On September 11, 2000 an e-network member stated that her institution wanted input regarding how other members document physician compliance with the Paul Gann Act? The inquiring member's institution currently includes a statement on their transfusion or procedure consent forms asking the patient and the MD to sign that information about blood transfusion/blood product options have been discussed. The institution is auditing these forms for compliance and have a "poor" response from her physicians. The inquiring member needs some creative ideas for assuring that patients are informed prior to elective transfusions or procedures requiring blood products.

Editor's NOTE: When this question was sent out on Sept. 11th, I requested that each member please review the previous e-Network Forum discussions of this vexing issue in the following years:

1998, 1999, 2000

What follows are the comments that have been submitted in response to the above question:

1. It is my understanding that the law requires the physician to document that the information was presented to the patient, but there is no requirement that transfusion services or blood centers follow up to see if that has been done. If there is concern about physician compliance, perhaps this is an issue that could be discussed with the hospital's transfusion committee or risk management department. Some facilities require a patient to sign a separate consent for transfusion, and this could be another way to improve the likelihood that the patient has been informed of options, risks, etc.

2. We are a 300-bed County hospital. Regarding the Paul Gann Act, we do the following:

• annual orientation of new MDs by transfusion service director emphasizing Paul Gann Act and the obligation of MDs to do informed consent without delegating to PAs or RNs
• written policy specifying that the MD do the consent with signature and that it is valid per each hospital admission
• informed consent form with three signatures: patient, MD, and witness
• audited by nurse QA unit monthly as part of their checklist to check form is in chart and signed by MD
• for trauma cases, the emergency consent form signed by two MDs substitutes for this

3. At this facility the information is contained in the patient information booklet that each patient receives before admission. The booklet also addresses Advanced Directives. When the patient is given this information it is logged into the electronic medical record and indicates the date the patient received the information.  This needs to be done only once. In addition the patient is required to sign a consent for blood for each treatment plan.

4. We currently audit the medical charts for compliance with the Gann Act. We have observed that the rate of compliance is greatly affected by the denominator one chooses. Initially, we used an order for crossmatch, autologous blood, or directed blood along with several selected high risk procedures as an indication that blood usage was likely. Our compliance with the Gann Act was poor. Currently, however, we do not consider a chart out of compliance if blood was never given. This has substantially increased our compliance. We are taking the position that if blood was not given, the patient was not terribly likely to preoperatively been considered at a reasonable risk for transfusion. Our reasoning is that a surgeon may get "lucky" on rare occasions but eventually will end up transfusing patients if the patients are truly at a reasonable risk of transfusion.

5. While not in California, my observation has been that there is an advantage for surgical transfusion consent to incorporate it into the operative consent. Operating room nurses and anesthesiologists are pretty good at real time checking of paperwork before a procedure. This doesn't solve the non-O.R. aspect, but the latter requires the medical staff to have internal discipline, and nurses to refuse to do non-urgent transfusions without physicians obtaining consent. A few calls to attendings at 3 am saying the patient can't be transfused for lack of appropriate consent will improve compliance.

ADDENDA Jan. 29, 2008

6. Editors' Note: Senate Bill 102 was introduced by Senator Carole Migden in January 2007. The bill was approved by the Governor in July 2007 and has been chaptered. The previous version of the Paul Gann Blood Safety Act required that a physician inform the patient of the positive and negative aspects of receiving autologous blood and directed and nondirected homologous blood from volunteers, whenever there was a reasonable possibility that a blood transfusion may be necessary as a result of a medical procedure, and by means of a standardized written summary that is published by the Medical Board of California. The new version of the law expands the list of individuals who may provide the written summary to include doctors of podiatric medicine. Furthermore, the new law permits that the information be given directly by the physician or doctor of podiatric medicine, or indirectly via a nurse practitioner, certified nurse midwife, or physician assistant, who is authorized to order a blood transfusion. Click HERE for full text of the chaptered bill.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator