Handout #1

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Handout #1

    ?483.35(i) Sanitary Conditions (F371) Instructor’s Guide

    Handout #1

    Sanitary Conditions Overview

    Sanitary conditions encourage safe food handling systems to prevent, reduce or eliminate

    potential hazards associated with food handling. Unsafe food handling poses serious risk of

    foodborne illness in nursing home residents.

     Nursing homes must incorporate effective food safety systems for residents. These safety

    systems involve identifying hazards at specific points during food handling and preparation, and

    identifying how the hazards can be prevented, reduced or eliminated.

     It is important to focus attention on the risks that are associated with foodborne illness by

    identifying critical control points (CCPs) in the food preparation processes that, if not controlled,

    might result in food safety hazards for residents.

     Thawing, cooking, cooling, holding, reheating of foods, and employee hygienic practices are

    considered some of the operational steps that are critical to control in order to prevent or

    eliminate food safety hazards.

    ?483.35(i) Sanitary Conditions (F371) Instructor’s Guide


    Centers for Medicare & Medicaid Services

    7500 Security Boulevard, Mail Stop S2-12-25

    Baltimore, Maryland 21244-1850

Center for Medicaid and State Operations/Survey and Certification Group

    Ref: S&C-08-09

    DATE: January 11, 2008

    TO: State Survey Agency Directors

    FROM: Director

     Survey and Certification Group

    SUBJECT: Nursing Homes: Surveying Facilities that Receive Food Prepared by Off-Site


    Memorandum Summary

     When a nursing home (facility) receives food services from an off-site location, the surveyor must assess whether the facility is compliant with 42 C.F.R. ? 483.35(i) which states: “a

    facility must procure food from sources approved or considered satisfactory by Federal, State, or local authorities.”

    The purpose of this memorandum is to instruct surveyors on the appropriate action when surveying

    nursing homes that procure food prepared by sources external to the facility for the purpose of

    consumption by residents.

    The nursing home regulations at 42 C.F.R. Part 483 subpart B require nursing homes to ensure the safe

    procurement of food for the purpose of consumption by residents. The food sources must be approved or

    considered satisfactory by Federal, State, or local authorities. The regulation further states that the facility

    must store, prepare, distribute, and serve food under sanitary conditions.

    Determining Compliance

    It is not always necessary for surveyors to routinely survey off-site kitchens (any kitchen that is not operated by

    the “facility”) in cases where the food preparation entity is inspected by other Federal, State, or local authorities.

    Page 2 - State Survey Agency Directors

    The instructions below provide direction for surveyors when surveying nursing homes that receive food from

    external sources (off-site kitchens) for residents’ consumption. Surveyor(s) should determine if there are any:

    ?483.35(i) Sanitary Conditions (F371) Instructor’s Guide

    ? Food safety and/or sanitary condition concerns related to when, where, and how the food received for

    residents’ consumption is prepared, packaged and delivered;

    ? Food safety and/or sanitary condition concerns related to when, where, and how the food is stored and

    served once it arrives at the facility; and

    ? On-site food safety and/or sanitary condition concerns such as but not limited to food-borne illness.

    If the surveyor(s) determine that a facility has food safety concerns warranting further evaluation, the surveyor(s)

    have the authority to inspect (survey) the food supply source (last point of preparation off-site kitchen).

    Even if the surveyor(s) determine that a facility has no food safety concerns, if the off-site kitchens are not

    inspected by other Federal, State or locally authorized food safety entities, or if the inspection results are not

    satisfactory (did not meet standards) then the surveyor(s) should cite the facility at 483.35(i)(1).

    If the off-site kitchen(s) are satisfactorily inspected (meeting standards) by other Federal, State or local authority

    and the surveyor(s) find no food-borne illness or other related issues at the primary survey location (the facility),

    the surveyor(s) may accept the results of the other Federal, State or locally approved inspection. The surveyor(s)

    must obtain documentation of the authorized inspection to satisfy compliance with the regulatory requirement

    related to the kitchen inspection.

    Even when the above criteria are met and the surveyor(s) accept the authoritative documentation of a

    kitchen inspection, once the food prepared off-site is brought to the facility, the surveyor(s) should

    proceed to investigate all on-site areas of the survey related to ?483.35(i).

    Note: See section ?483.35(i) and the State Operations Manual for further State Agency (SA) and the

    Centers for Medicare & Medicaid Services (CMS) Regional Office (RO) guidance when determining

    compliance with this regulation. The new guidance forthcoming for F tag 371(projected 2008) will

    include the above direction for surveying facilities serviced by off-site kitchens.

    For questions regarding this memorandum, please contact Debra Swinton-Spears at (410)-786-7506 or e-

    mail at Effective Date: Immediately. Please ensure that all appropriate staff are fully informed within 30 days

    of the date of this memorandum, and disseminate the information to affected providers.

    Training: The information contained in this announcement should be shared with all nursing home

    surveyors and supervisors.


     Thomas E. Hamilton

cc: Survey and Certification Regional Office Management

    Handout #3

    ?483.35(i) Sanitary Conditions (F371)

    Instructor’s Guide

    Strategies to Control Foodborne Illness

    Source of Contamination Primary Agents of Concern PHF/TCS Primary Control Strategies Fruits and vegetables, fresh ? E. coli O157:H7 ? Cook to proper temperature

    ? Salmonella ? Prevention of cross-contamination to

    ready-to-eat foods ? Norovirus

    ? Hepatitis A virus

    ? Shigella

    Ready-to-eat meat and poultry ? Listeria monocytogenes ? Proper refrigeration during storage products

    Pasteurized dairy products ? Listeria monocytogenes ? Proper refrigeration during storage Ice ? Norovirus ? Cleaning and sanitizing the internal

    components of the ice machine

    according to manufacturers’

    guidelines Eggs, raw or unpasteurized ? Salmonella ? Cook to proper temperature

    ? Prevention of cross-contamination to

    ready-to-eat foods Poultry, raw ? Campylobacteria ? Cook to proper temperature

    ? Salmonella ? Prevention of cross-contamination

    ? Clostridium perfringens to ready-to-eat foods Meat, raw ? E. coli 0157:H7 ? Cook to proper temperature

    ? Salmonella ? Prevention of cross-contamination to

    ready-to-eat foods ? Campylobacter

    ? Clostridium perfringens

    Infectious food workers ? Norovirus ? Exclusion of infectious food workers

    ? Hepatitis A virus ? Proper hand-washing procedures

    ? Shigella ? Avoid bare-hand contact with

    ? Salmonella ready-to-eat foods

    ? Staphylococcus aureus

    Handout #4

?483.35(i) Sanitary Conditions (F371)

    Instructor’s Guide

    Safe Food Preparation

    Cross-contamination can occur when harmful substances or disease-causing microorganisms are transferred to food by hands, food contact surfaces, sponges, cloth towels, or utensils that are not cleaned after touching raw foods. Ways to reduce cross-contamination are to store raw meat (e.g., beef, pork, lamb, poultry, and seafood) separately and in drip-proof containers; sanitize towels/cloths, and test the sanitizing solution; wash and sanitize cutting boards; and clean and sanitize work surfaces and food-contact equipment.

    Thawing frozen foods is often the first step in food preparation. Thawing food at room temperature is not acceptable because the food is within the danger zone for rapid bacterial proliferation. Recommended methods to safely thaw frozen foods include: thawing in the refrigerator, in a drip-proof container; completely submerging the item under cold water; microwaving the item and then cooking and serving immediately; and thawing as part of a continuous cooking process.

    Cooking is a critical control point in preventing foodborne illness that will either kill dangerous organisms or inactivate them sufficiently to prevent foodborne illness. Foods should reach the internal temperatures listed in the guidance.

    In particular, unpasteurized eggs when cooked to order in response to resident request and to be eaten promptly after cooking: 145 degrees F for 15 seconds, until the white is completely set and the yolk is congealed.

    Reheated cooked foods present a risk because they have passed through the danger zone multiple times during cooking, cooling, and reheating. The PHF/TCS food that is cooked and cooled must be reheated so that all parts of the food reach an internal temperature of 165 degrees F for at least 15 seconds before holding for hot service. Ready-to-eat foods that require heating before consumption are best taken directly from a sealed container.

    (Although proper reheating will kill most organisms of concern, some toxins, such as that produced by Staphylococcus aureus, cannot be inactivated by reheating food).


    Using the steam table to reheat food is unacceptable since it does not bring the food to the proper temperature within acceptable timeframes.

     Fresh, frozen, or canned fruits and vegetables that are cooked do not require the same level of microorganism destruction as raw animal foods.

    Handout #5

    ?483.35(i) Sanitary Conditions (F371)

    Instructor’s Guide

    Selected Cooking, Reheating, and Cooling Temperatures

    For Foodborne Illness Prevention

    Process Food Item Temperatures Final Cooking Poultry and Stuffed Foods 165 degrees F Temperatures

    Ground Meat 155 degrees F

    Fish and Other Meats 145 degrees F

    Unpasteurized Eggs 145 degrees F Reheating Foods Internal Temperature 165 degrees F

    Intact Package 135 degrees F

    Process Time Temperatures Cooling Within 2 hours From 135 degrees F to 70 degrees F

    Within 4 hours Cooled to 41 degrees F

    Total time cooling not to exceed 6 hours Cooled from 135 degrees F to 41 degrees F

?483.35(i) Sanitary Conditions (F371)

    Instructor’s Guide

    Handout #6

    Prevention of Foodborne Illness Another major factor in causing foodborne illness is improper cooling. Taking too long to chill PHF/TCS

    foods has been consistently identified as one factor contributing to foodborne illness. Cooled food items

    can be re-contaminated by unsanitary handling practices or cross-contaminated from other food products,

    utensils, and equipment.

    Large or dense food items, such as roasts, turkeys, soups, stews, legumes, and chili, may require

    interventions in order to be chilled safely within an allowed time period. These foods take a long time to

    cool because of their volume and density.

    Residents who require a modified consistency diet may be at risk for developing foodborne illness

    because of the increased number of food handling steps required when preparing pureed and other

    modified consistency foods. When hot pureed, ground, or diced food drops into the danger zone (below

    135 degrees F), the mechanically altered food must be reheated to 165 degrees F for at least 15 seconds.

    Pooled eggs are raw eggs that have been cracked and combined together. Salmonella infections associated

    with unpasteurized eggs can be prevented by using pasteurized shell eggs or egg products in foods that

    require pooling of eggs or foods that will not be thoroughly cooked.

    The U.S. Department of Agriculture, Food Safety and Inspection Service, Salmonella Enteritidis (SE)

    Risk Assessment states “A partial list of persons with increased susceptibility to infectious agents

    includes persons with chronic diseases, and nursing home residents. The elderly are particularly

    susceptible to infectious agents such as SE for a number of reasons. The disproportionate impact of

    severe complications and death from Salmonellosis in the elderly is illustrated by epidemiologic

    evidence.” Waivers to allow undercooked unpasteurized eggs for resident preference are not acceptable.

    Pasteurized shell eggs are available and allow for safe consumption of undercooked eggs.

    NOTE: Raw eggs with damaged shells are also unsafe because of the potential for contamination.

    ?483.35(i) Sanitary Conditions (F371) Instructor’s Guide

    Handout #7

    Food Service and Distribution Nursing home facilities use different systems to serve and distribute food items to residents.

    Some of these include tray lines, portable steam tables transported to a unit or dining area, open

    shelved food transport carts with covered trays, or enclosed carts that have hot and cold

    compartments. Some systems incorporate a heating element (pellet) under each plate of hot food.

    ? The tray line may include, but is not limited to the steam table where hot prepared foods

    are held and served, and the chilled area where cold foods are held and served.

    ? Dining locations include any area where one or more residents eat their meals.

    ? Snacks refer to those foods that are served between meals or at bedtime.

    ? Facility-sponsored special events, such as cookouts and picnics where food may not be

    prepared in the facility’s kitchen and is served outdoors or in other locations.

    ? If residents take prepared foods with them out of the facility, such as bag lunches, the

    foods must be handled and prepared for them with the same safe and sanitary approaches

    used during primary food preparation in the facility.

    ? Appropriate ice and water handling practices prevent contamination and the potential for

    waterborne illness.

    ? A potential cause of foodborne illness is improper storage of PHF/TCS food. The

    refrigerator must be in good repair and keep foods at or below 41 degrees F. The freezer

    must keep frozen foods frozen solid.

    Handout #8

    Equipment and Utensil Cleaning and Sanitation

    ?483.35(i) Sanitary Conditions (F371) Instructor’s Guide

    Dishwashing machines use either heat or chemical sanitization methods. The guidance

    references specifications according to the U.S. Department of Health and Human Services,

    Public Health Services, Food and Drug Administration Food Code (or according to

    manufacturer’s directions) for each method.

    A three-step process is used to manually wash, rinse, and sanitize dishware correctly. The first

    step is thorough washing using hot water and detergent after food particles have been scraped.

    The second is rinsing with hot water to remove all soap residues. The third step is sanitizing

    with either hot water or a chemical solution maintained at the correct concentration, based on

    periodic testing, and for the effective contact time according to manufacturer’s guidelines.

    When cleaning fixed equipment that cannot readily be immersed in water, the removable parts

    should be washed and sanitized while the non-removable parts are cleaned with detergent and

    hot water, rinsed, air-dried and sprayed with a sanitizing solution.

    Handout #9

    Potential Tags for Additional Investigation

During the investigation of 42 CFR ?483.35(i)(1)(2), the surveyor may have identified concerns

    related to these requirements. The surveyor should investigate these requirements before

    ?483.35(i) Sanitary Conditions (F371)

    Instructor’s Guide

    determining whether noncompliance may be present. The following are related outcome,

    process, and structure requirements that may be considered:

? 42 CFR 483.25(g)(2), F322, Nasogastric Tubes

    o Determine if residents have experienced nausea, vomiting, diarrhea, or other

    gastrointestinal symptoms as a result of the failure to store, handle,

    administer, or remove and discard tube feeding solutions in a safe and

    sanitary manner.

    ? 42 CFR 483.25(i), F325, Nutrition

    o Determine if multiple residents have experienced nausea, vomiting, diarrhea,

    or other gastrointestinal symptoms related to foodborne illness, which may

    impact their nutritional status.

    ? 42 CFR 483.30(a)(b), F353 Sufficient Staffing

    o Determine if the facility has sufficient staffing to meet the needs of the


    ? 42 CFR 483.35(a)(1)(2), F361, Dietary Services - Staffing

    o Determine if the facility employs or consults with a qualified dietitian. If

    not employed full-time, determine if the director of food service receives

    scheduled consultation from the dietitian concerning storage, preparation,

    distribution and service of food under sanitary conditions. ? 42 CFR 483.35(b), F362, Standard Sufficient Staff

    o Determine if the facility employs sufficient support personnel competent to

    carry out the functions of the dietary service. ? 42 CFR 483.35(h) Paid Feeding Assistant

    o Determine if the Feeding Assistant has successfully completed a State-

    approved training course that meets Federal requirements and that the

    Feeding Assistant is utilizing proper techniques to prevent foodborne illness. ? 42 CFR 483.65(a), F441, Infection Control

    o Determine if the facility’s infection control program included investigation,

    control, and prevention of foodborne illness. ? 42 CFR 483.65(b)(3), F444, Hand washing Techniques

    o Determine if the facility has practices in place to prevent the spread of

    infection, including proper hand washing techniques. ? 42 CFR 483.70(c)(2), F456, Maintain All Essential Equipment

    o Determine if the equipment in the kitchen, such as refrigerators, food carts,

    tray line equipment, freezers, dishwashers, ovens, stoves, and ranges etc. is

    maintained in safe operating condition and according to manufacturers’


    ? 42 CFR 483.70(h), F465, Other Environmental Conditions

    o Determine if the kitchen physical environment, such as, floors, walls,

    ceilings, and vent hoods are safe, clean, and sanitary.

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