42 CFR §491.11

1. (a)The clinic or center carries out, or arranges for, a biennial evaluation of its total program.
2. (b)The evaluation includes review of:
   1. (1)The utilization of clinic or center services, including at least the number of patients served and the volume of services;
   2. (2)A representative sample of both active and closed clinical records; and
   3. (3)The clinic's or center's health care policies.
3. (c)The purpose of the evaluation is to determine whether:
   1. (1)The utilization of services was appropriate;
   2. (2)The established policies were followed; and
   3. (3)Any changes are needed.
4. (d)The clinic or center staff considers the findings of the evaluation and takes corrective action if necessary.