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Interpretive Guidance Investigative Protocol

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1 Interpretive Guidance Investigative Protocol
483.25(i) Nutrition (F325) Surveyor Training: Interpretive Guidance Investigative Protocol Instructor Notes: Introduce yourself and the other presenters Welcome the participants Provide: Agenda Training Materials Handouts 1 1

2 With regard to the revised guidance F325 Nutrition, there have been significant changes. Specifically, F325 and F326 were merged. However, the regulatory language has remained the same. The revisions to F325 were made to provide definition, education, explanation, and examples for the surveyors to reference. Instructor Notes: 2

3 Federal Regulatory Language
The facility must ensure that a resident— 483.25(i)(1) Maintains acceptable parameters of nutritional status, such as body weight and protein levels, unless the resident’s clinical condition demonstrates that this is not possible; and 483.25(i)(2) Receives a therapeutic diet when there is a nutritional problem. Instructor Notes: This is the regulatory language for Nutrition at F325. Please note that this regulatory language has not changed. The regulatory text which follows this introductory regulatory language includes some very specific requirements regarding a number of health conditions, but not all conditions or care required by residents has its own regulatory language. The guidance that has been added to F325 addresses care related to recognizing and managing risks and deficits. The F326 Regulatory Language is now merged with that of F325. 3

4 Intent The intent of this requirement is that the resident maintains, to the extent possible, acceptable parameters of nutritional status and that the facility Provides care and services to each resident as identified in their comprehensive assessment Recognizes, evaluates, and addresses the needs of the resident at risk for, or already experiencing, impaired nutrition Instructor Notes: Ask a surveyor in the class to read this slide aloud to encourage participation and engage the class. This will also emphasize the importance of intent. The facility is expected to take action to help the resident attain or maintain his or her highest practicable level of physical, mental, and psycho-social well-being, including managing the resident’s nutritional status. Nutritional well-being is a critical aspect of care and services necessary to assist the resident to attain or maintain his or her highest practicable level of well-being. Understanding the regulation is key to facilitating the accurate documentation of the findings. 4 4

5 Intent (cont’d) Provides a therapeutic diet that takes into account the resident’s clinical condition or other appropriate intervention, when there is nutritional indication Instructor Notes: It will be necessary to understand the Protocol and to be able to identify those residents for whom the Investigative Protocol would be followed. The Protocol will help the surveyors determine whether the facility is in compliance with this regulation. If the facility is not in compliance, it will be important to assign an appropriate level of severity to the deficiency. Are there any questions regarding the intent of this requirement? 5

6 Training Objectives Describe the relationship between the regulation and the nutrition guidance Describe the care process related to nutrition Identify when the Investigative Protocol would be used Instructor Notes: It is important to focus on maintaining nutritional status that can enhance the quality of life for nursing home residents. This learning module is designed to help the surveyor understand factors that affect nutritional status and that may cause medically unavoidable decline in that status. 6 6

7 Training Objectives (cont’d)
Describe and apply components of the Investigative Protocol Identify compliance with the regulation as it relates to nutrition Appropriately categorize the severity of noncompliance Instructor Notes: 7

8 Interpretive Guidelines
483.25(i) Nutrition Interpretive Guidelines Instructor Notes: 8

9 Definitions Acceptable Parameters of Nutritional Status Albumin Anemia
Anorexia Artificial Nutrition Avoidable/Unavoidable Clinically Significant Current Standards of Practice Dietary Supplements Insidious Weight Loss Nutritional Supplements Parameters of Nutritional Status Qualified Dietitian Therapeutic Diet Usual Body Weight 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 nutrition status. 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 Handout #1. 9

10 Acceptable Parameters of Nutritional Status
Interpretive Guidance Acceptable Parameters of Nutritional Status Refers to factors that reflect that the individual’s nutritional status is adequate, relative to his/her overall condition and prognosis. Albumin Refers to the body’s major plasma protein, essential for maintaining osmotic pressure and also serving as a transport protein. Instructor Notes: The following slides will introduce you to the terminology encountered within the guidance. While we will not discuss all the definitions here, we will discuss a few of the definitions to help clarify survey processes. During this discussion, share with other surveyors your experiences identifying these concerns during actual nursing home facility surveys. 10 10

11 Interpretive Guidance
Anemia Refers to a decrease in the percentage of blood cells relative to total blood volume. Anorexia Refers to a loss of appetite, including loss of interest in seeking and consuming food. Instructor 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. Definitions continue onto the next slide. 11 11

12 Interpretive Guidance
Artificial Nutrition Refers to chemically balanced mix of nutrients and fluids to sustain life, usually administered via percutaneous endoscopic gastrostomy tube (peg tube). Instructor Notes: 12

13 Avoidable Interpretive Guidance
The resident did not maintain acceptable parameters of nutritional status and the facility did not do one or more of the following: evaluate the resident’s clinical condition and nutritional risk factors define and implement interventions that are consistent with resident’s needs, resident goals and recognized standards of practice monitor and evaluate the impact of the interventions or revise the interventions as appropriate Instructor Notes: What are some other examples you have found in your practice and experiences? Encourage class discussion. Let’s look at the definition of unavoidable on the next slide and compare the two. 13 13

14 Interpretive Guidance
Unavoidable The resident did not maintain acceptable parameters of nutritional status even though the facility: evaluated the resident’s clinical condition and nutritional risk factors defined and implemented interventions that are consistent with resident needs, goals and recognized standards of practice monitored and evaluated the impact of the interventions Instructor Notes: Unavoidable outcomes are those that occur despite the facility’s appropriate practices related to assessment, interventions, and monitoring. The outcomes (weight loss, etc.) are similar to those in the preceding definition, but the difference is that they have occurred despite the facility’s efforts, instead of because of some deficient practice. 14 14

15 Clinically Significant
Interpretive Guidance Clinically Significant Refers to the effects, results, or consequences that materially affect or are likely to affect an individual’s physical, mental, or psychological well-being either positively by preventing, stabilizing, or improving a condition or reducing a risk, or negatively by exacerbating, causing, or contributing to a symptom, illness, or decline in status. Instructor Notes: Clinically significant refers to effects, results, or consequences that are more than just incidental. Let’s take a moment to discuss some clinically significant examples. 15 15

16 Current Standards of Practice
Interpretive Guidance Current Standards of Practice Refers to approaches to care, procedures, techniques, treatments, etc., that are based on research or expert consensus and that are contained in current manuals, textbooks, or publications, or that are accepted, adopted or promulgated by recognized professional organizations or national accrediting bodies. Instructor Notes: Current standards of practice are more than just personal opinion, or habit or facility preference, but rather that they reflect a broader or more authoritative base of evidence or opinion. Ask surveyors if there are any questions. 16 16

17 Dietary Supplements Refers to nutrients (e.g. vitamins, minerals, amino acids, and herbs) that are added to a person’s diet when they are missing and not consumed in enough quantity Instructor Notes: Some examples of dietary supplements are: Vitamin B12 injection, multivitamins, calcium with D, Zinc, and Vitamin C Let’s look at the definition of nutritional supplements. 17

18 Nutritional Supplements
Refers to dietary substances intended to supply nutrients (e.g., vitamins, minerals, fatty acids or amino acids) that are missing or not consumed in sufficient quantity in a person’s diet. These substances may also be referred to as food supplements. Instructor Notes: Some examples of nutritional supplements are Boost, Glucerna and Ensure. Ask surveyor to discuss the differences between dietary supplements and nutritional supplements. 18

19 Insidious Weight Loss Parameters of Nutritional Status
Interpretive Guidance Insidious Weight Loss Refers to a gradual, unintended, progressive weight loss over time. Parameters of Nutritional Status Refers to factors (e.g., weight, food/fluid intake, and pertinent laboratory values) that reflect the resident’s nutritional status Instructor Notes: Gradual weight loss may not appear as obvious as a more aggressive weight loss that may be associated with a wasting disease. Insidious weight loss is defined here to emphasize the importance of looking at weights overtime and so that weight changes are further evaluated to determine the underlying cause. Where appropriate solicit examples from surveyors. 19 19

20 Qualified Dietitian Interpretive Guidance
Refers to one who is qualified based upon either registration by the Commission on Dietetic Registration of the American Dietetic Association or as permitted by state law, on the basis of education, training, or experience in identification of dietary needs, planning and implementation of dietary programs. Instructor Notes: 20 20

21 Interpretive Guidance
Therapeutic Diet Refers to a diet ordered by a physician or practitioner as part of treatment for a disease or clinical condition, to eliminate or decrease certain substances in the diet (e.g., sodium) or to increase certain substances in the diet (e.g., potassium), or to provide mechanically altered food when indicated. Instructor Notes: An example of a therapeutic diet would be the following: Evidence of cardiac dysrhythmias or other changes in medical condition due to hyperkalemia, resulting from the facility’s failure to provide a potassium restricted therapeutic diet that was ordered. Ask surveyors to provide another example for discussion. 21 21

22 Interpretive Guidance
Usual Body Weight Refers to the resident’s usual weight through adult life or a stable weight over time. Instructor Notes: We will reference criteria to determine usual body weight and/or weight changes when we address assessment criteria later in the presentation. The guidance uses this term because it is generally considered more relevant to the elderly population than “ideal” body weight. What are some other examples you have found in your practice and experiences? Encourage class discussion. 22

23 Overview Interpretive Guidance
Nutrients are essential substances for critical metabolic processes, the maintenance and repair of cells and organs, and energy to support daily functioning. Instructor Notes: Nutrients are essential to body function. The body must be able to use nutrients effectively. Normal aging or illnesses and other conditions may affect food and fluid intake as well as the body’s ability to use nutrients effectively. For example, the aging resident may have a surgical site, wounds or other conditions that may not heal as effectively without addition nutrients added to the diet e.g. additional protein supplements, vitamin C and Zinc may be added to encourage wound healing. Dental or oral conditions, including pain, may affect eating and can impair nutrition and cause weight loss. Ask surveyors, What information can we gain from our observations, interviews and record reviews about the systems the provider employs to deliver care and services as they relate to potential nutritional impairments? 23 23

24 Other key factors affecting nutritional status
Interpretive Guidance Other key factors affecting nutritional status The body may not absorb or use nutrients effectively Age-related loss of muscle mass, strength and function Wasting that occurs as a consequence of illness and inflammatory processes Disease causing changes in mental status Instructor Notes: Various factors can affect weight and nutritional status. It is important for the surveyor to understand that not all of them can be readily influenced by diet and nutrition. Bullet 2 and 3: For example, muscle mass may be lost with age, and illnesses and inflammatory processes may cause wasting. Nutrition may not affect these causes of weight loss. Bullet 4: Changes in mental function may affect food intake and may be related to other illnesses that impair the absorption and use of nutrients. 24

25 Other key factors affecting nutritional status (cont’d)
Interpretive Guidance Other key factors affecting nutritional status (cont’d) Changes to the ability to eat and taste food may occur in later life Instructor Notes: Bullet 1: Aging may bring changes in the ability to eat and taste food. Sometimes, adjustments in the preparation and presentation of food can help. What are some other examples you have found in your practice and experiences? Encourage class discussion. 25 25 25

26 Nutritional Assessment
Interpretive Guidance Nutritional Assessment An in-depth assessment will identify factors that existed prior to admission, such as insufficient intake, progressive weight loss/gain, CVA, or recent surgery. Instructor Notes: In addition to the Resident Assessment Instrument (RAI), other in-depth nutritional assessments may be needed to identify the nature and causes of impaired nutrition and nutrition-related risks. The assessments will identify usual body weight, a history of reduced appetite or progressive weight loss or gain prior to admission, medical conditions and events which may have affected a resident’s nutritional status and risks. Please refer to Handout #2, ADA Nutrition Care Process Model and Handout #3, ADA’s Nutrition Care Process for additional information. 26 26

27 Assessment Interdisciplinary Approach
Interpretive Guidance Assessment Interdisciplinary Approach General Appearance with Height/Weight Food and Fluid Intake Parameters Nutrient Utilization Chewing Difficulties Swallowing Abnormalities Instructor Notes: For example, what type of diagnosis would direct you to look for whether or not the person has a swallowing abnormalities? 27 27

28 Assessment (cont’d) Functional Abilities Medications
Interpretive Guidance Assessment (cont’d) Functional Abilities Medications Goals and Prognosis Laboratory/Diagnostic Evaluation Instructor Notes: A resident with cognitive impairment may not be able to accurately express their likes and dislikes relative to food preferences or whether or not they want to eat. If a resident has multiple co-existing conditions or the resident is receiving many medications, these can affect their appetite and weight, directly or indirectly. Various factors may affect how and whether a resident’s nutritional status is addressed. These variables may include, for example: High staff turnover Lack of familiarity with the resident’s usual and customary behavior and routines Lack of staff and resident’s education about the aging process and its effect on food and fluid intake, evaluation of the causative factors, and treatment options available. 28 28

29 Interpretive Guidance
Analysis Refers to use of information from Resident Assessment Instrument (RAI) Comprehensive and Quarterly Additional assessments as indicated Caloric, Protein, and Fluid Needs Analysis Specific to the nature of the nutritional abnormality Instructor Notes: The care process provides the foundation for clinicians and staff to help each resident attain and/or maintain his or her highest practicable level of well-being, including preventing or managing weight loss and other nutritional deficits to the extent possible. Throughout this guidance, the care process has been based upon an interdisciplinary approach to identifying and meeting the resident’s needs. The care process involves at a minimum: Assessing the resident’s needs and strengths Determining a diagnosis and identifying causative factors to the extent possible Identifying resident centered goals and implementing approaches determined to be the most appropriate to facilitate reaching those goals Monitoring the outcome of the interventions Depending upon the effectiveness of the interventions or onset of adverse consequences, modifying the approaches 29 29

30 Care Planning and Interventions
Interpretive Guidance Care Planning and Interventions Resident Choice Meeting Nutritional Needs Diet Liberalization Weight-Related Interventions Weight Gain Instructor Notes: Care Planning and Interventions Include: Bullet 1: Note the emphasis in the guidance on considering the context of nutritional recommendations, including resident wishes and goals, and on allowing residents to decline proposed interventions, including those related to chewing and swallowing abnormalities. Bullet 2: Nutritional interventions are based on factors including the resident’s medical conditions (especially, underlying causes of impaired nutritional status, choices, and needs). Pertinent nutritional interventions are also based on past habits and patterns, cultural consideration, and the patient’s current environment, not just norms for age, size and weight. Bullet 3: The nursing home, based on input from the dietitian and others, can liberalize the diet to try to stimulate appetite, especially in at-risk residents with conditions such as Alzheimer’s Disease that affect their mental and physical function. Bullet 4: Direct care staff can often intervene to address weight changes or fluctuations. They may observe changes in behavior, physical or functional status, or appetite. In such situations, the staff and practitioner may be able to stabilize weight and nutritional status by making pertinent interventions based on identified causes. 30 30

31 Care Planning and Interventions (cont’d)
Interpretive Guidance Care Planning and Interventions (cont’d) Environmental Factors Anorexia Wound Healing Functional Factors Chewing and Swallowing Factors Medications Instructor Notes: A Care plan that reflects the actions taken by facility staff to facilitate wound healing may include: An assessment the resident’s functional ability to feed themselves and resultant support and assistance by facility staff Providing prescribed nutritional support which may include increased calories or food sources of protein to encourage wound healing Encouraging family member participation in the meal by visiting at meal time for additional socialization at meal After an assessment it may be determined that the resident eats better while in the dining room rather than in the resident’s room Ask surveyors if they can think of any additional appropriate interventions that may be included on the care plan? 31 31

32 Care Planning and Interventions (cont’d)
Interpretive Guidance Care Planning and Interventions (cont’d) Food Fortification and Supplementation Maintaining Fluid and Electrolyte Balance Use of Appetite Stimulants Feeding Tubes End of Life Instructor Notes: Care plan approaches or interventions for residents with feeding tubes at end of life reflect the resident’s or resident representative’s input into decisions made to maintain acceptable parameters for nutrition where possible. The facility staff demonstrate the actions, approaches or interventions employed. Some demonstrated interdisciplinary actions maybe recorded on the care plan are: Resident and resident responsible party training and education regarding tube feeding, type and frequency of feeding, and the bodies utilization of nutrients in light of the disease state of the resident. Facility staff offer socialization in the form of verbal interaction while feedings are provided The resident is provided oral care for hygienic and comfort purposes The resident’s or resident representative’s wishes are consistently respected and upheld as appropriate The resident and or resident representative are provided opportunities to verbalize feelings and concerns Tube feeding are given as prescribed and interventions are in place to minimize complications e.g. head of bed elevated to minimize potential for reflux, Tube placement is assessed prior to initiating feedings End of life issues will be discussed further in the upcoming guidance revision. 32 32

33 Monitoring To ensure intervention has stabilized nutritional concern
Interpretive Guidance Monitoring To ensure intervention has stabilized nutritional concern Review of factors contributing to the resident’s nutritional deficits for changes Instructor Notes: Review information including the RAI, diet and medication orders, activities of daily living worksheets, physician, nursing, dietitian, rehabilitation, and social service notes. Determine if the resident’s weight and nutritional status were assessed in the context of his/her overall condition and prognosis, if nutritional requirements and risk factors were identified, and if causes of the resident’s nutritional risks or impairment were sought. 33 33

34 Interpretive Guidance
Monitoring (cont’d) Monitor new risk factors that do not develop after the intervention Current intervention may need modification Instructor Notes: 34

35 Investigative Protocol Nutrition
Use this protocol to investigate compliance at (i)(1)(2) tag F325 Instructor Notes: 1. To determine if residents maintained acceptable parameters of nutritional status, relative to his/her comprehensive assessment; 2. For a resident who did not maintain acceptable parameters of nutritional status, to determine if the facility assessed and intervened (e.g., therapeutic diet) to enable the resident to maintain acceptable parameters of nutritional status, unless the resident’s clinical condition demonstrated that this was not possible; and 3. For a resident who is at nutritional risk, to determine if the facility has identified and addressed risk factors for and causes of, impaired nutritional status, or demonstrated why they could not or should not do so.

36 Investigative Protocol
Objectives To determine if the facility has practices in place to maintain acceptable parameters of nutritional status for each resident based on his/her comprehensive assessment. Instructor Notes:

37 Investigative Protocol
Objectives (cont’d) To determine if the resident has received a therapeutic diet when there is a nutritional indication. Instructor Notes:

38 Investigative Protocol
Objectives (cont’d) To determine if failure to maintain acceptable parameters of nutritional status for each resident was avoidable or unavoidable. Instructor Notes: 38

39 Investigation Procedures
Investigative Protocol Investigation Procedures Observation Interviews Record Review Instructor Notes: The investigation includes various approaches for gathering data including observation; interviews with residents/responsible party/facility staff/practitioners; and record reviews. Gather information regarding the resident's physical, functional, and psychological status and care goals outlined within the current written assessment document. Include in your review physician orders and dietitian notes relevant to nutritional status and interventions. Information about interventions may be found in various locations within clinical documentation (electronic or paper). Surveyors should have all relevant information available to determine whether a potential noncompliance exists. 39 39 39

40 Observation Initial Tour Resident Observations Dining Observation
Investigative Protocol Observation Initial Tour Resident Observations Dining Observation Instructor Notes: Bullet 1: Surveyors are to observe residents during the initial tour of the facility and continuously throughout the survey. To facilitate the investigation, gather appropriate information (e.g. dining style, nourishment list, schedules and policies). Bullet 2: Surveyors should observe residents while they are eating in the environment in which they usually eat. Remember to note any traditional or non-traditional or alternate approaches to dining services such as buffets, restaurant style dining, or family style dining. Residents may be more involved in food choices and meal options. Dining experiences may differ from those traditional services that include tray cards or diet lists. Bullet 3: Remember to date and time your observations. Who was involved? What was the staff name and professional discipline? The objective of documenting your observations is to note specific evidence that relates to compliance or noncompliance with the regulations. 40 40 40

41 Observation – Resident Dining
Investigative Protocol Observation – Resident Dining Observe two meals during the survey, including an observation on the first day if a meal is being served during the tour, and an evening meal. At least one meal observation should be conducted after the record review. Instructor Notes: While conducting the resident dining observations: Observe a resident’s physical appearance for signs that might indicate altered nutritional status and note any signs of dental and oral problems. Observe two meals during the survey. At least one meal observation must be conducted after the record review. Observe the delivery of care to determine if interventions are consistent with the care plan. Observe the serving of food as planned, with attention to portion sizes, preferences, nutritional supplements, prescribed therapeutic diets and between-meal snacks. Follow up and note differences between the care plan and interventions. Determine if staff responded appropriately to the resident’s needs. 41

42 Interview Interview resident and responsible party to identify:
Investigative Protocol Interview Interview resident and responsible party to identify: Participation in care planning and decision making Consideration of nutritional interventions Results/effectiveness of nutritional interventions and care approaches Instructor Notes: The resident interview is intended to elicit information about the resident’s participation in the care planning process and decision making on: What approaches were considered to address the particular symptom/sign or condition Whether staff are responsive to the resident’s eating abilities and support needs, including the provision of adaptive equipment and personal assistance with meals as indicated Whether pertinent nutritional interventions, such as snacks, frequent meals, and calorie-dense foods are provided If the resident refused needed approaches, whether treatment options, related risks and benefits were discussed with the resident or resident’s representative If information obtained via the interview conflicts with that obtained from other sources (i.e. observations, interviews), further investigation may be needed. 42 42 42

43 Investigative Protocol
Interview (cont’d) Interview interdisciplinary team members to determine: Impact of nutritional assessment on resident Clinical rationale of nutritional intervention Awareness of any signs and symptoms of nutritional deficits requiring clinical interventions Instructor Notes: Interview interdisciplinary team members on various shifts (e.g., certified nursing assistant, registered dietitian, dietary supervisor/manager, charge nurse, social worker, occupational therapist, attending physician, medical director, etc.) to determine how: Food and fluid intake, eating ability and weight are monitored and reported Nutrition interventions, such as snacks, frequent meals, and calorie- dense foods are provided to prevent or address impaired nutritional status (e.g., unplanned weight changes) Nutrition-related goals in the care plan are established, implemented, and monitored periodically Care plans are modified when indicated to stabilize or improve nutritional status (e.g., reduction in medications, additional assistance with eating, and therapeutic diet orders) 43 43 43

44 Investigative Protocol
Interview (cont’d) Interview interdisciplinary team members to determine: Physician response to notification of suspected functional impairments related to nutritional deficits Dietitian assessment and communication Instructor Notes: During the interview, the surveyor should inquire about: Whether or not staff notified the dietitian and physician of nutritional concerns and the nature of the response Whether the physician responded to the notification of nutritional deficits, anorexia, and weight loss, and the nature of the response Whether the dietitian communicated recommendations that were based on pertinent aspects of the assessments (including causes of anorexia and weight loss). 44 44 44

45 Investigative Protocol
Interview (cont’d) If interventions defined or care provided are inconsistent with current standards of practice, interview one or more physicians or other licensed health care practitioners who can address resident’s nutritional status. Instructor Notes: Examples include, but are not limited to: How staff evaluated the effectiveness of current interventions How staff managed interventions How the interdisciplinary team decided to maintain or change interventions The rationale for chosen intervention The rationale for decisions not to intervene to address identified risks Note: If you have specific questions for a resident’s attending physician, the facility staff should take the opportunity to provide the physician the necessary information about the resident and your concerns. This will allow the physician to familiarize himself/herself with the circumstances prior to responding to your questions. 45 45 45

46 Investigative Protocol
Record Review Review the resident’s medical record to determine how the facility: Evaluated and analyzed nutritional status Identified residents who are at nutritional risk Evaluated the effectiveness of the interventions Instructor Notes: Review information including the RAI, diet and medication orders, activities of daily living worksheets, and nursing, physician, dietitian, rehabilitation, and social service notes. Determine if the resident’s weight and nutritional status were assessed in the context of his/her overall condition and prognosis, if nutritional requirements and risk factors were identified, and if causes of the resident’s nutritional risks or impairment were determined. 46 46 46

47 Record Review (cont’d)
Investigative Protocol Record Review (cont’d) Investigated and identified causes of anorexia and impaired nutritional status Identified and implemented relevant interventions to try to stabilize or improve nutritional status Monitored and modified approaches as indicated Instructor Notes: Review the comprehensive care plan to determine if the plan is based on the comprehensive assessment and additional pertinent nutritional assessment information. If information is not readily available within the resident’s medical record, request facility staff to retrieve documentation. If time permits, ask surveyors to offer examples in relation to the content of this guidance. 47

48 Investigative Protocol
Documentation Findings and conclusions related to nutritional status may be found in various locations in the medical record, including but not limited to interdisciplinary progress notes, nutrition progress notes, the RAI summary, care plan, or resident care conference notes. Instructor Notes: Review of the documentation will help you determine how the facility developed approaches to meet each resident’s nutritional needs. This information will help you determine whether a resident’s decline or failure to improve his/her nutritional status was avoidable or unavoidable. 48

49 Assessment and Monitoring
Investigative Protocol Assessment and Monitoring Review information including -RAI -Diet and medication orders -Activities of daily living worksheets -Nursing, dietitian, rehabilitation, and social service notes. Instructor Notes: Determine if the resident’s weight and nutritional status were assessed in the context of his/her overall condition and prognosis, if nutritional requirements and risk factors were identified, and if causes of the resident’s nutritional risks or impairment were sought. Additional determinations to consider can be found in Handout #4, Assessment and Monitoring Determinations. 49

50 Investigative Protocol
Care Plan Review the comprehensive care plan to determine if the plan is based on the comprehensive assessment and additional pertinent nutritional assessment information Instructor Notes: If surveyors identify care plan concerns related to nutritional status, interview staff responsible for care planning about the rationale for the current plan of care. If questions remain, interview the resident’s attending physician or licensed health care practitioner or the facility’s medical director (e.g., if the attending physician or licensed health care practitioner is unavailable) concerning the resident’s care plan. 50

51 Investigative Protocol
Care Plan (cont’d) Determine if the facility developed measurable objectives, approximate time frames, and specific interventions to maintain acceptable parameters of nutritional status, based on the resident’s overall goals, choices, preferences, prognosis, conditions, assessed risks, and needs Instructor Notes: 51

52 Interview with Health Care Practitioners
Investigative Protocol Interview with Health Care Practitioners If the interventions defined, or the care provided, appear to be inconsistent with recognized standards of practice, interview one or more health care practitioners. Instructor Notes: For purposes of this interview activity, health care practitioner is classified as, but not limited to a physician (or medical director), nurse practitioner, or another medical practitioner. Depending on the issue, ask: How it was determined that chosen interventions were appropriate Why identified needs had no interventions How changes in condition that may justify additional or different interventions were addressed How staff evaluated the effectiveness of current interventions 52

53 Review of Facility Practices
Investigative Protocol Review of Facility Practices Investigate whether the facility has a system in place to identify residents with nutritional deficiencies or risk and a process in place to consistently address identified needs. Instructor Notes: Examples of such a review may include but are not limited to staff practices, policies, and procedures and training . If a resident(s) nutritional status is not within acceptable parameters without clinical justification, interview to determine (e.g. management) if quality assurance activities were initiated to evaluate the facility’s approaches to nutrition and weight issues. 53

54 DETERMINATION OF COMPLIANCE (Appendix P)
42 CFR (i) (1)(2) Nutrition DETERMINATION OF COMPLIANCE (Appendix P) Instructor Notes: 54 54 54

55 Determination of Compliance
Did the facility: Ensure that each resident maintains acceptable parameters of nutritional status unless the resident’s clinical condition demonstrates that this is not possible, and Ensure to the extent possible the resident receives a therapeutic diet when indicated? Instructor Notes: Review the Synopsis of the Regulation (F325) with the group. 55 55 55

56 Criteria for Compliance with F325
Determination of Compliance Criteria for Compliance with F325 The facility is in compliance if staff: Assessed the resident’s nutritional status and identified factors that put the resident at risk of not maintaining acceptable parameters of nutritional status; and Analyzed the assessment information to identify the medical conditions, causes and problems related to the resident’s condition and needs. Instructor Notes: Discuss with the group the criteria for determining Compliance and Noncompliance of this regulatory requirement. The next five slides relate to this discussion. 56 56 56

57 Criteria for Compliance with F325 (cont’d)
Determination of Compliance Criteria for Compliance with F325 (cont’d) The facility is in compliance if staff: Defined and implemented interventions to maintain or improve nutritional status that are consistent with the resident’s assessed needs, choices, goals, and recognized standards of practice, or provided clinical justification why they did not do so Provided a therapeutic diet when indicated. Instructor Notes: 57 57 57

58 Criteria for Compliance with F325 (cont’d)
Determination of Compliance Criteria for Compliance with F325 (cont’d) The facility is in compliance if staff: Monitored and evaluated the resident’s response to the interventions; and Revised the approaches as appropriate, or justified the continuation of current approaches. Instructor Notes: If failure to maintain acceptable parameters of nutritional status is avoidable, cite at Tag F325. 58

59 Noncompliance with F325 Determination of noncompliance occurs after:
Determination of Compliance Noncompliance with F325 Determination of noncompliance occurs after: Failure to Completing the investigative protocol, and The team analysis of data to determine whether noncompliance with the regulation exists. 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. 59 59 59

60 Noncompliance with F325 (cont’d)
Determination of Compliance Noncompliance with F325 (cont’d) Noncompliance with F325 may include (but is not limited to) one or more of the following: Failure to Accurately and consistently assess a resident’s nutritional status on admission and as needed thereafter Identify a resident at nutritional risk and address risk factors for impaired nutritional status, to the extent possible Instructor Notes: Noncompliance may relate to deficient practices in assessment, identification and management of risk factors, or [move to next slide]. 60 60 60

61 Noncompliance with F325 (cont’d)
Determination of Compliance Noncompliance with F325 (cont’d) May include failure to: Identify, implement, monitor, and modify interventions consistent with the resident’s assessed needs, choices, goals, and current standards of practice, to maintain acceptable parameters of nutritional status. Notify the physician as appropriate in evaluating and managing causes of the resident’s nutritional risks and impaired nutritional status. Instructor Notes: This includes but is not limited to the failure to implement, monitor, and modify pertinent interventions, or to notify the physician for help in identifying and managing causes of nutritional risks and impairments. 61

62 Additional Investigation
Potential Tags for Additional Investigation Instructor Notes: During the course of the review for compliance with F325, 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 those additional requirements before citing tags. Please refer to Handout #5, Potential tags for Additional Investigation for additional information during the investigation. 62 62 62

63 DEFICIENCY CATEGORIZATION (Part IV, Appendix P)
Instructor Notes: Once the 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 harm or potential for harm to the resident. 63 63 63

64 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 compliances, 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 effect or potential for harm to the resident. 64

65 Determining Actual or Potential Harm
Actual or potential harm/negative outcomes for F325 may include: Significant unplanned weight change Inadequate food/fluid intake Impairment of anticipated wound healing Failure to provide a therapeutic diet, as ordered Functional decline Fluid/electrolyte imbalance . Instructor Notes: The key elements for severity determination for F325 are as follows. Examples of actual or potential harm/negative outcomes for F325 may include but are not limited to: Significant unplanned weight change Inadequate food/fluid intake Impairment of anticipated wound healing Failure to provide a therapeutic diet, as ordered Functional decline Fluid/electrolyte imbalance 65 65 65

66 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 F325. 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). 66

67 Severity Level 4 Deficiency Categorization
Immediate Jeopardy to Resident’s Health or Safety Instructor Notes: This is a critical situation because of immediate jeopardy to the health or safety of one or more residents. Examples of avoidable actual or potential resident outcomes that demonstrate severity at Level 4 may include, but are not limited to: Continued weight loss and functional decline resulting from ongoing, repeated systemic failure to assess and address a resident’s nutritional status and needs, and implement pertinent interventions based on such an assessment Development of life-threatening symptom(s), or the development or continuation of severely impaired nutritional status due to repeated failure to assist a resident who required assistance with meals Substantial and ongoing decline in food intake resulting in significant unplanned weight loss due to dietary restrictions or downgraded diet textures (e.g., mechanical soft, pureed) provided by the facility against the resident’s expressed preferences. 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. 67 67 67

68 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: The death or transfer of a resident who was harmed as a result of facility practices does not remove a finding of immediate jeopardy. The facility is required to implement specific actions to correct the deficient practices which allowed or caused the immediate jeopardy. Continue onto next slide. 68 68 68

69 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. 69

70 Severity Level 4 Example
Severity Determination Severity Level 4 Example Development of life-threatening symptom(s), or the development or continuation of severely impaired nutritional status due to repeated failure to assist a resident who required assistance with meals. Instructor Notes: Examples of avoidable actual or potential resident outcomes that demonstrate severity at Level 4 may include, but are not limited to: Continued weight loss and functional decline resulting from ongoing, repeated systemic failure to assess and address a resident’s nutritional status and needs, and implement pertinent interventions based on such an assessment 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. Ask surveyors to share their experience when they encountered a nursing home facility with a Level 4 deficiency. Let’s look at another Level 4 example. 70

71 Severity Level 4 Example
Severity Determination Severity Level 4 Example Substantial and ongoing decline in food intake resulting in significant unplanned weight loss due to dietary restrictions or downgraded diet textures (e.g., mechanic soft, pureed) provided by the facility against the resident’s expressed preferences. Instructor Note: Ask surveyors to share an experience with the group regarding a Level 4 deficiency determination. 71

72 Severity Level 3 Deficiency Categorization
Actual Harm that is not Immediate Jeopardy The negative outcome can 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 Notes: What is harm that is not immediate jeopardy? 72 72 72

73 Severity Level 3 Example
Severity Determination Severity Level 3 Example Significant unplanned weight change and impaired wound healing (not attributable to an underlying medical condition) due to the facility’s failure to revise and/or implement the care plan to address the resident’s impaired ability to feed him/herself. Instructor Notes: Ask surveyors to share their experience when they encountered a nursing home facility with a Level 3 deficiency. Continue onto another Level 3 example. 73

74 Severity Level 3 Example
Severity Determination Severity Level 3 Example Unplanned weight change and declining food and/or fluid intake due to the facility’s failure to assess the relative benefits and risks of restricting or downgrading diet and food consistency or to obtain or accommodate resident preferences in accepting related risks. Instructor Notes: Ask surveyors to discuss some other types of Level 3 examples. 74

75 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. 75 75 75

76 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. 76 76 76

77 Severity Level 2 Example
Severity Determination Severity Level 2 Example Failure to provide additional nourishment when ordered for a resident; however, the resident did not experience significant weight loss. Instructor Notes: Let’s consider another example. 77

78 Severity Level 2 Example
Severity Determination Severity Level 2 Example Failure to provide a prescribed sodium-restricted therapeutic diet (unless declined by the resident or the resident’s representative or not followed by the resident); however, the resident did not experience medical complications such as heart failure related to sodium excess. Instructor Notes: In this case, the resident may have a diagnosis of CHF and hypertension. The resident has a physician’s order for low sodium diet. The resident is on diuretic therapy as well as other cardiac medications. This resident continues on a regular diet without sodium restriction and there is not evidence in the record nor from the resident that the therapeutic diet was refused or attempted. 78

79 Severity Level 1 Deficiency Categorization
No Actual Harm with Potential for Minimal Harm Instructor Notes: 79

80 Level 1 Deficiency Categorization
The failure of the facility to provide appropriate care and services to maintain acceptable parameters of nutritional status and minimize negative outcomes places residents at risk for more than minimal harm. Therefore, Severity Level 1 does not apply for this regulatory requirement. Instructor Notes: 80 80 80

81 Questions? Instructor Notes: 81


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