Economic cost for implementation of the U.S. Food and Drug Administration's Code of Federal Regulations Title 21, Part 1271 in an egg donor program.
OBJECTIVE
To assess the economic cost of implementing the U.S. Food and Drug Administration's Code of Federal Regulations Title 21, Part 1271 for infectious screening of egg donors in our practice during the first year.


METHODS
Physicians and employees of our practice were surveyed to ascertain the scope of duties and the number of hours spent to implement the regulations. The economic cost to the practice and the cost of additional laboratories were calculated.


METHODS
Private practice.


METHODS
Egg donors and recipient couples who underwent treatment in our center from May 25, 2005 (the day regulations became effective) to May 25, 2006; and physicians, administrators, and staff who were employed by the practice during this time frame.


METHODS
Using a questionnaire, structured interviews were conducted for all physicians and employees of our practice. The information regarding number of hours was provided to our chief financial officer, who calculated the cost to the practice. The cost that recipient couples paid for laboratory tests that would not otherwise be required to meet American Society for Reproductive Medicine guidelines and the cost of an external audit were also added to the overall practice costs to determine a total cost associated with the regulations in the first year.


METHODS
List of activities associated with implementation of the regulations, personnel hours involved to implement the regulations, and economic cost to the practice and to recipient couples.


RESULTS
The total number of personnel hours spent by our practice in preparation for implementation of the regulations was 623.3 hours. In the first year, 675.2 additional hours were required to implement the regulations for 40 donors who cycled during this time. The economic cost to the practice for both preparation and implementation of the regulations was $219, 838, and the cost of additional laboratory work borne by the recipient couples was $15,880. Thus, the total cost was calculated to be $235,718 at 1 year after implementation of the regulations.


CONCLUSIONS
Implementation of the FDA 21 CFR, Part 1271 was associated with a very high economic cost, even if the costs incurred by the government to develop and implement the regulation are excluded.
Baker
Valerie L
VL
Fertility Physicians of Northern California, San Jose, California, USA. vlbaker@stanford.edu
Gvakharia
Marina O
MO
Rone
Heather M
HM
Manalad
James R
JR
Adamson
G David
GD
D002140:California; D003140:Communicable Disease Control / Q000191:economics*; D005260:Female; D019983:Guideline Adherence / Q000191:economics* / Q000706:statistics & numerical data; D017048:Health Care Costs / Q000706:statistics & numerical data*; D006801:Humans; D014019:Tissue Donors / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration / Q000191:economics* / Q000331:legislation & jurisprudence*