While it’s unlikely you will ever encounter a case of Ebola, it’s best to be prepared. The CDC has a health advisory page full of information, including specimen requirements for Ebola testing. The laboratory’s first step is to contact their state health department.
In February I wrote about the Department of Health and Human Services regulation that amends the Clinical Laboratory Improvement Amendments of 1988 and the Health Insurance Portability and Accountability Act of 1996 in regards to reporting of patient results. The deadline for implementation is fast approaching–9/27/2014–and so I’m curious as to how prepared laboratories are for this change.
Is your lab ready? What sort of changes have you made, if any? And do you see this as a way for pathologists and laboratory professionals to become a bigger part of the healthcare team? Or is it simply going to make everyone’s life harder?
–Kelly Swails, MT(ASCP), is a laboratory professional, recovering microbiologist, and web editor for Lab Medicine.
The Institute on Medicine (IOM), the health arm of the National Academy of Sciences that provides analysis and advice on national health issues, released its report “Graduate Medical Education that Meets the Nation’s Health Needs” on July 29, 2014. Citing a lack of transparency and accountability in our current system and discordance with producing the types of physicians necessary to meet our nation’s health needs, the IOM recommended a significant overhaul of our current system of graduate medical education (GME) financing and governance over the next ten years.
Since the creation of Medicare in 1965, the federal government has provided the majority of funding for the post-graduate training of physicians with about two-thirds provided by Medicare. Originally intended as a temporary measure until a more suitable one could be found, this system has financed GME since 1965. Approximately, $15 billion ($9.7 billion from Medicare) was spent in 2012 to support GME funding.1 The IOM’s report remain recommendations unless enacted into law by Congress so aggressive lobbying efforts are expected in the forthcoming months.
In fact, there has already been quick and varied response by multiple academic medical organizations: the American Association of Medical Colleges (AAMC), the American Hospital Association (AHA), and the American Medical Association (AMA) vehemently opposed and warned that the IOM’s recommendations would destabilize our current GME infrastructure while the American Association of Family Physicians (AAFP) supported the recommendations and the American College of Physicians (ACP) falls somewhere in between. If we break down the major recommendations of the report, the reasons for each organization’s opinions become more apparent but this does not necessarily help us to determine the best way to distribute GME funding to address our future healthcare workforce needs.
Currently, there are two components to GME funding from the federal government: direct and indirect. Direct graduate medical education (DGME) funding provides for the “direct costs” of teaching hospitals for the training of residents: the salaries and benefits of residents and the faculty who supervises them, the salaries of GME administrative staff, and allocated institutional overhead costs such as electricity, space rental, and maintenance. Each hospital receives DGME funding as a per-resident amount (PRA) which is hospital specific and calculated as the DGME costs in 1984 (or 1985) divided by the number of full-time equivalent (FTE) residents per year.2 This PRA is updated annually with an inflation factor and adjustment for that hospital’s resident count, limited, of course, by that hospital’s resident cap (number of allowed total residents) set by the Congressional Balanced Budget Act (BBA) of 1997.
The Medicare portion of DGME is calculated by a ratio based on the number of total in-patient days in that hospital spent by Medicare patients divided by the total number of in-patient days by all patients. There are separate PRA’s for primary care and non-primary care residents with those in primary care specialties (family medicine, general internal medicine, general pediatrics, OB/Gyn, preventative medicine, geriatric medicine, general osteopathic medicine) receiving a slightly higher amount. This is due to a congressional freeze on PRA inflation updates on non-primary care residents in 1994 and 1995.
Indirect graduate medical education (IME) funding are additional amounts paid to teaching hospitals for the “indirect costs” of being a teaching hospital. They generally incur more costs than non-teaching hospital settings due to having a sicker patient load and more “non-quantifiable” costs (eg – residents ordering extra tests).3 This payment is based on a formula that takes into account the ratio between the number of interns and residents and the number of patient beds (IRB ratio) adjusted with a variable multiplier and IRB ratio caps that are set by Congress. IME funding is not weighted like DGME funding where the number of residents in their “initial residency period” (IRP) are counted as 1.0 FTE and those beyond this period as 0.5 FTE.
Of course, these funding formulas can get very complicated and are adjusted with each new Congressional legislative action on GME. But now that you have a rudimentary idea of how the federal government and Medicare fund our education as residents, let’s consider the recent IOM recommendations.
IOM Recommendation #1: aggregate GME funding should remain at current levels ($15 bil/yr) with adjustments only made for inflation over the next ten years while the recommended new GME policy is implemented; the bulk of funding ($10 bil/yr) will continue to come from Medicare.
Supporting Argument: the current GME system is unsustainable and needs to become more performance- and value-based as healthcare system evolves under healthcare reform; this would provide stable (albeit not increased) funding over this transitional period.
Opposing Argument: for years, academic medical associations and their allies have recommended an increase in GME funding stating that the rate of increase has not kept up with inflation and the expense of educating our nation’s future healthcare workforce; additionally, they have consistently recommended lifting the GME cap with little success.
IOM Recommendation #2: a new GME Policy Council should be established within the Office of Health and Human Services to provide guidance on GME issues and a new GME Center within the Centers for Medicare and Medicaid Services to administer GME funding.
Supporting Argument: more transparency and accountability is needed to make sure that our dollars are well spent to produce more efficient use and better health outcomes for patients.
Opposing Argument: more bureaucratic and inefficient “red tape” and hoops to jump through without added benefit.
IOM Recommendation #3: eliminate the DGME and IME structure and replace with an Operational Fund to finance existing GME programs; the other portion of funding would support a Transformational Fund focused on innovation and programs in needed and underserved areas.
Supporting Argument: the Operational Fund would provide for currently existing programs so as not to destabilize GME funding during the proposed transition; the Transformational Fund would be targeted to address the current geographic and subspecialty maldistribution that exists.
Opposing Argument: the geographic and subspecialty maldistribution is nothing new but merely funneling more money toward these areas will not necessarily provide more healthcare professionals in these underserved areas or specialties, especially as long as student loan financing structures remain as they are currently. This recommendation also will significantly affect the funding amounts currently received by teaching hospitals, especially urban based hospitals, where the majority of GME takes place.
IOM Recommendation #4: provide funding based on PRA only with geographic adjustments and end payments based on Medicare in-patient days, IRB ratio, and other factors currently in the funding formula. These PRA funds would be directed to the GME sponsors who are responsible for the actual educational content for the training of interns and residents rather than to teaching hospitals alone. GME sponsors can be teaching hospitals, educational institutions, community health centers, or GME consortia.4
Supporting Argument: funding would go directly to those responsible the actual educational content which may be a non-teaching hospital setting; studies do not support a physician workforce shortage, especially in primary care specialties.
Opposing Argument: this recommendation again will disproportionately hurt teaching hospitals as they tend to have a sicker patient load, have more patient beds, and have access to more expensive tests and treatments than more community-based and/or non-teaching hospitals; teaching hospitals often are the main settings for GME, although not necessarily the only settings, and may need to make cuts based on resident education versus operational costs of the hospital with reduction of resident slots as the outcome when a physician workforce shortage is looming.
The IOM recommendations assert to support a more targeted, performance-based investment in the training of our future healthcare workforce but do they really? Obviously, GME funding has been a hotly debated topic for the past 50 years so there are no simple solutions and everyone has their own biased opinion. Even though I have some health policy and advocacy training from my MPH and grassroots organizing background, I don’t profess to be a health policy wonk by any means so I encourage you to become more informed and decide your own opinion. And if so inclined, become more involved in health policy advocacy with the political action committees (PAC) of your affiliated academic medical organizations to lobby for your beliefs.
You can read or download an electronic copy of the report free online at: http://www.iom.edu/Reports/2014/Graduate-Medical-Education-That-Meets-the-Nations-Health-Needs.aspx
References
1. Institute on Medicine (IOM). Graduate Medical Education that Meets the Nation’s Health Needs. July 29, 2014. 256 pages.
2. American Association of Medical Colleges (AAMC). Medicare Direct Graduate Medical Education (DGME) Payments; accessed on 8/8/14 at https://www.aamc.org/advocacy/gme/71152/gme_gme0001.html
3. T Johnson and TW Coons. Recent Developments in DGME and IME Payments. American Health Lawyers Association. Updated by Laurie Garvey on 3/16/10; accessed on 8/9/14 at http://www.healthlawyers.org/Events/Programs/Materials/Documents/MM10/coons_johnson.pdf
4. E. Salsberg. IOM Graduate Medical Education Report: Better Aligning GME Funding with Healthcare Workforce Needs. Health Affairs Blog. July 31, 2014; accessed on 8/10/14 at http://healthaffairs.org/blog/2014/07/31/iom-graduate-medical-education-report-better-aligning-gme-funding-with-health-workforce-needs/
-Betty Chung, DO, MPH, MA is a third year resident physician at Rutgers – Robert Wood Johnson University Hospital in New Brunswick, NJ.
In July 2012 I traveled to Dushanbe, Tajikistan as part of a team that conducted initial site visits and needs assessments at laboratories around the country. Clearly it has been a couple of years since that visit and I must admit that I haven’t done a good job at keeping up on any developments. I am sure there is much we did not see, and did not learn and various items that were lost in translation, and I realize that one visit does not an expert make. All that being said, however, I wanted to share my impressions from that visit, as I was surprised by the differences between the challenges laboratory services face in Tajikistan (and reportedly much of the Central Asia region) and those faced in many countries in Africa. In many African countries, challenges related to laboratory services and infrastructure can be linked to lack of resources, materials, testing supplies, supply chain issues and difficulty for rural patients to access the laboratory.
In Tajikistan, at the time of our visit, there was a severe lack of reagents needed to continue running multiple tests. This was due to a delay in receiving a specific international source of funding dedicated to purchasing these reagents. In general, however, the laboratories we visited appeared to be better supplied and stocked than many I have seen in various African countries.
To me, the most striking observation was how the structure of the laboratory system made it difficult for patients to obtain the appropriate testing and care. There was one lab for TB tests, and one lab for routine CBC’s, and another one for HIV tests, etc. Some of this separation was due to different sources of funding for the labs, which restricted those funds to be used only for specific tests (an issue for sure, but one related more to international aid and funding than the Tajik structure). Another explanation we received was that some of the separation was due to bygone practices from the communist era government where many services were very siloed. No matter the explanation, however, it could be challenging; a patient who needed multiple tests had to traipse around to numerous locations in order to have samples taken for each test.
Imagine what that would be like as a patient. Would you follow through on doctor’s orders if it was going to take all day and multiple stops? I’d like to think I would, but perhaps not if it was too much of a challenge.
-Marie Levy spent over five years working at American Society for Clinical Pathology in the Global Outreach department.
As this summer passes quickly by, I find myself, once again, anticipating the fall Annual Meeting of ASCP. Deadlines are fast approaching as I pull together my own power point presentation, review the schedule for sessions to moderate as well as those I wish to attend on my own time.
Many of you are involved in the planning process for the Annual Meeting and understand the deliberation and organization that this entails. The plethora of educational proposals is vast, submitted by numerous respected individuals and teams. Given the back-drop of this immense undertaking, I must say that I was thrilled this year to be a part of the discussion for the newly -created Hot Topics in Clinical Pathology. This has been a long-awaited moment for me and many of my cronies who have felt for quite a long time that the focus on Surgical Pathology at the Annual Meeting has essentially pushed aside the importance of Clinical Pathology and Laboratory Medicine as a vital part of everyday pathology practice.
With the creation of the “Hot Topics” track, we at least begin to see a small, but significant move forward. Clinical Laboratory Scientists clearly identify their work and the laboratory as primary contributors to patient care. Pathologists should begin to embrace this concept more fervently. The fields of Microbiology, Coagulation, Hematology, Transfusion Medicine, Serology, Chemistry (and a multitude of other areas) are expanding rapidly and are the KEY to understanding, diagnosing, monitoring and treatment of disease. Our clinical laboratories support and enhance our Surgical Pathology practices as well and the sooner pathologists regain the interest and care for these areas within our expertise, the better off our patients will be (and yes…they are OUR patients too!)
Hats off to the Annual Meeting Planning Committee for taking this bold step (although a “baby” one) toward bringing Clinical Pathology back into the fold. I hope to see this agenda pushed forward and expanded, not just at the Annual Meeting, but also in our other educational offerings. We are, by the way, the American Society for Clinical Pathology!
Our clinical laboratories and clinical pathologists are not the departments or doctors of the lesser god! Hope to see you in Tampa, in attendance at the Hot Topics sessions!
-Dr. Burns was a private practice pathologist, and Medical Director for the Jewish Hospital Healthcare System in Louisville, KY. for 20 years. She has practiced both surgical and clinical pathology and has been an Assistant Clinical Professor at the University of Louisville. She is currently available for consulting in Patient Blood Management and Transfusion Medicine. You can reach her at cburnspbm@gmail.com.
The test utilization seminar I attended at the AACC annual meeting (I talked about it here) presented fascinating information that I’m going to try and sum up for you.
Test utilization isn’t just about ordering the right test, making sure the order entry system is efficient, or even about the accuracy of the test. Sure, all those factors are important, but patients aren’t treated by laboratory data. They’re treated by doctors, and those doctors are human. Humans are irrational and make mistakes for all sorts of reasons like fear, cognitive limitations, and social complications. Medical decisions are incredibly complex and driven my mounds of data. This complexity contributes to medical errors.
I found this notion counter intuitive—one would think that more data would mean better decisions. However, a study conducted by the CIA on horse race prediction found that when analysts were given more data, the accuracy of their predictions didn’t improve. However, the analysts had more confidence in their predictions. What does this mean? Just because your doctor runs fifty tests doesn’t mean he’ll diagnose you accurately. It probably means, though, the doctor will be confident they are right.
Another tidbit from the seminar: diagnostic error is usually the convergence of several different factors that are organizational, cognitive, and technical in nature. Any laboratory professional who has dealt with major errors has seen this in action—an event investigation will usually reveal that anything that could go wrong did, and that’s why the event occurred. The authors of this particular study did note that technical/equipment problems contributed to only a small fraction of diagnostic errors. This speaks to the integrity, critical thinking, dedication to quality that laboratory professionals possess.
If you want to read more, here are a few of the studies mentioned during the talk:
Diagnostic Error in Internal Medicine http://archinte.jamanetwork.com/article.aspx?articleid=486642
CIA: Do You Really Need More Information? https://www.cia.gov/library/center-for-the-study-of-intelligence/csi-publications/books-and-monographs/psychology-of-intelligence-analysis/art8.html
–Kelly Swails, MT(ASCP), is a laboratory professional, recovering microbiologist, and web editor for Lab Medicine.
Medscape interviewed the CDC about the current Ebola outbreak. In it, the CDC reiterates that healthcare workers are at particular risk for infection. While the interview doesn’t specifically mention laboratory professionals, of course they are included in that risk group. Protect yourself using standard precautions (sometimes called contact or droplet precautions). This includes gloves, gowns, face mask, and eye protection when handling specimens from a potential victim.
You can read the entire interview here.
Last week, I attended the American Association of Clinical Chemistry (AACC) conference in Chicago. I attended molecular diagnostics talks but also talks about quality improvement, the use of “big data,” and lab stewardship. I have an interest in QI as my AACC poster presentation last year was on lab interventions to reduce lab error frequency and I am also a resident on my hospital’s performance improvement committee.
So, what exactly is “big data?” It’s a word that we are hearing more often in the media these days. It’s also a term that is increasingly being used in our healthcare systems. In 2001, analyst Doug Laney defined “big data” as the “3 V’s: volume, velocity, and variety” so that’s as good a point as any to start deconstructing its meaning.
Volume refers to the enormous amounts of data that we can now generate and record due to the blazing advancement of technology. It also implies that traditional processing matters will not suffice and that innovative methods are necessary both to store and analyze this data. Velocity refers to the ability to stream data at speeds that most likely exceed our ability to analyze it completely in real-time without developing more technically advanced processors. And finally, variety refers to the multiple formats, both structured (eg – databases) and unstructured (eg – video), in which we can obtain this data.
I’m always amazed at the ability of the human mind to envision and create something new out of the void of presumed nothingness. Technology has always outstripped our ability to harness its complete potential. And the healthcare sector has usually been slower to adopt technology than other fields such as the business sector. I remember when EMR’s were first suggested and there was a lot of resistance (in med school, not that long ago, I still used paper patient charts). But now, healthcare players feel both pressure from external policy reforms and internal culture to capture and analyze “big data” in order to make patient care more cost-effective, safe, and evidence-based. And an increasing focus and scrutiny (and even compensation) on lab stewardship is a component of this movement.
I often find myself in the role of a “lab steward” during my CP calls. The majority of my calls involve discussing with, and sometimes, educating, referring physicians about the appropriateness of tests or blood products that they ordered…and not uncommonly, being perceived as the test/blood product “police” when I need to deny an order. But lab stewardship goes both ways. And these days, the amount of learning we need to keep up with to know how to be a good lab steward is prodigious, daunting, and sometimes, seemingly impossible.
So do you believe in this age of lab stewardship that it’s the job of the pathologist to collect and analyze “big [lab] data” and to employ the results to help ordering physicians to choose the right test at the right time for the right patient? Or is it a collaborative effort with ordering physicians? With patients? How do you foresee that the future practice of medicine needs to change from standards of practice currently?
-Betty Chung, DO, MPH, MA is a third year resident physician at Rutgers – Robert Wood Johnson University Hospital in New Brunswick, NJ.
Assalomu Alaikum!
As I write this to you, I am working in Dushanbe, Tajikistan with my ASCP Volunteer colleague, Dave Gingrich. We are teaching and training in preanalytical processes. Our Tajik colleagues come from the far and remote reaches of their country, where they provide blood drawing and patient services to the people of their respective regions. They’re calling me Bunafsha…Beverly doesn’t translate, so they’ve given me the name of a flower. By description, it sounds like a yellow water lily…strange for a country with so little water, but perhaps it’s because I come from over water they’ve never seen. In my travels I can’t help but compare and contrast different cultures and their reaction/interaction to us as “foreign experts.” We were told Tajiks could be shy, yet nothing is further from the truth! What lovely, respectful, personable people.
Our last few days of teaching/training in laboratory processes have been eye-opening. We heard that due to lack of supplies in some remote and rural clinics, safe practices are very difficult to adopt because they aren’t able to get basic resources like syringes. I was certain this had been translated incorrectly, so asked again several times…only to hear I’d heard right the first time. It was also described for us that tubes of blood were centrifuged, the serum transferred to glass tubes (hand-washed, not sterilized) and the patient requisition is twisted into a cork-like cap for the tube so it can be transported 3-4 hours to a regional lab for HIV/AIDS testing…and no one had ever heard of Parafilm. My heart breaks for conditions of such limited and much needed resources that could so easily be remedied. And yet, despite such circumstances, they are so eager for knowledge of better techniques, safer ways of doing things, and so positive about their situation without bitterness for what they don’t have—that I am in the confused state of being humbled and enthusiastic all at the same time. How can what we are doing make a difference? And yet, how can it not?
In just a few short days, we have shared ideas, techniques, and the passion for our professions—and I’ve shared several of your “best practices” with them that I’ve been writing about over this past year—and the circle of our collective desire to improve laboratory services is truly global. Dave and I both feel we now have many new laboratory friends in Tajikistan!
Cheers!
–Beverly Sumwalt, MA, DLM, CLS, MT(ASCP) is an ASCP Global Outreach Volunteer Consultant.
It seems like everyone is getting into the act these days, related to the regulation of laboratory developed tests (LDTs). Even politicians and lawyers are talking about LDT regulation. A recent online post (http://thehill.com/policy/healthcare/211250-lawmakers-push-fda-oversight-of-lab-tests) reported that several lawmakers are now writing to the Office of Management and Budget (OMB), asking it to quickly approve the FDA’s guidance document for FDA regulation of LDTs, in order to protect the public from the depredations of the evil lab people developing tests that will harm the public. That last clause is my paraphrase of course, but is not that far off what the post actually says.
The harm in posts like this is that the general public, including lawmakers and politicians, have no understanding of the laboratory field in general, and definitely no understanding of the regulatory environment that all reputable labs operate under. The majority of hospital labs and big reference labs are accredited and operate under the regulations of an accrediting agency including such agencies as CMS, CLIA, various State regulatory bodies, CAP and The Joint Commission. The combined regulations of these agencies result in labs which not only produce test results using good laboratory practice, but when these labs develop tests (LDTs) they do so meeting many regulatory standards already. FDA oversight of these labs is overkill, in my opinion.
Where FDA oversight of LDTs would be useful is in the plethora of start-up companies offering the public a variety of tests to diagnose disease, monitor their health, or determine their genetic code. Many of these labs have no accreditation and have used LDTs as a loophole for bypassing FDA regulation of their tests. In fact it’s likely that many of them are in need of regulation from some agency.
John Q. Public in general is just beginning to understand what a lab test is. He has no idea that he should be looking for an accredited lab, and asking for some sign that minimum standards were used to develop tests. He simply Googles his symptoms and gets 4 million options for lab tests he can have run to diagnose his disorder. Laboratory professionals have an obligation to try harder to educate the public. We need to be involved and be visible. FDA regulation of laboratory tests is a “hot” issue currently that is being picked up by the public. We should take every opportunity to set the record straight.
-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.
Lablogatory 