A colleague in group practice in a multi-hospital network has a question about how facilities are complying with the following item on the CAP Checklist:

TRM.40220 Phase ll: "Are critical values established for certain tests that are important for prompt patient management decisions?

NOTE: The laboratory must establish critical values for certain tests in immunohematology, in conjunction with the medical staff, to ensure immediate notification of a physician or other clinical personnel responsible for patient care. These critical values may be indicated in the procedure manual and /or in a separate manual or policy. The bench technologists must be familiar with critical values and the related procedures."

She reports that their pathologists and lab managers do not believe there are critical values in the Transfusion Service (TS) as there are in other areas of the laboratory with values that can be quantified and ranges set. Since TS does not fit into the usual method of alerting physicians, and documenting the notification, they question if TS really has critical values. Some of the locations, in order to meet this requirement, have developed a policy that states that there are no critical values in the TS, but there are critical situations that would require immediate physician notification. Some of these critical situations are any results from a transfusion reaction work up that suggests a hemolytic transfusion reaction, release of a unit on emergency waiver that later proves to be incompatible, etc. And of course some of our facilities feel that this a policy on this issue is not warranted as the information is clearly covered in our individual procedures, and that this policy is only prepared to placate the CAP inspector and offers no value to the facility. Her group is wondering how others are complying with this item on the CAP checklist.

The following responses have been received.

ADDENDA Aug. 4, 2005

1. Dr. James P. AuBuchon, Chair of the CAP Transfusion Medicine Resource Committee (attribution used with permission) comments that the intention of the CAP checklist requirement (TRM 40220) is to ensure that information that is critical for the care of a patient be relayed to a responsible provider promptly. Information generated in the laboratory and remaining there is of little value! The requirement for the establishment of "critical values" is most readily evident where quantitative results are generated, but assays yielding qualitative results can also be considered as potentially yielding "critical" results. He adds that "One could peruse the list of assays or procedures performed in a laboratory and ask the simple question: What outcomes or results might be encountered that should be immediately relayed to the healthcare provider to ensure that the best possible care is provided to the patient? Just as the finding of malarial parasites on a peripheral blood smear would probably be considered "critical", so too would findings suggestive of acute hemolysis during a transfusion reacton workup. If problems were to arise in the processing of hematopoietic stem cells or the handling of autologous bone in a Transfusion Service Laboratory, these, too, might be considered critical "results" since knowledge of the outcome might prompt the patient's physician to immediately take another course of action. Therefore, the concept of creating a "criticals list" is applicable in all sections of the laboratory. A careful review with the medical director of the analyses and procedures performed, and possibly discussions with clinicians about their reaction to certain outcomes, would help establish an appropriate list for the lab. Questions regarding this - or any other - item on the CAP's TRM checklist may be directed to me (james.p.aubuchon@hitchcock.org) or the CAP. The Transfusion Medicine Resource Committee is always anxious to help clarify issues such as this or learn how the checklist can be made a more useful tool for the improvement of the delivery of laboratory medicine services.

2. A transfusion medicine physician in Boston reports that at his hospital they treat the following situations as a 'critical value' and therefore phone the patient care area each time either of the following situations occurs:

1. Transfusion Reaction Investigation Results: the clerical and serologic results (to evaluate for hemolysis) are called back to the floor (nurse or doctor) for all suspected transfusion reactions.
2. Unacceptable samples and miscollected samples (designated as Wrong Blood In Tube "WBIT")*

A call back is made whenever the laboratory receives either a sample with unacceptable labeling or whenever there is an ABO/Rh result that is unexpectedly discrepant with previous results suggesting that the labeled specimen contains the blood from another patient.

*References:

• Murphy, MF; Stearn, BE and Dzik, WH. Current performance of patient sample collection in the UK. Transfus Med. 2004 Apr;14(2):113-21.
• Dzik, WH. An international study of the performance of sample collection from patients. Vox Sang. 2003 Jul;85(1):40-7.

3. Dr. Steve Apfelroth, a transfusion medicine physician in the Bronx, NY reports that at his hospital the following "critical values" in their blood bank are phoned to the responsible physician:

• Positive DAT on cord blood
• Positive DAT on transfusion reaction workup specimen, or results which support an interpretation of hemolysis or mistransfusion
• Incompatible crossmatch completed after emergency uncrossmatched issue of red cells.
• Blood issuing error (wrong patient or unit number)
• ABO discrepency of current type and screen specimen with previous record.

4. A transfusion medicine physician in Virginia reports that the attached table lists 'critical values' that were used by the transfusion service at his 'old place' in Texas. Some of the categories represent 'situations' while others are specific test results. He comments that he is not sure there can be a clear distinction. He adds "Thinking about critical values as based only on quantifiable results is a bit narrow - the issue in my mind is that one needs to clearly delineate when rapid communication is needed, whether based on a test result or on a situation as it were. The comment that situations are covered by information in policies/procedures other than the critical value procedure begs the question in that the CAP checklist question note already states that the list need not be in a separate procedure. Be that as it may, it can be very useful to have staff think of these results/situations as critical and that notification has to occur, particularly if generalists are covering the blood bank (2nd/3rd shift) who may be more in tune to a critical value policy related to electrolyte, TDM results, etc., than they may be to a immediate notification section of a Blood Bank procedure."

5. Dr. Ronald E. Domen (attribution used with permission) reports that at the Penn State Milton S. Hershey Medical Center they do not have a separate procedure in the Blood Bank that details "critical values" but each procedure, as appropriate, indicates when a resident or attending physician should be notified. In the transfusion service all transfusion reactions and panel workups are reviewed by their residents and attending physicians and a separate, consultation report is generated that goes to the patient's medical record. They also have a "deviations from standard operating procedure" policy that defines certain clinical situations (e.g., change in blood type of units issued by the blood bank, factor VII administration, continuous platelet infusion, etc.) that is reviewed and documented on a consult form that goes on the patient's medical record. A change in blood type following a bone marrow transplant that necessitates a change in the ABO/Rh type for transfusion also gets reviewed by a physician. Another example is an antibody titer and hemolytic score in a pregnant patient that also generates a consultation report. If necessary, the patient's physician is contacted by telephone, e-mail, or other means. For blood donors, all positive infectious disease tests get reviewed by the medical director. In the Apheresis Service, all moderate to severe patient reactions get reviewed by the medical director. And, so on. It would be virtually impossible to list every possible clinical scenario for the transfusion or donor services. Dr. Domen speculates that perhaps part of the problem with the CAP Checklist question (and its accompanying note) is relating the intention of the requirement and the wording that is used. He says "The intent, I think, is to notify the appropriate physician(s) about something identified in the laboratory that is potentially harmful to the patient (i.e., a critical value). What is a critical value? It implies a definable number, as in chemistry, where it might be a potassium of 7.0; or, in microbiology (another gray area) where it might be any positive spinal fluid culture; or, in the transfusion service where it might be a transfusion reaction. But, a transfusion reaction is not a numerical "value," it is a clinical event that has multiple layers of significance. The same is true for a positive antibody identified in an antibody screen. Thus, these events are reviewed by the blood bank physician who makes the appropriate decisions on interpretation, clinical significance, and what further course of action should be taken." He agrees with the comment above that since appropriate courses of action are defined in individual procedures, the intent of the Checklist question has been met. He concludes saying that trying to put all critical events/situations that could conceivably occur in the transfusion service into one policy is unnecessary, virtually impossible, and does nothing, that he can see, to improve patient care.

6. A transfusion medicine physician who practices in Illinois comments that as reviewed in a CAP Q-Probe publication (Howanitz PJ et al, Arch Lab Pathol Med 2002:126:663), the concept of "critical values" traditionally refers to chemistry, hematology, microbiology and drug-level test results which warrant prompt notification of physicians and other caregivers about "a potentially life-threatening situation." The responding physician adds that the word "value" implies quantitation, but microbiology results are not quantitative, so perhaps "critical results" would have been a better term. Seen from this perspective, he believes that there are a small but important set of critical results in the blood bank which fit this definition. In fact, the inquiring colleague who initiated this discussion mentioned two: a possible hemolytic transfusion reaction, or a retrospectively incompatible emergency transfusion. He adds "We could also include serious recall notices from the blood supplier about blood components which have been recently issued but which might pose an infection risk, such as detection of bacteria in a platelet unit or a co-component, or a blood donor who reveals very recent HIV or hepatitis exposure; in these cases, immediate notification could prevent or interrupt transfusion, or trigger rapid antimicrobial therapy as indicated. As discussed by Howanitz, some labs have expanded this concept to include non-life-threatening but important results which warrant prompt and confirmed communication to the caregiver." He reports that his hospital uses the term "alert value" rather than "critical value," and in this context, their transfusion service considers a positive fetomaternal hemorrhage screen as an alert value needing prompt followup (i.e., fetal RBC quantitation within the 72-hr recommendation for giving extra RhIG if needed). He adds "We have also included discovery of delayed hemolytic transfusion reactions and of clinically significant RBC alloantibodies in women during pregnancy, although these are more for confirmation of the physician's awareness than for urgency. If the laboratory covers "critical values" in individual procedures, then a very brief policy which lists and refers to these individual procedures may be helpful for laboratory staff and for internal and external assessments."

ADDENDA Aug. 5, 2005

7. A medical technologist at a hospital in the San Fernando Valley in Southern California reports that their blood bank critical values list includes positive direct antiglobulin tests (DATs) on newborns and hemolytic transfusion reactions.

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