The Editor has been made aware of a meeting on February 5, 2007, where the Joint Commission, formerly known as JCAHO, held a stakeholders meeting to determine whether there was a need to incorporate blood management performance measures into their survey and accreditation process. The meeting was attended by representatives of various professional societies, as well as by representatives from the United States Department of Health and Human Services, the American Red Cross, the National Institutes of Health (NIH), the Food and Drug Administration (FDA). Reportedly, the Joint Commission will proceed with forming an Advisory Committee that will work toward developing specific performance measures.

The Editors ask if any colleagues who were present at the meeting might comment.

The following comments have been received.

ADDENDA Feb. 20, 2007

1. Dr. Jonathan Waters (attribution used with permission) attended the stakeholders meeting as a representative of the Society for the Advancement of Blood Management (SABM). He reports that the following individuals were also present, and which organizations they represented:

• Katherine Brown - National Partnership of Women & Families
• Ellen Clough and Vic Ferraris - Society of thoracic surgeons
• Gerry Hoeltge - Cleveland Clinic
• Jerry Holmberg - DHHS
• Mike Joyce - American Association of Orthopedic surgeons
• Harvey Klein - AABB
• Karen Lee and Alan Williams - FDA
• Vijay Maker - American College of Surgeons
• Jeffrey McCullough - ASH
• Greg Nuttall - ASA
• Charles Peterson - NIH
• Barbara Russell - American Nurses Association
• Jerry Squires - American Red Cross
• Aryeh Shander - Society of Critical Care Medicine

ADDENDA Mar. 17, 2007

2. A doctoral scientist in Illinois is encouraged by the actions being taken by The Joint Commission to proceed with forming an Advisory Committee that will work toward developing specific performance measures for transfusion practice. He feels that this is as an important step in improving patient care and reducing costs, while conserving blood supply and reducing adverse effects due to transfusions. He wonders if any colleagues are privy to information on whom to contact for more information on the future potential membership of this committee.

ADDENDA July 25, 2008

3. According to Dr. Steve Apfelroth, Director, Blood Bank at the Jacobi Medical Center of the Albert Einstein College of Medicine (attribution used with permission), the blood bank community should be aware that a Joint Commission technical advisory group of "stakeholders" has come up with a list of 19 "performance measures" that are being proposed for tracking performance in blood management.

In his opinion, while there is some basis for each of the measures individually, compiling and analyzing the data for the proposed measures may be extremely burdensome. He is concerned that these measures will be considered "patient care and safety related" and be applied even to blood banks that are already CAP and/or AABB accredited. This is on the basis of the interpretation that the deemed status of the inspections of those organizations only applies to "in the laboratory" issues and that the Joint Commission is entitled to reinspect patient care related "overlap" issues. To begin with, he thinks that this is an interpretation (already applied to critical value notification issues) that if allowed to stand will ultimately lead to the end of the utility of submitting to those peer-group organization inspections, and for this reason should be vigorously resisted by those who believe in peer inspections. Secondly, he does not think there has been enough involvement by the working blood bank community in developing (or resisting the scope of) these measures, and the community should consider providing input through the online survey process (by August 19th), or directly to the 20 technical advisory group members identified below. The following information is from the Joint Commission website.

Performance Measurement Initiatives
The Blood Management Performance Measures Technical Advisory Panel has identified 19 Blood Management Candidate Measures addressing key aspects of Blood Management. At this time, The Joint Commission is requesting stakeholder review and public comment of these measures. Responses to the Blood Management Performance Measurement Survey must be received by Tuesday, August 19, 2008. Direct project inquires to Harriet Gammon, MSN, RN, CPHQ at hgammon@jointcommission.org.

Background
In February 2007, key thought leaders from various organizations convened a stakeholder meeting to discuss whether sufficient evidence existed to develop Blood Management Performance Measures (Phase I). These stakeholders supported proceeding with this project, and suggested that priority areas in blood management be identified utilizing a multi-focused approach of three intersecting activities: blood conservation, appropriate transfusion and a patient-centered focus. In January 2008, Phase II of the Blood Management Performance Measures Project was initiated to identify, develop, and test a set of standardized measures to help assess blood management in the hospital setting. A "Call for Technical Advisory Panel Nominations" and "Call for Measures" was posted. There will also be an opportunity to submit measure suggestion for TAP consideration at the end of the survey. Partial funding for the project is provided through an unrestricted educational grant from Bayer Healthcare LLC. Additional funding is currently being sought to test the measures. The Call for Technical Advisory Panel (TAP) Nominations and the Call for Measures were posted from January 10, 2008 through February 2, 2008. Submissions from 65 well-qualified candidates were received; however, the panel was limited to a maximum of twenty members. There will be future opportunities to participate and provide valuable feedback throughout the project. The TAP members convened in April 2008 and identified 19 Candidate Blood Management Performance Measures to address key aspects of Blood Management. Following analysis and review of the public comment results, the TAP will reconvene and recommend a measure set to move forward for testing.

Technical Advisory Panel
David J. Ballard MD, MSPH, PhD, FACP, Co-Chair
Baylor Health Care System
Dallas, TX

Jonathan H. Waters, MD, Co-Chair
Magee Women’s Hospital
University of Pittsburgh
Pittsburgh, PA

Neil Bangs, MS, MT (ASCP) SBB
DPH-Lemuel Shattuck Hospital
Jamaica Plain, MA

Richard J. Benjamin, MD, PhD, FRCPath, MS
American Red Cross, National Headquarters
Washington, DC

Laurence Bilfield, MD
Cleveland Clinic HS - Lutheran
Cleveland, OH

Victor A. Ferraris, MD, PhD
Division of Cardiovascular & Thoracic Surgery
University of Kentucky Chandler Medical Center
Lexington, KY

John Freedman, MD, FPCPC
St. Michael’s Hospital
University of Toronto
Toronto, Ontario, Canada

Jonathan C. Goldsmith, MD
U.S. Department of Health and Human Service
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Blood Research and Review
Rockville, MD

Lawrence Tim Goodnough, MD
Stanford University Medical Center
Stanford, CA

Penny S. Gozia, MD, FACOG, MBA
St. Joseph’s Hospital,
Breese, IL

Jerry Holmberg, PhD., MT (ASCP) SBB
Department of Health and Human Services
Rockville, MD

Harvey G. Klein, MD
National Institutes of Health
Bethesda, MD

Joseph E. Kiss, MD
The Institute for Transfusion Medicine
University of Pittsburgh
Pittsburgh, PA

Mark T. Lucas, MPS, RCS, CCP
Denver Cardiovascular Perfusionists
Denver, CO

Vijay K. Maker, MD, FACCS
Advocate Illinois Masonic Hospital
Chicago, IL

John (Jeffrey) McCullough, MD
University of Minnesota
Minneapolis, MN

Aryeh Shander, MD, FCCM, FCCP
Englewood Hospital and Medical Center
Englewood, NJ

Bruce D. Spiess, MD, FAHA
Virginia Commonwealth University Medical Center
Richmond, VA

Jeffrey Wagner, BSN, RN
Virginia Mason, Medical Center
Seattle, WA

Rosalyn Yomtovian, MD
Department of Veterans Affairs, Louis Stokes Medical Center
Case Western Reserve University School of Medicine
Cleveland, OH

ADDENDA July 30, 2008

4. The following reply has been submitted by Dr. Waters in response to the July 25, 2008 comments of Dr. Apfelroth.

"As the co-chair of the Joint Commission committee which formulated these performance measures, I feel obligated to respond to Dr. Apfelroth's commentary. First, the committee representation was composed of individuals who were recommended by societies or organizations which play a role in transfusion therapy. This would include the blood banking community as well as end users. The committee had membership from the ARC, FDA, NHLBI and AABB as well as several independent blood banks. The committee also had representation from end users such as the American Society of Anesthesiologists, the American College of Surgeons, the Society of Critical Care Medicine and the American Society of Hematology. I would encourage the Forum readers to go to the Joint Commission website and review who these individuals were. I personally feel that the committee was a fair representation of groups that would be impacted by the measures. The goal of the committee was to review approximately 80 measures that were submitted to the Joint Commission. The submission period was open to all parties that had an interest in the project. Virtually, all hospitals in the US were notified of this open submission process. The committee reviewed these measures for validity and whether the measures would have an impact on patient safety. These 19 measures were the final result of the committee review."

"Once the measures were vetted by this group, a Joint Commission staff member and myself worked to put the measures into a format which provided a numerator and denominator for the measure as well as providing an evidence based rationale for the measure. I can state unequivocably that this was not easy. These measures now appear on the Joint Commission web site for public commentary. As Dr. Apfelroth suggests, I too would strongly encourage everyone who has an interest to provide commentary which we will try to incorporate into the final measures. The final measures will be a sub-segment of what currently appears for public comment."

ADDENDA July 31, 2008

5. A bench tech who works in a hospital setting is concerned that if the Joint Commission added the proposed measures, the data gathering for all these measures would fall on her. She has read each of the measures carefully and from her past experience as a blood bank supervisor, she believes each measure does need to be in place. However, if these measures are adopted by Joint Commission, then AABB and CAP would probably also put guidelines in place to ensure their accredited facilities performed the adopted measures. She does not believe the fears of having peer-review organizations excluded are well-founded. She does agree that the fact gathering would be extremely time-consuming, possibly one FTE in hospitals of greater than 500 beds. Once an algorithm is in place to collect this information, then keeping track would not be so overwhelming. She knows of at least one hospital software program that could be "tweaked" to collect most of the information suggested by the measures. She sees the biggest problem as lack of documentation of the pretransfusion, mid-transfusion and post-transfusion hemoglobins, reasons for the transfusion and the mind-set that one unit of blood is never a valid treatment. If these measures are put in place, is there an entity within (especially) smaller hospitals that can ensure physician compliance?

6. A transfusion services medical director in New England is concerned that most of the representation of the Advisory Group co-chaired by Dr. Waters does NOT include TRANSFUSION SERVICE directors. The New England physician only recognizes two on this Advisory Group that are possibly Transfusion Service directors. Also, many of the Transfusions Service directors in the US are PATHOLOGISTS at medium to smaller-sized hospitals and are not affiliated with the AABB, but are affiliated with the College of American Pathologists, which was not mentioned as a group that was represented. Blood suppliers and end users seemed to be well represented in this Advisory Group, but are unlikely to be the ones responsible for coordinating the collection and analysis of this type of data, which is maintained mainly in the Transfusion Service databases (many of which may require manual review for data collection).

ADDENDA August 12, 2008

7. Dr. Irwin Gross, Medical Director, Transfusion Services at Eastern Maine Medical Center (attribution used with permission) comments that he is surprised by what he perceives to be a generally negative tone of the document posted by the AABB “detailing issues, concerns, advantages and disadvantages of the Joint Commission’s 19 proposed Blood Management Performance Measures.” The AABB document seems to reluctantly suggest that many of the measures “may lead to outcomes improvement” while going into great detail about the disadvantages of each proposed measure. He adds that gathering the data required for many of the measures presents a challenge for many hospitals. However, he believes that in many instances the resources to do this might be made available by redirecting resources currently dedicated to gathering data for “quality measures” that have had little impact on transfusion practices and quality of care. The tremendous variation in transfusion practices between institutions and between providers within institutions strongly suggests the need to improve transfusion practices. In his opinion, AABB needs to be more proactive in ensuring appropriate clinical use of blood products. Under the guiding principle of “no opposition without a proposition” he would like to see the relevant AABB committees make a greater effort to suggest constructive alternatives to the Joint Commission’s proposed Blood Management Performance Measures or suggestions on how the proposed measures might be improved. He urges e-Network Forum readers to review the Draft Blood Management Candidate Measure Profiles, fill out the survey, and provide constructive suggestions on how the proposed measures might be improved."

ADDENDA August 17, 2008

8. Dr. Waters (see his postings of Feb. 20, 2007 and July 30, 2008) concurs with Dr. Gross (posting of August 12, 2008) in that multiple criticisms of the Joint Commission performance measures have been vocalized, but few of these criticisms have been constructive. Having spent considerable time pondering these measures, Dr. Waters can tell the readership that it was not easy to formulate the performance measures so that they are fair to all parties affected. The point of putting the proposed performance measures out for public comment is to gather good ideas to improve them. In this way, it is hoped that they make positive improvements in patient care. So, if colleagues don't like the measures, Dr. Waters asks for constructive suggestions for how to write a nominator and denominator with appropriate exclusion groups that gets at the heart of the proposed outcome improvement.

ADDENDA August 21, 2008

9. Dr. Richard Spence, Medical Officer of Infonale, a Haemonetics Company, attribution used with permission) acknowledges that he is troubled by several of Dr. Apfelroth's statements, including the characterization that there is only "some basis for each of the measures individually." In Dr. Spence's opinion, one can find strong, evidence-based literature to support every one of the measures. The sample references included in the Joint Commision document are only a few among the many to be found in a PubMed search. The measures are "patient care and safety related" and colleagues certainly must be aware of the strong associations between blood products and patient morbidity. This list is long, including not only transfusion-transmitted infections but TRALI, development of microchimerism, volume overload, cytokine and free hemoglobin infusion, transfusion reactions, and immunomodulation with its associated increased risk of systemic inflammatory response syndrome, postoperative infection, nosocomial pneumonia, etc. More importantly, all must be aware of the ongoing "burden" created by indiscriminate and inappropriate use of blood products. These are ALL valid patient care and safety issues, and, as such have gained the attention of patient safety watchdogs including the Leapfrog Group and CMS. Dr. Spence adds that "Blood bankers are to be congratulated for having aggressively addressed some of these issues but their reach is limited. CAP and AABB certification helps but its focus is on the laboratory, not in the clinical wards. I venture to guess that few, if any, clinicians outside the laboratory even know what CAP and AABB are. Although hospital transfusion committees have attempted to bridge the gap between the lab and the patient floors they have been 'burdened' from the outset. In my experience, clinicians assigned to the committee rarely attend, data sampling from chart review is haphazard, and transmitting all information in the form of a scolding letter is too little and too late to make any difference. The main role of the transfusion committee has been to create a paper trail that fulfills current requirements of the Joint Commission to "monitor the use of blood and blood components." There are examples of proactive committees and programs but these are few in number." He concludes saying: "We can no longer accept business as usual in monitoring and promoting safe practices in transfusion. Consider that some still adhere to the"10/30" rule published in 1941. Imagine the impact of using 65+ year-old practice guidelines in all we do. Is it possible that compiling and analyzing data ... may be extremely burdensome? Yes, if hospitals persist in using 65+ year old methodologies such as manual chart review, data entry and analysis of the numerous variables involved in the measures. There are ways available to do this much more efficiently. However we do this, I believe we must not shy away from our responsibility to "do no harm." The proposed Joint Commission measures are designed to focus us on this responsibilty and, as such, are a long-awaited and much needed wake up call. "

ADDENDA August 22, 2008

10. A Blood Bank Medical Director in New York City shares some of the concerns raised by Drs. Apfelroth (July 25) and a transfusion services medical director (July 31) regarding the proposed Joint Commission performance measures for transfusion. The College of American Pathologists certainly should have been represented on any such working group. Although there is a need for greater consensus and uniformity in the practice of transfusion medicine nationally if not globally, the New York Blood Bank Medical Director thinks that it should come about as a result of well-funded prospective studies. These should be performed as research projects in institutions that can support such activity. Those practices that hold up under such scrutiny then should be put forward and adopted by the Transfusion Medicine community.

The responding physician is sympathetic to the intentions of the Joint Commission working group and respects the amount of effort that was expended in compiling the proposed measures. However, the physician thinks that some of the suggested measures constitute mini-research projects. Many hospitals do not have the resources to undertake such projects. Also, if hospitals are forced to adopt performance measures mandated by outside agencies, resources may be diverted from institution-specific quality assurance issues that need to be addressed, but are not on the list of externally imposed performance measures. Blood Bank Directors and other stakeholders within individual institutions are in the best position to know what performance issues need to be addressed within their own hospitals. Moreover, these issues change over time in a given institution and they need to be examined when relevant. Externally imposed performance measures do not offer that flexibility. In summary, the New York physician does not think that we need additional unfunded mandates for hospital Blood Banks, particularly when there has been inadequate representation by the a significant segment of the real stake holders.

ADDENDA February 26, 2009

11. A colleague calls our attention to the Joint Commission website: Blood Management Performance Measures Project - Last Updated 12/08. The Blood Management Technical Advisory Panel (TAP) has recommended that 12 of the 19 candidate measures be incorporated into nine performance measures. These measures will move forward for detailed specifications development. The areas recommended for measurement include: transfusion indication, informed consent, blood administration, pre-operative testing, transfusion of multiple units and specimen testing. The Joint Commission is actively seeking funding to test the measures to ensure their feasibility and reliability for national use.

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