This section will discuss the general transfusion-related responsibilities of medical directors and when it is essential to obtain medical consultation, particularly as related to emergency transfusion. This case will focus mainly on medical expertise and consultation, although much of the discussion can be applied in general to nursing and technical needs.The discussion is not meant to be definitive or all inclusive.
Special thanks to the following hematopathologists, who kindly provided advice, information, and ideas on aspects of medical consultation. The discussion below benefits from their valuable input.
- Gwen Clarke, MD FRCPC, Dynacare Kasper, Capital Health Authority, and Canadian Blood Services (Edmonton)
- Susan Nahirniak, MD, FRCPC, Medical Director, Capital Health Transfusion Services (Edmonton)
- General role of TS medical directors
- This case
- Self study questions
- Further Reading
In urban centres TS medical director are on-site or at a nearby hospital within the same city. Depending on the degree of centralization, the medical director may be responsible for a single TS or for several within the health region. Typically an urban TS medical director is a pathologist, sometimes a hematopathologist with a specialty in transfusion medicine.
In rural areas a TS medical director (physician who may or may not be a pathologist) may be responsible for one TS or for several TS in widely dispersed hospitals. In such cases TS staff within a given small rural hospital may not have easy access to consultation with the medical director or TM consultant. The director may be on-site for consultation one day a week or much less, e.g., once per year. Regardless of the frequency of on-site visits, consultation is theoretically available 24/7 for 365 days a year.
Small dispensary-only laboratories often lack the on-site technical, nursing, and medical expertise in transfusion medicine (TM) required to develop and implement transfusion-related policies, processes and procedures. Thus, access to external TM expertise is essential to develop policies and procedures, as is ongoing access.
Technical staff may have limited experience in TM and lack exposure to unusual transfusion-related situations. Attending physicians and nurses may similarly have a limited understanding of some of the serologic problems and transfusion reactions that could occur, and their undergraduate TM education was likely superficial at most. As well, the basic education of all professional groups may have occurred years ago when practices were different.
Similaraccess and expertise issues may also apply to medium-sized and larger facilities.
In small rural facilities with dispensary-only functions, clinical and technical staff may have limited experience in dealing with critical values in TM, also called critical results. Such results are more usefully called alert values or alert situations, since they may include both life-threatening and non-life-threatening but significant results or situations that merit prompt communication to the patient's physician and/or to the TM medical director/consultant.1
- See below for concrete examples
As one TM specialist put it, "... 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."1 (#4)
Sometimes technologists or nurses may think that -to avoid delays - they should not call the TM expert until after the emergency has settled. As well, some staff in small facilities may feel that they must handle everything on their own and that asking for help means that somehow they have failed in their jobs. Unfortunately, these practices of delayed or no consultation can result in risks and harm to the patient. Another issue is possible liability for adverse consequences.
For all of these rationales, clinical and technical staff in smaller facilities should have timely and on-going access to consultants with TM expertise.
A quality system approach to transfusion stresses that quality and safety of the blood system is everyone's responsibility. Some of the specific roles that TS medical directors play are reviewed by AuBuchon2. Despite quality being everyone's responsibility, every TS must have a medical director who is ultimately responsible for all medical and technical policies and procedures in the TS.
Often the medical director is a licensed physician (as opposed to another health professional). Some countries have standards requiring that the TS medical director be a licensed physician qualified by training or experience in transfusion medicine, e.g., Canada (CSTM and CSA Standards), USA (AABB Standards), and others.
A2.3. All TS policies and procedures shall be under the jurisdiction of a Medical Director who is a licensed physician and qualified by training and/or experience in the practice of transfusion medicine. All operating procedures shall be approved by the Medical Director and/or his or her delegate. (CSA 126.96.36.199 ; 188.8.131.52)
A3.1.5. The TS Medical Director shall:
a. be a licensed physician
b. meet applicable provincial or territorial laboratory licensing requirements
A1.2. All subsidiaries (e.g., satellite sites) of the TS that perform activities related to the activities covered in this Standard, shall be in compliance with the Standard. (CSA 4.1.2)
Setting Medical and Technical Policies and Procedures
The TS medical director, in consultation with other health professionals, sets all medical and technical policies and procedures for the TS. The medical director also works with the multidisciplinary hospital transfusion committee, which traditionally has been charged with oversight of transfusion safety.
Some examples of policies and procedures set by TS medical directors:
E4.3.6. Red cells - frozen shall be stored for a maximum of ten years at a temperature appropriate to the cryoprotectant and defined in the facility's operating procedures. Donor units with a rare phenotype may be kept beyond ten years with the approval of the medical director. (CSA 184.108.40.206 ; 220.127.116.11)
G9.1. The TS medical director shall establish a policy for abbreviated compatibility testing when a patient receives a massive transfusion. (CSA 10.9.2)
G9.2.1. The TS medical director shall establish a policy for the release of blood and blood products prior to the performance of pretransfusion testing. (CSA 10.9.3.1)
M2.1.2. The medical director shall establish guidelines for autologous donor-recipient eligibility.
When is medical consultation required? Standards exist for some of the situations in which the TS medical director and the patient's attending physician must be consulted. For example:
G9.2. Emergency Transfusion
G9.2.2. When blood and blood product are released prior to the completion of pretransfusion compatibility testing, the requesting physician shall sign a declaration that the clinical situation warranted the release, and, if possible, informed consent shall be obtained from the recipient. (CSA 10.9.3.5)
G9.2.3. If red cell units are issued before pretransfusion compatibility testing is complete, the issue voucher and a label attached to the product shall indicate that testing is incomplete. Should the red cell units subsequently prove incompatible, the attending physician and the TS medical director (or their designates) shall be informed. Infusion of incompatible units shall be stopped immediately, and the units set aside pending the physicians' decision. (CSA 10.9.3.4, 10.9.3.6)
H. Selection of Blood & Blood Products for Transfusion
H1.3. Blood and blood products shall not be used after their expiry date, unless approval is obtained from the TS Medical Director and written approval from the treating physician. (CSA 10.7)
The following examples, not necessarily specified or implied in blood safety standards, are suggestions for when laboratories should consult physicians with TM expertise.
1. Possible transfusion reactions and other adverse events
Any suspected transfusion reaction falling outside the definition of a febrile non-hemolytic reaction or a simple mild allergic (urticarial) reaction requires TM consultation.
This implies that laboratories should have written definitions of these reaction types such that anything outside the definition can lead to immediate follow-up with the TM consultant:
- A list of common signs and symptoms of suspected adverse reactions shall be included in both the nursing and TS manuals. (CSTM N2.1; CSA17.2.1)
Depending on the reaction type, the consultant may make recommendations about
- specific tests on the recipient and/or donor units (i.e., culture)
- appropriate treatment
- the safety and advisability of additional transfusions
Depending on the circumstances, delays in providing blood products may require TM consultation.
For example, in the case of a complex antibody problem or warm autoadsorption that is going to take awhile, calling the TM consultant has potential benefits. Consultation between the TM specialist and the attending or ordering physician will facilitate the best product being provided in a time frame that is safe for the patient. Put another way, there is no point in giving crossmatch-compatible blood following warm autoadsorption if the patient dies while waiting for the warm auto to be completed!
3. Near misses
Near misses require TM consultation to determine the cause and help prevent future occurrences.
The UK Serious Hazards of Transfusion (SHOT) scheme3 defines a near miss as any error which, if undetected, could result in the determination of a wrong blood group, or issue, collection or administration of an incorrect, inappropriate or unsuitable component, but which was recognised before transfusion took place. (For interest, SHOT 2004 includes 1076 near miss reports.) Specific examples include
- inappropriate issue of a blood product (e.g., an ABO-incompatible RBC unit that is caught before transfusion; a grossly hemolysed RBC that is caught by the transfusing nurse)
- patient misidentification (e.g., wrong patient sample that was caught due to past records)
- inappropriate blood product requests that are caught by the reference laboratory (e.g., failure to order irradiated blood for patients for whom it is indicated, such as patients treated with purine analogues or who have undergone stem cell transplantation)
4. Unusual requests
Requests that are unusual with respect to quantity or product type should/could result in a call to the consultant- again allowing for consultation between the attending physician and TM physician to ensure the most appropriate transfusion therapy.
This implies that the dispensary laboratory should have written "typical" indications for components and some fractionation products. Orders outside the typical indications (which should be written inconsultation with local medical staff) should result in the laboratory initiating a call to the TM consultant so that medical consultation can occur.
5. Issue of crossmatch-incompatible blood
Transfusion of crossmatch-incompatible is potentially life-threatening and requires consultation with a physician with TM expertise.
If time permits, the TM consultant should be called before issuing the blood. If the attending physician believes that the patient needs blood immediately, it should be issued and the TM consultant called by the laboratory concomitantly, so that the attending physician and consultant can discuss the case.
Emergency release of RBC
In this case, the requesting physicians ordered blood for both patients as emergency requests for uncrossmatched RBC but there was no procedure for documenting that the clinical situation warranted the release.
Fulfilling CSTM G9.2.2 requires a signed declaration that the clinical situation warranted release of blood prior to completion of compatibility testing.Ways to meet this requirement (with varying degrees of rigour), include4:
- For uncrossmatched blood the laboratory information system (LIS) can automatically create a line for uncrossmatched blood on the blood tag (and/or issue voucher) destined for the patient's chart: "Authorized by ____________" or "Authorized by ____________, who declares the clinical situation warrants the release of uncrossmatched RBC".This line can be highlighted to remind the physician to sign before filing in the patient's chart.
- Using an emergency release form printed on adhesive labels that are attached to a tag which is then attached to the unit. The physician signs the tag and sends it back to the TS laboratory.The unit is issued using the emergency issue routine in theMeditech computersystem and the form is attached as a canned comment.The physician signs the requisition when the blood is transfused and the requisitionis retained as part of the patient chart.
- Issue products before obtaining a signature, but ask the requesting physician to sign after the crisis is over. Theycheck a box to specif that they require uncrossmatched blood and indicate the number of units. The disclaimer reads:
"In my opinion the delay (45 minutes to 60 minutes) in obtaining crossmatched blood and in obtaining the consent or refusal of, or on behalf of, the patient for the use of uncrossmatched blood will endanger the life or wellbeing of the patient.The paper record with the signature is kept in the TS as part of indefinite record storage, but not in the patient's chart.
Attending Physician's signature:_____________"
- Using a Request for Emergency Release Form that requires the physician to take into account the possibility of adverse effects and declare that the transfusion is justified in view of the urgency of the patient's condition.
- Using a form to request blood products on which there is a specific section to ask for products in "EXTREME URGENCY":
EXTREME URGENCYThe doctor must sign this form and forward it to the TS. Ifthe urgency of the situation allows a delay of a few minutes,so that the blood group to be determined, the doctor will ask for cells of the same blood group; if not, group O Rh negative RBC will be sent.
The doctor thus assumes the responsibility for incidents resulting from the omission of the usual compatibility tests as his/her signature attests.
Product / Number of units
___O negative cells without compatibility
___cells of the same blood group without compatibility
Signature of the doctor:
Consultation on issuing RBC based on historical blood group
In this case, technologists issued RBC based solely on historical blood groups without consulting anyone, not the laboratory's supervisor, not the patient's physician, and not the central TS or its medical director. The dispensing facility's standard operating procedure (SOP) for emergency transfusion was to
- issue group O Rh negative RBC from emergency inventory
- send patient samples to the central TS for pretransfusion testing
- wait for group-specific crossmatched blood to arrive
Laboratory staff were unaware that issuing group-specific RBC based on records alone was prohibited. There were no policies and procedures in place for when medical consultation was required.
The medical director from the central TS visited the facility periodically, generally once every 6 months, and seldom spent more than 1?2 hours with the laboratory manager.
Because on-site medical consultation was rare and it was not always easy to contact the off-site TS medical director, the laboratory manager often made independent decisions involving clinical issues without obtaining medical input, believing this was an expected part of the job.
- TS medical directors and attending physicians must be consulted whenever standard policies and operating procedures are not followed that can affect patient treatment and safety and have an impact on clinical decisions.
- Timely medical consultation is critical for a variety of situations involving deviations in testing and the selection of blood components, and for alert values and alert situations.
- Without adequate medical oversight of transfusion-related decisions, inappropriate transfusions can occur resulting in serious adverse events.
- Good communication between all transfusion staff and between staff and TM consultants is essential
- Requesting TM consultation should be strongly encouraged.
- The laboratory must have an up-to-date contact number (e.g., through their reference laboratory) that can quickly provide a current number for the on call TM physician-consultant.
- The dispensing facility's relevant SOPs should clearly state that there is no abilityfor technologists or medical staff to make independent decisions for specific deviations from normal practice, e.g., release of non-group O red cells if current testing results are not available.
- The dispensary-only laboratory should have a list of critical values (alert values and situations) that require immediate consultation.
- A list of common signs and symptoms of suspected adverse reactions included in the nursing and TS manuals should be readily available to clinical and technical staff at satellite sites.
- When visiting dispensaries and other satellite facilities, the medical director/TM consultant should include local medical staff and/or other consultants who visit periodically. The periodic visits should allow for
- free-ranging Question and Answer sessions
- reviewing those instances in which it would be appropriate to call for advice or intervention
- confirming the best route to follow when trying to reach the consultant out-of-hours
1. In a TS who is ultimately responsible for all
- technical policies and procedures?
- medical policies and procedures?
2. Does each TS require a medical director, including dispensary-only facilities?
3. Can the TS medical director delegate responsibilities to others?
4. Provide two concrete transfusion-related examples for when the following must be consulted:
- TS medical director
- patient's physician
5. What are alert values or alert situations and why are they especially important to staff in small facilities?
- Part 1: Use of historical blood groups
- Part 2. Issuing blood to the OR
- Part 3. Medical consultation <--You are here
- Part 4: Transfusion-related responsibilities
- Part 5: Training and competency assessment
1. CBBS e-Network Forum: Reporting of critical values by transfusion service laboratories.
2. AuBuchon JP. The role of transfusion medicine physicians. A vanishing breed? Arch Pathol Lab Med 1999;123(8): 663?7.
4. Examples courtesy of discussion of CSTM G9.2.2 on Canada's Transfusion Safety Officer mailing list, "transfusion" (Sept. 2005).