A transfusion medicine physician (and CBBS member) has a question specific to practice in the Golden State of California. He wonders if e-Network colleagues can advise him if any California law requires an attending physician to countersign a blood transfusion consent, or if a resident under the supervision of an attending physician can countersign the consent. Apparently, at the inquiring physician's hospital in Southern California the medical staff bylaws require that an attending physician must obtain transfusion consent and countersign the form.

However each time an audit of this informed consent process is performed the audit shows non-compliance with the aforementioned policy. What appears to be happening is that residents (who are licensed physicians) are obtaining the informed consent and countersigning the forms. The inquiring physician wonders if it would be acceptable under California law for a resident (who is licensed to practice medicine in California) to write an order for transfusion and to provide informed consent information, and then to obtain consent from the patient and countersign a transfusion consent form. (Editor's note: While this may seem to be a California issue, input from colleagues outside the Golden State would be appreciated.)

The e-Network Forum Editor & Moderator suggests that one or more of the following links might contain information germane to this discussion:

• Informed Consent for Transfusion of Blood Components and/or Plasma Derivatives
• Does The Gann Act in California Require Informed Consent for Transfusion?
• University of Michigan Blood Transfusion Policies and Standard Practices: 6- Transfusion Procedures Version July 2004
• Patient's Guide to Blood Transfusions (revised June 2006)

In response to the above, the following replies have been submitted

1. A Sacramento physician and member of the CBBS reports that in his opinion, under California law, it is entirely acceptable for ANY licensed physician (attending level or not) who is caring for a particular patient to countersign that patient's blood transfusion consent. If the inquiring physician's hospital wishes to require only attending level physicians to countersign consents, that's their prerogative. However, in the responding Californian's opinion, it is an excessive choice on their part, and will continue to lead them down the path of noncompliance.

2. A resident physician at a large teaching hospital in Southern California comments that when covering a clinical service as an on-call intern (before being licenced to practice medicine in California), she would occasionally be asked in the middle of the night to obtain consent for transfusion, if her attending physician had forgotten to obtain it during the day. She reports that performing the consenting process and countersigning consent forms was a common practice for residents, even unlicenced interns. She adds that she has rotated at different hospitals, and each hospital seems to have its own policies for what residents can and cannot do. For example, some hospitals allow residents to write orders on the chart without a cosignature by an attending physician, but do not allow those same residents to discontinue prescriptions or discharge prescriptions. She is not certain if the aforementioned practices are compliant with California law, but she reports that they are common practices.

ADDENDA Sept. 12, 2002

3. A transfusion medicine physician in San Diego reports that it is his understanding that it is NOT A REQUIREMENT that a physician sign a consent form prior to a blood transfusion in California. However, a physician in the care of the patient must provide informed consent (risks, benefits, alternatives and the choice of no transfusion) to the patient. The patient then asks any questions that may be of concern. Documentation of this event requires the patient's signature and a witness. But, the witness does not have to be the physician. The "informed consent form" simply documents that the patient acknowledges that he has completed the informed consent process. The physician should write in the medical record that he did provide the informed consent. He could do this by signing the "informed consent form" or commenting in the progress notes or, for those who wear belt and suspender, both.

4.A transfusion medicine physician in Santa Monica reports that at two community hospitals in which she has practiced (and at other hospitals in the immediate community), there is NO requirement for physician countersignature of an informed consent FORM for transfusion. She correctly points out that in teaching institutions, interns, residents and fellows are on site 24/7. This is most definitely not true in the community setting.

ADDENDUM Sept. 18, 2002

5. A surgeon wrote that physicians should check with their hospital risk management personnel to determine if the hospital's policies require a signature. He is of the opinion that JCAHO requires hospitals to document that risks, benefits and alternatives to transfusion have been discussed with the patient, and that to comply with JCAHO, the hospital must create a policy or procedure for dealing with this issue. In his experience, most hospitals have attempted to comply with JCAHO by requiring a separate transfusion consent form that needs a physician signature, since only a physician can give true informed consent (or so juries have ruled). He is NOT a Californian, but he is aware that California is also one of only two states with a separate law dealing with transfusion practice. New Jersey is the other. As he understands this law (The Paul Gann Act), physicians are required to do what is stated above, i.e., explain risks, benefits and alternatives. So, California physicians are governed by more than just hospital policies when it comes to transfusion. For more information about the Paul Gann Act and transfusion consent in California, click on the following links to earlier e-Network discussions related to this issue:

• More on Documenting Gann Act Consent
• Does The Gann Act in California Require Informed Consent for Transfusion?
• The Paul Gann Blood Safety Act - Documentation Questions
• Informed Consent for Transfusion of Blood Components and/or Plasma Derivatives

ADDENDA Jan. 29, 2008

6. Editor's 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.