Guidelines for Preparation of Formula and Breastmilk in Health Care Facilities

As adapted from Infant Feedings: Guidelines for Preparation of Formula and Breast Milk in Health Care Facilities. Pediatric Nutrition Practice Group of the American Dietetic Association, 2003

Chapter 1. Physical Facilities

1. If infant formula is prepared on-site, it is strongly recommended that there be a separate room that

a. has the appropriate physical separation from direct patient care areas;
b. has the preparation area divided from the storage and anteroom areas;
c. is used solely for the purpose of preparing infant formula, breastmilk, and enteral feedings by aseptic (clean, no-touch) technique.

2. The design of the formula room must facilitate work flow that supports aseptic technique in feeding preparation.

3. A separate handwashing sink with controls for water that do not require the use of hands must be available within the infant formula preparation area.

4. Formula preparation and storage areas should be securable, to prevent adulteration of formula and supplies and to control the traffic of unauthorized individuals through the room(s).

5. Office space sufficient to support the function of the formula room, including receipt of orders, label preparation, and record keeping, must be available.

6. A clean air supply with appropriate pressure gradient is required for the infant formula preparation room.

7. The surface of the floors, walls, and ceiling of the infant formula preparation room must be made of material that can be maintained in a sanitary condition.

8. The closet for cleaning supplies should be in close proximity to, but should not open directly into, the infant formula preparation room.

9. Lighting within the infant formula preparation room should be easily cleanable, enclosed, and adequate for accurate preparation of formula and maintenance of a sanitary environment.

10. A sufficient number of electrical outlets should be available in the infant formula room.

11. When there is no formula room, a separate formula preparation area should be designated that complies with all construction considerations and facilities needed to support aseptic technique for preparation of formula and breastmilk feedings, as described in this chapter.

Chapter 2. Equipment, Utensils, and Supplies

1. The equipment and utensils in the infant formula preparation room should be in compliance with applicable health regulations and sanitation codes.

2. All small equipment and utensils in the infant formula preparation room must be constructed so that they can be sanitized.

3. There should be written guidelines for regularly scheduled preventive and corrective maintenance of equipment in the infant formula preparation room. The preventive and corrective maintenance must be documented and monitored.

4. Refrigeration must be adequate in capacity to chill ingredient water and to cool prepared formula to 4°C (40°F) within 1 hour of preparation. The refrigerator for infant feedings must be securable to prevent tampering.

5. Freezers used to store expressed breastmilk should hold milk at -20°C (-4°F) or less.

6. Supplies (eg, gowns, bottles, nipples, sanitizing solutions, utensils, and equipment) must be adequate to implement aseptic technique in the preparation of infant formula.

7. Single-use bottles and nipples are recommended whenever feasible; they should never be reused. Only specialty products not available as single-use items should be reused.

8. Each mother’s expressed breastmilk must be stored in a separate bin to discourage misadministration and cross-contamination of feedings.

9. Microwave ovens, blenders, and garbage disposals are not recommended for use in formula rooms.

10. Cleaning supplies must be stored separately from infant formula products and ingredients.

11. Cleaning supplies should be used exclusively for the infant formula preparation area; cleaning equipment, such as mops, should not be shared with other areas of the facility.

12. Only chilled, sterile ingredient water is recommended for infant formula preparation.

13. Equipment that ensures that formula remains chilled to 4°C (40°F) and prevents contamination to the formula should be available to safely transport infant formula to the patient unit.

14. Trash containers in the infant formula preparation room must be covered and must have a foot-operated lid.

Chapter 3. Personnel

1. Administrative responsibility for the infant formula preparation room must be assigned to a qualified individual--eg, a registered dietitian, a registered pharmacist, or a registered nurse.

2. The supervisor of the infant formula preparation room should be experienced in formula room techniques and operations.

3. Minimum qualifications for infant formula preparation room technicians should include an ability to read, write, and use mathematic skills at the high school level or above.

4. A dress code that is in keeping with aseptic technique should be defined for formula preparation room personnel.

5. A written training policy must be developed and implemented that requires an orientation of sufficient duration and substance, training, in-service experiences, and evaluation of competency at appropriate intervals for each staff member responsible for preparation of infant formulas.

6. A sufficient number of trained staff must be available to ensure the continuity and quality of preparation and distribution of infant formula.

7. The infant formula room technician must be in good health, as defined by the employee health policies of the health care facility and appropriate regulatory agencies.

8. Staff working in the infant formula preparation room must practice good personal hygiene.

Chapter 4. Formula Preparation and Handling

1. There must be written guidelines for safe receiving and storage of infant formula products and ingredients, to maintain product integrity.

2. Expired or damaged infant formula products must be discarded in such a way as to prevent human consumption.

3. Care should be taken to avoid freezing temperatures (0°C, 32°F) or excessive heat (35°C, 95°F) in stock storage areas.

4. All cleaning supplies must be stored separately from infant formula products and ingredients.

5. The health care facility should establish a process for identifying suspected problems with a product’s integrity or physical appearance (eg, check with the manufacturer).

6. There must be written guidelines for ordering formulas, transmitting orders to the formula room, and maintaining formula order records for individual patients.

7. The infant formula order should include the following:

a. Patient’s name
b. Patient’s medical record ID number
c. Patient’s location
d. Formula name plus additives
e. Caloric density/volume/feeding frequency
f. Name of authorizing physician
g. Date of order

8. During infant formula preparation, no other activities (such as heavy cleaning) should take place. Doors to the infant formula preparation room should be kept closed and secured during formula preparation. Only authorized personnel should be allowed access to the infant formula preparation room.

9. In facilities where there is no formula room, a dedicated clean space with facilities for aseptic technique must be used for formula preparation.

10. Aseptic technique must be practiced for all infant formula preparation. Preparation procedures should be appropriate to the conditions in the specific facility.

11. There must be written guidelines for aseptic technique used in the infant formula preparation room, including hand hygiene and care of work area, equipment, and supplies. These policies and procedures should address hand soaps and gels.

12. Autoclaving or a thermal process such as a dedicated dishwasher is recommended for cleaning equipment used in formula preparation.

13. Single-use containers are recommended for dispensing prepared formula.

14. Written formulations should be maintained in the infant formula preparation room for all infant formulas prepared. Formulations must be verified for accuracy and appropriateness, preferably by a registered dietitian trained in infant formula preparation.

15. Commercially sterile ready-to-feed and liquid-concentrate formulas should be used when available and nutritionally appropriate. The powdered form of infant formula should be used only when alternative commercially sterile liquid products are not available.

16. Only chilled, commercially sterile ingredient water is suggested for preparation of infant formula. Distilled, deionized, or bottled waters that are not commercially sterile must be sterilized.

17. A new or sanitized container should be used to prepare each formula type, to prevent possible exposure of the patient to allergens.

18. Powdered formula must be measured by weight. The scoop inside the can should be aseptically removed and discarded.

19. Opened cans of formula must be covered and labeled with expiration date. These cans should be stored in a clean, secured location.

20. Written guidelines governing acceptable ingredients that may be added to infant formulas should be available.

21. It is recommended that medications including electrolytes not be added in the formula room.

22. Colorants should not be added to infant feedings.

23. Prepared infant formula must not be frozen.

24. Terminal heating of infant formula is not recommended.

25. Generation of labels should occur away from the formula preparation area (such as in the anteroom), to avoid a break in aseptic technique.

26. Each unit of prepared formula must have a label that includes the following items:

a. Patient’s name
b. Patient’s medical record/ID number
c. Patient’s location
d. Formula name plus additives
e. Caloric density/volume
f. Volume in container
g. Expiration date and time
h. "For enteral use only"
i. "Refrigerate until use"

27. Unit of use packaging (single feeding or the appropriate amount for one hang time) of prepared formula is recommended.

28. Opened, ready-to-feed-formula and house-prepared formula may be stored in bulk containers and refrigerated up to 24 hours in health care facilities. All opened formula products, including liquid concentrate, powders, and additives, should be labeled with an expiration date and time.

29. Dedicated refrigerators with adequate chill capacity (4°C, 40°F) for infant feedings in the formula room and on the patient care units are recommended. Unless state regulations prohibit, formula and breastmilk may be stored in the same refrigerator.

30. Labels of prepared formulas should be checked against the individual patient’s feeding order before dispensing the formula/breastmilk to the patient unit.

31. There must be written guidelines for the safe transport of infant formula that ensure maintenance of the appropriate temperature (4°C, 40°F) until it reaches the patient care unit refrigerator.

32. There should be written guidelines, developed by the department responsible for preparation of infant feedings and the Department of Nursing, which prescribe proper clean handling and storage of infant feedings on patient care units.

33. There should be written guidelines for reporting and follow-up of infant feedings that are flawed in any way (eg, defective, adulterated, contaminated, or preparation error).

34. There should be written guidelines for reporting and follow-up of recalled formula products in the health care facility. Formula products recalled by the manufacturer or a regulatory agency should be handled in accordance with their instructions.

Chapter 5. Expressed Human Milk

1. Mechanical expression needs to begin as soon as possible after giving birth, with the use of a hospital-grade electric breast pump.

2. Personal collection kits should be sterilized daily.

3. Human milk expression in the hospital can take place at the infant’s bedside or in designated private pump rooms.

4. Mothers must be instructed in writing and/or verbally regarding appropriate pumping, labeling, storage, and transport technique.

5. Human milk must be stored in "food-grade" plastic containers or glass.

6. To prevent errors in breastmilk delivery, human milk supplied to the facility must be labeled with complete and accurate information, including infant’s name, medical record number, and date and time of pumping.

7. Human milk transported to and from the hospital should be maintained at proper temperatures (2°-6°C, 35°F-42°F), to prevent loss of nutrients and to minimize bacterial growth.

8. Dedicated freezers and refrigerators should be provided for storing human milk. Unless state regulations prohibit, formula and breastmilk may be stored in the same refrigerator. Food should be in a separate refrigerator.

9. Human milk should be stored in separate labeled bins or zippered bags, to prevent misadministration of breastmilk and to prevent cross-contamination of that milk with other feedings.

10. For proper breastmilk storage, refrigerator temperatures should be maintained at 2°C to 4ºC (35°F to 40°F) and freezer temperatures at -20ºC (-4°F).

11. To prevent unnecessary thawing and loss of frozen milk, freezers should be tilted backward during installation, units should be plugged into the emergency power supply, and an alarm should be installed to alert hospital staff if temperatures go above acceptable levels.

12. A written policy on access to breastmilk freezers and refrigerators should be established.

13. Fresh human milk can be safely stored at 2°C to 4°C (35°F to 40°F) in the refrigerator for 48 hours.

14. Fortified breastmilk should be stored in the refrigerator at 2°C to 4°C (35°F to 40°F) and should be used within 24 hours.

15. Frozen breastmilk can be safely stored in a home freezer for 3 months and in a -20°C (-4°F) freezer for 12 months.

16. Infants should receive fresh breastmilk whenever possible, because of the enhanced activity of cellular components.

17. Frozen breastmilk should be used in the order in which it was expressed (oldest milk first).

18. Frozen breastmilk may be placed in the refrigerator to thaw gradually. The container must be labeled with the expiration date.

19. Thawed breastmilk must be used within 24 hours.

20. Containers of breastmilk may be warmed or thawed under running water. Microwaves or hot water should never be used to warm or thaw human milk.

21. Aseptic technique must be used in breastmilk preparation and handling.

22. Fortifiers must be measured accurately, using aseptic technique. If using fortifiers other than commercially available human milk fortifier that is individually packaged, the fortifiers should be premeasured and packaged in the formula room, using techniques described in Chapter 4. Powdered products must be measured by weight.

23. Bolus tube feeding of human milk is preferred, to minimize fat loss and time for bacterial growth.

24. Hang time for feeding human milk should not exceed 4 hours. Syringe and tubing must be changed every 4 hours for continuous feedings.

25. Breastmilk remaining in a bottle after feeding an infant should be discarded.

26. Health care facilities should have a plan for handling misadministration of human milk (baby receives breastmilk other than his own mother’s milk). The attending physician must be notified, and an incident report may need to be filed. Risk Management may also be notified, depending on facility protocol for management and follow-up.

27. Any donor milk available as an option for infants whose mothers are unable to provide breastmilk must be pasteurized. Fresh or thawed pasteurized milk may be stored refrigerated for 48 hours.

Chapter 6. Delivery and Bedside Management of Infant Feedings

1. All formulas, expressed breastmilk, feeding additives, and supplies should be stored on the patient unit in a secured or limited-access area and under the proper storage conditions.

2. Formula and breastmilk should not be stored with food in the same refrigerator.

3. In the event that feedings are not dispensed in unit of use containers, individual feedings poured from a bulk container should be handled on a clean, dry, disinfected surface. The container should be removed from the refrigerator immediately before pouring and returned promptly. Patient information on the container should be verified for current formula order.

4. Any items taken into an individual patient room should not be returned to the storage area or used for other patients.

5. Bottles, nipples, and graduated feeders should be for single use.

6. Warming is not recommended for continuous feedings. Warming time for oral or bolus feedings should be limited to no more than 15 minutes. Acceptable methods for warming include electric warming units and warm running water. Water level should not reach the level of the nipple ring or submerge the lid.

7. Microwaves should never be used to warm infant feedings.

8. A designated person must verify the formula label before feeding an individual patient.

9. For infants being nipple fed, any feeding remaining in the bottle after 1 hour should be discarded.

10. Medications should be added to feedings only by properly trained personnel and with appropriate checks for compatibility.

11. Tube-feeding administration systems should be assembled on a clean, dry, disinfected surface, avoiding touch contamination of any portion of the feeding system that will come into contact with the feeding.

12. Aseptic technique should be used when filling, refilling, or changing feeding containers. It is recommended that tube-feeding reservoirs (syringe, bag, or bottles) not be reused in health care facilities.

13. Tubing should be flushed with sterile water or air after intermittent feeds and any medication additions.

14. A policy for hang time for formulas and feeding sets must be established in each facility. Hang times for formula in the NICU, for other immune-suppressed patients, and for human milk should be 4 hours or less. Ready-to-feed sterile formulas for other patients may tolerate longer hang times.

15. When enteral feeding pumps are used, they should be selected to meet the special feeding needs of infants and neonates.

16. The feeding-pump housing should be disinfected before initial use by each patient and on a regular basis during use.

17. Modular formula additives should be added to the formula in the formula room, using aseptic technique whenever possible.

18. If formula additives must be added at the bedside, premeasured amounts or smaller labeled containers of the additive with sterilized measuring devices are recommended.

19. Vitamin, mineral, electrolyte, or medication additives are to be added by the appropriate nursing or pharmacy personnel, in compliance with facility and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) standards for medication administration.

20. Colorants should never be added to an infant feeding for any reason.

21. A policy should be developed to establish guidelines for parent education for formula-mixing technique after discharge.

22. Any measuring devices, mixing equipment, or other utensils should be sterilized before coming into contact with formula or additives.

Chapter 7. Microbiology and Infection Control

1. When nutritionally appropriate sterile liquid formula products are available, they should be used in preference to formulas prepared from nonsterile powdered formula products.

2. Infection control procedures must be in place throughout the process of enteral feeding, from procurement to administration.

3. A multidisciplinary committee that includes at minimum the expertise of food handling, nursing, and medicine should approve the infant feeding preparation policies and review quality monitoring.

4. The Hazard Analysis Critical Control Point (HACCP) plan for infant formula and enteral feeding should address all aspects of the feeding process, including infection control elements. The key elements of such a plan include the following:

a. Prevention of exogenous contamination of infant formula products during receiving, preparation, storage, delivery, and administration
b. Prevention of growth of organisms present in the prepared formula during receiving, preparation, delivery, storage, and administration
c. Detection, as soon as possible, of any infection or toxin that may be due to formula contamination

5. The infant formula container or ingredient container must be inspected before use. The product must not be used if the expiration date has passed or if the container is damaged, leaking, or swollen.

6. The product contents must be inspected after opening the container. The product must not be used if it appears adulterated, contaminated, or otherwise abnormal (eg, lumpy, grainy liquid or clumped powder).

7. Aseptic technique must be practiced for all infant formula and expressed human milk preparation. Preparation procedures should be appropriate to the conditions in the specific facility.

8. The use of chilled sterile ingredient water is recommended to facilitate achieving formula temperature of 4°C (40°F) quickly.

9. All feedings in the NICU and facility-prepared infant feedings for other patient care units should be packaged in quantities required for a feeding or per 4-hour period. Outside the NICU, commercially sterile feedings not manipulated (no water, modules, or medications added) may extend hang time to 8 hours.

10. The manufacturer should be consulted for assistance if any questions arise involving the microbiological quality of the infant formula product or ingredients.

11. Surveillance cultures of infant feedings are not recommended routinely by the Centers for Disease Control and Prevention. State regulations may differ.

12. When patients have symptoms of food-borne illness, consideration of contaminated enteral feedings should be a part of the diagnostic evaluation.

Chapter 8. Quality Assurance

1. The department responsible for infant formula preparation must establish an HACCP plan that includes continuous quality improvement functions as well as corrective action and follow-up, when deemed necessary. A separate HACCP plan may be needed for expressed breastmilk

2. The HACCP plan must include measurable indicators for use in monitoring the most important aspects of infant feeding preparation, storage, delivery, and feeding administration.

3. The infant feeding preparation HACCP plan should be integrated into the facility’s overall performance improvement program, as described in Chapter 7. The seven steps that must be considered when formulating an interdisciplinary HACCP plan are as follows:

a. Assess potential hazards.
b. Identify critical control points (CCPs).
c. Establish policies and procedures for CCPs.
d. Monitor CCPs.
e. Plan for procedure failure, and take corrective action when needed.
f. Verify that the system is working.
g. Set up a record keeping system.

4. Results of continuous monitoring of quality improvement should be routinely reviewed in accordance with the facility’s performance improvement plan.

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