New Rule Gives Patients More Access

Yesterday the Obama Administration and the Department of Health and Human Services implemented a 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. Basically, the new regulations state that patients (or their personal representatives) can receive lab results directly from the laboratory. In most cases the laboratory has 30 days to comply with the request. This regulation goes into effect 3/31/14 and laboratories must comply by 9/27/14.

So what does this mean for laboratory professionals? The language of the final rule gives laboratories a lot of flexibility in terms of dealing with a request for information. In a nutshell:

  • Individual laboratories can set up systems to receive, process, and respond to requests for results however they choose to do so.
  • If a state law is different than the federal regulation, laboratories must comply with the “more stringent” law, with “more stringent” meaning “greater rights of access.” For example, the federal regulation requires results to be given within 30 days of the request; if state law requires those results be given with 15 days, then the laboratory should follow the state law.
  • Laboratories need to have “verification of identity” policies in place. There is no mandate that requires specific forms of identification.
  • Laboratories that currently have patient portals in place may continue to use them.
  • Laboratories CANNOT require patients to make requests only through their providers; mechanisms must be in place for a patient to make requests directly to the laboratory. However, laboratories CAN require patients to make these requests directly to the laboratory.
  • Laboratories can recoup the costs of providing results to patients, but the fees must be cost-based and reflect labor, supplies, postage, and preparation of an explanation of PHI. Laboratories CANNOT charge fees that reflect the cost of searching and retrieving information, nor can they charge fees for costs associated with verification, documentation, liability insurance, maintaining systems, etc.  It should be noted that laboratories cannot withhold future lab results if a patient chooses not to pay the fee.
  • Laboratories must provide results in the form (electronic or paper) requested by the individual if readily producible.  This could be a MS Word or Excel document or PDF as well as access to an electronic portal.
  • Laboratories are required to reasonably safeguard information (electronic or paper).
  • Laboratories are not required to include test interpretations but may do so if desired.
  • Providers are encouraged, but not required, to tell patients they have access to their laboratory results directly from the laboratory.

 

Swails

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

 

Patient Data as QC

One of the most important things we do as a laboratory is run Quality Control (QC) material on every assay we perform in order to ensure that the assay is working correctly and the test results are valid. The importance of QC cannot be overstated, as it allows us to confidently report analyte values that allow correct diagnostic, treatment and treatment monitoring decisions for each patient for which we provide service. And yet every laboratorian knows that running QC is often problematic.

QC material is not true serum, plasma, urine or CSF and as such, it frequently does not act like a patient sample. This is referred to as commutability – the ability of a synthetic or non-human-based material to act like a human sample in a test system. As hard as manufacturers try to make their QC product commutable, problems still exist.  Every tech knows that a shift in QC is not always reflected by a shift in patient sample results, and conversely a shift in patient sample results may not be mirrored by a shift in QC.

In some cases it may be possible to use patient samples as a kind of Quality Control.  For those tests with high volumes, calculating a running mean of all patient data each month can supply a nice overview of the performance of your assay. For example, if you run 5000 sodiums each month, the average of those 5000 will be consistent from month to month, as long as your analysis system is performing consistently. Very high or very low outliers will be smoothed out by the sheer volume of tests in the data set. Our average monthly sodium has run 140 or 139 mEq/L for the last year. If it were to run 142 or 137 one month, I would look at what happened in the system to shift 5000 sodiums enough to cause that difference.

A test that this system has been useful for is tacrolimus.  At roughly 600 tacrolimus tests per month, our rolling patient mean has been stable for the last 6 months at  7.9 ng/mL, with a range of 7.7 – 8.1 ng/mL. In September, the mean dropped to 6.8 mg/mL. The data was still distributed as it had been previously, with no increased number of values around the lower end, suggesting that the shift was systemic. A look back discovered a new calibrator and calibration. None of this had been reflected by a shift in the regular QC.

Use of patient data as QC will not work with low volume tests, or with tests having a wide reportable range, because a low number of outliers will affect the mean too much. For instance, diabetics in crisis with massively elevated glucose can skew a glucose average even if you run a couple thousand per month. Also this method takes a long-term view of the system. It will not pick up an assay failure on a given day. Despite those things, it can be very useful for looking at systemic issues that affect patient data rather than QC data.

 

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

 

Medical Essay Contest

This came across the desks of Lab Medicine’s editors today and we’d like to pass it on. The folks at Hektoen International are running an essay contest.

We invite you to submit an essay of 1,500 to 2,000 words on a subject related to medicine and culture by March 1, 2014. Suggested topics include medicine and art or literature, history of medicine, ethics, music, philosophy, anthropology, linguistics, etc. Clinical studies or case reports are not eligible.

We will be offering two prizes:

  • The Hektoen Grand Prix, for the winner – $1,500
  • The Hektoen Silver Prize, for the runner-up – $1,000

If you’d like more information, please check out the essay contest page.

 

Bird Watching

Every inspection cycle we receive our checklists from the regulatory organizations and that is usually when the latent lawyer in me breaks out like the Hulk and I start interpreting the meaning of every word contained within the document. CAP has said on multiple occasions that some of the checklist items are open to interpretation and that there can be several ways to satisfy them. CLIA has their 6 elements of competency and when I first read them my eyes started to turn green and my clothes started to get a little snug. The element that I think is open to the most discussion is the first: “Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing.”  Some of my colleagues have interpreted this as once a year directly observing a technologist/technician perform each test and then signing them off. When I read this element I can’t help but think that once a year is not enough to verify that an employee is correctly performing each test. The question I always ask is how do we know that an employee does it correctly when we are watching but then does it a different way when we aren’t?

I am a very hands off leader. The reason I can do this is because when I train a new employee it is rigorous and I make sure that they can handle pretty much anything that comes their way. When I read that first CLIA element I feel as if they want us to babysit our employees. I understand the importance of direct observation but where is the line drawn that says so much observation is enough? If you ask me once a year is not enough; however, the more we observe the less time we have to do our countless other tasks as supervisors/managers.

When I thought about it, I came up with a couple methods or ways to “directly observe” my employees. The first obviously is to stand behind them and watch them perform a test. Then the question of how do we observe the off shifts without actually being there? We all have smart phones with cameras so could employees could set up their phones to record a procedure and then we could watch it back later. In blood bank I can have each employee save their gel cards so that I can read them at a later time and make sure the volumes in each well look ok. That would qualify as direct observation of their results and process since if the volumes are incorrect I would be able to tell. As supervisors we are also called to consult with other technologist/technicians frequently. Troubleshooting with your employees usually involves something test related and that to me would count as direct observation as well. Finally, we have students almost year round and our employees usually take on the role of teacher when they are in that spot for the day. When I observe them teaching the students how to perform tests this is a great way to confirm that the employee is competent.

My favorite way to observe is when my employees don’t know I’m watching. I have an office that is not directly in the blood bank so I have to wander in and out fairly often. Sometimes I will sit down or file papers all the while observing my employees and their technique and processes. There are many ways to “directly observe” and using all of them ensures that you are meeting the guidelines enforced by CMS. When inspection time comes you can show the signature that says you directly observed but also have a list of answers when they ask how you did it. When I need some practice I grab my binoculars and do a little bird watching.

 

Herasuta

Matthew Herasuta, MBA, MLS(ASCP)CM is a medical laboratory scientist who works as a generalist and serves as the Blood Bank and General Supervisor for the regional Euclid Hospital in Cleveland, OH.

Classified

“I retweeted an Instagram picture someone posted on their Facebook page that shows how to place blood tubes in a centrifuge. There is also a vine of it on their LinkedIn profile.” Confused yet? I’m a millennial, more commonly known as generation Y, and if there is a social network out there people my age are either on it or bored with it already. The question that keeps coming up is where do the social networks fit in to professional life? Perhaps the bigger question is can you be yourself while maintaining a professional persona? Most large organizations have social media policies that prohibit their employees from speaking badly about them on social media sites. Some policies also allow a company to terminate someone if the person lists them as their employer and does or posts something that the employer feels isn’t up to their standards.

The reality is if you are on these sites and you list your employer you must be careful. If people ask my advice on social media I usually tell them to stay as ghosts, and don’t list your employer. In my personal situation I don’t even have my real last name on my Facebook account plus it is private and even if you knew what my name was you couldn’t search it. Now, I really have nothing to hide seeing as I have over 1000 friends on my Facebook account but I not only want to control what goes out but more importantly who sees it. My feelings are, keep your personal life personal and your professional life exactly that.

Some may find it surprising that a young person isn’t posting every aspect of their life but I just feel that my organization doesn’t need to know what I have for dinner after I leave for the day. It is really each individual’s choice on what they want to follow or add but it just seems to me that it is a little to easy to become emotional about something and next thing you know it’s out there for all to see. It is pretty much a daily occurrence that some celebrity has to apologize for something that is taken out of context and the same goes for everyone else. When you tweet out that you can’t stand your boss, smiley face; you may not be around to explain the sarcastic nature of the post.

As a supervisor, I would never recommend being friends with people you lead unless you understand and realize that everything you post will be fair game in the workplace. I think a lot of people either forget that or simply don’t understand the significance of social media until it’s too late. Just because something happens outside of the organization, if one of your coworkers sees it you can bet that it will find its way back to the workplace. This is the personal aspect of social media and if your organization requires you to have a public account as a leader to be available for comment and questions nothing says you can’t have two accounts. Have a public profile and a personal one that you can set to private. When people ask me at work if I have any social media accounts I just tell them that information is classified.

Herasuta

Matthew Herasuta, MBA, MLS(ASCP)CM is a medical laboratory scientist who works as a generalist and serves as the Blood Bank and General Supervisor for the regional Euclid Hospital in Cleveland, OH.

 

Harmonization

What does “harmony” mean to you? And how does it apply to lab testing?

One of the biggest problems that arise where lab testing is concerned is that tests run in two different labs will give you two different results unless the labs happen to be using the same equipment (and sometimes even then the results won’t match!) This is a huge problem for doctors of patients who use different laboratories for their testing or patients who move across the country and need to continue following lab test results.  A prime example of this dilemma is the current state of T4 testing. The same CAP sample when analyzed using different assay methods for thyroid stimulating hormone (TSH) can yield results which range anywhere from 2.66 to 8.84 mIU/L. Although CAP samples are not always commutable with patient samples, thyroid testing on patients shows this same lack of harmony.

This example underscores the need for harmonization. In our increasingly small world, where nearly everyone will soon be using the electronic medical record, and all lab results on a patient will be in one place whether they were all performed at the same place or not, it will be paramount that the lab results for any given test can be compared. Efforts to date have successfully harmonized several important analytes, including creatinine (IDMS-creatinine), cholesterol and hemoglobin A1c.  Efforts are on-going to harmonize vitamin D assays against the NIST standards. These harmonization efforts took a massive amount of coordination and work between the in vitro diagnostic industry, regulatory agencies and laboratory and clinical societies.

Laboratory professionals have long recognized this problem, and sought to inform non-laboratorians of the realities at every opportunity. Lack of comparable test results can lead to patient safety issues, including misdiagnoses and/or inappropriate treatment. Recently an international consortium has recognized the need for harmonization of all lab results and begun to work on the problem. Although this effort is just beginning and the road ahead is long until general test harmonization can occur, it is a road worth traveling.

 

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

Reference Ranges

According to Wikipedia, reference ranges in health-related fields are generally defined as “the prediction interval between which 95% of values of a reference group fall into, in such a way that 2.5% of the time a sample value will be less than the lower limits of this interval, and 2.5% of the time it will be larger than the upper limit of this interval, whatever the distribution of these values.”

In other words, reference ranges are important! They provide the necessary context for medical analysis and diagnosis. Without a reference range (also sometimes referred to as reference value or reference interval) medical professionals have no comparison group for which to make diagnosis and advise treatment.

In all instances where reference ranges are used, context is key. In sub-Saharan Africa many labs use European established reference ranges which represent a primarily Caucasian population. This is because reference ranges specific to populations in sub-Saharan Africa do not universally exist. This presents a problem as many factors can contribute to what is considered “normal” in different populations. Genetics, dietary patterns, pregnancy, gender, age, ethnic origin, and prior exposure to pathogens all can influence reference range values.

Establishing accurate reference ranges for a given population takes time and an enormous amount of resources. It is often recommended that laboratories establish their own reference ranges based upon the population that they serve. This is cost and resource prohibitive for many laboratories in the developing world. In absence of region specific reference ranges, it is recommended that each lab validate existing ranges using their own population. However, even this can be prohibitive in resource (both physical and human) limited settings.

This can lead to egregious errors in disease diagnosis and treatment. Clement Zeh, Collins Odihiambo and Lisa Mills write that reference range research thus far reveals that African populations differ from their European/Caucasian counterparts with lower hemoglobin, red blood cell counts, hematocrit, mean corpuscular volume, platelet counts, and neutrophil counts  and higher monocyte and eosinophil counts (see http://www.intechopen.com/books/blood-cell-an-overview-of-studies-in-hematology/laboratory-reference-intervals-in-africa for their chapter on Laboratory Reference Intervals in Africa).

In addition to diagnosis and treatment of individuals, reference ranges are crucial components in drug and vaccine studies. Historically, clinical trials of drugs and vaccines have relied upon ranges developed in the Western world. This can have significant impact upon the research data resulting in health risks to study participants, poor data, and huge amounts of resources wasted.

Thus, while it is costly and time consuming, reference ranges specific to populations in countries in the developing world need to be established. This would help both the treatment of individuals, and the testing, study and development of important vaccines and drugs.

-Marie Levy