Is monitoring of transfusion reactions by a hospital committee required by any regulatory or accrediting agencies?

A nurse who works in the US writes that transfusion reactions are currently monitored by her hospital's Transfusion Practice Committee. However, she also reports that her hospital does not have an "in-hospital" blood bank or "in-house" blood bank director at their facility. Rather, these functions are overseen by their regional blood center, and the assistant medical director of the regional blood center heads their hospital transfusion practice committee. The blood center performs the hospital's transfusion reaction workups, and these reactions are reported to the hospital as "hemolytic or non-hemolytic." The blood center keeps track of the transfusion reactions for the blood center's AABB accreditation. Thus, the question has been raised "Does the hospital need to keep track of transfusion reactions for its own purposes, if that function is being taken care of by the regional blood center?" The inquiring nurse adds that one of the reasons that the hospital Transfusion Practice Committee is looking to discontinue the practice of monitoring transfusion reactions is that nobody is sure why the committee needs to do this monitoring. The inquiring nurse is skeptical of this proposed policy change and wants to know if monitoring transfusion reactions by a hospital committee is required by any regulatory or accrediting agencies. She is aware that JCAHO requires reporting of hemolytic transfusion reactions, but what about other non-hemolytic reactions? The inquiring colleague reports having looked at the CAP, FDA, and JCAHO websites, and the only information she could find pertained to hemolytic transfusions reactions. She requests input from the e-Network Forum.

The following responses were received.

ADDENDA April 1, 2003

1. Dr. Sunita Saxena, chair of both the Blood Use Review (Transfusion) Committee and of the Patient Safety Committee at the Los Angeles County+USC Healthcare Network (attribution used with permission), submits the foillowing response. She believes that institutions should collect data to monitor processes that are known to jeopardize the safety of patients. Since the use of blood and blood components involves risks, transfusion facilities should have a mechanism to review and monitor trends for all transfusion-related processes including transfusion reacions of all types. She says "I would encourage our colleague to check her institution's bylaws and JCAHO Standards." Furthermore, she adds "In many institutions, the hospital bylaws require that the committee responsible for reviewing blood usage also monitor transfusion reactions. In addition, there are at least two JCAHO Standards that specifically address the monitoring of blood use-related processes and transfusion reactions."
   
   JCAHO Standard PI.3.1.1 states, "The organization collects data to monitor the performance of processes that involve risks or may result in sentinel events." Dr. Saxena believes that this standard is applicable to transfusion reactions since they can result in sentinel events. The intent of this Standard (see below) published in the JCAHO manual supports that opinion.
   
   "Intent of PI.3.1.1 Organizations select processes that are known to be high-risk, high-volume, problem-prone areas related to the care and services provided. This information is correlated with the listing of frequently occurring sentinel events published by the Joint Commission, the organization's risk-management data, or information about problem-prone processes generated by field-specific or professional organizations. Organizations select performance measures for processes that are known to jeopardize the safety of the individuals served or associated with sentinel events in similar healthcare organizations. At a minimum, the organization identifies performance measures related to the following processes, as appropriate to the care and services provided:
   1. Medication use
   2. Operative and other procedures (see note 4) that place patients at risk
   3. Use of blood and blood components
   4. Restraint use
   5. Seclusion when it is part of the care or services provided
   6. Care or services provided to high-risk populations
   7. Outcomes related to resuscitation
   8. Staffing effectiveness (see HR.2.1).
   The detail and frequency of data collection have been determined and are appropriate for monitoring high-risk, problem-prone processes. Data are collected at the frequency and with the detail identified by the organization. The performance measure data are used to evaluate outcomes or performance of problem-prone processes."
   
   According to JCAHO Standard PI.4.3, "Undesirable patterns or trends in performance and sentinel events are intensively analyzed." The intent of this standard (see below) makes it clear that confirmed transfusion reactions should be analyzed and monitored.
   
   "Intent of PI.4.3 When monitoring performance of specific clinical processes, certain events always elicit intense analysis. Based on the scope of care or services provided, intense analysis is performed for the following:
   1. Confirmed transfusion reactions
   2. Significant adverse drug reactions
   3. Significant medication errors
   4. Hazardous conditions
   5. Staffing effectiveness issues."
      
      
2. A transfusion medicine physician in Pennsylvania (Alan E. Caroe, M.D., Blood Bank Medical Director, Department of Pathology at York Hospital; attribution used with permission) is of the opinion that febrile, non-hemolytic transfusion reactions serve as a surrogate for hemolytic transfusion reactions. He reports that "based on unpublished experience at York Hospital (and supported by data from Georgetown Hospital in D.C.), at least 1 out every 1000 non-leukocyte depleted red blood cell units is associated with a 1C temperature rise in the recipient. Bedside leukodepleted RBC have been associated with fever in about 1 in 2000 red blood cell transfusions. Monitoring to ensure that reactions such as these are reported and managed appropriately increases the likelihood that a much more serious (though rarer) hemolytic transfusion reaction will be recognized and managed before it becomes a fatal reaction". Dr. Caroe adds, "Remember that hemolysis is still the most common cause of immediate death from transfusion in America." In regard to oversight responsibility he states that "only a hospital-based committee can be expected to maintain this vigilance, since this type of surveillance tests the performance of a hospital system rather than the quality of the transfusion product. Even if a blood center could monitor the situation, it lacks the authority to correct any problem it discovers. (Most blood centers are already swamped just trying to keep up with mandated activities.)" Also, Dr. Caroe reports that Dr. Bala Carver at Lehigh Valley Hospital in Allentown, PA has found a way to increase interest in transfusion review. She engineered the shift of the Transfusion Committee into the Pharmacy and Therapeutics (P & T) Committee. P&T has much broader physician representation in most hospitals, and deals with many of the same issues of product selection, appropriate prescribing, patient identification and complications. Questions about this committee may be emailed to Dr. Carver.

ADDENDA April 9, 2003

3. A colleague in California was concerned that a hospital might be considering discontinuing the practice of having a committee monitor transfusion reactions. He wonders if the hospital has explored whether or not such a change would be compliant with CLIA, and he wonders if the facility even has a CLIA license or certificate. He also wonders if transfusions are occurring within the hospital or under the auspices of the facility's operating license.

ADDENDA April 15, 2003

4. A California laboratory inspector reports that there are sections of Title 22 (§70243 for California) that require a facility to have equipment and services on-site to perform basic functions (e.g. - Type and cross, etc.). If these services are contracted, the arrangements must indicate that the hospital (facility) retain professional and administrative oversight of all functions such as monitoring transfusion reactions. He is not sure how this would apply to other states, including that of the inquiring colleague.

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