Dear Ms. Gammon:
AABB is an international association dedicated to advancing transfusion medicine and cellular therapies worldwide. Our members include approximately 1,800 hospital and community blood centers and transfusion and transplantation services as well and 8,000 individuals involved in activities related to transfusion, cellular therapies and transplantation medicine. For over 50 years, AABB has established voluntary standards for, and accredited institutions involved in, these activities. AABB is focused on improving health through the advancement of science and the practice of transfusion medicine and related biological therapies, and developing and delivering programs and services to optimize patient and donor care and safety.
AABB appreciates the opportunity to provide comments on the nineteen Blood Management Candidate Measures. AABB has been a long time supporter of transfusion standardization as evidenced by the AABB Standards for Blood Banks and Transfusion Services, now in its 25th edition (AABB Standards). Accordingly, AABB is fully supportive of The Joint Commission’s initiative. The following comments are intended to raise issues for further consideration, with the intent to further enhance the performance measures of greatest importance.
General Comments: Overall, AABB recommends and encourages further coordination between AABB and The Joint Commission moving forward. AABB is concerned with the development of The Joint Commission Blood Management Performance Measures that are not coordinated with AABB Standards, as the value of a uniform nationwide approach to maximizing patient care and safety may be jeopardized as blood collection facilities and transfusion services try to coordinate individual responses to what could become two sets of standards. Renewed attention by The Joint Commission to blood transfusion is beneficial, and carries great impact for hospitals. For measures which are not being implemented already, the availability of transfusion performance measures could be an inducement to find ways and means to accomplish these measures.
AABB is considering incorporating elements of The Joint Commission Blood Management Performance Measures into the AABB Standards. Conversely, AABB requests that The Joint Commission consider conforming its performance measures to the AABB standards. We respectfully request that AABB standards experts have an expanded role in The Joint Commission Performance Measures selection and revision process.
The Joint Commission should incorporate or select performance measures that reflect existing Joint Commission or AABB standards. Otherwise these are “performance measures” in theory, but become additional “Joint Commission Standards” in practice, without going through the more rigorous Joint Commission or AABB standards creation and review process.
AABB also notes that simpler is generally better. There may be significant concern over the fact that there are 19 measures currently proposed. Consolidation where possible should be considered.
Participants should be advised that these measures when reported to The Joint Commission become part of the public domain (i.e., accessible to the general public). The Joint Commission should also clarify that these measures are mandatory only if the hospital chooses to use them as one of its performance measure sets.
Also, since not all hospitals will choose to use these performance measures, there is a possible participation bias as to which hospitals would choose to use these performance measures. Results if not clearly explained could be misinterpreted as benchmarks for all hospitals.
The AABB notes that although well intended, there may be a number of hospitals which are in the process of creating or designing Computer Physician Order Entry (CPOE) and Electronic Health Record (HER) systems and may be compelled to create mandatory documentation requirements (i.e., hard stops in the ordering or documentation process) that may be compliant by design but may impede life-saving treatments instead of creating electronic auditing or reporting processes that capture data. For example, a system could be created where no transfusion order can be transmitted, issued, or started without all required documentation and indications being met despite an exsanguinating bleed from a patient with a previously normal hematocrit. The performance measures would be superb in this design (100% because of the hard stops) but there would be avoidable fatalities due to systems flaws (see Han et al. Pediatrics 2005; 116:1506-1512). Clear and unambiguous directives must be given to hospitals customizing their CPOE and EHR to avoid these types of systems flaws with the implementation of any mandatory performance measure.
Specific Comments: With regard to the 19 Blood Management Candidate Performance Measures, AABB assembled an ad hoc working group of experts from its Scientific Section Coordination Committee (SSCC) and Clinical Transfusion Medicine Committee (CTMC) to review the proposed performance measures. The remaining comments are specific to each performance measure. While the working group agreed with and is supportive of the value of the performance measures, specific comments, which are included as the Attachment to this letter, identify potential concerns for further consideration.
AABB strongly supports initiatives that improve the safety of transfusion for blood and blood component recipients. AABB would appreciate the opportunity to work more closely with The Joint Commission to ensure that all performance measures are consistent with established and future standards.
Questions concerning these comments may be directed to Phil Schiff, (301) 215-6550, Phil@aabb.org.
Phil Schiff, JD
Division Director, Government Affairs, Administration and Business Development
BM-1 Transfusion Indication
· Depending on the health care system, this measure may be very difficult and labor intensive to monitor. Few institutions can capture these data electronically. In addition, some order-entry systems include standing orders (e.g., ECMO, heme-onc) that are separated from the blood orders and laboratory tests. Manual review would be required to retrospectively tie the pre-post lab tests with the time of issue in many settings.
· It will be difficult to monitor this measure in operating rooms.
· The category of “patients that receive blood emergently” must be more explicitly defined, and may also require some corresponding documentation (e.g., trauma protocol).
BM-2 Blood Transfusion Informed Consent
· It is important that clinicians obtain some form of documentation for indicating consent; that either informed consent was obtained from the patient or legal guardian or that the urgency of the clinical situation warranted transfusion without obtaining informed consent first. Note: because informed consent is often documented in different ways, in some institutions monitoring this parameter would require manual chart reviews. Efforts must be made to avoid further burdens on the hospital staff.
· This measure should also address how often a consent needs to be signed for chronic transfusion patients (e.g., sickle cell anemia patients), and whether the informed consent policy for blood can be separate from other informed consent (e.g., informed consent associated with surgery).
BM-3 Blood Administration Documentation
· This measure may combine too many elements (e.g., patient identification, monitoring and vital signs, and adverse reactions and interventions) into a single measure to be useful as a basis for outcome improvements.
· Definition of active bleeding as 4 units of RBCs within 1 hour is too stringent, does not address other emergency situations, and may lead to additional difficulties in identifying patients that fit these criteria.
· In pediatrics, “patient education” should be parent or guardian education. It is also noted that there is an overall lack of attention to pediatric transfusion patients in these draft measures. Pediatric transfusions should be addressed.
· It is anticipated that capturing these data will require considerable manual effort. Again, given procedures already in place, every effort should be made to minimize additional efforts demanded of hospital staff.
BM-4 Time to Crossmatched Blood Administration
· Time to crossmatched blood administration is only one aspect of emergency transfusion. The objective is to measure adequacy and timeliness of transfusion. As written this measure would not accomplish the objective.
· It would be difficult to identify, track, and measure this small patient subset.
· Outcomes for this measure are significantly affected by technologies that are differentially available or applied in different settings (e.g., use of electronic crossmatch, availability of emergency release units in the emergency department).
· The specifics of the proposed measure do not take into account currently available technology. Most automated testing requires 45 minutes at a minimum, excluding labeling, dispensing, transport, etc.
· It is important to consider how one would correct the results for patients who, following initial evaluation, did not need crossmatched blood after all. It is likewise important to ensure that the specimen is drawn prior to transfusion.
· The numerator of patients transfused with crossmatched blood within 60 minutes of arrival in emergency department (ED) who receive uncrossmatched blood is not meaningful. This presumes that all uncrossmatched blood in ED is requested before or at arrival which is not always the case. The measure should consider 60 minutes following receipt of uncrossmatched blood rather than 60 minutes from time of arrival.
· This measure might be improved by focusing on turn around time from receipt of stat emergency department samples in the blood bank to completion of ABO type and antibody screen. Also, one could separately focus on time from entry of patient into the emergency department to the time the specimen arrives in the blood bank.
BM-5 Time to Uncrossmatched Blood Administration
· These patients represent a very small population in some hospitals, which can confound and skew analysis.
· Manual audits will probably be required to track this measure, and may lead to inaccuracies. Uncrossmatched blood orders are often verbal, and documentation of start times is probably handwritten.
BM-6 Pre-operative Blood Tests
· This is an important patient safety indicator, especially in light of a recent FDA report on transfusion fatalities which shows from 2005 to 2006 there were more fatalities due to acute hemolysis caused by incompatibilities at "minor" blood groups, rather than ABO. For example, after an elective surgery case has started the sample sent to the blood bank may show a positive antibody screen – unfortunately, if there is no time for antibody identification the risk to the patient may be unnecessarily increased.
· The denominator should be elective surgical patients having operations that often require red cell transfusion, as opposed to all elective surgical patients (this would include cases that generally require blood).
· This measure is difficult to control, and is driven by market forces and patient preferences outside control of the hospital. For example, many patients prefer not to come in for testing prior to surgery. In addition, this measure is most relevant for patients with surgeries schedule in the morning, not all elective surgical patients.
· The Q-Probe looked at whether screening or crossmatches were completed before the start of surgery, not one day before. Although encouraging preadmission testing is very laudable, the start of surgery (or entering the operating room) is probably the better endpoint.
· The term “elective surgery” and the identification of this patient subgroup for auditing should be more clearly defined.
BM-7 Pre-operative Hemoglobin Level
· There is no clear benchmark for this measure. The number of patients with preadmission anemia (as defined by The Joint Commission Criteria) should be identified.
· This measure appears to be based on isolated studies that have not been subjected to systematic review and guideline formulation. These kinds of measures should await analysis, integration, and interpretation of better clinical data.
· Not all elective surgery patients have a hemoglobin level. This would be hard to track since it does not correlate with the audit criteria of a given facility.
· There is still substantial variation in practice patterns. Different patient populations (requiring different transfusion approaches) may predominate in different institutions.
· If adopted in its present form, and at this time, this measure may well create a false standard for transfusion.
BM-8 Blood Salvage Documentation
· This is not currently tracked or monitored by most transfusion services, since it is not often under the auspices of the transfusion service. Most of these data are recorded in surgical records, and would require manual compilation.
· This measure should also include the volume salvaged, especially postoperatively. There should be documentation that the time between beginning of salvage to infusion is less than eight hours.
BM-9 Transfusion Complications
· The specific codes being proposed are not specifically transfusion related (e.g., hemolysis NEC, sepsis/infection, shock, thromboembolism). To be useful, the reaction rates should reflect the standard transfusion reaction categories (e.g., hemolytic, fever/chill non-hemolytic, urticarial, anaphylactic, TRALI, sepsis, hypotension associated with ACE inhibition, circulatory overload, non-immune hemolysis, air embolus, hypocalcemia).
· Not all of the complications listed are true measures of performance (i.e., there is no way for hospital to lower the complication rate). Only incompatible reactions can be improved upon, but the frequency is likely to be too low and should just continue to be treated as sentinel events.
BM-10 Red Blood Cell Administration
· There is no clear benchmark for this measure.
· This measure appears to be based on isolated studies that have not been subjected to systematic review and guideline formulation.
· Is there evidence for excluding neurosurgical patients?
· Despite the TRICC trial there is a great deal of controversy about the red cell transfusion trigger. This might be more meaningful if broken down by specific patient populations such as adult intensive care without cardiac disease. Also, intraoperative transfusions rarely have an accurate pretransfusion hemoglobin.
BM-11 Multiple RBC Units Transfused
· There is no clear benchmark for this measure.
· This is based on isolated studies that have not been subjected to systematic review and guideline formulation.
· It may be difficult to identify those patients who receive more than one unit of RBCs and to then look at the pre-transfusion hemoglobin.
· The exclusion criteria are too stringent.
· This measure does not appear to account for bleeding. Intraoperative transfusions rarely have a serial hemoglobin.
BM-12 Platelet Administration A
· Specific patient populations known to have higher platelet requirements, e.g., transplant patients with fever, sepsis, undergoing invasive procedures, etc. should be excluded.
· The excluded populations are too narrow, given that they include stem cell patients. It is not uncommon to have to raise platelet thresholds to 30-40K or more for hemorrhagic cystitis and other complications.
· ECMO is also another procedure requiring platelets but <4 units/RBC per hour.
· A cut-off of < 20,000 for outpatients, particularly for patients who live in a rural community at a distance from medical care, is not uncommon. Also for patients on weekly outpatient transfusions, platelet counts are not always obtained before transfusion.
BM-13 Platelet Administration B
· The platelet thresholds proposed here are not based on well-performed studies but appear to be largely anecdotal.
· The measure does not appear to account for patients who are on platelet inhibitors (clopidogrel). The auditing will probably be manual, and the large number of various exclusion criteria makes auditing more difficult (e.g., exclusion criteria of 4 U of RBCs transfused is too stringent).
· While this is a significant issue, it is also highly controversial.
BM-14 Plasma Administration
· This is based on isolated studies that have not been subjected to systematic review and guideline formulation.
· This measure is weak in terms of appropriate use of fresh frozen plasma (FFP). There is no reference range for INR or any directive as an indication for transfusion. It does not address any kind of liver implications, as well as whether it is appropriate to use FFP to reverse warfarin (as opposed to vitamin K administration).
· This is a significant issue, but the population needs to be more clearly defined. The numerator should be INR <1.5. Children should be excluded as the INR reference range is not defined.
BM-15 Patient RBC Transfusion Rate
· Many of the procedures in this list are only performed in larger tertiary care centers and are not applicable to the majority of institutions.
· In some institutions, usage rates are routinely generated in cardiac surgery by diagnosis-related group (DRG), with expansion of the data warehouse to other procedures. Whether this is feasible in institutions with limited computer infrastructure and support should also be of concern.
· This measure is too general for specific guidance or use to improve transfusion practice. Also the measure might be a reflection of greater or lesser access to care, or to elective surgeries vs. similar levels of healthcare in other countries but with greater rationing of invasive procedures.
· Why does this measure exclude exchange transfusions?
· This measure should be broken down for specific patient populations. Even breaking it down by DRG may not be sufficient.
BM-16 DRG Blood Utilization
· It is possible that stratifying by age would be useful.
· Collecting data for this measure would require significant resources. There are many included DRGs so to learn from any data gathered at an individual hospital level may be difficult.
· No specific blood products were identified (RBCs vs. platelets vs. plasma).
· The calculation as described is confusing. Is the numerator per patient, not per total patients in a DRG?
· There is considerable intra-center variation seen in liver transplants and cardiac surgery.
· High blood use in and of itself does not necessarily mean inappropriate use. For example, a heart transplant after VAD usually requires more blood than a previously unoperated patient. Liver transplantation for PBC usually uses much less than alcoholic cirrhosis.
BM-17 Specimen Testing Criteria
· Measurement of mislabeled specimens is appropriate, important, and broadly applicable to most hospitals.
· Pre-transfusion specimen labeling is very important and it should be fairly easy to obtain relevant data.
· There is no clear benchmark. The percentage should be 100%, but is that realistic?
· It would be better to focus on specimen rejection rate and to then focus on some categories of rejection. It seems this measure was drafted in an attempt to capture all issues in one number, but to do so would hide or obscure specific trends in errors in certain categories of specimen collection.
· This data will be hard to collect. Many labs capture specimen rejections but do not split out specific areas. Much of this may have to be collected manually.
BM-18 Blood Product Wastage
· This measure can be affected by the complexity of the patient mix in each hospital. In this regard, platelets are probably the least helpful type of units to monitor here and thus would not lead to outcomes improvements.
· This measure is not particularly relevant since there is still variation in practice patterns and since certain patient populations may predominate from institution to institution. For example, it probably would not be valuable to compare red cell transfusion rates of Hospital X, which is a cardiac surgery center, to Hospital Y, which has a large obstetrics patient base; or to compare platelet transfusion rates at a large academic center with stem cell transplant, to someplace that provides little oncology service.
· This measure is not stratified by any demographic distinction: size, scope of practice, etc. The numerator and denominator only address platelets not other products.
· Wastage is an economic issue, not a quality of care issue.
BM-19 Blood Inventory Level
· Blood shortages are usually a supply problem, not an inventory management problem. There are no exclusions, ignoring the dramatic impact that a few patients can have on the entire hospital system — particularly during times of preexisting short supply.
· This measure is not sufficiently defined as written. The number of occurrences of adequate inventory is confusing. It would be better to capture number of days inventory was below set requirements for adequacy. However, this requires that transfusion services already have formal inventory level requirements. Also, the measure should consider what time of day would inventory assessment be performed and for which blood products?
· Inventory management depends not only on the hospital but also the blood supplier. Fore example, as more specific and sensitive methodologies are introduced, existing surrogate testes should be retired.
· The numerator and denominator for this measure are not clear. These issues are not under hospital control, so tracking this would be of limited value for improving patient care by the hospital.
· Adequacy of blood inventory is important, but it is very difficult to define. It is common for the inventory to be below an arbitrarily established target, but it is rare that surgery or other patient care is delayed or denied. More should be given to measuring the clinical impact because as written, this would not likely lead to outcome improvements