May 2014 – Lablogatory

Halfway Through…and What’s Left to Do

I had originally started writing about a recent article I read on residents organizing as a collective bargaining unit for salary negotiations. But I’ll leave that for another day and give you a more informal blog post today.

So, for those of you who don’t know, I will be transferring to a program in my home state of NJ for personal reasons for my last two years. When I initially applied to residencies, I didn’t apply to any of the three programs in NJ because I wanted to be in a large (>4 residents/year), urban program that served a significant number of underserved minority and immigrant patients. Chicago was a familiar choice as I had attended college at The University of Chicago alongside my brother here many moons ago. It was also where I first began working with minority and immigrant community advocacy and grassroots organizing groups and my oppas (“older brothers”) and unnis (“older sisters”) then, are the leaders of these groups now.

But two years later, circumstances in my life change, priorities change, and the reasons to go home were more compelling than those to stay. It wasn’t an easy decision. My chairman and attendings here have been very supportive, especially of my extracurricular activities and research. I know that when I go to fellowship interviews, people will ask why I transferred. The reasons are innocent and legitimate enough but I do wonder if they may affect how programs will view me as a potential candidate when they hear my reasons. After all, fellowships are more competitive to obtain than residencies and any small possibly of negative perception, whether true or erroneous, can make or break whether you get those fewer positions available.

I took this week off to deal with moving tasks and my apartment is a mess of half-packed boxes. I need to get as much done before I’m back at our busiest surgpath site again next week until I leave for NJ. But the déjà vu act of packing, calling up moving companies for quotes, and selling items in order to lighten my load has put me in a contemplative mood. I realize that now I am almost halfway through this part of my journey to become a practicing pathologist.

Sometimes, I feel as if I have been weighed and measured and found wanting in terms of where I should be in AP. With my research and heavy science background, CP has always been a comfortable fit. I haven’t had any cytology rotations yet but I get to do four months in NJ. In terms of surgpath, I’m knowledgeable enough with the “bread and butter” that I see during sign-outs but not knowledgeable enough when it comes to unknowns. I know I should read more and often wonder why I don’t do as much as I could.

But now that I’ve come to this fork in my journey, moving back to NJ and thinking about applying for my first fellowship, I wonder what do I need to become the best pathologist I can with the time I have left? I don’t want to be cramming everything I should’ve learned in three years into my last year when boards studying fever hits. If anyone has some advice or anecdotes about their training to illustrate something that is working for them, please feel free to share.

And yet, even though our studies and service duties are, of course very important, how should we engage in molding our profession into the pathology of the next age? What are the most salient skills we need to acquire and how do we show the clinical care teams that are evolving within healthcare reform just where our place is within it? What are the most pressing issues for residents? Salaries, autonomy to influence our education, didactics, service duties, or clinical care? Where should we most focus our efforts?

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

It’s That Time of Year Again

It’s a few days after a major holiday (Memorial Day in the United States), and clinical microbiologists knows what that means. It’s foodborne illness season! According to the CDC, Norovirus and Salmonella are the biggest culprits, but several organisms can be implicated.

If your lab doesn’t recover Salmonella, Campylobacter, or E. coli O157:H7 often, consider brushing up on the identifying characteristics of these organisms. (Do you know which one doesn’t ferment sorbitol?) It’s also helpful to keep the patient history (in particular, their travel history) in mind when reading enteric cultures or performing a microscopic ova and parasite examination. Also, now is a good time to be sure your reporting procedures (including local public health contact information) are up to date.

Check out the CDC’s website for more information on foodborne outbreaks, including how many people are affected.

–Kelly Swails, MT(ASCP), is a laboratory professional, recovering microbiologist, and web editor for Lab Medicine.

Improving Patient Safety: Effective Communication for Performance Improvement

In 2014, the Joint Commission updated its National Patient Safety Goals (NPSGs) in order to address areas of concerns for patient safety to reduce harms to patients. These goals include standards for clinical alarms, transfusion errors related to patient misidentification, reducing likelihood of patient harm due to anticoagulation therapy, reducing the risk of healthcare-associated infections, implementing evidence-based practices to reduce healthcare associated infections due to multidrug resistant organisms, and prevention of central-line associated blood stream infections. A multidisciplinary team comprised of all clinical areas including nursing, laboratory, pharmacy, radiology, biomedical engineering, and environmental services are necessary to become compliant in all of the NPSGs.

How do you effectively communicate the NPSGs (or any other change initiative) to all personnel? Sometimes organizations will implement initiatives and performance improvement training with score cards, only to find that the initiatives did not produce the expected results. Prior to launching any new initiative for performance improvement toward NPSGs compliances, management needs to take the extra steps to communicate clearly to employees the background of the current situation within the organization, explain why there is a need for performance improvement, and emphasize what the stake are if the organization isn’t compliant.

The transformation process in change management involves changing employees’ behavior to enhance personnel capabilities. According to Kurt Lewin’s model in the traditional change management, there are three phases of change: (1) unfreezing, (2) change, and (3) refreezing that specifically focuses on employees’ behavior or involvement. In general, employees would not necessarily change their behavior just because the organization performs poorly or there are new standards to follow. Employees will keep their attitudes or behaviors when they feel comfortable or safe with the current behavior and there’s no sense of urgency to change their behavior or the work environment allows them to choose not to change. Lewin’s model identifies that in the unfreezing phase there should be open communication and motivation to employees to understand the situation fully. Allowing employees to question the status quo or feel discomfort with the current practices creates “buy-in.” Employees feel invested in the process and that in turn facilitates employees’ participation in the next phase: “change,” when the new improvement strategy is adopted. The last phase, “refreeze,” is implementing and sustaining the change.

Employees’ attitudes are structured along three dimensions labeled as cognitive attitudes (beliefs), emotional attitudes (individual feelings), and intentional attitudes (evaluations based on past or intentional behavior). Communication to explain and motivate employees will help overcome uncertainties and enhance employees’ control and well-being, which in turn promotes empowerment. McEwan studied the indicators of personal empowerment include improved perceptions of self-worth, empathy and perceived ability to help others, the ability to analyze problems, a belief in one’s ability to exert control over life circumstances, and a sense of coherence about one’s place in the world. McEwan pointed out that within the empowerment framework change begins at an individual level; as an individual becomes more empowered, their increased personal capacity makes a positive impact on an organization or group, and ultimately, the wider community. In general, people are not resistant to change; however, they mostly object on being told to change. By investing the extra time and efforts on open communication to motivate employees and create buy-in, the organizational change initiatives will have a much higher probability of success and sustainability.

References:

http://www.jointcommission.org/assets/1/6/HAP_NPSG_Chapter_2014.pdf

Lewin, K. (1947), “Frontiers in group dynamics”, Human Relations, 1(2), 143-53.

Pideret, S.K. (2000), “Rethinking resistance and recognizing ambivalence: a multidimensional view of attitudes toward an organizational change”, Academy of Management Review, 25(5), 783-94.

McEwan, Alexandra B,B.A. (Anthropology)(Hons), L.L.B.(H., Tsey, K.,PhD.(Social Sciences), McCalman, J., & Travers, Helen J,GradDip Primary Health Care. (2010). Empowerment and change management in aboriginal organizations: A case study. Australian Health Review, 34(3), 360-7.

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.

-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.

Molecular Testing in Transfusion Medicine

Last week, the FDA approved the Immucor PreciseType Human Erythrocyte Antigen (HEA) Molecular BeadChip assay. This method determines non-ABO antigens on red blood cells and is the first molecular assay for determining blood compatibility to be approved by the FDA.

What do you think, blood bankers? When it comes to blood compatibility, do you trust molecular diagnostics as much as serological methods?

Newborn Screening for Severe Combined Immunodeficiency

The most recent disorder that has been recommended for addition to all US newborn screening (NBS) programs is severe combined immunodeficiency (SCID). SCID is actually a group of at least 14 primary immunodeficiencies which affect the individual’s immune system, making it impossible for them to adequately fight off infections. A baby with SCID who does not receive treatment rarely survives the first year of life, being unable to clear repeated and massive infections. Everyone probably remembers the story of the “Bubble Boy” who survived 12 years in a completely sterile environment. The “Bubble Boy” had SCID.

Screening newborns for this disorder would seem like a no-brainer; however, because SCID is actually many different primary immunodeficiencies, finding a screening test that would pick up all or the majority of them has been problematic. In recent years, people began looking at one of the hallmarks of all SCID, a lack or very low number of functional T-cells.

During maturation in the thymus, T-cells undergo gene rearrangement, and during this process small extra-chromosomal circles of DNA are created as the segments of DNA are clipped out of the gene. These small DNA circles are call T-cell receptor excision circles, or TREC. In 1998, Douek et al (1) developed a PCR assay to quantify TREC as a measure of thymic function. When that assay was published, researchers began wondering whether there would be any TREC produced in a disorder like SCID with no functional T-cells. Very quickly the TREC PCR assay was adapted to measure the presence of TREC in dried blood spots, and several papers showed that in SCID individuals, essentially no TREC are produced. Thus the PCR assay for TREC became a viable screening test for SCID in newborns.

Currently 18 States are either already screening for SCID or are in the process of adding SCID screening to their NBS. There is a ways to go before this screening becomes part of all programs in the US, however, given the morbidity and mortality associated with the disease and the availability of a test, it’s hopefully only a matter of time.

1. Douek DC, McFarland RD, Keiser PH, Gage EA, Massey JM, Haynes BF, et al. Changes in thymic function with age and during the treatment of HIV infection. 1998. Nature. 396:690-695.

-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.

Training Towards Boards and/or Practice? Or a Little of Both?

So when I was in medical school, we all had our medical licensing boards (aka “the Steps”), at least two of them, to worry about passing in order to matriculate into residencies and to start the process for obtaining our medical licenses. It was a rite of passage. And even though many of us stressed and spent many a sleepless night in worry and study to pass them, they were not seen as insurmountable by most. The Steps were perceived as an important exam we had to take while going about the actual practice of medicine. During my second year, we only got two weeks off at the end for Step 1 study time. During my clinical years, we didn’t get any specifically designated time off to study for Step 2 unless we used our two week vacation.

And yet, when it comes to our specialty boards, the stakes feel immeasurably higher and most training programs do not set aside an uninterrupted study time period for these exams. After all, we are employees, where our absence means someone else is doing our work. While I was rotating as a medical student on elective pathology rotations and from what I’ve seen and heard since becoming a resident, many PGY-4 everywhere spend their senior year using their saved up vacation time and/or lighter CP rotations to study mainly for boards. Some are even barely seen on the rotation service and are more often seen glued to their cubicles studying or listening to boards review lectures. But what does this say for how we train our pathology residents?

Full disclosure…I am a concentrated crammer, always have been – a habit that I am still working to break but since I generally so well on standardized tests, I haven’t had the selective pressure to change as quickly as I probably should. So, I can’t imagine consistently studying for a year or two for these exams. Although I can imagine stressing over them for that long, I don’t have the attention span, memory abilities, or discipline to learn in this way. There is nothing wrong with the slow and steady study personality. But for me, I learn more by doing than by just reading or listening to lectures. And hopefully, this translates to needing to study less and not needing to feel as if I have to learn everything I should have in 3 years of residency crammed into 1 when my time comes.

But the specialty boards really seem to push our buttons, even to the point where there have been headlines of residents and fellows punished for their use of remembrances with some cases resulting in cancellation of scores. For many of those providing such remembrances to others, suspension of medical licenses have even occurred. Are we conditioned to feel that we need protected study time in order to feel confident that we will pass? Because as residents, who are no longer medical students, no such time is allotted because we need to carry out patient care.

So why do we seem to freak out so much more about our boards exams as a resident/fellow, then we did as a medical student? As a medical student, we learned most of the material for Step 1 during our basic science years. If we studied for our clinical rotations and attended clinical lectures, then we also were exposed to much of the material we would see on Steps 2 and 3. But do we learn enough while on pathology rotations to recognize most of the material we will see on our AP and CP boards? Or is it just the perception that we aren’t exposed to everything we need to be during our rotations that makes many residents spend a year or more studying for these exams?

From my experience, residency training programs are more variable than medical schools are in terms of their curriculum and exposures. So, how can we transform our training within the confines of our specific program’s idiosyncrasies to provide what we need?

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

Improving Patient Safety: What is Your Laboratory’s Preanalytical Error Rate?

Errors can occur at any point in the preanalytical process: during patient preparation; the ordering process; sample collection; sample transportation, preparation, and storage. Some common errors include wrong test orders, missing specimens, improper mixing, and specimens contaminated with line fluid. Use of laboratory automation has reduced preanalytical errors within the laboratory, but what about those errors made outside of the laboratory’s four walls?

One way to decrease errors would be to implement computerized physician order entry. Due to the increased number and complexity of lab tests along with minimal training in medical schools, improper testing ordering is not uncommon. It would be wise for the core laboratory to provide adequate technical information on those commonly misunderstood tests by clinicians that could be accessed readily, such as an intranet website. Placing additional guards on high-priced molecular testing (such as requiring additional information at order entry) would be prudent. Making pathologists and laboratory professionals available to consult with clinicians about test ordering is also one way to reduce this sort of error.

As more facilities centralize their laboratory operations as a way to cut costs, preanalytical errors due to specimen transportation issues could be rise. Currently, there are no specific regulatory constraints on monitoring temperature and/ or humidity during sample transportation; however, studies show that depending upon the length of time and pressure and humidity involved, these external environment could influence the integrity, and therefore the result accuracy, of transported samples. Inaccurate test results could lead to delay in treatment or treatment errors that might harm patients, which also increase the organization’s liability and threaten the medical licensure and/ or the organization livelihood.

Quality Improvement or Performance Improvement program addressing these pre-analytical errors combined with appropriate training and tools to mitigate the errors by tracking the time points related to the sample transportation would improve patient care quality and safety. As part of a good quality management system, laboratories should track the preanalytical errors made each month and categorize them to make designing improvement efforts easier.

Your Microbiome and Your Health

The fine folks at Scientific American recently published a fascinating blog post about the diversity of one’s fecal bacteria. While it’s long been thought gut microbiomes can vary widely from day to day within the same person, the advent of direct-to-consumer microbiome testing has uncovered that variety can exist within the same specimen.

What? You’ve never heard of personal microbiome testing? Think of it as 23andMe for feces. Ubiome and American Gut provide this service for folks who aren’t squeamish about collecting their own stool swabs.

From the laboratory professional perspective, what do you think about this type of direct-to-consumer testing? Do you think testing a patient’s microbiome has a future in diagnostic or preventative medicine?

–Kelly Swails, MT(ASCP), is a laboratory professional, recovering microbiologist, and web editor for Lab Medicine.

General Versus Subspecialty Surgical Pathology Sign-Out

I’m currently on a month of neuropathology/autopsy at our main academic center. After 2 months at a busy surgpath site with a 1-1.5 hour drive each way, it’s finally nice to be able to take a breather. Here, I’m responsible for any neuro frozen and grossing that doesn’t go to the SP resident, helping with the cutting of autopsy brains, and sign-out of neuropath cases. Since we don’t have a heavy neurosurgery service, this allows me more time to learn at my own pace and I feel that I’m able to retain more.

Not including CP rotations, I’ve always learned more, retained knowledge, and performed better on the subspecialty rotations that I’ve had – hematopathology, pediatric pathology, and now neuropathology. While I acknowledge that part of this is my own fault because when I’m on surgical pathology (we do general SP sign-outs), I read up pretty much only on my cases. I know that I need to preview them for sign-out so I read up on the SP diagnoses and differentials. But I often am not motivated to read up on general systems, so I can be real hot mess (and as one senior resident called me recently, “stupid”) during unknown conferences. In CP topics and those subspecialty areas I’ve had rotations in, I’m quite the opposite and tend to excel.

Yesterday, was the first time I’ve been at consensus conference since my first year. At the community and VA hospitals where I’ve spent most of my SP rotations during my second year, we didn’t have group consensus conferences. I remember last year thinking during consensus, “please don’t pick on me to answer a question” during the inevitable pimp sessions that evolved. But yesterday, besides the fellow, I was the only senior resident present. But I was less apprehensive and intimidated than I had been when I sat in the same place the year before. So even though I don’t consider myself a person who is good at SP, I was adequate enough and I must have learned something over the past year without realizing it.

Obviously, how we teach surgical pathology is restricted by the type of sign-out practiced at the institution we are at and this often is dictated by specimen volumes, faculty expertise, and the cultural philosophy dominant there. Even though I thought that I had taken this question into consideration when interviewing and ranking programs, I realize now that I didn’t have a complete grasp on how training styles and cultures really would affect me. Probably since I’m graduate school trained first and naturally think more like a scientist that focuses on one area and learning everything about that area, subspecialty sign-out works best for me.

Before starting residency, I had an intuition that this was true but thought that I would eventually adapt to a general sign-out format since that is how my institution practices. And I’ve adjusted, albeit maybe not progressed as quickly as my peers. It’s difficult to maintain all surgical pathology as subspecialty unless the volume is high enough and this usually means a large, well-known academic center if that’s what you need during your training. The majority of residents will end up in private practice and many often train at places where the sign-out is a more generalized one. So how do we match our learning needs with practice requirements at our training institutions with our eventual responsibilities as a pathologist in terms of sign-out? I can’t say that I have a solution for this conundrum but would welcome opinions on the topic. What works best to train our residents in surgical pathology?

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

Does Your Laboratory Personnel Meet the CLIA Regulation and Accreditation Requirements?

On December 21, 2012, the Centers for Medicare and Medicaid Services (CMS) published Survey & Certification letter: (S&C-13-07-CLIA) with Brochure #10 on Personnel Competency. It cites the six minimal regulatory requirements for assessment of competency for testing personnel:

Direct Observation of testing procedure
Monitoring the recording and reporting of test results
Review of test results
Performance of instrument Preventive Maintenance
Test performances, i.e. blind unknowns, etc.
Assessment of problem solving skills.

Since early 2013, some CMS surveyors have joined accrediting agencies such as The Joint Commission (TJC) and College of American Pathologists (CAP) in their bi-annual lab accrediting surveys to check testing personnel’s qualification. This qualification includes proof of a minimum education requirement (usually a college diploma). Healthcare organizations need to assure the qualifications for testing personnel are fully met pursuant to the federal, state, and accrediting agency requirements. This includes personnel that perform point-of-care testing (POCT). Because this testing might be performed by non-laboratory staff, these personnel might not have the required education requirements for moderate complexity testing pursuant to the CLIA requirements.

In such cases where the testing personnel licensure is required (for example, by the state) copies of staff diplomas would not be necessary. Licensure is different than certification, which is sponsored by a private sector, nongovernmental institution, such as American Society of Clinical Pathology (ASCP). By requiring personnel licensure, the state government has taken additional measures to protect harm to the public in the state. Currently, there are 12 states with laboratory personnel licensure requirements (California, Florida, New York, North Dakota, Rhodes Island, Tennessee, Louisiana, Nevada, West Virginia, Montana and Georgia). The components of the laws for personnel licensure vary from one state to another; it usually involves a fee, a continuing education provision, and a minimum education requirement, and a professional competency requirement.

Due to the economic situation in the United States and the laboratory workforce shortage, some state government agencies have not actively enforced all compliance aspects among healthcare organizations. For example, some laboratories allow medical lab technicians (MLTs) to perform high-complexity testing due to the medical lab technologists’ (MTs) shortages across the country. However, according to CLIA regulations, MLTs should only work in moderate complexity testing areas that require limited independent judgments. The high complexity testing environments that include blood banking, microbiology identification procedures, microscopy, etc. require a high level of independent judgment and should only be performed by MTs.

Technical supervisory positions in the clinical laboratory require a minimum of five years technical experience. It would not be in compliance with the regulations when the clinical laboratory general supervisors are chosen from MLTs or related field, such as cytology or histology or radiology. Healthcare organizations need to assess their lab personnel qualification and competency to assure that they are meeting the standard requirements pursuant to CLIA regulations, state regulations, and accreditation requirements.

If you’d like more information about these regulations, please read the Code of Federal Regulations part 493.

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.