Archiving of medical records and specimens from animal sources
Archiving of records allows a rapid and accurate linkage between
- medical records of a named recipient of fetal precursor cell transplants;
- release records of each fetal precursor cell transplant used for treatment;
- frozen specimens of last supernatant of tissue culture flasks of each fetal precursor cell transplant of a batch;
- records of autopsy of each rabbit female whose fetuses or newborns were used for preparation of fetal precursor cell transplants of the patient; and
- health data of the closed colony of rabbits that contain:
1/ record cards posted on cages of each rabbit female, with identification number;
2/ records of all incidents affecting the health of the colony: diseases, sudden death of rabbit(s), environmental breaks, etc.;
3/ records of all closed colony health surveillance programs;
all of the above linked to the number of fetal precursor cell transplant as it appears on its label.
Such recordkeeping is essential for the safety of fetal precursor cell transplantation as a treatment method, because it allows a public health investigation and containment of suspected new xenogeneic infection.
The following records must be kept for 50 years, as per U.S. FDA:
1/ Record cards posted on the cage of each rabbit female of the closed colony, which contain the identification number, and written notes of all pertinent facts and observations of that rabbit female, which information is entered into the computerized data base as well, where genetic relationships of each animal within the same generation and between generations is documented, too.
2/ Records of all incidents possibly affecting the health of closed colony, such as disease outbreaks, sudden animal death, breaks in environment barriers, etc.
3/ Documentation of the colony health maintenance and surveillance program, including standard operating procedures for the closed colony.
4/ Results of autopsy of each deceased rabbit female.
5/ Release records of each batch of fetal precursor cell transplants.
The above records are linked to the number of the fetal precursor cell transplant as it appears on its label.
For the purpose of retrospective public health investigations the following are banked of each batch of fetal precursor cell transplants:
1/ samples of the last supernatant of each culture flask of each fetal precursor cell transplant, kept in liquid nitrogen for 5 years;
2/ blood samples from each rabbit female taken at the initiation of the breeding cycle and every 6 months thereafter, and consisting of five 0.5 cc aliquots of blood serum and plasma, and three aliquots of viable leukocytes, kept in liquid nitrogen for 5 years;
3/ paraffin embedded, formalin fixed and cryopreserved (in liquid nitrogen) specimens of spleen, liver, bone marrow and brain of each autopsied rabbit female.