(a) Maintenance records.

1. (1) There must be a documented preventive maintenance program for each piece of equipment, based upon the manufacturer’s recommendations.
2. (2) Maintenance records must be maintained for the life of the instrument.
3. (3) There must be documentation of remedial action taken when there is equipment failure.

(b) Individual usage records. There must be documentation of the following on each day that the facility is open if the particular piece of equipment is in use:

1. (1) Temperature of each refrigerator, freezer, and incubator;
2. (2) Adequate humidity of each incubator;
3. (3) External verification of the gaseous environment in each incubator;
4. (4) Level of liquid nitrogen in any embryo or gamete storage container; and
5. (5) Status of gas cylinders and/or liquid nitrogen reservoir supplies.

(c) Alarm systems.

1. (1) Incubators and frozen embryo storage facilities must be equipped with alarms that would sound at a location that is staffed twenty-four (24) hours per day.
2. (2) Alarms must be tested at least monthly for proper operation.

(d) Emergency generator.

1. (1) There must be an automatic emergency generator in the event of power failure.
2. (2) The system must be exercised weekly and tested under load monthly.