§483.35(i) Sanitary Conditions (F371) Surveyor Training: Interpretive Guidance Investigative Protocol Instructor Notes: Greet and Welcome all Participants.

§483.35(i) Sanitary Conditions (F371) Surveyor Training: Interpretive Guidance Investigative Protocol Instructor Notes: Greet and Welcome all Participants Introduce Yourself Provide: Agenda Training Materials Handouts 1

With regard to the revised guidance F371 Sanitary Conditions, there have been significant changes. Specifically, F370 and F371 were merged. However, the regulatory language has remained the same. The revisions to F371 were made to provide definition, education, explanation, and examples for the surveyors to reference.

Federal Regulatory Language
The facility must — §483.35(i)(1) Procure food from sources approved or considered satisfactory by Federal, State or local authorities; and §483.35(i)(2) Store, prepare, distribute and serve food under sanitary conditions. Instructor Notes: This is the regulatory language for Sanitary Conditions at Tag F371. Please take a moment and read this carefully. This training will represent the updates and revisions to the interpretive guidance for the regulation at (i). 3

Intent The intent of this requirement is to ensure that the facility: Obtains food for residents’ consumption from approved sources, and Follows proper sanitation and food handling practices to prevent the outbreak of foodborne illnesses. Instructor’s Notes: Ask a surveyor in the class to read this slide aloud to engage the class and emphasize the importance of intent. Safe food handling practices begin when food is received from the vendor and continue throughout the facilities handling processes. Ask are there any questions regarding the intent of this requirement? 4

Training Objectives Describe the relationship between the regulation and the interpretive guidance Describe how to use the investigative protocol Describe and apply components of the investigative protocol Instructor Notes: At the conclusion of this training you will be able to: Describe the relationship between the regulation and the guidance Describe how to use the investigative protocol Describe and apply the components of the investigative protocol Identify areas of non-compliance with the sanitary conditions regulation Appropriately categorize the scope and severity of noncompliance 5

Training Objectives (cont’d)
Identify areas of non-compliance with the sanitary conditions regulation Appropriately categorize the scope and severity of noncompliance Instructor Notes: The Investigative Protocol will be used to survey how nursing homes obtain and handle foods for residents’ consumption to prevent foodborne illness and to determine whether the facility is in compliance with this regulation. The deficiency categorizations section of this guidance will assist the surveyor to appropriately assign the scope and severity to the deficiency.

Definitions Cross-contamination Danger Zone Dry Storage
Food Contamination Food Preparation Food Service/Distribution Foodborne Illness Highly Susceptible Population Pathogen Potentially Hazardous Food (PHF) Ready-to-Eat Food Storage Toxins Instructor Notes: There are several important definitions associated with this guidance. We will briefly review each of these definitions to clarify the terms related to sanitary conditions and prevention of foodborne illness. For the purpose of this guidance, the definitions are specific to the interpretive guidance. Carefully review these definitions as they are very important to your overall understanding of this guidance. You may need to refer back to the definitions as we go through the training. They are provided in the Interpretive Guidance. 7

Cross-contamination The transfer of harmful substances or disease-causing microorganisms to food by hands, food contact surfaces, sponges, cloth towels, or utensils that are not cleaned after touching raw food, and then touch ready-to-eat foods. Cross-contamination can also occur when raw food touches or drips onto cooked or ready-to-eat foods. Instructor’s Notes: Ask a surveyor to read the definition aloud. Ask if there are any questions specific to the definition as it relates to the regulatory guidance. Ask surveyors to provide examples of cross-contamination. 8

Danger Zone Temperatures above 41 degrees Fahrenheit (F) and below 135 degrees F that allow the rapid growth of pathogenic microorganisms that can cause foodborne illness. Potentially Hazardous Foods or Time/Temperature Control for Safety foods held in the danger zone for more than 4 hours if being prepared from ingredients at ambient temperature, or 6 hours if cooked and cooled, may cause a foodborne illness if consumed. Instructor Notes: The temperatures noted in the danger zone are referred to in other places throughout the guidance. It is important to refer to this definition as often as necessary during the survey. Additional note: Ambient temperature refers to room temperature. 9

Dry Storage Storing/maintaining dry foods (e.g., canned goods, flour, sugar) and supplies (disposable dishware, napkins and kitchen cleaning supplies). Storage The retention of food (before and after preparation) and associated dry goods. Instructor Notes: Encourage participation with examples of surveyor findings of improper storage from their own experiences. 10

Food Contamination The unintended presence of potentially harmful substances, including but not limited to microorganisms, chemicals or physical objects in food. Instructor Notes:

Food Preparation The series of operational processes involved in getting foods ready for serving, such as: washing, thawing, mixing ingredients, cutting, slicing, diluting concentrates, cooking, pureeing, blending, cooling and reheating. Instructor Notes: As you review the definition of food preparation, think of some of the observable processes involved in food preparation, service and distribution. 12

Foodborne Illness Illness caused by the ingestion of contaminated food or beverages. Instructor Notes: Ask surveyors to provide you with examples of foodborne illness as it relates to the nursing home surveying process. Foodborne illness will be discussed throughout this training.

Food Service/Distribution
The processes of getting food to the resident: Holding foods hot on the steam table or under refrigeration for cold temperature control Dispensing food portions for individual residents Family style and dining room service Delivering trays to residents’ rooms or units Instructor Notes: Here are just a few examples of food service and distribution. Any process used to get food to the residents is “food service and distribution” therefore this list is not exclusive. 14

Highly Susceptible Population
Persons who are more likely than the general population to experience foodborne illness because of their susceptibility to becoming ill if they ingest microorganisms or toxins (e.g., immunocompromised, chronic disease and advanced age). Instructor Notes: Discuss some examples of residents who are classified as highly susceptible. Engage the class for examples. The prevention of foodborne illness is important in this highly susceptible population. Residents of nursing homes are considered a highly susceptible population. They tend to have multiple comorbidities and age-related debility. They are therefore at increased risk for serious complications related to foodborne illness. 15

Pathogen An organism capable of causing a disease (e.g., pathogenic bacteria or viruses). Instructor Notes: What are some other examples you have found in your practice and experiences? Encourage class discussion. 16

Potentially Hazardous Food (PHF or TCS)
Food that requires time/temperature control for safety to limit the growth of pathogens or toxin formation Instructor Notes: Potentially hazardous foods or time and temperature control for safety foods are used interchangeably in this guidance.

Ready-to-Eat Food Food that is edible with little or no preparation to achieve food safety. It includes foods requiring minimal preparation for palatability or culinary purposes, such as mixing with other ingredients (e.g., tuna, chicken or egg salad). Instructor Notes: Ask surveyors for some examples and why these types of food require special attention. Some foods considered to be “ready-to-eat” may be included as ingredients in food items like tuna salad in which the tuna would be considered a “ready-to-eat” food. The tuna is edible and ready to eat with or without preparation of the tuna salad. 18

Toxins Poisonous substances that are produced by living cells or organisms (e.g., pathogenic bacteria) that cause foodborne illness when ingested. Instructor Notes: The term “toxins” refers to substances that are produced by living cells or organisms within the food, which may be caused by (among other things) improper handling or storage. 19

Interpretive Guidance Overview
The risk of foodborne illness Importance of effective food safety systems Identification of hazards and Critical Control Points (CCPs) Operational steps to eliminate hazards Instructor Notes: Please refer to Handout #1 ”Sanitary Conditions Overview” for additional information. 20

Types of Food Contamination
Interpretive Guidance Types of Food Contamination Biological Chemical Physical Instructor Notes: The next several slides cover the three types of food contaminants listed here: biological, chemical and physical. 21

Biological Contamination
Interpretive Guidance Biological Contamination Most common types of disease producing organisms Pathogenic bacteria, viruses, toxins, and spores contaminate food Parasites Instructor Notes: Bullet 1: Bacteria and viruses are the most common types of organisms that cause disease. Bullet 2: Some bacteria can be pathogenic and may cause illness or death (e.g. some strains of Escherichia Coli). Bullet 3: What about parasites? Yes, it is also true that parasites cause disease in humans, but in the United States and most other industrialized countries not as often as bacteria and viruses. Ask surveyors to name some types of harmful and non-harmful bacteria. 22

Pathogenic Bacteria Non-harmful vs. harmful bacteria
Interpretive Guidance Pathogenic Bacteria Non-harmful vs. harmful bacteria Food storage and preparation Instructor Notes: Bullet 1: Not all bacteria in food cause illness in humans. For example, many of us are familiar with yogurt, which may have live cultures of Lactobacillus bacteria added to enhance digestion. An example of harmful bacteria is Escherichia Coli. Ask surveyors to provide additional examples of harmful and non-harmful bacteria they may encounter in a nursing home environment. Bullet 2: Some bacteria can be pathogenic and may cause illness or death. Therefore, adhering to measures that control the growth of bacteria during food storage and preparation is important. Raw or uncooked food may naturally contain pathogenic organisms, such as Salmonella in poultry, that can cause foodborne illness. Ask surveyors, what are some of the factors that influence bacterial growth? 23

Interpretive Guidance
Factors Influencing Bacterial Growth Hazardous nature of the food Acidity (pH) of the food Water percent of the food Time and temperature control of the food Instructor Notes: Bullet 1: If not properly handled and stored, all foods can become contaminated. However some foods are more hazardous than others. These foods are referred to as PHF or TCS. Ask surveyors to provide some examples of PHF or TCS foods? Examples of PHF/TCS foods include ground beef, poultry, chicken, seafood (fish or shellfish), cut melon, unpasteurized eggs, milk, yogurt and cottage cheese. Bullet 2: The acidity of foods also influences bacterial growth. Higher acidity of foods (that is, a pH less than 5) more effectively inhibits bacterial growth. Ask surveyors to provide an example of a highly acidic food. Examples of highly acidic foods are pineapple, vinegar, and lemon juice. Bullet 3: Foods that have a high percent of water encourage bacterial growth. Bullet 4: Time and temperature together influence bacterial growth. The risk of such growth increases with the amount of time that food remains in the danger zone. Next, we will discuss viruses. What are some of the more frequently occurring viruses found in nursing homes? 24

Viruses Require a host for reproduction Examples: Hepatitis A
Interpretive Guidance Viruses Require a host for reproduction Examples: Hepatitis A Norovirus (formerly known as Norwalk virus) Instructor Notes: While viruses cannot reproduce in or on food, viruses may survive long enough in or on a food to be transmitted to a new host. Two viruses that are well known for being spread by poor food handling practices are Hepatitis A and Norovirus (formerly known as Norwalk virus). What are some of the more frequently occurring toxins relative to the nursing home environment? 25

Toxins Origin Poisonous substances Variety of sources
Interpretive Guidance Toxins Origin Staphylococcus aureus Clostridium botulinum Poisonous substances Variety of sources Instructor Notes: Toxins - Pathogens such as Staphylococcus aureus and Clostridium botulinum can produce toxins (that is, poisonous substances). High temperatures do not destroy most toxins. A PHF/TCS food that is allowed to remain in the danger zone long enough for the bacteria to produce toxins will become unsafe to eat. Ask surveyors to provide examples of the sources of toxins. 26

Spores Origin Reactivation and favorable conditions for growth
Interpretive Guidance Spores Origin Reactivation and favorable conditions for growth Temperature control Instructor Notes: Bullet 1: A spore is an inactive form of a microorganism. Spores are typically highly resistant to extreme temperatures, acidity and dehydration. Bullet 2: The organism is reactivated once conditions become favorable for its growth. Bullet 3: Temperature control is the preferred way to minimize the danger associated with spore-forming organisms. Examples: Bacillus cereus and Clostridium botulinum are two common spore-forming pathogens. 27

Chemical Contamination
Interpretive Guidance Chemical Contamination Cleaning supplies should be stored separately from food items. The most common chemicals include but are not limited to glass cleaners, soaps, oven cleaners and insecticides. Instructor Notes: Bullet 1: When food is being prepared, it may become exposed to chemical agents (e.g., cleaning supplies). Proper labeling of chemicals is very important to prevent chemical contamination. Common chemicals that can be found in a food system are cleaning agents (such as glass cleaners, soaps, oven cleaners and insecticides). Storing chemical products, including but not limited to cleaning supplies, away from food and food preparation areas will reduce the risk of chemical contaminants in food items. Bullet 2: Nursing home staff may use chemicals in the course of their duties that can contaminate food. For example, the surveyors would observe for whether spray cleaners are used to clean a work surface in close proximity to food that is being prepared. 28

Chemical Contamination (cont’d)
Interpretive Guidance Chemical Contamination (cont’d) An inadequately identified chemical inadvertently mistaken as a food product added to food can cause illness. Instructor Notes: Bullet 3: Chemical contamination could also result from staff using improperly identified chemical products. For example, if dishwashing liquid is stored in an empty syrup bottle. Ask surveyors to provide examples of some of the more common physical contaminants found in a nursing home environment.

Physical Contamination
Interpretive Guidance Physical Contamination Foreign objects that may inadvertently enter food. Examples: Hair Fingernails Pieces of glass Instructor Notes: Examples of such physical contaminants include but are not limited to staples, fingernails, jewelry, hair, glass, and metal shavings from can openers. Ask surveyors to provide additional examples. 30

Other Factors Implicated In Foodborne Illnesses
Interpretive Guidance Other Factors Implicated In Foodborne Illnesses Poor personal hygiene Inadequate cooking and improper holding temperatures Contaminated equipment Unsafe food sources Instructor Notes: Bullet 1: Numerous studies have shown that employee health and hygiene are significant factors in preventing foodborne illness. Foodborne illness in nursing homes has been associated with Norovirus. Because "infectious” individuals (persons capable of transmitting an infection or communicable disease whether they be colonized or infected) are a source for Norovirus, proper hand washing techniques and exclusion of infectious workers from handling food are critical for preventing the spread of Norovirus, which can cause foodborne illness. Bullet 2: Poorly cooked food promotes the growth of pathogens that may cause foodborne illness. Bullet 3: Equipment can become contaminated in various ways, including but not limited to: poor personal hygiene; improper sanitation; and contact with raw food (e.g., poultry, eggs, seafood and meat). Bullet 4: Sources not approved or considered satisfactory by Federal, State or local authorities. 31

Surveying Facilities That Receive Food Prepared By Off-site Kitchens
Interpretive Guidance Surveying Facilities That Receive Food Prepared By Off-site Kitchens When a nursing home receives food services from an off-site location, the surveyor must assess whether the facility is compliant with 42 CFR (i). Instructor’s Note: When food is brought in from an off-site kitchen that is approved by a Federal, State or local entity, the surveyor should verify the last approved inspection. Did the facility procure food from sources approved or considered satisfactory by federal, state, or local authorities? NOTE: See Handout #2 for the official CMS Survey and Certification Letter Ask surveyors, what types of sources would be approved by federal, state or local authorities? 32

Culture Change Provisions
Interpretive Guidance Culture Change Provisions Family members or other resident guests who bring in food for the resident’s consumption are not regulated under this Federal tag. Many State regulations address this issue. Instructor Notes: As the discussion continues regarding unsafe food sources, remember that this regulation does not address family members or other resident guests bringing food to their loved one. However many State and local laws do. The facility may still need to investigate and act if the resident develops symptoms of possible foodborne illness after eating food obtained from family or guests. As part of culture change, the surveyors should recognize the practice of allowing family members to bring food from home to the residents. The facility may need to act. For example, investigate if a resident becomes ill following the consumption of food received from family or guests. 33

Pathogenic Microorganisms and Strategies for Their Control
Interpretive Guidance Pathogenic Microorganisms and Strategies for Their Control Commonly identified ingestible items associated with illness-producing organisms Primary agents of concern (hazards) are organisms associated with the food source PHF/TCS primary control strategies to minimize potential for foodborne illness outbreak Instructor Notes: The primary control strategies list the preventive actions to inhibit the growth of these organisms. These strategies must be in place to prevent foodborne illness. Before we move to the next slide, what are some examples of hazards associated with food and some strategies to control them? The following tables illustrate the more commonly identified ingestible items, primary agents of concern and strategies to minimize the potential for foodborne illness outbreak. 34

Source of Contamination Primary Agents of Concern PHF/TCS Primary Control Strategies Fruits and vegetables, fresh  E. coli O157:H7  Salmonella  Norovirus  Hepatitis A virus  Shigella  Cook to proper temperature  Prevention of cross- contamination to ready-to-eat foods Ready-to-eat meat and poultry products  Listeria monocytogenes  Proper refrigeration during storage Pasteurized dairy products Ice  Cleaning and sanitizing the internal components of the ice machine according to manufacturers’ guidelines Instructor’s Notes: This table may be a helpful review for some of the participants, while for others this is new information. You may want to give the surveyors a few minutes to review its contents and formulate questions. Please take the time to examine each column. The strategies outlined on the table will minimize the potential for limited or widespread foodborne illness. You can also find these tables in Handout #3 “ Strategies to Control Foodborne Illness.” 35

Source of Contamination Primary Agents of Concern PHF/TCS Primary Control Strategies Eggs, raw or unpasteurized  Salmonella  Cook to proper temperature  Prevention of cross-contamination to ready-to-eat foods Poultry, raw Campylobacter  Salmonella Clostridium perfringens Prevention of cross-contamination to ready-to-eat foods Meat, raw E. coli 0157:H7 Campylobacter Cook to proper temperature Infectious food workers Norovirus Hepatitis A virus Shigella Salmonella Staphylococcus aureus Exclusion of infectious food workers Proper hand washing procedures  Avoid bare-hand contact with ready-to-eat foods Instructor Notes: Continue the discussion to engage the class. Ask for examples and past experiences. 36

Interpretive Guidance Prevention of Foodborne Illness
Food Handling and Preparation Employee Health Hand washing, Gloves, Antimicrobial Gel Hair Restraints/Jewelry/Nail Polish Instructor’s Notes: This may be a good time to discuss how the surveyor can acknowledge a facility’s efforts to encourage non-conventional food service systems to provide a more homelike environment and yet support safe food handling. Ask the surveyors if anyone can describe some of the steps for safe food handling. Then acknowledge the correct responses and fill in by extracting as appropriate from the following bullets: Bullet 1: Food handling and preparation includes the education of food service staff. The staff’s knowledge of related procedures can be evaluated during the employee interview as part of the survey process. Note: when documenting your findings remember that the facility quality improvement and infection control measures in the kitchen area are cited at the Sanitary Conditions tag F371. Bullet 2: Employees should be free of communicable disease and skin lesions. Bare-hand contact with food is prohibited. Bullet 3: The use of disposable gloves is not a substitute for proper hand washing with soap and water. Gels should not be used in the kitchen as a substitute for hand washing. Proper use of utensils such as tongs, deli paper and spatulas are also important in preventing foodborne illness. Hand washing deficiencies are cited at F371 when staff are in the kitchen and/or dining area in addition to citing at the Infection Control tag F441. Bullet 4: Since jewelry can harbor microorganisms, jewelry should be removed or covered with gloves while handling food. 37

Safe Food Storage Dry Food Storage should be maintained in a clean and dry area free of contaminants Refrigerator Storage Safe Practices include: -Monitoring temperatures -Proper handling of hot food -Separation of raw animal foods and vegetables -Labeling, dating and monitoring foods Instructor Notes: Ask surveyors, what are some examples of proper food storage? What unsafe practices have you seen in your experience? Continue discussion with the points below: Bullet 1: Dry foods should be stored in a contaminant-free environment, with control of temperature, humidity, rodents and insects to prevent infestation or accelerated deterioration. The surveyor should observe foods such as flour and sugar removed from original packaging and placed in labeled bins. Foods should be off the floor and clear of ceiling sprinklers, sewer pipes and vents. Bullet 2: Refrigerated storage for PHF/TCS foods must be maintained at or below 41 degrees F. Freezers must keep food frozen solid. Refrigeration slows bacterial growth. Adequate circulation of air around refrigerated products is essential to maintain food temperatures. Proper labeling, with dates, of all foods placed in the refrigerator or freezer is important to ensure that residents are not served foods that are beyond there safe for consumption date. 38

Safe Food Preparation Cross-Contamination Thawing Final Cooking Temperatures Reheating Food Instructor Notes: Ask the class, what do we mean by cross contamination? (remember, we discussed this in the definition). Ask surveyors to provide some examples. How are they prevented? Fill in with the bullets if necessary. You can refer to Handout #4 “Safe Food Preparation” for additional information. The prevention of foodborne illnesses requires many steps in the safe food preparation process. Identification of the critical control points can reduce the risk of food contamination. Bullet 1: 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. Bullet 2: Thawing frozen foods is often the first step in food preparation. Bullet 3: Cooking is a critical control point in preventing foodborne illness that will either kill dangerous organisms or inactivate them sufficiently to prevent foodborne illness. Bullet 4: Reheated cooked foods present a risk because they have passed through the danger zone multiple times during cooking, cooling, and reheating. 39

Process Food Item Temperatures Final Cooking Poultry and stuffed foods 165 degrees F Ground Meat 155 degrees F Fish and other meats 145 degrees F Unpasteurized eggs Reheating foods Internal temperature Intact package 135 degrees F Instructor Notes: This guidance provides many temperatures related to ensuring safe handling of foods. The next 2 charts outline temperatures when cooking, reheating and cooling. When microwaving raw animal foods, they should be stirred or rotated and have a final cooking temperature of 165 degrees F. The authoritative source for food temperature is the USDA Food Code. Please refer to this reference for additional information. Please note this is not an exhaustive list, but it does provide temperature recommendations related to cooking PHF foods. These charts can also be found in Handout #5 “Selected Cooking, Reheating and Cooling Temperatures for Foodborne Illness Prevention”. 40

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 Instructor Notes: Listed here are the cooling temperatures. 41

Interpretive Guidance Prevention of Foodborne Illness
Cooling Modified Consistency Pooled Eggs Instructor Notes: Bullet 1: Another major factor in causing foodborne illness is improper cooling. Refer to Handout #5 “Selected Cooking, Reheating and Cooling Temperatures for Foodborne Illness Prevention” for additional information. Bullet 2: 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. Bullet 3: Pooled eggs are raw eggs that have been cracked and combined together. Pooled eggs are a great risk for foodborne illness in the elderly population. Serving pasteurized eggs reduce this risk. For additional information, please refer to Handout #6 Prevention of Foodborne Illness. Ask surveyors for examples of risk associated with cooling, modified consistency and pooled eggs. 42

Food Service and Distribution
Interpretive Guidance Food Service and Distribution Tray line, alternative meal preparation and service area Food distribution Snacks Special events Transported foods Ice Refrigeration Instructor Notes: Engage surveyors in a discussion addressing the following questions: What are some examples of alternative meal preparation and service areas? How many hours are allowed between dinner and breakfast before bedtime snacks are required? How are snacks monitored for safety? Who is responsible for storing and serving snacks? How do we survey snacks, special events and alternative dinning areas? Additional information can be found in Handout #7 “Food Service and Distribution”.

Interpretive Guidance Equipment and Utensil Cleaning and Sanitization
Machine Washing and Sanitizing Manual Washing and Sanitizing Cleaning Fixed Equipment Instructor Notes: Ask surveyors what are some potential causes of foodborne outbreaks related to equipment. A potential cause of foodborne outbreaks is improper cleaning (washing and sanitizing) of contaminated equipment. Protecting equipment from contamination via splash, dust, grease, etc. is indicated. Dishwashing machines, operated according to the manufacturer specifications, wash, rinse, and sanitize dishes and utensils using either heat or chemical sanitization. For detailed information refer to Handout #8 “Equipment and Utensil Cleaning Sanitation”. 44

Equipment and Utensil Cleaning and Sanitization (cont’d)
Interpretive Guidance Equipment and Utensil Cleaning and Sanitization (cont’d) Wiping Cloths Service area wiping cloths are cleaned and dried, or Placed in a chemical sanitizing solution of appropriate concentration. Instructor Notes: After being used to clean stationary machines in the kitchen, the wiping clothes must be cleaned, dried or placed in chemical sanitizing solutions to prevent them from becoming a medium for microorganisms to grow. 45

Investigative Protocol Sanitary Conditions
Use this protocol to investigate compliance at F371 (483.35(i) (1) and (2)). Instructor Notes:

Investigative Protocol
Objectives To determine if the facility procured food from approved sources To determine if the facility stores, prepares, distributes, and serves food in a sanitary manner to prevent foodborne illness Instructor Notes: The objectives of this investigative protocol are to focus the investigation. Surveyors use the protocol to determine whether the facility obtained food from approved sources and utilized sanitary conditions to prevent foodborne illness. The protocol helps the surveyor investigate the facility’s storing, preparing, distributing and serving of foods.

Objectives (cont’d) To determine if the facility has systems (e.g. policies, procedures, training, and monitoring) in place to prevent the spread of foodborne illness and compromising of food safety Instructor Notes: Policy and procedures manuals, training documents and monitoring tools may be reviewed during this investigation to assist in determining the facility systems. However it is important to remember that the facility’s written policy alone does not confirm compliance with Federal regulatory requirements. During the survey process, the surveyor must observe the facility staff practices to determine compliance with procuring, storing, preparing and handling food in a manner that prevents foodborne illness and promotes food safety.

Objectives (cont’d) To determine if the facility utilizes safe food handling from the time the food is received from the vendor and throughout the food handling processes in the facility Instructor Notes: The safety of food provided to residents in the nursing home is impacted by how it is handled, transported and stored. Investigate if the facility inspects the foods received from the vendor and uses safe handling processes within the facility. Investigate the facility practice once the facility has received the food from the vendor.

Procedures Observations Interviews Record Reviews Review of Facility Practices Instructor Notes: It is helpful to review this protocol prior to beginning the survey. Throughout the survey, observe the kitchen(s) and food service area(s) and review planned menus to determine when to assess food preparation processes. Observe subsequent kitchen/food services during times when food is being prepared, cooked, plated, transported, and distributed to determine if safe food handling practices are being followed. Corroborate observations through interview, record review, and review of other appropriate documentation. 50

Observe Food Procurement Procedures Observe when, where and how food is procured Concurrently with the observations, review: Invoices Vendor records Source verification Instructor Notes: Ask surveyors, what are food procurement procedures? What are some examples of what you are looking for during the survey of food procurement procedures? Add to their answers filling in with the information below. Procurement procedures include observations of when, where and how food is received for the residents’ consumption. When observing food procurement, the surveyor may concurrently review the invoices from food vendors when necessary to verify the source of food acquisition and the date of delivery. 51

Investigative Protocol Observe Food Preparation Procedures
Food handling practices Food labeling and dates Hand washing Handling of potential cross-contamination foods Acceptable cooking and cooling temperatures Instructor Notes: Observe staff food handling practices, such as proper hand washing and the appropriate use of utensils, gloves and hairnets. Hand washing is essential in all aspects of care and services to the residents of nursing homes. This includes hand washing practices in the kitchen and other food service areas. Ask: What do you look for in food labeling and dates? Ask: What are some potential cross-contamination risks? Ask: What are acceptable cooking and cooling temperatures for…(poultry, stuffed foods, or fish)? Please refer to Handout #5 regarding safe food temperatures. Question: If you are observing a kitchen staff testing the temperature of a roast, where should they place the thermometer when testing? Answer: Inserting the stem of a calibrated thermometer into the middle or thickest part of the food is important to evaluate if a PHF/TCS food has reached the acceptable final cooking temperatures. Question: What other foods should be observed closely for safe temperature? 52

Observe Service of Food during Trayline Operations
Investigative Protocol Observe Service of Food during Trayline Operations Observe staff measuring the temperature of all hot and cold menu items Cold foods should be at or below 41 degrees F Hot foods should be at or above 135 degrees F Instructor’s Notes: All food items should be observed to determine if the facility has practices in place to keep food out of the danger zone where organisms can grow to a level that may cause foodborne illness. The surveyor may observe the staff measuring the food and reading the thermometer. Also, the surveyor may confirm the food temperature by measuring with their own thermometer. The staff interview can be used to corroborate how staff measure food temperatures. For additional information regarding food temperatures, refer to Handout #5. This data was obtained from the USDA Food Code Regulations. 53

Investigative Protocol Observe Dish Room Operations
Observe whether staff are properly operating dish machine and evaluate sanitization processes Check for proper equipment and supplies to evaluate dish machine operation Observe the three-step process of manual pot and pan washing Instructor Notes: Cleaning and sanitizing the dish machine is essential to minimize potential for foodborne illness. After the meal, observe dish machine operation and equipment and supplies in safe operation. Observe the water temperature of the machine and the use of sanitizing chemicals and test strips. For additional information regarding these procedures, refer to Handout #8. 54

Investigative Protocol Observe Service of Food after Meal Times
Observe stored dishes, utensils, pots/pans, and equipment for evidence of soiling Evaluate whether proper hand washing is occurring between handling soiled and clean dishes to prevent cross-contamination of the clean dishes Instructor Notes: Dishes, utensils and pots/pans should be stored in a clean, dry location and not exposed to splash, dust or other contamination. Dietary Aides must thoroughly wash their hands when going from the dirty side to the clean side of the dishwashing machine. They should not just rinse their hands or use a hand sanitizer. Proper hand washing with soap and water is required. If time permits, ask surveyors to share previous surveyor experiences regarding service of food after meal times. 55

Observe Food Storage Look for evidence of pests, rodents and droppings and other sources of contamination Observe whether foods are labeled and dated Observe whether foods are stored off of the floor Instructor Notes: Food storage area is observed to determine risks of food contamination. Observe where the food is stored, what the food is stored in and around and how staff handle the food. Observe if food is labeled and dated within the specified “use by” guidelines. Ask surveyors, what are some examples of things to document to support food contamination issues with storage Document evidence of food contamination, including the date and time of the observation, list any staff present and any staff information. 56

Investigative Protocol Observe Food Storage (cont’d)
Check for canned goods that have a compromised seal Observe whether staff access bulk foods without touching the food Instructor Notes: Observe for foods stored away from objects or items that may come in direct contact with the food item. Containers used to store food including cans may be ineffective if they are not properly secured or sealed. Observe the dry storage and refrigerator areas for intact containers. Observe for dry foods being stored to maintain the integrity of the packaging until they are ready to use. It is recommended, but not required, that foods stored in bins (e.g., flour or sugar) be removed from their original packaging. Keeping food off the floor and clear of ceiling sprinklers, sewer/waste disposal pipes, and vents can also help maintain food quality and prevent contamination. Staff should remove foods not safe for consumption and keep dry food products in closed containers. 57

Interview During the course of the survey, interview multiple staff who perform the task, about the procedures they follow to procure, store, prepare, distribute and serve food to residents. Instructor Notes: The interview questions may be asked while the observations are being conducted or separate from the observation. In either case, the surveyors should be sure to document responses accurately to include the name and title of the staff person interviewed. In addition to interviewing the staff involved in the food handling and preparation processes, interviews should also include other personnel including but not limited to the designated person in charge of the kitchen. If time permits, ask surveyors to provide the types of questions to be posed to the nursing home staff regarding the procurement, storage, preparation, distribution and service of food to residents. 58

Record Reviews Resident records Dietary/kitchen policies and procedures Maintenance records, such as work orders and manufacturer’s specifications, related to equipment used to store, prepare, and serve food Facility infection control records Instructor’s notes : As part of the investigative protocol, obtain the records and interviews to monitor the facility’s practice in the procurement, storage, preparation, distribution and service of foods to residents of the facility. Conduct the documentation review and staff interviews to identify and analyze any concerns or facility practices that may put residents at risk of foodborne illness. Ask surveyors to discuss additional information sources that would be helpful to review (e.g., training records, competency testing, equipment repair records, and infection control records regarding surveillance of foodborne illness and outbreaks of gastrointestinal illnesses).

Investigative Protocol Review of Facility Practices
Review facility documents and interview staff to establish if the facility has processes and practices to promote food safety and prevent the spread of foodborne illness. Instructor’s notes : Review of facility practices may include, but is not limited to, review of policies and procedures for sufficient staffing, staff training, and following manufacturer’s recommendations as indicated. In order to establish if the facility has a process in place to prevent the spread of foodborne illness, interview the staff to determine how they: Monitor whether the facility appropriately procures, stores, prepares, distributes, and serves food; Identify and analyze pertinent issues and underlying causes of a food safety concern (e.g., refrigerator or dishwasher malfunction); Implement interventions that are pertinent and timely in relation to the urgency and severity of a concern; and Monitor the implementation of interventions and determine if additional modification is needed. 60

42 CFR 483.35(i) (1)(2) Sanitary Conditions
DETERMINATION OF COMPLIANCE (Appendix P) Instructor Notes: 61

Determination of Compliance
Did the facility: Procure food from approved sources? Properly store, prepare, distribute and serve foods for residents’ consumption? Instructor Notes: Compliance with the Sanitary Conditions regulation occurs when a facility has met both aspects in the procurement and safe handling of food to prevent foodborne illness in nursing home residents. The next two slides relate to this discussion. 62

Criteria for Compliance with F371
Determination of Compliance Criteria for Compliance with F371 The facility is in compliance if staff: Procures, stores, handles, prepares, distributes, and serves food to minimize the risk of foodborne illness Maintains PHF/TCS foods at safe temperatures, cools food rapidly, and prevents contamination during storage Instructor’s Note: Discuss with the surveyors the criteria for determining Compliance and Noncompliance with this regulatory requirement. 63 63

Criteria for Compliance with F371 (cont’d)
Determination of Compliance Criteria for Compliance with F371 (cont’d) The facility is in compliance if staff: Cook food to the appropriate temperature and hold PHF/TCS foods cold or hot Utilizes proper hand washing and personal hygiene practices to prevent food contamination Maintains equipment and food contact surfaces to prevent food contamination Instructor Notes: Compliance at F371 is based in part on the facility’s compliance with the critical control points in the handling of foods. For additional information, refer to Handouts #4 and #5. 64 64

Determination of Compliance
Noncompliance with F371 May include, but is not limited to, one or more of the following, failure to: Procure, store, handle, prepare, distribute, and serve food in accordance with the standards summarized in this guidance Instructor Notes: A clear understanding of the facility’s noncompliance with requirements (i.e., deficient practices) is essential to determine how the deficient practice(s) relates to any actual harm or potential for harm to the resident. Noncompliance must be established before determining severity. 65 65

Noncompliance with F371 (cont’d)
Determination of Compliance Noncompliance with F371 (cont’d) Failure to: Maintain PHF/TCS foods at safe temperatures, at or below 41 degrees F (for cold foods) or at or above 135 degrees F (for hot foods) Exception: during preparation, cooking, or cooling Ensure that PHF/TCS food plated for transport was not out of temperature control for more than four hours. Instructor Notes: When foods are allowed to remain in the danger zone, reproduction of pathogenic organisms can eventually produce foodborne illness. The danger zone is between 41 degrees and 135 degrees. Observed facility practice, interviews that reveal lack of knowledge among staff members about these processes, and inadequate facility documentation of compliant practices would help confirm deficient practices in this area. Additional information can be found in Handouts #4 and #5. 66 66

Noncompliance with F371 (cont’d)
Determination of Compliance Noncompliance with F371 (cont’d) Failure to: Store raw foods properly to reduce the risk of contamination of cooked or ready- to-eat foods Ensure that foods are cooked to the appropriate temperature and cooled properly to prevent foodborne illness Instructor Notes: For additional information, please refer to Handouts #4 and #5. 67 67

Additional Investigation
Potential Tags for Additional Investigation Instructor Notes: During the course of the review for compliance with F371, questions or issues may have arisen with regard to whether the facility is in compliance with additional requirements. It is important to investigate for compliance with these additional requirements before citing tags. Please refer to Handout #9 “Potential Tags for Additional Investigation” for other potential tags for additional investigation that the surveyor may determine during the investigation. 68 68

DEFICIENCY CATEGORIZATION (Part IV, Appendix P)
Instructor Notes: Once the survey team has completed its investigation, analyzed the data, reviewed the regulatory requirements, and determined that noncompliance exists, the team must determine the severity of each deficiency, based on the resultant effect or potential for harm to the resident. 69 69

Severity Determination Key Components
Harm/negative outcome(s) or potential for negative outcomes due to a failure of care and services, Degree of harm (actual or potential) related to noncompliance, and Immediacy of correction required. Instructor Notes: We will briefly review the basis for determining the severity of a deficiency and provide examples of the severity levels. The team must determine the severity of each deficiency, based on the resultant harm or potential for harm to the resident. 70

Determining Actual or Potential Harm
Severity Determination Determining Actual or Potential Harm Actual or potential harm/negative outcomes for F371 may include: Foodborne illness; or Ingestion or potential ingestion of food that was not procured from approved sources, prepared, distributed or served under sanitary conditions. Instructor Notes: The key elements for severity determination for Tag F371 are as follows: Examples of actual or potential harm/negative outcomes for F371 may include but are not limited to: Foodborne illness; or Ingestion or potential ingestion of food that was not procured from approved sources, and stored, prepared, distributed or served under sanitary conditions.

Determining Degree of Harm
Severity Determination Determining Degree of Harm How the facility practices caused, resulted in, allowed, or contributed to harm (actual/potential) If harm has occurred, determine if the harm is at the level of serious injury, impairment, death, compromise, or discomfort; and If harm has not yet occurred, determine how likely the potential is for serious injury, impairment, death, compromise or discomfort to occur to the resident. Instructor Notes: Determine whether the noncompliance requires immediate correction in order to prevent serious injury, harm, impairment, or death to one or more residents. The survey team must evaluate the harm or potential for harm based upon the following levels of severity for Tag F371. First, the team must rule out whether Severity Level 4, Immediate Jeopardy to a resident’s health or safety, exists by evaluating the deficient practice in relation to immediacy, culpability, and severity. (Follow the guidance in Appendix Q). 72 72 72

Severity Level 4 Deficiency Categorization
Severity Determination Severity Level 4 Deficiency Categorization Immediate Jeopardy to Resident’s Health or Safety Instructor Notes: This is a critical situation because of the immediate jeopardy to the health or safety of one or more residents. If immediate jeopardy has been ruled out based upon the evidence, then evaluate whether actual harm that is not immediate jeopardy exists at Severity Level 3 or the potential for more than minimal harm at Level 2 exists. 73 73

Level 4 Immediate Jeopardy
Severity Determination Level 4 Immediate Jeopardy Has allowed/caused/resulted in, or is likely to cause serious injury, harm, impairment, or death to a resident; and Instructor Notes: If harm has occurred, determine if the harm is at the level of serious injury, impairment, death, compromise, or discomfort. If harm has not yet occurred, determine how likely the potential is for serious injury, impairment, death, compromise or discomfort to occur to the resident. Determine whether the noncompliance requires immediate correction in order to prevent serious injury, harm, impairment, or death to one or more residents. The survey team must evaluate the harm or potential for harm based upon the following levels of severity for Tag F371. First, the team must rule out whether Severity Level 4, Immediate Jeopardy to a resident’s health or safety, exists by evaluating the deficient practice in relation to immediacy, culpability, and severity. (Follow the guidance in Appendix Q). 74 74

Level 4 Immediate Jeopardy (cont’d)
Severity Determination Level 4 Immediate Jeopardy (cont’d) Requires immediate correction, as the facility either created the situation or allowed the situation to continue by failing to implement preventative or corrective measures. Instructor Notes: Ask surveyors: What are some examples of immediate jeopardy that you have seen in your experiences?

Severity Determination
Level 4 Example A roast thawing on a plate in the refrigerator had bloody juices overflowing and dripping onto uncovered salad greens on the shelf below. The contaminated salad greens were not discarded and were used to make salad for the noon meal. Instructor Notes: Let’s discuss examples of avoidable actual or potential resident outcomes that demonstrate severity at Level 4.

Level 4 Example The facility had a recent outbreak of Norovirus as a result of a food worker experiencing episodes of vomiting and diarrhea, and the facility allowed the staff to continue preparing food. Observations and interviews indicate that there are other food service staff experiencing gastrointestinal illnesses who are still permitted to prepare food. Instructor Notes: Engage the class. Discuss examples, ask for other examples. Ask how they distinguish between level 3 and level 4. Check for consistencies in their responses, and try to bridge any gaps in the responses.

Severity Determination Severity Level 3 Deficiency Categorization Actual Harm that is not Immediate Jeopardy The negative outcome may include but may not be limited to clinical compromise, decline, or the resident’s inability to maintain and/or reach his/her highest practicable level of well-being. Instructor Note: What is harm that is not immediate jeopardy? 78 78

Level 3 Example An outbreak of nausea and vomiting occurs in the facility related to the inadequate sanitizing of dishes and utensils. Instructor Notes: Let’s take a look at another example. Encourage discussion.

Level 3 Example A mild episode of food poisoning occurred because the facility had a special event in which tuna, chicken, and potato salads served in bulk were not kept adequately chilled and were left out for eating after 5 hours. Instructor Notes: 80

Severity Determination Severity Level 2 Deficiency Categorization No Actual Harm with potential for more than minimal harm that is not Immediate Jeopardy Instructor Notes: If Severity Level 3 (actual harm that is not immediate jeopardy) has been ruled out based upon the evidence, then evaluate as to whether Severity Level 2 (no actual harm with the potential for more than minimal harm) exists. 81 81

Level 2 Deficiency Categorization
Noncompliance that results in a resident outcome of no more than minimal discomfort, and/or Has the potential to compromise the resident's ability to maintain or reach his or her highest practicable level of well-being. Instructor Notes: For Level 2 severity, the resident was at risk for, or has experienced the presence of one or more outcome(s) (e.g., unplanned weight change, inadequate food/fluid intake, impairment of anticipated wound healing, functional decline, and/or fluid/electrolyte imbalance), due to the facility’s failure to help the resident maintain acceptable parameters of nutritional status. Let’s take a look at a Level 2 example. 82 82

Level 2 Example Food service workers sliced roast pork on the meat slicer. The meat slicer was not washed, rinsed, and sanitized after usage. During the dietary service system assessment, two days later, the surveyor observed the meat slicer soiled with dried meat underneath the blade. The facility failed to educate and train staff on how to clean and sanitize all kitchen equipment. Instructor Notes: Let’s consider another example.

Level 2 Example During the tour of the kitchen, two food service workers were observed on the loading dock. One was smoking and the other employee was emptying trash. Upon returning to the kitchen, they proceeded to prepare food without washing their hands. Instructor Notes: Let’s consider this example.

No Actual Harm with Potential for Minimal Harm Instructor Notes:

Level 1 Deficiency Categorization
The failure of the facility to procure, prepare, store, distribute and handle food under sanitary conditions places this highly susceptible population at risk for more than minimal harm. Therefore, Severity Level 1 does not apply for this regulatory requirement.

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§483.35(i) Sanitary Conditions (F371) Surveyor Training: Interpretive Guidance Investigative Protocol Instructor Notes: Greet and Welcome all Participants.

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§483.35(i) Sanitary Conditions (F371) Surveyor Training: Interpretive Guidance Investigative Protocol Instructor Notes: Greet and Welcome all Participants.

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Presentation on theme: "§483.35(i) Sanitary Conditions (F371) Surveyor Training: Interpretive Guidance Investigative Protocol Instructor Notes: Greet and Welcome all Participants."— Presentation transcript:

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