Seheult JN, Dunbar NM, Hess JR, et al. (on behalf of the Biomedical Excellence for Safer Transfusion [BEST] collaborative) Transfusion. 2020;1–12.

https://europepmc.org/article/med/32901965

Reviewed by Mary Berg, MD

The authors conducted a retrospective study, gathering information from nine level I trauma centers regarding trauma patients who required emergency transfusion.  They separated them into categories, depending on whether or not they received incompatible plasma.  The trauma centers provided information regarding the nature of the trauma (blunt force versus penetrating), amount of blood & components infused, patient demographics, and patient outcomes.  The amount of plasma infused per product was standardized, with the following values assigned: 40 mLs per RBC unit, 342 mLs per whole blood unit, 234 mLs per plasma unit, 68 mLs per whole blood derived platelet, 239 mLs per apheresis platelet, and 23 mLs per cryoprecipitate unit.  For example, if a non-group O patient received a unit of low-titer O whole blood (LTOWB), they were listed as receiving 342 mLs of incompatible plasma; if a group B patient received a unit of A liquid plasma and an O RBC unit, they would be recorded as having received 234 + 40 = 274 mLs of incompatible plasma.  Most patients who received incompatible plasma also received compatible plasma.   The median amount of incompatible plasma infused was 342 mLs.  Comparisons were made between the patients who only received compatible plasma and those who received incompatible plasma; the incompatible plasma was further divided into those who got less than or equal to 342 mLs and those who got more than 342 mLs.

The statistical analysis showed that the patients who received only compatible plasma had similar demographics to the patients who received incompatible plasma.  There was no statistical significance in their injury severity scores or in their mortality at 6 hours, 24 hours, or 30 days.  As would be expected, group O patients were only represented in the compatible plasma transfusion patients so there was a difference in ABO types between the two categories of patients.

When comparing the compatible plasma patients only to those who received more than 342 mLs of incompatible plasma, differences were seen in that the >342 mL incompatible plasma group received more transfusions overall (e.g. 71% received platelets, compared to 53.5% of compatible plasma patients who received platelets). For the >342 mL incompatible patients, 36.1% received > 10 RBC and/or LTOWB units in 24 hours and had higher injury severity scores, compared to 19.5% of the compatible plasma patients who also had lower injury severity scores.  With that background, it might not be surprising that mortality in the >342 mL incompatible plasma patients was higher than that of the compatible plasma patients (7.5% versus 4.5% at 6 hours, 14.2% versus 9.0 % at 24 hours, and 28.0% versus 19.6% at 30 days).  No comparison was made between the patients who received >342 mLs of only compatible plasma and those who received > 342 mLs of incompatible plasma.

The authors point out several reasons as to why patients who received higher amounts of incompatible plasma might have done worse than those received only compatible plasma.  It might have been that patients received more incompatible plasma because they received more plasma overall, due to higher injury severity scores.  Laboratory parameters were not included with the patient data, so coagulopathy or degree of anemia could not be assessed, but might have played a role.  Bearing in mind that data was collected from nine sites, differences in practices might have affected how patients were transfused & thus how much incompatible plasma they received.  As an example, only three sites reported giving LTOWB, with one site giving it to 3 patients and another site giving it to 172 patients.  Differences such as this could have contributed to the amount of incompatible plasma given especially if, for example, LTOWB was only given to the most severely injured patients.

The authors emphasized that no difference in mortality was noted between the compatible and incompatible plasma patients when all patients where considered.  They also emphasized the need for additional studies to investigate whether giving higher volumes of incompatible plasma might be clinically significant.

The Centers for Medicare & Medicaid Services (CMS) Laboratory Date of Service (DOS) exception Policy at 42 CFR 414.510(b)(5) requires laboratories performing Advanced Diagnostic Laboratory Testing (ADLT) and molecular pathology testing on outpatients covered by Medicare discharged within the prior 14 days to bill CMS directly instead of seeking payment from hospital.  The DOS is a required field in Medicare claims submission. In many cases, the DOS for a laboratory test is the date the specimen was collected. However, with this DOS policy, CMS stipulates that for molecular pathology test or an ADLT that meets the criteria of section 1834A(d)(5)(A) of the Act, the DOS must be the date the test was performed if:

• The test is performed following the date of a hospital outpatient’s discharge from the hospital outpatient department; and
• The specimen was collected from a hospital outpatient during an encounter (as both are defined 42 CFR 410.2); and
• It was medically appropriate to have collected the sample from the hospital outpatient during the hospital outpatient encounter; and
• The results of the test do not guide treatment provided during the hospital outpatient encounter; and
• The test was reasonable and medically necessary for the treatment of an illness.

For blood centers that have molecular immunohematology laboratories and/or histocompatibility laboratories that perform DNA-based testing, this policy would have had a significant impact on their operations. Specifically, many blood centers are not HIPAA covered entities and do not have the systems in place to bill Medicare directly. Instead, most blood center laboratories offering testing services to hospital clients bill those hospitals for testing performed, and the hospitals then submit the testing for reimbursement with the third-party payers, including Medicare.  If compliance with this policy were required, it could have had significant impact on the ability of blood centers to continue offering these services to hospital customers. Specifically, it would have required significant financial investment and placed considerable administrative burden on most blood centers to become HIPAA covered entities and establish revenue cycle management systems in their centers such that they could bill payers directly. It also was predicted to cause confusion and possibly billing irregularities since blood centers typically would not have the patient information necessary to determine if specific patient testing would fall under the policy or not.

This policy was published in the CY 2018 Hospital Outpatient Prospective Payment System (OPPS)/Ambulatory Surgical Center (ASC) final rule on December 14, 2017, with implementation July 2018. On July 3^rd, 2018, CMS announced enforcement discretion would be exercised until January 2, 2019 and then on December 26, 2018, CMS announced a 6-month extension to enforcement discretion period, until July 1, 2019.  Finally, on June 25, 2019, CMS extended that period a third time until January 2, 2020. 

AABB, Americas Blood Centers (ABC) and American Red Cross (RC) worked together to assess the potential impact of this policy as well as request that CMS consider a revision to the policy. On July 29, 2019, CMS released a proposed revision to the DOS policy. Specifically, CMS offered three alternatives and requested public comment.  The three alternatives were

• Exclusion of blood centers and blood banks from the Laboratory DOS policy
• Exclusion of molecular pathology tests from the policy, limiting it to ADLTs
• Limiting inclusion to testing that is deemed by the ordering physician to that not intended to guide treatment during the hospital outpatient encounter

In late July 2019, CMS released a request for comment on potential revisions to the policy that may exempt Red Cross testing. In late September 2019, responses were submitted by Red Cross as well as joint response from Red Cross/ABC and AABB. Both responses supported an exemption for laboratories located in “blood centers”.

On September 26, 2019, the three organizations (AABB, ABC, RC) submitted a letter to CMS urging them to finalize the exclusion of all molecular pathology testing of red blood cells, white blood cells and platelets performed by blood banks and blood centers from the laboratory DOS policy. The reasoning was that these centers perform this testing primarily to identify the most compatible blood products for patients. This strong advocacy was effective.

On November 12, 2019, CMS published revision to the laboratory DOS policy within its OPPS final rule. It excluded blood banks and blood centers from the policy. Therefore, though enforcement discretion ended January 2, 2020, there is no change to the process by which laboratories performing molecular pathology testing on patient samples are billed. Specifically, hospitals continue top bill Medicare “under arrangement” for the testing performed by the blood center-based laboratory.  After nearly 2 years of uncertainty, blood bank labs performing molecular pathology testing and the hospitals they serve have clarity and certainty about the billing process for this important and growing area of transfusion medicine.

Useful Links

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Lab-DOS-Policy

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-

Outpatient-Regulations-and-Notices-Items/CMS-1717-FC

NOTE: The views expressed do not necessarily represent the view of the American Red Cross.

Reviewed by Mary Berg, MD

There has been much debate about the ‘30-minute-rule’ with regard to the transport and storage of red blood cell (RBC) units.  The authors of this study performed two well-controlled experiments to get a better understanding of the factors that affect RBC unit temperature.  First, they applied two different temperature sensitive indicators to 50 RBC units that were then issued for transfusion and recorded how long it took for the indicators to achieve a color change indicative of the unit reaching 10 degrees celsius.  The temperature indicators used were the SafetyVue10 (STV10, Temptime Corporation, Morris Plains, NJ) and the Timestrip Blood Temp 10 (BT10, Timestrip UK Ltd, Cambridge, UK).  Factors that were controlled for this study included when the temperature indicators were applied (at the time of issue), where on each unit of blood the indicators were applied (lower portion, near the ports), the age of the units (25-27 days), the type of unit (CPDA-1), where the units were transfused (for consistent transport time and environmental conditions during transfusion), and duration of the transfusion (92-113 minutes, median 100.5 minutes).

One author was responsible for reading the temperature indicators (for consistency) and another author verified the first author’s finding in five cases.  What was described for this experiment is that the BT10 changed color much earlier than the STV10 (median 5.6 minutes versus 19.0) minutes.  The STV10 had great variability as to when the color changed (interquartile range 10.1 to 23.0 minutes) compared to the BT10 (interquartile range 4.9 minutes to 7.5 minutes).  In addition, the authors indicate that 4% of the STV10 and 18% of BT10 showed initial color change during transport; 94% of STV10 and 100% of BT10 showed the color change within 30 minutes of being issued.  In addition to the variability of time for the color change, the authors commented on the difficulty in interpreting the color change. (Was it partially red or pink or completely red?)

The second part of the experiment involved 18 RBC units that were intended to be discarded, usually due to an elevated ALT measurement in the donor.  A type K thermocouple was inserted into each unit and the BT10 and STV10 temperature indicators were applied to the surface, similar to the units in the other experiment.  These units were then transported similar to the units in the first experiment to simulate transfusions.  Also similar to the first experiment, a second observer verified the reading of the temperature indicators for five units.

For this second experiment, the time to reach 10 degrees C was 24.4 + 7.4 minutes for the STV10, 14.3 + 6.4 minutes for the BT10, and 20.6 + 7.6 minutes for the core temperature reading.  With continuous reading of the core temperature, they found the median to be 10.1 C at 20 minutes, 11.0 C at 25 minutes, and 12.0 C at 30 minutes.

Although this was a small study, it was well-controlled and did a good job to demonstrate the variability of temperature indicators available for clinical use.  In addition to the debate of whether the ’30 minute rule’ is appropriate, the authors ask if the ’10 C’ rule is appropriate. (Is a unit more likely to be contaminated at 10.2 C than it might be at 9.8C?)  Reaching a consensus on these questions will require future debate, more data, and the ability to more consistently measure the temperature of units of blood.

Q:  Tell us a little bit about your practice and current position.    

A:  I am in a pathology group, Gulf Coast Pathology Associates, which provides Transfusion Medicine Consultative Services that are somewhat beyond the usual. The beginning of our service can be traced back to the 1970’s at the Texas Heart Institute in the Texas Medical Center, during the era of famed cardiac surgery pioneers such as Dr. Denton Cooley. As these early cases were quite a strain on blood resources, the Blood Banker of the time, Dr. John Milam, was frequently called to the CV OR to assist with massive transfusion. As Transfusion Medicine Physicians, our understanding and application of coagulation testing, blood components, and in the modern era, hemostatic agents, is beyond that of other specialties’. We choose to be directly involved in bedside care of the patients, and the Service is very much appreciated by our colleagues. Dr. Art Bracey can be credited with increasing the visibility of the service in later decades, and as new technologies arose in heart transplantation, artificial hearts, ventricular assist devices, extracorporeal membrane oxygenation, and other cardiovascular support, our Service grew rapidly. Other institutions within the Texas Medical Center are now performing these procedures, and in the last few years I have been involved in establishing this same Service at UT-Memorial Hermann.

Q:  What is a typical day like for you?                                                                                                     

A:  On call, our Service is a bit of a blend between Medicine and Surgery, built on a core of Pathology. We usually round on our ICU patients first thing in the morning, prioritizing ones we know have had bleeding issues. We perform histories and physicals on new patients, write progress notes on established patients, order coagulation testing, evaluate the results with our understanding of the limitations of the testing, and then order blood products and hemostatic agents as we deem needed. By later morning, the ORs are busy, and we will be consulted on cases with ongoing or high risk of bleeding, such as redo-sternotomies, complicated surgical plans, or recent anticoagulant and/or antiplatelet effect. We stay in the OR during the most critical portions. OR cases or rounding often extend into the afternoon and not uncommonly evening, and a little teaching usually happens with residents or fellows in the afternoon. Probably once a week there will be a late night / early morning case, typically a heart transplant. Fortunately, we have a team of Blood Bankers taking this call, so we take turns and give each other a chance to recuperate!   

Q:  What do you enjoy most about what you do?

A:  I very much enjoy being able to apply knowledge in our field to care of a patient in front of me. I think most Blood Bankers appreciate direct patient care to some extent, and our Service fosters this to a greater extent. I also know that this exposure as a Transfusion Medicine Consultant gives me a better understanding of what our clinician colleagues experience, whether the issue is difficulties with blood ordering in the electronic system, or inefficiencies in resulting or viewing of reference labs, or confusion with nursing staff over protocols. This allows me to serve as a better intermediary between the clinicians and the Blood Bank, improving trust and communication, which benefits all, including the patients.

Q:  What are three events that helped to shape your life/career?              

A:  My career, as I suspect with most, has been greatly influenced by outstanding mentors. I was an MD / PhD student in the Genetics Department at Baylor College of Medicine, and I had started in a lab studying yeast genetics. However, I then met Dr. John Belmont, a member of the department who was studying hematopoiesis at the time, and was struck by how a brilliant physician-scientist could also be a nice guy. Being nice is one of my life goals, by the way. I switched to Dr. Belmont’s lab, completing a thesis searching for genes involved in murine hematopoiesis, and this started my path into blood.

My fellowship in Blood Banking was also at Baylor College of Medicine, and I was the first to go through several months of rotations at St. Luke’s, under the direction of Dr. Art Bracey. Until working with Dr. Bracey, I had not seen how closely a Blood Banker could be integrated into the daily care of these critically ill patients. I had again found the unique combination in a mentor of both brilliant and nice, and one easily sees the effect of this as Dr. Bracey is simultaneously respected and adored by the hospital staff, whether lab, nursing, or clinical. My current clinical work is modeled after the services Dr. Bracey developed.

One other event that had a tremendous impact on me actually happened before the other two. After graduating from college at Rice University, I was award a Thomas J. Watson Fellowship, a national grant for independent international study. My project was the study of Endangered Parrot Species in the Eastern Caribbean, Australia, and Indonesia, and I traveled alone for a year to these locations. The Fellowship does not permit coming back to the States during the year, nor enrolling in any educational institution, so I experienced real life in parts of the rest of the world. As a result, I value seeing issues from different viewpoints, thinking on a larger scale, and coming up with ideas outside the box. I am also now an avid world traveler!  

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o   I haven’t done video for several years, but the old videos that I did (some of which are getting outdated and will soon be removed) were the result of an enormous amount of work. I am a blood banker, so it will surprise no one that I suffer from the curse of perfectionism! Because I tried to make everything “just right,” each video took weeks to produce. I look at those videos today and see so many things I would change (they are NOT perfect!), but they seem to have helped many, many people, so I’m grateful.

For new content, I usually just follow the emails and questions I receive. Early on, I set up a link on BBGuy.org for people to ask me things (BBGuy.org/Ask). Today, I receive dozens of questions every week from the site, as well as from Facebook and Twitter. When you get that much input, certain themes often start to pop out. For example, I mentioned earlier that I did a recent podcast on the DAT with Sue Johnson. In 2016, I received numerous technical and interpretation queries about the DAT, so I asked Sue to discuss it with me on the podcast early in 2017. I was shocked at the response, as the episode (BBGuy.org/028) was downloaded over 2000 times in the first three days after it was released!

You’ve started podcasting recently, what has been your most memorable interview so far? Who would you like to have on your podcast but haven’t been able to yet?

o   I feel so fortunate to have had so many people that I respect be guests on the Blood Bank Guy Essentials Podcast so far! There’s no way I could pick just one! I had Nancy Heddle on shortly after the RECESS trial on the age of blood controversy was published, Jeff Carson after the AABB RBC transfusion guideline came out, and I interviewed two people that I really admire in immunohematology, Connie Westhoff and Sue Johnson. Those were terrific, but I guess if I had to choose, two interviews really stand out as being most memorable: First, episode 033 (BBGuy.org/033) with Dr. Scott Weingart. Scott is an Emergency Medicine/Critical Care physician, and he had me on his podcast (EMCrit.org/202) to discuss blood bank issues for his audience, and I had him on mine to discuss Emergency Medicine issues for mine. Those interviews generated lots of interest, and were eye-opening for many! Second, episode 012 with Cassandra Josephson was so much fun! Cassandra is a world-renowned pediatric transfusion specialist, and like me, she talksreallyfast when she gets excited! We had an absolute blast discussing pediatric transfusion topics.

As far as other “dream guests,” I’ll just have to keep that one to myself! You’ll find out!

What advice would you have to someone following in your footsteps or someone wanting to educate others out there about transfusion medicine?

o   I always tell those that I am teaching that they must follow their passions. Don’t ever try to be something that you aren’t. I realized very early in my career that I just loved to teach people the essentials of blood banking and transfusion medicine. I didn’t need to be standing up at the AABB Annual Meeting discussing super high-powered and esoteric research topics. I’m grateful for those that are gifted to do that; clearly, we need smart people to make new discoveries and publish cutting edge stuff! However, that isn’t my sweet spot, or my desire, and I love the platform from which I get to operate. Everyone should find their own path, suited to their passions and talents.

As far as future educators, my advice is simply that they should be sure that education is the pathway they really want. In my view, lousy teachers do more harm than good to those they are teaching, so people who hate to teach, shouldn’t teach! Further, all teachers should prepare to be committed to those you are teaching. I truly believe the old saying, “People don’t care how much you know until they know how much you care.” Whether I am teaching someone one-on-one or speaking into a mic to an unknown listener while recording a podcast, I am deeply invested in their success. I want to see a new generation of blood bankers take our field to something far beyond anything I could have imagined! My mission is to help them lay a solid educational foundation on which those amazing future discoveries can be built.

Can you tell us what to expect on any future interviews, podcasts or videos?

o   Blood banking can be difficult and complex, especially to those who are just starting out or who have been away from the field for a while. The future of BBGuy.org is to continue hammering home the principles of basic blood banking and transfusion medicine. I will keep putting together content that accomplishes that goal. I see the site as a place where people can always go and learn the basics. I’m excited to let SCABB folks know that I have teamed up with TransfusionNews.com on an exciting new collaboration that will help people get even more benefit from listening to my podcast (check back soon for more details)!

In addition, I am working on a new project for those who want to take things to the next level in their progression to mastery of blood banking. I believe people learn better with personal interaction with an educator who cares about their success and with a community of other learners. As a result, I am developing an online blood banking educational course that will offer on-demand, high quality, on-camera video teaching as well as direct, regular access to me and to others who can help answer their questions. The idea is to guide people along the pathway toward not just passing a test, but achieving true mastery of the topic! Details are coming soon, but people can get on the information list at BBGuy.org/subscribe and I’ll keep them posted.

What has been your favorite Blood Bank Guy interview?  Do you have any additional questions for Dr. Joe Chaffin? 

 Or any thoughts for future interviews or educational content?

 SCABB offers a variety of educational webinar topics including SCABB Online Accredited Resources (SOAR) and upcoming SCABBinars.

 Please check out the educational opportunities and additional information available at SCABB.org and BBGuy.org. 

o   I still see those three things as crucial and think that the past two years have only reinforced my thoughts from back then. In addition, the current financial climate in our industry is rapidly taking us to places we have not seen before. The consolidation of hospitals into large systems, in conjunction with the startling financial savings some large institutions have reported after implementation of PBM programs, as well as a commodity approach to blood by hospital supply chain folks, has led to an era of unprecedented declines in blood product pricing. Saving money seems like such a great thing for a hospital, of course, but I’m not sure how much of that savings is being passed on to patients (the cynic in me says very little). Further, the millions of dollars of revenue being removed from blood centers has led to an environment where consolidations, mergers, and affiliations of blood centers is inevitable.

Since we’re discussing changes in the industry, how do you see the current merger and affiliation mania especially amongst blood centers playing out? Do you think it will lead to better service and patient care?

o   Caveat: I can’t and don’t speak either for my blood center or for any organization with which my blood center is affiliated. I am currently in the middle of “merger and affiliation mania,” as you aptly put it, so it’s hard to have perspective on this issue. I will say that, in my opinion, mergers and affiliations are usually done with a primary aim of reducing costs and stabilizing or increasing revenues rather than improving service. I think that some of them can lead to better service (in particular, if a smaller center is now able to offer more advanced procedures and products by affiliating or merging with a larger system), but I also think that some of what makes medicine fun is lost in the process. Specifically, fewer smaller, independent centers can mean fewer dissenting opinions and less variety, and I think that we as an industry are strengthened when people are trying different things in different places. The short answer: We will see.

What are your thoughts on centers diversifying their product and services offered? For example, some options out there are large volume plasma collections for manufacturing, large volume blood grouping by DNA sequencing, and manufacturing of CAR-T or other immune based products.

o   Diversification of products and services is not optional for blood centers in 2017 and beyond. Due to decreasing demand for our product (a good thing) and decreasing blood product pricing (ummm, a good thing for someone!), blood centers must move in different directions to keep their doors open! You have mentioned some options, and certainly, cellular therapy offers many possibilities, but they often feel somewhat vaguely defined. There is no “one size fits all answer” out there, and centers must try to define what they can do to distinguish themselves. Some have chosen to move heavily into new research, while others have focused on performing collections for cellular therapy products, and still others on supplying raw materials for further manufacture.

What do you think our industry will look like in 5-10 more years? 

What have we learned from the recent changes that have faced our industry?

 Visit SCABB.org or BBGuy.org for more information and opportunities to become more involved in the transfusion medicine community.

 Tomorrow: The Blood Bank Guy: A Conversation with Dr. Joe Chaffin Part IV