Meeting the AABB 2024 Checklist Risk Analysis Requirement

Inspections are a great learning opportunity. Our recent American Association of Blood and Biotherapies (AABB) introduced us to the risk analysis requirement in its 2024 checklist. Though the requirement is specifically stated in 3.7 Information Systems #13, the requirement can be applied to instruments as well as software. The update is significant as it emphasizes the need to proactively identify, assess, and mitigate risks associated with introducing or modifying software and instruments within the laboratory setting.

AABB-accredited laboratories will need to review their validation procedures to ensure they include a risk analysis with mitigation for identified risks. There are a few steps to conducting a risk analysis.

First, clearly define the changes being made. This could include new software installations, updates to existing software, introduction of new instruments, or modifications to current equipment. Understanding the full scope of changes is essential for a comprehensive risk analysis.

Secondly, if possible, form a multidisciplinary team that includes IT specialists, laboratory managers, quality assurance personnel, and end-users. In reality, for many small to medium laboratories, frequently one person fills more than one role. It’s conceivable for the laboratory manager to be the quality person and an end user since they often may have to fill in during staff shortages.

Next, identify the risks. Structured techniques like Failure Modes and Effects Analysis (FMEA) can be used to identify potential risks. Consider software-based risks such as data loss or corruption, system incompatibility, user interface issues, and cybersecurity vulnerabilities. Calibration errors, operational failures, compatibility with existing systems, and maintenance requirements are some instrument-based risks that should be considered. And, of course, human-based risks involving user errors, poor or insufficient training, and workflow disruptions.

The fourth step would be to assess each identified risk, assessing its potential impact on laboratory operations and patient safety and evaluating the likelihood of occurrence and the severity of consequences if the risk materializes. Use a risk matrix to categorize risks as low, medium, or high.

For each high or medium risk identified, develop mitigation strategies to reduce the likelihood of occurrence or minimize the impact. Some examples are increasing training programs, additional testing, or developing contingency plans for failures.

Ensure the entire risk analysis process is documented, including the identified risks, evaluation results, and mitigation strategies. Documentation is crucial for compliance with the AABB checklist and is a reference for future audits or inspections.

The risk analysis requirement in the AABB’s 2024 checklist underscores the importance of proactive risk management in clinical laboratories. Through the implementation of the outlined steps, laboratories can not only meet this requirement but also enhance their operational resilience and commitment to patient safety. Conducting a thorough risk analysis for software and instrument changes is an investment in the quality and reliability of laboratory services, ultimately contributing to better patient outcomes.

-Darryl Elzie is the Regulatory Affairs Manager Inova Blood Donor Services. He has been an ASCP Medical Laboratory Scientist for over 25 years, performing CAP inspections for two decades. He has held the roles of laboratory generalist, chemistry senior technologist, and quality consultant. He has a Master’s in Healthcare Administration from Ashford University, a Doctorate of Psychology from The University of the Rockies, and is a Certified Quality Auditor (ASQ). Inova Blood Donor Services is the largest hospital-based blood center in the nation. Dr. Elzie is also a Counselor and Life Coach at issueslifecoaching.com.  

Three Cheers for a Three-Cell Population

Back in the olden days – wait, can I use that line yet? I graduated from my cytology program ten years ago, which feels like two decades ago or just yesterday. Depends on the day. Anyway, there are little nuggets from my training that stick with me whenever I’m screening a case. This case revolves around the concept of a two-cell population in body fluids, namely pleural, peritoneal, and pericardial. We were taught that if you see a two-cell population, the case is malignant. I remember asking in school, “But what if the diagnosis is mesothelioma?” “Okay,” my professor said, “that applies to any malignancy except mesothelioma. The two-cell population indicates a population of benign mesothelial cells and a second population of malignant cells.” Noted! I live by this rule, and every now and then, I have a case of a peritoneal fluid where the slides are covered in “wall-to-wall” adenocarcinoma, and I can’t find a benign mesothelial cell for the life of me. Obviously, we let years of experience with morphology take the reins there, but there are still those cases where the native mesothelial cells are so reactive in appearance that we start hunting for a two-cell population. This case was a perfect blend of wall-to-wall tumor and more-than-reactive mesothelials.

When a patient is being worked up for the first time or the nth time, we recognize their names and recall their clinical history and previous morphologies. Quite often we have patients with genetic predispositions to cancer who present with one type of cancer and are treated accordingly, and during surveillance imaging, come back to us with a second primary cancer. In this case, we received a right-sided pleural fluid on a 73-year-old woman with a history of ER+/PR+/HER2- breast cancer. After a history of incomplete medical follow-up, the patient presented to a local emergency room with pleuritic pain, upon which a CT Scan identified a lung mass, breast mass, and multiple liver and upper thoracic bone lesions. The assumption, given the clinical history, was metastatic breast cancer, and the clinician submitted the pleural fluid for cytology to repeat ER/PR/HER2 testing to determine if there is a better treatment strategy than her current aromatase inhibitor, which appeared to be failing.

Upon screening the cytopreparations, we observed very obvious malignant cells (Image 1). It was evident that we had a two-cell population. One of the cell populations was characterized by cohesive clusters of relatively uniform tumor cells (Image 2 & 4) and the second cell population was less cohesive with larger pleomorphic cells (Image 3 & 4). Hmm, something doesn’t make sense here. We already have a group of tumor; the other cells are supposed to be benign mesothelials cells. Is there a mixed morphology going on? Like a combined small cell carcinoma and non-small cell carcinoma that we might see in lung cancer? It’s not small cell though. These two populations are clearly two adenocarcinomas. That still can’t be. There has to be a population of mesothelials. No, no… the benign mesothelials are scattered throughout the background. It looks like a double-malignant three-cell population!

Images 1-4: Pleural Fluid, Right: 1. DQ-stained cytospin; 2-3: Pap-stained smear; 4: H&E Cell Block section (600X).

We submitted the case to the cytopathologist on service for the day. When they asked what we had, we replied, “All the adenocarcinoma,” and noted that we definitely need ER/PR/HER2 as clinically and now morphologically, it appears that the patient’s breast cancer is involving the pleural fluid. The cytopathologist agreed that there was something to the case. Metastatic breast cancer likes to appear as cannon balls in fluid (Image 2), the second cell population is too unlike the first. The cytopathologist performed immunocytochemical stains on paraffin sections of the cell block with adequate controls. The first type of cells shows positive staining for CK7, CK19, GATA3 (Image 5), and ER, and negative staining for CK20 (Image 6), CDX-2 (Image 7), BRST2, and PR. The second type of tumor cells show positive staining for CK7, CK20 (Image 6), CK19, and CDX-2 (Image 7), and negative staining for GATA3 (Image 5), ER, PR, and BRST2. The former group of cells has a morphology and immunoprofile consistent with breast origin, and the latter group of cells are morphologically and immunophenotypically suggestive of a pancreaticobiliary or gastrointestinal tract origin.

Image 5-7: Pleural Fluid, Right: 5: GATA3; 6: CK20; 7: CDX-2.

Final Diagnosis: Positive for malignancy. Adenocarcinoma, consistent with metastatic breast and metastatic pancreaticobiliary or gastrointestinal tract origin.

Interestingly, the patient had a paracentesis and liver biopsy the following week, and only the pancreaticobiliary or GI tract origin immunoprofile was positive in the peritoneal fluid and FNA. The patient’s breast cancer seemed to remain above the diaphragm.

-Taryn Waraksa-Deutsch, DHSc, SCT(ASCP)CM, CMIAC, LSSGB, is the Cytopathology Supervisor at Fox Chase Cancer Center, in Philadelphia, Pennsylvania. She earned her master’s degree from Thomas Jefferson University in 2014 and completed her Doctorate of Health Science from Bay Path University in 2023. Her research interests include change management and continuous improvement methodologies in laboratory medicine. She is an ASCP board-certified Specialist in Cytology with an additional certification by the International Academy of Cytology (IAC). She is also a 2020 ASCP 40 Under Forty Honoree. Outside of her work, Taryn is a certified Divemaster. Scuba diving in freshwater caverns is her favorite way to rest her eyes from the microscope.

The Power of Safety Stories: Enhancing Lab Safety through Real Experiences

In the hazardous and dynamic environment of the laboratory, precision and safety are paramount, and it is crucial to both understand and adhere to proper safety protocols. Despite comprehensive training and strict guidelines, lapses in safety practices still occur, and in many labs, these deviant behaviors are the norm. One powerful tool to bridge the gap between knowledge and practice is the sharing of personal stories about the consequences of laboratory injuries and exposures. This storytelling can enhance compliance with personal protective equipment (PPE) use, and it can even foster safer lab work practices.

Stories are a fundamental part of human communication. They resonate with us on a personal level, making abstract concepts tangible and memorable. In the context of laboratory safety, sharing real-life incidents of injuries and exposures can drive home the importance of following safety protocols in a way that theoretical training cannot.

Consider the case of a histology technician who suffered a severe laceration because they used their bare hand to handle a cutting blade as it was being replaced on the microtome. Hearing this technician’s account of the pain, the disruption to their work, and the long recovery process is far more impactful than a generic reminder to always use implements or cut-resistant gloves to handle blades. It personalizes the risk and underscores the real consequences of non-compliance.

Understanding the potential consequences of unsafe lab practices is vital. Many lab workers know the rules but might not fully appreciate the risks involved in breaking them. Let’s delve into three common unsafe practices and their possible repercussions.

Using Cell Phones in the Lab

The use of cell phones in the laboratory is a growing concern. Phones can be a source of distraction, but more importantly, they can harbor contaminants. Imagine a scenario where a lab worker uses their phone in a biohazard area. Pathogens from their gloved hands can transfer to the phone’s surface. Later, they use the same phone outside the lab without proper decontamination, potentially spreading harmful agents to themselves, colleagues, or even their family.

I recall a story from a colleague who witnessed a near-miss incident involving a phone. A technician was distracted by a text message and accidentally knocked over a beaker of caustic chemicals. Fortunately, no one was injured, but the incident was a wake-up call about the dangers of distractions in the lab. This story is one way to highlight the importance of keeping personal devices out of the laboratory environment.

Eating or Drinking in the Lab

Despite clear prohibitions, some lab workers still eat or drink in the lab, often thinking that it is harmless if they are careful. However, the risk of contamination is significant. A real-life example involved many lab workers who developed a serious gastrointestinal infection after unknowingly ingesting a pathogen that had contaminated their food. They had been eating at their workstations, where they also processed clinical specimens.

This case underscores the critical importance of designated eating areas and the strict separation of food and drink from laboratory activities. Sharing such stories can vividly illustrate the hidden dangers of complacency and reinforce the necessity of adhering to safety protocols.

Not Using PPE When Necessary

On the Hierarchy of Controls, PPE is the last line of defense against many laboratory hazards, yet some workers skip this vital protection for the sake of convenience or comfort. The consequences of such decisions can be severe. For instance, a lab worker handling corrosive chemicals without proper eye protection suffered a splash injury, leading to partial vision loss. Hearing this person’s experience, from the immediate pain and panic to the long-term impact on their life and career, can be a powerful motivator for consistently using PPE. It is likely there are several other real stories in your own labs that can be used.

To foster a culture of safety in the laboratory, it is essential to create an environment where sharing stories about injuries and near-misses is encouraged and valued. This openness helps to demystify safety protocols and makes the abstract risks more concrete. There are strategies to build this culture.

Create forums for lab workers to share their experiences without fear of blame or retribution. This could be in the form of regular safety meetings, anonymous reporting systems, or informal discussions. The key is to ensure that these stories are used constructively to improve safety practices.

Integrate real-life stories into safety training sessions. Use the narratives to illustrate the importance of compliance and to discuss what went wrong and how it could have been prevented. This approach not only makes the training more engaging but also more relatable.

Lastly. Lab leadership plays a crucial role in shaping the overall safety culture. Managers and senior staff should model safe behaviors and share their own experiences with safety lapses and near-misses. When leaders demonstrate a commitment to safety, it sets a powerful example for the entire team. Stories can be a potent tool for enhancing laboratory safety. By sharing real experiences of injuries and exposures, we can bridge the gap between knowing and doing, making the importance of safety protocols vividly clear. In a laboratory setting, where the stakes are high, these stories can drive better compliance with PPE use and foster a culture of safety that protects everyone. Remember, every story shared is a lesson learned and a step towards a safer work environment in your laboratory.

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.

Microbiology Case Study: Not all Gram-Positive Bacilli from Positive Blood Cultures are Contaminants

A 78 year old woman was transferred from a nursing home to the Emergency Room because of delirium and worsening bilateral chronic foul-smelling hip wounds. Physical exam was notable for a fever of T103.2°F and purulence from the right hip wound.

Lab results included wbc 17.2K/mm3, hct 26%, platelets 694K/mm3, CRP 9.4 mg/dL, and ESR >130 mm/hr. A pelvic CT scan and X-rays of the hips and femurs showed signs of necrotizing infection, with soft tissue defects over both hips accompanied by subcutaneous fluid, inflammation, gas tracking deep to the femurs, and cortical irregularities of both greater trochanters.

Gram-positive rods grew from the anaerobic bottles of two blood culture sets drawn on arrival at the hospital. Anaerobic blood agar plate growing colonies of gram-positive rods after 48 hours of anaerobic incubation are shown in Figure 1, and Gram stains of the same organism grown in cooked meat broth are shown in Figures 2A and 2B.

Fig 1. Anaerobic CDC blood agar plates growing gram positive bacilli
Fig 2A and 2B: Gram stain from Cooked meat broth

Gram-positive bacilli (GPB) were isolated from the blood. GPB in blood cultures are often brushed off as possible contaminants. However, in the setting of a possible necrotizing soft tissue infection (NSTI) and the growth of GPB in anaerobic bottles only, concern for Clostridium spp. is reasonable. NSTI can be caused by a variety of different bacteria, but empiric treatment should reliably cover Clostridium species, Streptococcus pyogenes, and Staphylococcus aureus, as they are the most commonly implicated pathogens. While C. perfringens is a common cause for gas gangrene, C. septicum frequently causes non-traumatic gas gangrene because of its aerotolerance.1

The GPB in this patient’s blood was identified by Matrix-assisted laser desorption ionization time of flight mass spectrometry (MALDI-ToF MS) as C. sporogenes/botulinum group I. While C. botulinum is a more familiar pathogen, both of these two closely related bacteria can produce botulinum neurotoxin (BoNT). In a comparative genomic study, C. botulinum Group I was found to possess genes for BoNT A, B, and/or F, while the C. sporogenes possessed BoNT B only.2 Detection of BoNT remains a challenge. Additionally, MALDI-ToF MS cannot distinguish between C. botulinum and C. sporogenes in most cases due to the similarity between these two species.

Since BoNT is considered a category A Biological agent, caution must still be taken when processing suspicious C. botulinum isolates in the laboratory during the identification. While the specimen collection and transport guidelines from American Society of Microbiology (ASM) described not attempting to culture the organism, the guidelines stated that clinical laboratories may still perform routine cultures that may contain Botulinum that potentially produces BoNT.

While it can be challenging to determine the presence of C. botulinum in wound cultures due to the gram feature similarities to skin flora gram positive rods, the laboratories should process the culture workup in biosafety level-2 (BSL-2) cabinet and avoid aerosol-generating procedures (e.g. catalase) to minimize the potential aerosolization of the toxin. The best practice would be an open communication between clinicians and the laboratory – for clinicians to notify the laboratory of potential BoNT cases/cultures when they send microbiology specimens. Post-analytical safety measures must be performed. So, what lesson did we learn here? While it is challenging to distinguish between C. botulinum and C. sporogenes in this case, a proper chain of actions (analytical and post-analytical measurements) should have been taken place to rule out/in BoNT-producing C. botulinum.

Susceptibility testing for anaerobes is not performed routinely and is only appropriately performed on isolates from sterile sources. Globally, rates of clindamycin resistance appear to be increasing among Clostridium spp. However, metronidazole and amoxicillin-clavulanate remain viable options for treatment of Clostridium spp.3-6 

References

  1. https://www.nejm.org/doi/full/10.1056/NEJMra1600673 
  2. https://asm.org/ASM/media/Policy-and-Advocacy/LRN/Sentinel%20Files/Botulism-July2013.pdf
  3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7551954/
  4. Sárvári KP, Rácz NB, Burián K. Epidemiology and antibiotic susceptibility in anaerobic bacteraemia: a 15-year retrospective study in South-Eastern Hungary. Infect Dis (Lond). 2022 Jan;54(1):16-25. doi: 10.1080/23744235.2021.1963469. Epub 2021 Sep 24. 
  5. Ali S, Dennehy F, Donoghue O, McNicholas S. Antimicrobial susceptibility patterns of anaerobic bacteria at an Irish University Hospital over a ten-year period (2010-2020). Anaerobe. 2022 Feb;73:102497. Epub 2021 Dec 5. 
  6. Di Bella S, Antonello RM, Sanson G, Maraolo AE, Giacobbe DR, Sepulcri C, Ambretti S, Aschbacher R, Bartolini L, Bernardo M, Bielli A, Busetti M, Carcione D, Camarlinghi G, Carretto E, Cassetti T, Chilleri C, De Rosa FG, Dodaro S, Gargiulo R, Greco F, Knezevich A, Intra J, Lupia T, Concialdi E, Bianco G, Luzzaro F, Mauri C, Morroni G, Mosca A, Pagani E, Parisio EM, Ucciferri C, Vismara C, Luzzati R, Principe L. Anaerobic bloodstream infections in Italy (ITANAEROBY): A 5-year retrospective nationwide survey. Anaerobe. 2022 Jun;75:102583. Epub 2022 May 11.

-Antoinette Acobo, PharmD, is 2nd year pharmacy resident specialized in infectious diseases in her 2nd year of residency. She performed several quality initiative and improvement projects, including antimicrobial stewardship program (ASP) and cost/benefit analyses of rapid blood culture identification (BCID) multiplex panels.

-Phyu Thwe, Ph.D, D(ABMM), MLS(ASCP)CM is Associate Director of Infectious Disease Testing Laboratory at Montefiore Medical Center, Bronx, NY. She completed her medical and public health microbiology fellowship in University of Texas Medical Branch (UTMB), Galveston, TX. Her interests includes appropriate test utilization, diagnostic stewardship, development of molecular infectious disease testing, and extrapulmonary tuberculosis.

Microbiology Case Study: Tinea cruris in a Middle-Aged Male

Case Presentation

A middle-aged male presented for a chronic inguinal and back rash present for over two years (Figure 1A). Travel history was notable for trips to the Middle East and Canada during that time. He was clinically diagnosed with tinea cruris at an outside healthcare facility, and his history was notable for an extensive use of several topical antifungals including clotrimazole with betamethasone, ketoconazole, and triamcinolone without improvement. Months long oral therapy with terbinafine and fluconazole resulted in only mild improvement, after which he was started on itraconazole. The patient noted some improvement while taking itraconazole, but following subsequent disease recurrence, presented to our institution. 

Figure 1: A) Red annular, scaly rash of the inguinal skin involving the inner thigh.  Skin biopsy of the thigh rash (40X, PAS stain) revealing dermatophyte hyphal elements in the stratum corneum.

Laboratory workup

An inguinal skin scraping was obtained, which revealed the presence of a superficial fungal infection consistent with the diagnosis of tina cruris. Fungal cultures on Sabouraud Dextrose Agar (Figure 2A), lactophenol blue stain (Figure 2B), and a skin biopsy (Figure 1B) all confirmed a dermatophyte infection. The organism was morphologically consistent with Trichophyton sp. Due to the unusual clinical history of a recalcitrant dermatophyte infection persisting through multiple rounds of topical and oral antifungal therapy, additional testing for definitive identification was undertaken. MALDI-TOF identified the organism as a member of the Trichophyton tonsurans/mentagrophytes species complex, further confirmed to be Trichophyton indotineae by sequencing.

Figure 2: A) Dermatophyte growth from the skin scraping of the leg on Sabouraud Dextrose agar.  Fungal colonies were fast-growing and peripherally white-beige to light brown, flat and granular.  B)  Lactophenol Cotton Blue stain revealing septate hyphae with cigar-shaped macroconidia, small round microconidia clustered on branched conidiophores.

Discussion

Ringworm, also referred to as “tinea” or “dermatophytosis,” is a commonly occurring fungal infection affecting the skin, hair, or nails, caused by dermatophytes.1 Typical symptoms include itching, a ring-shaped rash, redness, scaliness, cracked skin, and/or hair loss. The transmission of ringworm happens through direct contact between individuals, contact with infected animals, or exposure to contaminated environments such as public showers.1 Around 40 different species of fungi can lead to ringworm infection.2 Over the last decade, healthcare providers have observed a rise in severe cases of ringworm that are resistant to topical antifungal treatment3 which are an emerging public health concern.

The emergence of drug-resistant dermatophyte infections is attributed to the inappropriate use of topical products containing combinations of antifungal agents and corticosteroids.4  T. indotiniae has a complicated taxonomic history.  The organism was initially identified as a sequence type of the Trichophyton mentagrophytes complex which exhibited elevated MICs to terbinafine. The earliest cases of T. indotineae infection were reported in India, quickly spreading to Australia, Oman, Iran, and other middle-eastern countries.  Subsequent spread to Europe and North America soon followed.5  Initial reports of T. indotineae infections in North America involved individuals with a history of travel to endemic locations.  Recently however, local transmission of T. indotineae within the United States has been documented among patients without travel history.6  It is hypothesized that resistant strains of T. indotineae emerged due to inappropriate antibiotic use, as infections are frequently terbinafine-resistant and require prolonged therapies with second-line therapies or antifungals traditionally utilized for invasive fungal infections.7

Diagnosis of T. indotineae infection is challenging as it requires advanced molecular techniques like genomic sequencing or expansion of MALDI-TOF MS capabilities to discriminate within the T. mentagrophytes complex, which many clinical laboratories lack.1 Thus, diagnosis is largely reliant on the activities of reference laboratories. A high level of clinical suspicion is required as well, as the degree of dermatophyte workup undertaken in the routine setting is variable among institutions. T. indotineae infections often show resistance to conventional antifungal therapies including allylamines (terbinafine) and azoles (itraconazole and fluconazole), further highlighting the importance of susceptibility testing before initiating treatment and reassessing nonresponsive cases,4 another testing capability not offered by routine laboratories. The patient in this case was managed with Posaconazole, leading to significant improvements symptomology.

References:

  1. Emerging antimicrobial-resistant ringworm infections (2023) Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/fungal/diseases/ringworm/dermatophyte-resistance.html (Accessed: 9 April 2024).
  1. Havlickova B, Czaika VA, Friedrich M. Epidemiological trends in skin mycoses worldwideexternal icon. Mycoses. 2008 Sep;51 Suppl 4:2-15.
  2. Hay RJ. The Spread of Resistant Tinea and the Ingredients of a Perfect Storm. Dermatology. 2022;238(1):80-81.
  3. Gupta AK, Venkataraman M, Hall DC, Cooper EA, Summerbell RC. The emergence of Trichophyton indotineae: Implications for clinical practice. Int J Dermatol. 2023 Jul;62(7):857-861. doi: 10.1111/ijd.16362. Epub 2022 Jul 22. PMID: 35867962.
  4. Jia S, Long X, Hu W, Zhu J, Jiang Y, Ahmed S, de Hoog GS, Liu W, Jiang Y. The epidemic of the multiresistant dermatophyte Trichophyton indotineae has reached China. Front Immunol. 2023 Feb 16;13:1113065. doi: 10.3389/fimmu.2022.1113065. PMID: 36874152; PMCID: PMC9978415.
  5. Caplan AS, Chaturvedi S, Zhu Y, Todd GC, Yin L, Lopez A, Travis L, Smith DJ, Chiller T, Lockhart SR, Alroy KA, Greendyke WG, Gold JAW. Notes from the Field: First Reported U.S. Cases of Tinea Caused by Trichophyton indotineae – New York City, December 2021-March 2023. MMWR Morb Mortal Wkly Rep. 2023 May 12;72(19):536-537. doi: 10.15585/mmwr.mm7219a4. PMID: 37167192; PMCID: PMC10208369.
  6. Lockhart, SR, Smith, DJ, and Gold, J.A.W. Trichophyton indotineae and other terbinafine-resistant dermatophytes in North America. J. Clin. Microbiol. 2023 Dec; 61(12): e00903-23. PMID: 38014979.

Tasnim Alkayyali is a second-year AP/CP resident at UT Southwestern Medical Center in Dallas, Texas.


Clare McCormick-Baw, MD, PhD, FACP is a board certified Anatomic and Clinical Pathologist with a subspecialty in Medical Microbiology. She has a love for Infectious Disease Pathology and teaching the pathologists of tomorrow. She is the Southwest Regional Medical Director for Quest Diagnostics, Inc and is based out of Dallas, Texas.

Andrew Clark, PhD, D(ABMM) is an Assistant Professor at UT Southwestern in the Department of Pathology and Director of the Microbiology Laboratory at Parkland Health and Hospital System. He completed a CPEP-accredited postdoctoral fellowship in Medical and Public Health Microbiology at National Institutes of Health.