Community Blood Banks For Animals - Veterinary Medicine - Business & Professions - CA

Section § 4920

This section defines key terms for animal blood banks. An "adverse event" involves harm to an animal. "Blood and blood component products" are blood-related items from donor animals. "Captive closed colony" refers to animals specifically kept to collect their blood. A "closed-colony blood bank" uses these animals to produce blood products. "Commercial blood bank for animals" refers to establishments selling blood products from captive or community animals for animal health purposes. "Community blood bank" uses blood from community animals with owner consent. "Community sourced" animals live with their owners and are only brought in for donation. "Production" includes all steps in preparing blood for transfusion.

For the purposes of this article, the following definitions apply:

(a) “Adverse event” means an event in which an animal is injured, sickened, rendered unconscious, or killed.

(b) “Blood and blood component products” has the same meaning as in Section 9201 of the Food and Agricultural Code and means whole blood collected directly from a donor animal for transfusion or the blood components for transfusion, including packed red blood cells, platelet-rich plasma, platelet concentrates, fresh plasma, fresh frozen plasma, frozen plasma, cryoprecipitate, and cryosupernatant. Antibody products like hyperimmune serums are considered “biologics” and are excluded from this definition of blood and blood component products.

(c) “Captive closed colony” means that an animal is kept, housed, or maintained in any way for the purpose of collecting its blood.

(d) “Closed-colony blood bank” means a commercial blood bank for animals that produces animal blood or blood component products solely from animals held in a captive closed colony.

(e) “Commercial blood bank for animals” means an establishment that produces animal blood or blood component products from captive closed-colony or community-sourced animals to market and sell for use in the cure, mitigation, treatment, or prevention of injury or disease in animals.

(f) “Community blood bank” means a commercial blood bank for animals that produces animal blood or blood component products solely from community-sourced animals whose owners voluntarily consent to the donation.

(g) “Community sourced” means that an animal is all of the following:

(1) Kept, housed, and maintained at the residence of its owner who is a person and not a partnership, association, corporation, or limited liability company.

(2) Brought by its owner to a community blood bank for animals to have its blood collected.

(3) Licensed in accordance with any pet licensing required by the pet owner’s state, county, or city of residence.

(h) “Production” means the collection of blood or the preparation, testing, processing, storage, or distribution of blood or blood component products for purpose of transfusion.

animal blood banks adverse event blood component products

Section § 4920.1

This law states that when whole blood, plasma, or their derivatives are produced and used for transfusions or injections in animals, it's considered a service, not a sale. So, anyone involved in this process, whether an individual or a company, is providing a service rather than selling a product.

For purposes of liability pursuant to this article, the production and use of whole blood, plasma, blood products, and blood derivatives for purposes of injecting or transfusing the same, or any of them, into an animal shall be construed to be, and is declared to be, the rendition of a service by each and every person, firm, or corporation participating therein, and shall not be construed to be, and is declared not to be, a sale of that whole blood, plasma, blood products, or blood derivatives.

animal blood transfusion blood product service blood derivatives

Section § 4920.2

This law applies to California veterinarians involved in producing animal blood products for their own practices or community blood banks. They must follow best practices and comply with current veterinary standards to ensure safety and prevent contamination. The process must not harm the donor animal's health, and blood donors should be tested for infectious diseases. They also need to adhere to federal regulations, keep detailed records, and have written consent from the animal's owner.

Each veterinarian who is licensed in California and engages in the production of animal blood and blood component products solely for use in their own practice or for a community blood bank operating under this article shall meet all of the following conditions:

(a) Follow current and best practices on community animal blood banking, which may include those developed pursuant to Section 9255 of the Food and Agricultural Code.

(b) Operate under conditions, and use methods of production, that are consistent with current standards of care and practice for the field of veterinary transfusion medicine to ensure that the animal blood and blood component products will not be contaminated, dangerous, or harmful.

(c) Ensure that the production of blood and blood component products is safe and not injurious to the donor animal’s health.

(d) Follow, to the extent possible, the latest blood banking standards, which may include the latest published edition of the American Association of Blood Banks’ standards, and maintain responsibility over all veterinary and technical policies and procedures that relate to the safety of staff members and donor animals.

(e) Utilize bloodborne pathogen testing for all canine and feline blood donors in accordance with the best clinical practices in the veterinary field, which may include the most recent Consensus Statement on blood donor infectious disease screening by the American College of Veterinary Internal Medicine.

(f) Ensure that the production of animal blood and blood component products complies with all applicable federal laws and regulations, including, but not limited to, Chapter 5 (commencing with Section 151) of Title 21 of the United States Code.

(g) Maintain onsite records available for inspection by the board, including information documenting any history of blood draws or use of anesthesia on the animal, the number and date of donations collected, the estimated milliliters of blood collected per donation based on weight in grams, any adverse events, and any complaints from owners regarding animals who donate blood or blood component products.

(h) Obtain the informed written consent of the owner of the animal blood donor and keep a record of that consent.

veterinary transfusion medicine animal blood banking donor animal health

Section § 4920.3

This law says that veterinarians and community blood banks can't pay people for bringing animals to donate blood. The term 'payment' here means giving any kind of money or value that can be converted into money. However, this doesn't include paying for any health care services for the animal, like tests or vaccinations, which benefit the animal's health.

(a) A veterinarian or a community blood bank operating under this article shall not provide payment to a person who provides an animal for the purpose of donating that animal’s blood and blood component products for use in their practice or for retail sale and distribution.

(b) For purposes of this section, “payment” means the transfer to any person of money or other valuable consideration that can be converted to money by the recipient. For purposes of this section, “payment” does not include fees for veterinary tests, medications, vaccinations, screenings, or other services that benefit the health of the animal from which the blood or blood component products were taken.

veterinarian community blood bank animal blood donation

Section § 4920.4

This law allows the board to set up a registration and annual renewal fee for community blood banks. The fee covers the costs of checking and managing these blood banks. However, the fees cannot be more than what it reasonably costs to regulate them.

The board may establish a community blood bank registration fee and annual renewal fee to be paid by community blood banks to cover costs associated with oversight and inspection of the premises. The fee shall not exceed the reasonable regulatory costs of administering, implementing, and enforcing this article.

community blood bank registration fee annual renewal fee

Section § 4920.5

This law requires community blood banks to follow specific registration rules for blood products as outlined in another section of the Food and Agricultural Code.

A community blood bank operating under this article shall comply with blood or blood component product registration requirements under Article 5 (commencing with Section 9241) of Chapter 1.5 of Part 1 of Division 5 of the Food and Agricultural Code.

community blood bank blood product registration blood components

Section § 4920.6

This law requires community blood banks that take blood from animals to report certain details every three months to the Department of Food and Agriculture. They must provide information on how much blood they've collected and sold, the types of animals involved, and any health problems these animals experienced as a result of donating blood. They also need to report if any blood tested positive for diseases according to the latest veterinary screening guidelines.

A community blood bank operating under this article shall submit a quarterly report to the Department of Food and Agriculture every three months that includes all of the following information:

(a) The number of donations from community-sourced animals and separate total amounts of whole blood, packed red blood cells, and fresh frozen plasma sold in California during that quarter, by species of animal in estimated milliliters based on weight in grams.

(b) The number and species of animal donors experiencing adverse events, the total number of adverse events, and the nature of adverse events experienced by animals that donate blood.

(d) The number and species of animal donors whose blood tested positive for known pathogens, in accordance with the best clinical practices in the veterinary field, which may include the most recent Consensus Statement for blood donor infectious disease screening by the American College of Veterinary Internal Medicine.

community blood bank quarterly report animal blood donations

Section § 4920.7

If you're a veterinarian in California running a closed-colony blood bank, you have to follow certain rules set out in a specific section of the Food and Agricultural Code.

Each veterinarian who is licensed in California and operates a closed-colony blood bank shall comply with Chapter 1.5 (commencing with Section 9201) of Part 1 of Division 5 of the Food and Agricultural Code.

licensed veterinarian closed-colony blood bank compliance

Section § 4920.8

If a community blood bank breaks the rules set out in this article, it can face consequences like corrective actions, losing their license temporarily, having limitations placed on their operations, or even completely losing their license to operate as determined by the board under Article 4.

A violation of this article by a community blood bank shall constitute a cause for corrective action, suspension, restriction, or the nonrenewal or revocation of a license or registration by the board pursuant to Article 4 (commencing with Section 4875).

community blood bank violations corrective action license suspension