generalist – Page 28

Regulation of Laboratory Developed Tests (LDTs) – Revisited

Two years ago this coming September I posted a blog about the FDA’s intent to regulate LDTs and the need for laboratory professionals to both keep an eye on what happens and to be a part of it. I believe it’s time for an update on what has been happening and a further exhortation to stay involved.

The FDA is definitely going to regulate all LDTs. This is no longer a future possibility, but is now an approaching reality. In October of 2014, the FDA put out two new draft guidance documents for 120-day comment periods. One document, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” lays out the FDA’s various risk categories and classifications for different LDTs and also lays out the FDA’s timeline for enforcing regulation of them. The second document, “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” delineates how labs will report their LDT testing to the FDA and the protocol for adverse event reporting to the FDA, which all labs performing LDTs will be required to do.

During the 120-day comment period, many groups commented, weighing in on their perspective about the FDA regulation of LDTs. AACC and the Association for Molecular Pathology (AMP) published position statements. CAP Today did a comprehensive article. Although nearly everyone agrees that some form of LDT regulation is necessary, there is a wide range of opinions on what that regulation should entail, and even who should ultimately be responsible for it.

Despite many suggestions that perhaps the FDA should approach this regulation differently, they plan to move forward. Their “Framework . . .” document lays out about a nine-year timeline for regulating all LDTs, starting first with the highest-risk group. LDTs will broadly be classified into three groups: low-risk, which are also known as “traditional” LDTS, moderate-risk and high-risk. Traditional LDTs are those developed by a single lab for use on a single patient population. This classification will cover many hospital-based LDTs and it will have the least rigorous regulation by the proposed guidance documents. Moderate and high-risk LDTs will be tackled first by the FDA and will require pre-market review and approval as part of the regulatory requirements.

The FDA is perhaps listening to some of the comments being generated however. Most recently the FDA has announced that an interagency taskforce will be formed to deal with LDT regulation. Currently that task force includes the FDA and CMS, although many laboratory associations are hoping it will be expanded to include more groups. As laboratory professionals, it’s up to us to stay informed of this new regulation headed our way, and to do our best to be involved in the process.

-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.

Markers of Inflammation

I thought today I’d do a little discussion related to two of the more non-specific, questionably useful tests that we have in the laboratory test arsenal, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), and their use as markers of inflammation. I’ve left out procalcitonin on purpose since I’ve posted about that inflammatory marker previously. And I won’t discuss hs-CRP and its use in cardiovascular disease risk assessment.

CRP and ESR are referred to as inflammatory markers because both rise when inflammation is present. However neither marker provides much more information other than the presence of inflammation. That leads to the questions: how are these tests useful, and why do we need both?

Good questions! First though, what exactly are these markers? Both of these markers will increase in inflammation, infection and tissue destruction, but at different speeds and to different degrees. CRP is a protein and an acute phase reactant. It is produced by the liver and released in response to inflammatory cytokines, usually within hours of a tissue injury, an infection, or any other cause of inflammation. ESR on the other hand isn’t any kind of analyte at all, but rather a measure of the ability of the red cells to settle out in a blood sample. This settling is affected by the fibrinogen and globulin concentration in the blood as well as by the red cell concentration and how normal the red cells are. Thus besides inflammation, things like anemia, polycythemia and sickle cell disease also will affect an ESR. ESR also increases in malignancies, especially paraproteinemias and other states with abnormal serum proteins, and in autoimmune diseases. ESR elevations are used to support the diagnosis of specific inflammatory diseases, like systemic vasculitis and polymyalgia rheumatic. CRP is useful for monitoring patients after surgery and since it rises rapidly in response to bacterial sepsis, it is often used to monitor response to antimicrobial therapy. Considering the differences in these two “markers” it’s perhaps not surprising that they do not correlate well when compared against each other. Nor is it surprising that the lab has been unable to retire either test.

The pattern of usage for these tests in my lab has shifted in the last several years. In 2007 we ran almost equal numbers of both tests, about 500 per month of each. Eighty percent of the time, both tests were ordered simultaneously. Of those, 20 percent had one normal result and one abnormal result, 50 percent were both abnormal and 30 percent were both normal. Surprisingly, 50 percent of the time, only one single CRP and ESR was ordered, even though these tests are probably more useful when used to trend response and the majority of the time, one or both results were abnormal. This year in 2015 we are running about 1400 CRP per month and 900 ESR per month, and still 70 percent of those ESRs that we do run, are run simultaneously with CRP samples. The same services tend to order both tests, with many of the orders coming from GI, the ED, Orthopedics, Rheumatology, Oncology or Infectious Diseases. CRP tends to be ordered more frequently by general hospitalists, intensivists and Cardiology. ESR orders are STAT 30 percent of the time, while CRP orders are STAT about 22 percent of the time.

Both of these analytes are markers for the presence of an inflammatory process. CRP seems to reflect bacterial or septic processes and response to therapy to a better degree than ESR does, probably because CRP is one of the liver’s acute phase proteins and reflects liver response to injury. CRP also tends to respond more quickly than ESR, rising faster and then falling more rapidly. ESR on the other hand tends to reflect a more systemic response. With either analyte, a one-time order is a snap-shot in time. Thus often one of these markers is normal while the other is abnormal, which may explain why physicians tend to order both. Ordering either analyte as a one-time order will only tell you that inflammation is present, and the results of the tests must always be used in conjunction with other tests and clinical signs and symptoms in order to have any diagnostic efficacy. Sequential CRP or ESR samples allow for trending and helping to determine response to therapy, thus providing more useful information.

CLSI Publishes New and Revised Standards on POC Testing

From the press release:

“CLSI recently released new and revised standards on point-of-care testing in relation to glucose measuring and monitoring. Effects of Different Sample Types on Glucose Measurements, 1st Edition (POCT06-Ed1), provides information to assist the clinical and point-of-care staff in result and measurement procedure comparisons of glucose tests. Glucose Monitoring in Settings Without Laboratory Support, 3rd Edition (POCT13-Ed3), focuses on performance of point-of-care glucose monitoring systems, with an emphasis on safety practices, quality control, training, and administrative responsibility.“

These documents, including their sample pages, can be found on the CLSI Shop.

What’s That Interference?

I’ve heard it said that there is no such thing as a lab test with no interferences, and I have to admit, I believe that to be true. For every method devised to measure a specific analyte, something else can interfere with that measurement. For example, photometric measurements using absorbance assume that only the analyte of interest absorbs light at the wavelength being used. Quite often, many other compounds absorb light at that wavelength as well. In chromatography methods, we assume only the compound of interest elutes from the column at a specific time point, and again, many other compounds often do. Various types of mass spectrometry are touted as specific for the compounds being measured, however, even using mass spectrometry, compounds may fragment in similar patterns when looking at mass spectra, or fragment into the same size precursor and/or product fragments using tandem MS.

Thus, we routinely report test results knowing that most often what we are reporting is accurate. However, we must always be aware that the result we’re reporting may not be accurate due to interferences.

I recently had an occurrence related to test interference. Like all such cases, the tech responding to the clinician’s call used our standard response. He located the original sample and repeated the test. The assay gave the same results on the repeat and the result was reported back to the clinician as real and accurate, even when questions were raised by the healthcare staff about the result not fitting the clinical picture. And in fact, although the result was reproducible and in the realm of possibility, in this case the result was wrong.

The analyte in this case was plasma free hemoglobin which is performed in our lab by an assay which measures absorbance at one of the wavelengths at which hemoglobin absorbs light and subtracts a background wavelength reading. The test was persistently giving very high plasma free hemoglobin results even though the patient had no other evidence of hemolysis. When the healthcare staff became adamant about the discrepancy, the sample was sent to an outside lab which performs the assay using a full spectrophotometer, and the sample was found to have no hemoglobin present. An interferent in this patient’s sample was being measured as hemoglobin by our method.

Of course, once it’s been determined that a test is experiencing interference the next question from the healthcare provider is always, what is interfering? That’s a much more difficult question to answer, although occasionally it can be answered with some investigation. Looking into the patient’s drug regimen can help, as well as checking other health parameters to see what else is occurring. In the case of the elevated plasma free hemoglobin, the patient did have an elevated myoglobin which may have interfered.

The take home message here is that no matter how reproducible the results are, interferences are possible. As laboratory professionals, we should always be ready to look for ways to prove our results other than by repeating them, especially when the result does not fit the clinical picture and is being questioned by our healthcare colleagues. Sending the test to be run by a different method is one good way of determining interference. Another way is to check the patient’s chart for drugs or other substances that are known to interfere and are listed in the package insert. Finally, understanding the realities of assay interferences, and being willing to continue looking for answers is also important in the laboratory.

Mentoring Throughout Your Career: A Q&A With Jennifer Hunt, MD

At the 2014 ASCP Annual Meeting in Tampa, Fla., Jennifer Hunt, MD, MEd, FASCP, chair of the Department of Pathology at the University of Arkansas for Medical Sciences, had the opportunity to discuss with curious audience members the influence her mentor has had on her since she started her career. What made the experience even more special was that her mentor, Virginia LiVolsi, MD, MASCP, professor of pathology and laboratory medicine at Penn Medicine, sat right next to her and provided her own view of their mentoring relationship.

The session, which also featured an interview with special guest Barbara Pierce Bush, was out of the norm for a scientific meeting, but the topic is an engaging one, and crucial for pathology and laboratory professionals as they advance in their careers. Here, Dr. Hunt talks to Molly Strzelecki, senior editor for ASCP’s Critical Values, about her experience as both a mentor and a mentee, as well as how pathology and laboratory professionals can develop such relationships for themselves.

Molly Strzelecki (MS): When did you start mentoring others, and what are some characteristics a good mentor should have?

Jennifer Hunt (JH): As a mentor, I think it started rather early on, mentoring people who were junior to me—for example, when I was a chief resident and talking to first-year residents, or talking to junior faculty members and working with fellows. No matter where you are in your career, you’re probably a mentor to someone, whether you know it or not. Sometimes people don’t see the role as a mentor; they see the role as a friend. But if there are generational differences or differences in your status, then you’re probably mentoring as well as being a friend.

The mentor role varies based on the relationship, and what you’re mentoring the person for. I think it’s important to remember that no one mentor will be everything to you, as a mentee. You can’t have just one person and have them teach you everything. More than likely you’ll need multiple mentors at any given time in your career. And that mentor needs to recognize his or her limitations, and be able to send that mentee off to other people rather than trying to be everything to one person.

Great mentors share willingly—not just their opinions, but their opportunities, their professional interests, and the culture of their profession. They connect people. Dr. LiVolsi is the best person at that I have ever known—at meetings she would introduce me to everybody. And that becomes very important. Mentors are generous with their time, even though they are busy, and they’re wise in the areas you need them to be.

Good mentors don’t need credit for what they do. The credit is appreciated, and the mentee needs to recognize what mentors have done for them, but that’s not why mentors do what they do. There’s a lot that goes on behind the scenes. Often, my best mentors have done things that I never knew about, and I may still not know the extent. I am sure that so many of the opportunities that have come my way in life are because Dr. LiVolsi recommended me or suggested my name.

MS: Is it better to let mentorship evolve naturally, or seek it out specifically?

JH: It’s a combination of both. My relationship with Dr. LiVolsi was a very natural evolution, but I’ve had other mentors I approached about being my mentor for something specific. For example, in one of my jobs I wanted to learn lean process improvement, and to explore Six Sigma. So I went to someone in the institution who was pretty senior, and not a physician, and was in charge of those elements, and asked for his help. And he became a mentor not just for those subjects, but for many things.

I think seeking people out in situations like that is very practical and reasonable. And it’s not as awkward as it can sometimes be to seek out a general mentor—you’re approaching a person with a specific skill set and a specific goal in mind. It’s good for both people in the potential mentorship to understand what you’re looking for, or what the skill set is you’re trying to gain, or what the area is you need help with, and to start off with a narrow focus rather than a broad one. It’s easier for you to ask for that, and it’s easier for the other person to say yes when there are well understood limits to the relationship.

Getting to know each other is part of the process, too, whether the mentorship evolves naturally or is asked for specifically. It can be a little clunky, getting to know your mentee and vice versa. It is usually a little bit social, not all professional, and involves figuring out what makes people tick.

MS: Once you’ve found a mentor, how can you make sure you are getting the most out of the mentoring relationship?

JH: Good mentees ask the right questions. One of the things I often see as a problem for mentees is they ask “yes or no” questions, when what they really want is someone to think through an issue with them, and talk through the pros and cons. You don’t want a one-word answer or guidance, because you, as the mentee, may decide differently, which could put you at odds with your mentor. Ask questions that are more open-ended or opinion-based and thought provoking. Not, “Should I write this paper?” Rather, “What would be the benefit to my career if I write this paper?”

Good mentees don’t wait until it is too late for meaningful assistance—they reach out early and they don’t wait until decisions are made and paths are created, when things are harder to turn around. They ask early and touch base and connect while they’re going through things.

Good mentees don’t demand too much. There is a fine line between touching base frequently and bothering your mentor. And I think good mentees follow through and take advantage of opportunities that their mentors create for them. I’ve encountered people for whom you’d find an opportunity, and in response they’d tell me they were too busy. That’s not a good answer. I am “too busy,” too, most of the time but if I find time to present a career enhancing opportunity for a junior faculty member, let us say, the least that person can do is express some interest and enthusiasm even if that person does not feel that way.

MS: How does mentoring benefit pathology and laboratory medicine overall?

JH: If you’re talking about clinical mentoring, we transfer a lot of our knowledge and experience to others through mentoring relationships. We share cases—pathologists are never shy about sharing cases with each other, ever, and I don’t know a lot of surgeons who call each other into the operating room to ask a colleague for help. They tend to be more independent. But in pathology, we share cases; it’s part of the culture. And that’s mentoring. You share a case, you hear people’s opinions, you gather from them, and it’s in many ways mentoring, even though it’s also education.

And it never stops. I still show cases to people. Sharing is part of the process of working through it intellectually—we’re in an extremely collaborative profession. And it also makes for really excellent patient care that way, because we know we have many people to tap into for the best diagnosis.

-Ms. Strzelecki is Senior Editor of Critical Values.

–This interview originally appeared in the digital July issue of Critical Values.

MERS Outbreak in the Republic of Korea

Lablogatory spoke to Kyung Jin Cho, PhD, from the Department of Health and Environmental Science at Korea University about the current outbreak of MERS in the Republic of Korea. This is what he had to say.

Lablogatory: What can you tell us about MERS in the Republic of Korea?

Dr. Cho: MERS is a viral respiratory infection caused by Middle East Respiratory Syndrome Coronavirus (MERS-CoV). The MERS-CoV belongs to the coronavirus family (beta coronavirus). Many MERS patients developed severe acute respiratory illness with symptoms of fever, cough, expectoration, and shortness of breath. The cause of MERS is not yet fully understood. Some infected people had mild symptoms or recovered. Incubation period is known as 2-14 days. The incubation periods are still under dispute since a few cases in Korea reported incubation periods longer than 14 days. Fortunately, the MERS outbreak appears to be subsiding with one or two new cases are reported daily. Many people under the house quarantine at the peak of MERS outbreak are now released.

STATISTICS
The Korean MERS portal reported that there are 27 deaths from 175 cases as of June 23, since the first MERS patient was confirmed on May 20, 2015 (Fatality rate: 15.4%). Most of the people who died had an underlying disease such as chronic lung and kidney disease, cancer, and diabetes mellitus. Of the 27 deaths, 74.1% were male and all were over the age of 40. Of the 175 confirmed cases, male 107 (61.1%), female 68 (38.9%); the Inpatient/outpatients 80 (45.7%), family members/visitors visiting sick persons 62 (35.4%), staff and other hospital employees 33 (18.9%). Most of the MERS cases were infected within the medical facilities. The cumulative number of released individuals from quarantine is 10,718. The current number of isolated is 2,805 (home 2,091 and institution 714).

Lablogatory: How fast is it traveling within Republic of Korea?

Dr. Cho: The major second place of MERS spread was a mammoth hospital which is a top-class institution in Seoul. Within a large hospital, the Hospital S, nearly half of the cases (82 of 166 cases, As of Jun 20, 2015) were exposed to the MERS during June 5th through June 10th. The hospital S admitted the 14^th case of MERS and became the epicenter of the second generation of MERS cases. The health authority failed to carry out timely control measures against MERS. The authority and the hospital S were harshly blamed for the late response in the beginning of MERS outbreak.

During the MERS outbreak, a few doubtful MERS patients roamed about a few institutions. Some local hospitals had to refer their untreated cases to the tertiary hospitals located in big cities, like Seoul or Busan, which have excellent specialists and more resources. Unfortunately, some of the hospitals could not cope with the unexpected MERS outbreak. The triage systems in some medical institutions and the house quarantines were not operated successfully at the beginning, which contributed to the spread.

Lablogatory: Beyond the basic protocols, what other measures are being put in place, or SHOULD be put in place to stop the spread of this virus?

Dr. Cho: The Government’s rapid-response team (RST) should have activated much earlier. Government should have timely announced the list of hospitals in which MERS cases appeared and should have issued the compulsory order for the closure or partial closure of the few target hospitals much earlier. We realized that there are too few officials who are working for the government as experts in the epidemiology.

Also, the number of efficient Airborne Infection Isolation Room (AIIR) is largely insufficient. The possibility of MERS spread within the patients’ rooms and emergency room might be much higher than we would have expected.

Even though the government and some hospitals didn’t make timely responses, they disclosed the list of 84 hospitals (As of June 20th, 2015) that had MERS cases onset or MERS cases passed by. They also announced the list of 251 safe hospitals so that general citizens and respiratory patients can take the treatment under the safe conditions.

Seoul City authority asked citizens of Seoul to report MERS outbreak to Dasan Call Center (120) or official website of the Seoul metropolitan city. Citizens of other areas can report the outbreak to Korea government’s official website.

Through text messages or phone calls, the Hospital S tried to reach all the people who visited the Hospital S during the periods of high MERS exposure. Most of citizens are now well complying with the government measures.

Since some MERS patients in Korea exhibited symptoms beyond the two-week latency period, local health authorities will maintain a tent at the entrance of the town for more five days with staff to monitor if any villagers show symptoms.

The health authority is monitoring three hospitals intensively ( Hospital G in Seoul, Hospital A in Chungcheong province and Hospital G in Busan) that could possibly become new epicenters for the spread of MERS.

Lablogatory: How should institutions protect laboratory workers? What steps can clinical laboratory scientists take to protect themselves?

Dr. Cho: Information can be found here:“The Guidelines on Diagnostic Testing for MERS.” These guidelines include information about specimen collection, transport, and testing.

Continue reading “MERS Outbreak in the Republic of Korea”

Troubleshooting Complex Instrumentation

When we talk about technological advances in laboratory medicine, the discussion usually focuses on analyzers, methodology, or ancillary equipment that makes testing more accurate or efficient (hello conveyer belts and molecular testing; goodbye bleeding time). While all of those are valid conversations, one component that gets left out of the mix is troubleshooting. After all, an instrument that runs 600 tests an hour is nothing more than a place to put sticky notes if it’s not working properly.

When I first started in the laboratory, “troubleshooting” more often than not meant “put a ‘do not use’ note on the analyzer and call in the service rep.” Unless the fix was something simple (like removing a jammed cartridge), we left it to the professionals. That attitude gradually changed, however. When I left the bench, most of my coworkers thought nothing of “lifting the lid” to change tubing, observing the inner workings of an analyzer as it operated, and repairing an instrument with the assistance of a service rep over the phone. In fact, manufacturers trained us fairly extensively in troubleshooting each time we bought a new analyzer. Thanks to the ubiquity of the internet, it is commonplace for a service rep to remotely take control of an analyzer in order to diagnose and repair software (and even some hardware) issues while offsite.

So what’s next? Videoconferencing software so a service rep can see a malfunction in action, maybe, or virtual reality software that can assist a bench technologist with complex repairs. Maybe even analyzers that diagnose or repair themselves!

What do you think? What is the next innovation in clinical laboratory instrumentation in terms of troubleshooting?

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

Diagnostic Value of Viral History

Recently, the New York Times published an article about a study that appeared in Science. In the study, researchers developed a test called VirScan that detects antibodies to hundreds of species of viruses that infect humans. The research applications are broad (epidemiology studies, determining the best times to vaccinate children, disease etiology), but what about the diagnostic value of this sort of test? For starters, it could streamline tests for immune response to vaccinations (hepatitis B and measles, for example). It could also become a routine test in a “personalized medicine” setting.

What do you think? How do you see clinical laboratories using this technology?

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

Bad Press

Have you heard the expression “there’s no such thing as bad Press?” This saying makes the assumption that getting your name out there is the important thing, whether it’s something good you did or something bad you did that put you forward. I think there’s some truth to this saying because people’s memory tends to be short. They’ll remember a name but not necessarily a context for that name. This probably explains why crooked politicians, even when it’s known that they’re crooked, continue to be elected.

Thinking about this saying from a lab perspective, it means that even when a mistake is made, you may be able to capitalize on it to make contacts outside the lab, to effectively put your name out there. Even if it is a significant mistake, or is a situation you had no control over, using it as an opportunity to introduce lab personnel and lab concepts to the greater medical community is a good thing. Okay, it may take them a bit to forget the bad incident, but they will remember you and now have a lab contact for other lab-related issues.

I was considering this in the context of notifying physicians of a reagent recall, on a reagent we have been using for about 3 months. Luckily, I have a good rapport with the majority of the physicians involved, but even when fielding negative phone calls from those who do not know me, I used this event as an opportunity, an introduction and an offer of lab help on any other issues they may be having.

As a field, the laboratory tends not to blow its own horn very much outside of lab and pathology. Because that’s true, we need to learn to grab opportunities when they arise, even if they arise from less than ideal situations. It’s also an opportunity to suggest that a laboratory professional sitting on various committees may prevent future issues. Being this “forward” sometimes places people firmly outside their comfort zone, but in this day and age of decreasing test reimbursement, and decreasing money in the medical and laboratory fields overall, being an integral part of the healthcare team is more important than ever.

So, the next time you have to notify other healthcare professionals that test results that were reported may be less than accurate, try considering it as an opportunity to create new contacts and build cross-medical-field relationships. Quickly acting on every opportunity to become a well-recognized and needed part of healthcare is the best way to keep our profession alive and flourishing.

Platelet-Rich Plasma: My View from the Transfusion Service

Platelets play a significant role in primary hemostasis, however they also serve as a reservoir of a number of important growth factors, including but not limited to platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), and epidermal growth factor (EGF). Thus, autologous platelets applied topically or injected into areas of recent surgical reconstruction or to wounds are thought to stimulate angiogenesis and aid in tissue repair/regeneration. Several instruments are available to harvest platelets, (re-suspended in plasma a.k.a. platelet-rich plasma, PRP), and this provides a vehicle for delivery as a topical or injectable product.

There is no doubt that basic science and in vitro studies substantiate the release of platelet-derived growth factors and their potential role in healing, however robust trials and in vivo studies are lacking and often show conflicting results. The lack of strong clinical evidence is due to the marked heterogeneity of PRP preparations, platelet counts, and growth factor yields or activity. Differences in the site of use, type of injury and tissue, and patient comorbidities likewise contribute to the broad range of study results. Dosing regimens for optimal use are also unknown. There are no evidence-based studies of head-to-head comparisons of these products or their relative efficacies on patient outcomes. Current literature maintains that there is insufficient evidence to support the routine use of PRP in clinical practice. In spite of this, there continues to be extensive utilization of this product.

And I purposefully highlight the word product.

In my view, when allowing the use of instruments to acquire PRP, this represents manufacture of a blood product and constitutes a transfusion activity for which the Transfusion Service and specifically, the Transfusion Service Medical Director are ultimately responsible. All relevant transfusion activities fall under the auspice of the Transfusion Service and applicable standards would demand oversight of policies, processes and procedures. The AABB Standards for Blood Banks and Transfusion Services(1) clearly identify elements to be included such as equipment, suppliers, informed consent, document and record control, along with relevant quality and patient safety activities.

There are limited standards applicable to PRP specifically, such as storage temperature, expiration and conditions of use listed in the AABB Standards for Perioperative Autologous Blood Collection and Administration.(2) To this end, the International Cellular Medical Society(3), in 2011, noted a serious lack of guidelines surrounding the use of PRP and submitted a draft document which outlined elements for training, indications/contra-indications, informed consent processes, preparation, injection/application, safety issues and patient follow-up. A 2014 Cochrane Review called for standardization of PRP methods.(4)

Overall, I would venture to say that few hospital Transfusion Services are aware of the scope of use of PRP within their facility(ies). Regardless of one’s opinion of the current literature, I would urge all of us involved in transfusion practice to be informed of the use of PRP and to be vigilant in oversight of this activity. It is not merely a regulatory and accreditation issue, but our duty as laboratory physicians and clinical scientists to provide quality, safe and effective transfusion therapies to all patients. Often this requires educating our clinical colleagues and enabling them to understand our role in this critical process.

REFERENCES AND SUGGESTED READING:

AABB Standards for Blood Banks and Transfusion Services, 29^th edition, 2014
AABB Standards for Perioperative Autologous Blood Collection and Administration, 5^th edition, 2013
cellmedicinesociety.org
Morae VY et al. Platelet-rich therapies for musculoskeletal soft tissue injuries. The Cochrane Library 2014
Griffin XL et al. Platelet-rich therapies for long bone healing in adults. The Cochrane Library 2012
Leitner GC et al. Platelet content and growth factor release in platelet-rich plasma: A comparison of four different systems. Vox Sang 2006; 91: 135-138
Everts PA et al. Platelet-rich plasma and platelet gel: A review. J Extra Corpor Technol 2006; 38: 174-187

-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.