactin. Therefore, macroprolactinemia should be considered while evaluating hyperprolactinemia cases in the absence of symptoms or pituitary imaging evidence. Laboratories could easily perform dilution study to test if interference exists. To confirm the presence of macroprolactin, polyethylene glycol (PEG) 6000 can be used to precipitate macroprolactin followed by prolactin measurement in the supernatant. The presence of macroprolactin is suggested when the pull-down percentage is greater than 40-50%. This test is offered by many reference laboratories.

These two pitfalls of prolactin biochemistry assays should always be kept in mind by laboratorians, to provide better guidance to clinicians’ concern and workups on prolactin related cases.   

 

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-Xin Yi, PhD, DABCC, FACB, is a board-certified clinical chemist, currently serving as the Co-director of Clinical Chemistry at Houston Methodist Hospital in Houston, TX and an Assistant Professor of Clinical Pathology and Laboratory Medicine at Weill Cornell Medical College.

Patients and Patience

Holiday season is around the corner! And, as such, I’d like to take this opportunity to share a few thoughts I have on how our professional scope as laboratorians extends all the way from the bench to the dinner table.

How many times have you been asked by friends and family what it is exactly you “do” at work? And how many times have you done your best to explain, being met with references to unrealistic television shows or generalizations that go beyond your scope of practice? It’s happened to me a million times. It’s the nature of our laboratory culture. It’s a vital role in patient outcomes, but often behind the scenes. But just for a moment, let’s say you get beyond those surface explanations—what happens next? Probably, in most cases, not much.

One of the main tenets of the ASCP mission which we all work together is advocacy: for our communities, our institutions, our teams, and our patients. More often than not I would bet that family members venture into that turnpike, mostly as patients. When a grandparent, uncle, sister, or friend says they’ve got an upcoming procedure or test, how many of us would share our knowledge with him or her? I know I would. Not in a way that goes beyond our scopes as phlebotomists, medical laboratory scientists, or cytotechnologists, or medical students, or pathologists—but as someone who wants to empower their loved one to be the most informed and prepared patient they can be. In 2012, the Agency for Healthcare Research and Quality (AHRQ) promoted their campaign “Questions to Ask Your Doctor.” In it, they cite that good health depends on good communication and that patients should not be afraid to ask their physician questions about their health outcomes. You remember, the commercials with the guy at the cell phone store that asked a hundred free train-of-thought questions but was speechless in front of his doctor…I loved those.

In that same holiday spirit that celebrates thankfulness, family, and relationships, let’s include laboratory professionals! If you have a loved one who it applies to, explain just what happens after those six different colored tubes were drawn, explain how that removed mole was set, sectioned, and reviewed, explain how staining different cells in a body fluid give a clinician important data about their health. Hundreds of thousands of laboratory professionals in the United States could offer not just invaluable information to their friends and family, but peace of mind. Demystifying the medical process might make those patience more confident in asking informed questions and, together with their provider, improve their health outcomes.

I find myself in an interesting position today. Having years of explaining what CBCs or CMPs actually measure and why someone might have to fast before a lipid panel, I’ve started a slow transition to learning how to explain what that means to an individual’s health. What a fantastic foundation lab medicine gave me to build on! (Really a recurring theme you’ll see in lots of my posts.) By moving from what different stains mean to a clinician, I am now on a path toward being able to use that information for the next step in professional scope: diagnosis and management.

Just like I’m on this academic and professional journey, lots of us are on a path through or toward something. But back to our ASCP message, advocacy for patients means recognizing their journey—especially when they’re our family and friends. The best outcomes for any patients rely on valuable information, communication, and rapport. And while you help your loved ones through the steps of their journey as a patient you might empower them to be a more involved member of their healthcare team. As a result, they might experience more personal and effective care. And a bonus just for us: maybe more people would appreciate some behind the scenes lab medicine. Who knows?

So, from me and mine to you and yours, have a great holiday season and a wonderful new year! I’ll return with stories, cases, and commentary on medical school clinicals in January!

Take care and thanks for reading!

 

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Constantine E. Kanakis MSc, MLS (ASCP)CM graduated from Loyola University Chicago with a BS in Molecular Biology and Bioethics and then Rush University with an MS in Medical Laboratory Science. He is currently a medical student at the American University of the Caribbean and actively involved with local public health.

Help! OSHA is in My Lab!

Hospitals and other healthcare facilities have been on OSHA’s “high-risk” workplace list for a few years. That means the regulatory agency has noticed an increased number of employee injuries there, and therefore OSHA inspections have increased in hospitals and labs as well. If an OSHA inspector arrives at your facility, you should not panic, but you should know some very specific steps to follow.

If inspectors come directly to your department and you belong to a hospital or larger facility, be sure to contact your administration and accreditation departments immediately. This is a government agency on site, and the facility representatives need to be aware and involved. Verify the identity of the inspector(s). Sadly, there are imposters who pose as inspectors for the purpose of collecting money. OSHA inspectors will never talk about fine amounts during an inspection, and they certainly would not collect money on site. To prove the inspectors’ identity contact the state or federal OSHA office and verify that an inspector is scheduled to be on site. Twenty seven U.S. states and territories operate OSHA-approved State Plans, and if that is true in your area, it will be the state inspector on site rather than someone from the federal government.

OSHA is legally authorized to conduct workplace inspections to enforce health and safety standards, so it is usually best to allow them to inspect if requested. That said, you do have the right to require the inspector to obtain a search warrant before allowing them into your lab. However, as you can imagine, this will give an inspector the wrong idea about what you may or may not be hiding. They may dig deeper when they do return with that warrant, so it may not be the best course of action to turn them away.

An OSHA inspection begins with an opening conference which details the scope and purpose of the inspection. In the initial meeting, it is acceptable to ask the purpose of the inspection and its anticipated length. Ask what documents the inspector will want to see, and ask if there are any specific employees he or she will need to interview. If the inspection was triggered by an employee complaint, ask for a copy of the written report. The inspector may review certain lab documents pertinent to the investigation, and these may include the chemical hygiene plan, exposure control plan, or other policies and procedures.

While on site, the OSHA inspector should always be accompanied by a representative of your employer, an escort, and their next steps will usually be a walk-through of the inspected areas to look for safety hazards and to talk to employees. The inspector may talk to staff, take notes, and take pictures. The lab escort should take copious notes while this is happening, and it is advisable to take pictures of whatever the inspector documents with photographs.

If the inspector asks to interview an employee, he may do so in private so long as the employee agrees to that. Train staff to never volunteer information during an OSHA inspection; they should answer only what is asked. An OSHA inspector may ask if the employee familiar with lab safety policies and procedures, and whether or not the employee follows those procedures. They will try to determine if staff is aware of hazards in the workplace. If the inspector points out safety violations he notes, do not agree to them; it may be taken as an admission of wrong-doing and could incur a fine. If you are able to correct the violation on site, do so immediately, but understand that you could still be cited. However, this goes a long way toward showing the inspector that your interest truly is in cooperating and keeping employees safe.

Once the investigation is complete, the inspector will hold a closing session on site. During that time the lab will be notified about citations that will appear in the written report. The inspector will explain your right to appeal noted violations and give information on how and by when to appeal. They will answer any questions you may have. If on-site corrections were allowed during the inspection, be sure the inspector states that the follow up was completed.

If a citation will be incurred, start right away to prepare your response while the information is fresh in your mind. An OSHA report can take up to six months to be sent to the facility. Post OSHA citations at or near the site of the violation in the department.  If the correction of the violation takes longer than three days, the posting must remain until the correction is completed. After correcting a hazard, notify OSHA in writing. Employers have up to 25 days to submit OSHA an abatement of the safety issue or issues. If the abatement will take a long time (greater than 90 days), the first abatement progress report is due to OSHA within 55 days.

OSHA fines increased in 2016 for the first time in over 30 years. A single fine amount can range from $12,500 up to $125,000 depending on the seriousness of the violation. That’s just one reason to make sure your lab is following OSHA safety regulations. Keep your staff safe, but if OSHA knocks on your door, remain calm, and follow the steps to ensure a smooth inspection and follow-up process.

 

 

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Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.

Pathologist on Call: There Is No Perfect Lab Test for Smoking Assessment

Cigarette smoking can affect both innate and adaptive immunity, and introduces concerns when evaluating a patient’s eligibility for surgery. It has been shown to hinder time required for healing and long-term survival of patients. It can promote vascular complications, increase the rates of hepatocellular carcinoma and reduce lung function.1 For lung transplantation, one of the common requirements of eligibility is smoking abstinence for at least 6 months. Smoking post-surgery is associated with worse outcomes for the patients including complications and higher rates of mortality.2 Relapse to smoking post lung transplantation has been reported to range from 11% to 23% in various patient populations.3 As a result, clinical testing for cigarette smoking abstinence is an important part of initial workup and follow-up of transplant patients.

In some situations, the burden of lung allocation weighs heavily on a single clinical laboratory result that is perceived to definitively confirm or exclude active cigarette smoking. This subsequently factors into the decision by the physicians to deem the patient eligible to receive a lung transplant. The perception of nicotine testing as definitive proof of smoking is misleading and does not reflect the complexity of situations that can lead to a positive test result.

How can we assess smoking?

Ideally, many factors should weigh into the final smoking status determination including self-reporting (used historically), witnesses to behavior, odor, and past history including cessation attempts. Clinical laboratory testing is important and thought to be more reliable means for smoking assessment. It can involve testing for nicotine (originating from tobacco or nicotine replacement therapy, NRT) and its metabolites: cotinine, 3-hydroxycotinine (3-OH-cotinine), and nornicotine. Moreover, nicotine contains a number of alkaloids that are not usually present in nicotine-replacement therapies (NRTs) including anatabine and anabasine.4 Nicotine testing can involve a combination of metabolites such as cotinine as well as alkaloids like anabasine. Various sample types have been used including saliva, blood and urine.5 In addition, measurements of the exhaled carbon monoxide (CO) have been used to assess recent smoking status (within the last 8 hours).6

Clinical case: patient with detectable nicotine metabolites

A case involving a patient being considered for lung transplantation was received by our department. The patient had been tested for anabasine, nicotine, and its metabolites in urine. Testing of random urine specimens was performed by liquid chromatography tandem mass spectrometry (LC-MS/MS) at different time points from samples collected during hospital visits (days 0, 38, and 62). The urine contained variable concentrations of nicotine and its metabolites, with anabasine concentrations below the detection limit in 2 out of the 3 testing instances. Testing at day 0 showed an interfering substance that prevented the determination of accurate anabasine concentration. The nicotine and its metabolite concentrations in the random urine specimens were lower from day 0 to day 38, but a noticeable increase of 3-OH-cotinine and cotinine concentrations was observed in the specimen collected on day 62. The physician was seeking information about the current smoking status of the patient and was planning to use this information to determine the patient’s lung transplant eligibility.

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Days 0 38 62
Analyte concentration (ng/mL)
3-OH-cotinine 4074 89 603
Anabasine interf. subst. < 3 < 3
Cotinine 1404 47 425
Nicotine 241 < 2 72
Nornicotine 58 < 2 6

 

Figure and table 1. Nicotine, metabolite and anabasine concentrations (ng/mL) at different time points for a patient evaluated for lung transplantation eligibility. Anabasine was not detected on days 38 and 62, with an interfering substance preventing quantitation on day 0.

How definitive are these results?

No information was available regarding self-reported smoking or NRT use history for this patient. The physician had high suspicion that the patient was an active smoker and was attempting to use higher concentrations of nicotine and metabolites observed on day 62 as evidence of recent tobacco use.

For cotinine, values can range from 20-550 ng/mL for daily tobacco use.5 Nicotine concentrations in urine can approach over 5000 ng/mL with daily use. Together, high nicotine and cotinine can support tobacco or high-dose nicotine patch use. Furthermore, presence of nornicotine above 30 ng/mL along with anabasine greater than 10 ng/mL would be consistent with current tobacco use rather than NRT.7

Given that these were random urine specimen and the urinary creatinine values are not routinely measured, it’s important to consider the possible contributions of the variable urine concentration to the analyte concentrations. It has previously been reported that individuals abstaining from smoking for at least two weeks should present with nicotine of <30 ng/mL, cotinine of < 23 ng/mL, 3-OH-cotinine of <120 ng/mL, nornicotine < 3 ng/mL, and anabasine of < 2 ng/mL in urine.7 Based on these cut-offs, all analytes except anabasine would suggest new nicotine intake within the last two weeks.

In general, a positive anabasine result, in combination with the presence of nicotine metabolites, is consistent with active use of a tobacco product, whereas anabasine values of < 2ng/mL may suggest that NRT is the likely source.8 This can imply that the patient is abstinent from smoked or chewed tobacco if anabasine is not detected. However, anabasine is not a sensitive marker of smoked tobacco. It has been reported that the compound may not be detectable in 60% of self-reported smokers (N=51; 3 ng/mL cut-off in urine)9  and its urinary concentrations do not correlate well with self-reported tobacco use.8

As a result, anabasine has low sensitivity for determining eligibility for UNOS (United network for organ sharing) listing. There are some recommendations that this marker should not be used alone. Given that other alkaloids can originate from tobacco plant, it has been proposed that anatabine should be added to analysis due to higher expected concentration.9 However, this alkaloid is not completely specific to tobacco as it has been proposed to also arise from other plant sources 10,11  leading to possible implications for the patient that may be misclassified. In addition, anatabine sensitivity in detecting smoked tobacco use varies depending on the tobacco source and the clinical cut-off used. Clinical tests that include anatabine are not routinely available.

Can we improve this process?

Unfortunately, there is no definitive marker distinguishing smoking from NRT.

The determination of smoking status has advanced from reliance on self-reporting to quantitative and specific measurements of metabolites of nicotine and minor components of tobacco. Additional analyte incorporation into a test panel leads to additional complexities and considerations in interpretation of the results. Therefore, it is important to educate the physicians about various nicotine sources causing a positive nicotine and/or metabolite test result including NRT or e-cigarettes. It is also important to convey the limitations of tobacco alkaloid testing in such scenarios. Both the lab and the physician need to be cautious about implying active smoking in the absence of indirect supporting evidence and/or positive clinical test results.

At the same time, there is a need to improve the utility and availability of other tobacco alkaloid testing in distinguishing cigarette smoking from NRT in specific transplant populations and consider the value of testing alternative specimens. This may lead to a more effective implementation of secondary markers of tobacco use.

References

  1. Qiu, F.; Fan, P.; Nie, G. D.; Liu, H.; Liang, C.-L.; Yu, W.; Dai, Z., Effects of Cigarette Smoking on Transplant Survival: Extending or Shortening It? Frontiers in Immunology 2017, 8, 127.
  2. Zmeskal, M.; Kralikova, E.; Kurcova, I.; Pafko, P.; Lischke, R.; Fila, L.; Valentova Bartakova, L.; Fraser, K., Continued Smoking in Lung Transplant Patients: A Cross Sectional Survey. Zdravstveno varstvo 2016, 55 (1), 29-35.
  3. Vos, R.; De Vusser, K.; Schaevers, V.; Schoonis, A.; Lemaigre, V.; Dobbels, F.; Desmet, K.; Vanaudenaerde, B. M.; Van Raemdonck, D. E.; Dupont, L. J.; Verleden, G. M., Smoking resumption after lung transplantation: a sobering truth. The European respiratory journal 2010, 35 (6), 1411-3.
  4. Hukkanen, J.; Jacob, P., 3rd; Benowitz, N. L., Metabolism and disposition kinetics of nicotine. Pharmacological reviews 2005, 57 (1), 79-115.
  5. Raja, M.; Garg, A.; Yadav, P.; Jha, K.; Handa, S., Diagnostic Methods for Detection of Cotinine Level in Tobacco Users: A Review. Journal of clinical and diagnostic research : JCDR 2016, 10 (3), Ze04-6.
  6. Sandberg, A.; Skold, C. M.; Grunewald, J.; Eklund, A.; Wheelock, A. M., Assessing recent smoking status by measuring exhaled carbon monoxide levels. PloS one 2011, 6 (12), e28864.
  7. Moyer, T. P.; Charlson, J. R.; Enger, R. J.; Dale, L. C.; Ebbert, J. O.; Schroeder, D. R.; Hurt, R. D., Simultaneous analysis of nicotine, nicotine metabolites, and tobacco alkaloids in serum or urine by tandem mass spectrometry, with clinically relevant metabolic profiles. Clinical chemistry 2002, 48 (9), 1460-71.
  8. Jacob, P., 3rd; Hatsukami, D.; Severson, H.; Hall, S.; Yu, L.; Benowitz, N. L., Anabasine and anatabine as biomarkers for tobacco use during nicotine replacement therapy. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 2002, 11 (12), 1668-73.
  9. Feldhammer, M.; Ritchie, J. C., Anabasine Is a Poor Marker for Determining Smoking Status of Transplant Patients. Clinical chemistry 2017, 63 (2), 604-606.
  10. Lanier, R. K.; Gibson, K. D.; Cohen, A. E.; Varga, M., Effects of dietary supplementation with the solanaceae plant alkaloid anatabine on joint pain and stiffness: results from an internet-based survey study. Clinical medicine insights. Arthritis and musculoskeletal disorders 2013, 6, 73-84.
  11. von Weymarn, L. B.; Thomson, N. M.; Donny, E. C.; Hatsukami, D. K.; Murphy, S. E., Quantitation of the minor tobacco alkaloids nornicotine, anatabine, and anabasine in smokers’ urine by high throughput liquid chromatography mass spectrometry. Chemical research in toxicology 2016, 29 (3), 390-397.

 

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-Dr. Valentinas Gruzdys developed interest in clinical chemistry early in his academic training which led him to pursue and obtain a PhD in Clinical and Bioanalytical Chemistry at Cleveland State University. Valentinas is enthusiastic about teaching and helping improve the understanding of limitations and utility of clinical laboratory testing. He is currently enrolled in a clinical chemistry fellowship program at the University of Utah. He enjoys learning more about various aspects of clinical chemistry and cannot wait to make his own contributions to the field after his training.

Boards and Wards

As a little detour before I start my medical school clerkship rotations as a 3rd year student, I’d like to take a moment to appreciate—yes appreciate—board exams. I just sat for the daunting and arduous United States Medical Licensing Exam (USMLE) called “Step 1.” It is roughly an eight-hour endeavor to prove that some of the tomes of information I was exposed to throughout my first two years of medical school made it somewhere into my hippocampus. That said, yes board exams are always daunting and yes, they can even be quite stressful. There’s a lot depending on your scores, in any field you find yourself testing in. Some are pass/fail and some provide you with a scaled score performance.

For what feels like forever ago to me now, I sat for a state licensure exam for the Illinois Department of Public Health as an Emergency Medical Technician Basic provider, or EMT-B. I absolutely failed it—missed it by a point or so. Scheduled a retake, studied hard, and passed round two. Lesson learned. That license opened many doors for me back in the day, and that’s precisely the point: professional certification, official licensures, and (often) professional society membership will bolster anyone looking to get ahead in their career.

Other times, these board exams are highly encouraged. After graduate school at Rush for my MLS degree I had to sit for the ASCP BOC Board Exam for the professional credentials of a Medical Laboratory Scientist, or MLS (ASCP). When I passed, I was able to advance in my career then and have excellent opportunities that would be unavailable otherwise. More so, certain jobs would have been completely unavailable to me without those clinical credentials! I would say that like ASCP cites 70% of patient results originate from the lab, 70% of my CV depends on those professional credentials.

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Figure 1. A previously renewed ASCP BOC certificate, proudly displayed.

This brings up a somewhat related point. There is a professional debate that’s been going on for a few years: board certification vs. regulatory licensure. Organizations like ASCP and CAP have been on board with licensure for a while, citing the critical roles we play in patient care and the specialized education training required. An article from 2015 had circulated well explaining the advantages and regulatory compliance improvement offered by licensure as medical laboratory science evolved since the Clinical Laboratory Improvement Act of 1988 (known as CLIA ’88). Those authors established that virtually all laboratory professional organizations, as well as local state public health departments, favor licensure to guarantee regulatory oversight for the quality of personal and testing results (Rohde et al., 2015). With so many questions today about what qualifies laboratory personnel since the Center for Medicaid Services decision in 2016 that says a bachelor’s degree in nursing is sufficient to perform and manage laboratory moderate to complex testing, professional organizations like ASCP, CAP, and ASCLS continue to investigate what measures would maintain quality and regulations for positive patient outcomes.

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Figure 2. States with licensure, and without. I was trained and practiced medical laboratory science in Chicago, Illinois, a state that does not require licensure. (Rohde et al., 2015)
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Figure 3. These graphs show the number of sanctions under CLIA imposed on labs in the following states. This demonstrates the ineffectiveness of CLIA improving laboratory testing or personnel quality. (Rohde et al., 2015)

Like the EMS exam, the USMLE is absolutely mandatory if I in any capacity wish to continue my medical education, match into a residency program, and ultimately practice as a physician. So, as daunting as these tests might be, they provide a good benchmark standard for the quality of physicians from around the world who want to practice in the United States. USMLE actually has a series of four board exams I’ll be taking in the coming years—so bear with me as I try to stay positive. The Step exams check the depth and breadth of one’s understanding of medical concepts from anatomy to the minutiae of biochemistry. Like ASCP’s board exam, it was a mix of hematology, microbiology, immunology, with added clinical vignettes and patient outcomes. At the end of the test day, I didn’t have a single neuron left working at 100%, but I’ve since recovered. And now it’s onto the next chapter: clinicals. Hope to catch you all again soon, as I’ll try to write up some interesting lab-related cases I will most assuredly come across. Thanks!

 

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Figure 4. One of many medical students’ bibles. (Stock photo from Amazon.com)

References

Rohde, R., Falleur, D. Ellis, J. (2015) “Almost anyone can perform your medical laboratory tests – wait, what?” Elsevier.com March 10th, 2015; retrieved from: https://www.elsevier.com/connect/almost-anyone-can-perform-your-medical-laboratory-tests-wait-what

 

Centers for Medicaid and Medicare Services (2016) Personnel Policies for Individuals Directing or Performing Non-waived Tests, Revised due to typographical error under citation of §493.1443(b)(3). Center for Clinical Standards and Quality/Survey & Certification Group. April 1, 2016; retrieved from: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-18.pdf

 

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Constantine E. Kanakis MSc, MLS (ASCP)CM graduated from Loyola University Chicago with a BS in Molecular Biology and Bioethics and then Rush University with an MS in Medical Laboratory Science. He is currently a medical student at the American University of the Caribbean and actively involved with local public health.

Friday Poll: Variable K+ Results

Bringing it Home

A recent report from the Centers for Disease Control (CDC) found that twenty-four laboratory workers were infected with a strain of Salmonella typhimurium, an enteric pathogen. The infections were reported in sixteen states across the country. Of those infected, six were hospitalized with symptoms such as diarrhea, fever, and severe abdominal cramps. Luckily, there were no deaths reported. These infections occurred in various teaching and clinical laboratories. The worst part? This could have been avoided.

When interviewed, some of those who became ill said they remembered specific exposure events. Many others who were unsure of how they became exposed described unsafe behaviors in the laboratory. Those victims admitted to working in the lab setting without lab coats or gloves, and many reported not washing their hands before leaving the department.

If you’re a laboratory leader, you very likely work during the day shift. Hopefully, when management is on site, staff is compliant with safety. If not, you may need to examine your safety program and leadership style. Do you enforce safety regulations in the lab? Do you lead by example? Do you don PPE when you pick up the phone or use a computer in the lab?

If safety seems to be good during the day, you may want to make a visit during the off-shifts. Depending on the level of safety culture, there may be anything happening from solid safe practices to open eating and drinking in the department. I know that was the norm in many labs 25 years ago, but those unsafe practices and safety violations should now be ancient history. Unfortunately, that is not the case, and that is one reason we have bacterial infection outbreaks in our laboratories.

An experienced lab auditor will tell you it is not difficult to assess the lab safety culture in a department, even on inspection day. I once entered a lab as part of an accreditation inspection team, and I watched as the lab staff struggled to find gloves. Even though they knew the inspection was imminent, they could not hide the fact that glove use was not the norm for them in that lab. A complete lab safety audit can reveal a number of inappropriate practices such as improper PPE use, gum chewing, cell phone use, and many others.

The National Institute for Occupational Safety and Health (NIOSH) has educated workers for years about hazard and exposure control. The “Hierarchy of Controls” is an excellent model to use in the laboratory setting, although certain facts about it may be surprising. The first and best two controls to remove hazards are elimination and substitution. Of course, these are not always possible in the lab setting. While there are substitutes for hazardous chemicals, the inherently dangerous specimens that are handled cannot be replaced or removed.

Engineering controls create physical barriers between the hazard and the employee. Biological Safety Cabinets (BSCs) and Chemical Fume Hoods are powerful engineering controls. Administrative and Work Practice controls are the safety policies and actual practices that help prevent infection. Written safety procedures are designed to change the way people work, and standard work practices include not eating or drinking in the lab setting and practicing hand hygiene when necessary.

The final control for infection prevention is Personal Protective Equipment (PPE). In the hierarchy, PPE is considered the last resort for staff protection. Since the lab hazard cannot be eliminated, and since humans commit errors with procedures, that final method of protection must be utilized. Lab coats, gloves and face protection need to be used at all times when working in the laboratory. Without it, the worker is at great risk for exposure- and that is what happened in the labs where the Salmonella infections occurred. Each of the controls that should be in effect in the lab were bypassed, and there were consequences.

It is always better to read about incidents that occur in other laboratories rather than have to report them about your own. When I hear of such stories, I always look at my own labs to see if such an event could occur there. What opportunities exist in my lab safety program? What about yours? Be sure to learn from these unfortunate events and keep your own staff safe.

The personal (and probably painful) part of the infection outbreak was that these laboratory workers were infected on the job, and then they brought it home. The CDC report says nothing about infections being spread to family members or friends, but it certainly could have happened. If there are weaknesses in your lab safety program, what could your staff be bringing home? What infections or diseases could be spread because of unsafe work practices? Now is the time to take the lead for your safety program before such an event can occur. Bring safety home for your staff. Teach them and lead them so that the unsafe practices of the past turn into practices that keep everyone healthy into the future.

 

Scungio 1

Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.