F322 – Feeding Tubes Script Slide 1
Hello, welcome to the Minnesota Department of Health Webex training on recent CMS revisions to surveyor guidance and investigative protocol concerning F tag 322, feeding tubes. This presentation is meant to provide clarification for determining compliance with the regulatory requirements at F322.
Slide 2
My name is Miriam Thornquist, I am an RN with the Minnesota Department of Health, Division of Compliance Monitoring, Licensing and Certification program. I will be presenting the information in this WebEx which was recorded on November 28th, 2012. This WebEx presentation, including power points, slides and script as well as the revised guidance from the SOM and the critical element pathways will be posted on the Minnesota Department of Health Clinical Web Window. You are responsible for checking the CMS website on a regular basis for any revisions or updates to this guidance. The facility is responsible for maintaining compliance with the regulatory requirements at F322.
Slide 3
Following the presentation the participant will be able to identify the merging of F tag 321 and F tag 322. The participant will be able to describe the terminology regarding tube feedings, state the considerations prior to the decision to use a feeding tube for a resident, and describe the benefits and possible complications related to the use of a feeding tube for the resident.
Slide 4
The objectives also include describing the investigative protocol regarding the correct use of feeding tubes and the determination of compliance or noncompliance with F tag 322, feeding tubes.
Slide 5
The federal regulation for F322 addresses feeding tubes, both naso-gastric and gastrostomy tubes, and requires that a resident’s clinical condition demonstrate that the use of a feeding tube was unavoidable;
Slide 6
that a resident with a feeding tube receives the appropriate treatment and services to prevent complications, and to restore, if possible, normal eating skills. The regulatory language has not changed, however, the revisions to the surveyor guidance include additional definitions and resources. An investigative protocol for surveyors has also been added to the interpretive guidelines.
Page 1 of 14
F322 – Feeding Tubes Script Slide 7
Understanding that nursing homes today use many different types of feeding tubes to provide enteral nutrition to residents, the following definition was added for the purpose of the interpretative guidelines at F tag 322, to allow the inclusion of all feeding tubes: The regulation at 483.25(g) Naso-gastric tubes is considered to include any feeding tube used to provide enteral nutrition to a resident by bypassing oral intake.
Slide 8
The revisions merged F tag 321 and 322 into one tag at F 322. Since we use the QIS survey process in Minnesota, surveyors will also use the QIS Critical Element Pathway for Tube Feeding Status when triggered. I will be discussing this pathway later in this presentation.
Slide 9
The intent of the regulation focuses on a clear assessment of the resident’s clinical need for a feeding tube, the correct use of the feeding tube according to current clinical standards of practice, and the provision of services to restore normal eating skills, if possible.
Slide 10
Now we will cover some of the definitions used in this presentation. The use of a feeding tube is considered avoidable if there is not a clear indication for it’s use and a lack of evidence that it provides a benefit that outweighs the risk. The use is considered unavoidable if there is sufficient evidence that the benefit does indeed outweigh the risk, and there is a clear indication for use.
Slide 11
A bolus feeding is the administration of a specific volume over a short period of time and is commonly used to mimic a meal pattern, when transitioning from enteral feedings to oral feedings and/or to allow the resident time away from feedings. A continuous feeding is an uninterrupted administration over extended periods of time.
Slide 12
Enteral nutrition, or tube feeding, is delivered through a feeding tube, a medical device providing the nutrition to the resident directly into the stomach, duodenum, or jejunum.
Slide 13
A gastrostomy tube, or G-tube is placed into the stomach through an incision into the abdominal wall. The most common type is placed during an endoscopic procedure and is called a percutaneous endoscopic gastrostomy, or PEG tube.
Page 2 of 14
F322 – Feeding Tubes Script Slide 14
The PEG tube is held in place inside the stomach with an attached internal bumper, much like a washer on a bolt, and on the outside of the abdomen with an external bumper which lies flush against the skin. Approximately six inches of the tube are outside the body and there is an adapter on the external end which can be hooked up to enteral nutrition, or used to administer liquid medications using a syringe.
Slide 15
A PEJ or jejunostomy-tube is also often placed using an endoscope and a percutaneous abdominal incision, however, the tip is placed inside the small intestine. A nasogastric tube, or NG, is a tube passed through the nose down the esophagus and into the stomach.
Slide 16
The trans-gastric jejunal feeding tube, (G-J tube) means a feeding tube that is placed through the stomach into the jejunum and that has dual ports to access both the stomach and the small intestine. A tube feeding, also known as an enteral feeding, means the delivery of nutrients through a tube directly into the stomach or small intestine.
Slide 17
The transgastric jejunal tube enters the body in the same way the PEG tube does with the internal bumper inside the stomach, except internally, it has more length and enters the jejunum. The exterior length of the tube, outside the body, separates into a “y” with two ports.
Slide 18
The decision to use a feeding tube greatly affects the resident’s quality of life and is based on the resident’s clinical condition and wishes, and federal and state laws. The use of a feeding tube must be consistent with the wishes and instructions of the resident, if known, such as verbal or written instructions of the resident, advance directives or a living will, or the instructions of the resident’s legal representative, if the resident is unable to make their wishes known. The use of feeding tubes varies among the states depending on opinions regarding non-oral nutrition and different facility policies and practices.
Page 3 of 14
F322 – Feeding Tubes Script Slide 19
Considerations for the use of a feeding tube include; The resident’s clinical condition must demonstrate that the use of the feeding tube is unavoidable, which means that there are no other viable alternatives to maintain adequate nutrition and hydration; and the use is consistent with the clinical objective to maintain or improve nutrition and hydration.
Slide 20
Other factors associated with the use of a feeding tube for a resident may include; A medical condition, such as a stroke that impairs chewing or swallowing, esophageal cancer, delirium, or reconstructive facial or oral surgery. Another factor may be a need to improve the resident’s nutritional status or level of comfort, or the desire to prolong the resident’s life. The duration of use of a feeding tube may vary, depending on the clinical situation. For example, if the resident who has suffered a stroke improves and can swallow and can maintain or improve their nutritional status, the use of a feeding tube may no longer be necessary.
Slide 21
Clinical rationale supporting the use of a feeding tube include but are not limited to; An assessment of the resident’s nutritional status: what is their usual food and fluid intake, laboratory values such as protein levels or hemoglobin, their appetite, and usual weight including any weight changes. An assessment of the resident’s clinical status. This may include the ability to chew, swallow, and digest food and fluid. Are there underlying conditions affecting those abilities. Another rationale may be relevant functional and psychosocial factors such as, the resident’s inability to feed him or herself, a stroke or neurological injury that results in loss of appetite, or a psychosis that prevents eating. The failure of prior interventions may also support the use of a feeding tube, for example, have there been diet modifications or changes in food consistency, or an attempt at fortifying the food, adjusting the eating environment, hand-over-hand feeding, cueing or staff feeding? The F tag 325 for nutrition in the state operations manual gives examples of interventions to improve and restore normal nutritional parameters.
Slide 22
Some potential benefits of tube feeding for the resident include addressing dehydration, malnutrition and wound healing.
Page 4 of 14
F322 – Feeding Tubes Script Slide 23
Some possible adverse effects of tube feeding may include: The resident with a feeding tube may feel self conscious about being around others which impacts socialization. It is important to minimize possible social isolation or a negative psychosocial impact. The resident being fed by a feeding tube may not have as many opportunities to experience the pleasure of eating or tasting their favorite foods. Facility staff may consider appropriate ways to offer some of this experience to the resident. Complications related to the feeding tube must be considered such as skin issues, aspiration, and perforation, and limitations on the resident‘s freedom of movement. Due to the possible side-effects and discomfort associated with the use of nasogastric tubes, there should be clinically pertinent documentation in the resident record for the use of NG tubes greater than 30 days. Residents with advanced dementia or other neurological disorders present a particular set of issues and considerations which are further addressed under nutrition at F tag 325.
Slide 24
The interdisciplinary team with support and guidance from the physician, is responsible for assuring the ongoing review, evaluation and decision-making regarding the initiation or discontinuation of all treatments, devices or approaches implemented to care for the resident. The physician’s input regarding the resident’s clinical condition, and comorbid conditions will factor into consideration to use or not to use a feeding tube. Involving the resident, family, and/or the resident’s legal representative in discussions about the indications, use, potential benefits and risks of tube feeding, types of approaches, and alternatives, helps support the resident’s right to make an informed decision to use or not use artificial nutrition and hydration.
Page 5 of 14
F322 – Feeding Tubes Script Slide 25
The technical and nutritional aspects of feeding tubes must be addressed in facility protocols. These protocols are developed with the medical director in accordance with clinical standards of practice. Protocols should include: Direction to staff regarding how to monitor and check that the feeding tube is in the right location. Protocols should include directions for: Securing a feeding tube externally; Providing needed personal, skin, oral, and/or nasal care to the resident; Examining and cleaning the insertion site in order to identify, lessen or resolve possible skin irritation and local infection; Using infection control precautions and related techniques to minimize the risk of contamination; for example, in connecting the tube and the tube feeding; and Defining the frequency of and volume used for flushing, including flushing for medication administration. Protocols should include direction for staff regarding the conditions and circumstances under which a tube is to be changed or replaced.
Slide 26
Facility protocols should also include: Direction to staff regarding the nutritional product and meeting the resident’s nutritional needs such as: Types of enteral nutrition formulas available for use; How to determine whether the tube feedings meet the resident’s nutritional needs and when to adjust them accordingly; How to balance essential nutritional support with efforts to minimize complications related to the feeding tube; Ensuring that the selection and use of enteral nutrition is consistent with manufacturer’s recommendations; Ensuring that the administration of enteral nutrition is consistent with and follows the practitioner’s orders; and Ensuring that the product has not exceeded the expiration date.
Slide 27
There are significant complications possible related to the use of a feeding tube itself. Some can be life threatening such as aspiration leading to pneumonia, and perforation which can lead to septic shock and death. The use of tubes not designed or intended for enteral feeding may increase the risk of complications.
Page 6 of 14
F322 – Feeding Tubes Script Slide 28
The resident care policies should address flushing tubes regularly, (and in association with medication administration), to help reduce the risk of clogging due to: Formula Pill fragments Medications incompatible with the formula
Slide 29
Additional complications can include nausea, vomiting, diarrhea and abdominal cramping.
Slide 30
While a feeding tube may be initiated with the intent to address certain medical conditions, the use of a feeding tube does not necessarily decrease the risk of aspiration for individuals with other risk factors. For example, aspiration risk may potentially be affected by factors such as a diminished level of consciousness, improper positioning of the resident during administration of the feeding, and failure to assure the feeding tube is correctly positioned within the stomach or intestine. There may be situations where other coexisting factors influence decisions about elevating the head of the bed; for example, a resident being fed by a tube who may be at risk for shearing by sliding down the sheets when the head of the bed is elevated to a recommended angle. Another example of an intervention to reduce the risk of aspiration would be to adjust the rate of flow. The important thing to remember is that each resident is assessed individually to assure the interventions are appropriate for them.
Slide 31
Staff should also be aware that enteral nutrition formula can reduce the effectiveness of some medications such as Dilantin.
Page 7 of 14
F322 – Feeding Tubes Script Slide 32
Metabolic complications may be reduced by calculating the nutritional needs of the resident, taking into account comorbid conditions and medications that affect these balances, monitoring for adequate nutritional status and complications, and adjusting the tube feeding accordingly.
Slide 33
The facility is expected to identify actual as well as potential complications and notify and involve the resident’s practitioner to address the issues.
Slide 34
As I mentioned earlier, CMS has included an investigative protocol for surveyors to use for residents with a feeding tube. The surveyor will investigate whether the facility conducted adequate assessment of the resident’s condition to determine an unavoidable need for the use of a feeding tube, whether services are provided to prevent complications, and whether attempts were made to restore normal eating skills to the extent possible.
Slide 35
The investigative protocol follows a format similar to others developed by CMS, such as for pressure ulcers, urinary incontinence, and activities, and focuses on observation, interview and record/document review. If there are concerns regarding the facility’s use and care of a feeding tube, surveyors are also directed to review the facility policies, procedures and protocols related to feeding tubes.
Slide 36
The surveyor will observe the resident and resident’s interactions with staff during various times of the day to determine if the facility’s policies and procedures for the initiation, continuation and termination of a feeding, medication administration, tube site and equipment care are being correctly implemented by staff,
Slide 37
And whether the staff are following the standards of practice, facility policy, individualized plan of care and prescriber’s orders for the resident.
Page 8 of 14
F322 – Feeding Tubes Script Slide 38
Additional observations of care that may minimize risk of complications include: Whether staff use standard precautions and clean technique and follow the manufacturer’s recommendations when stopping, starting, flushing, and giving medications through the feeding tube. Whether staff ensure the cleanliness of the feeding tube, insertion site, dressing (if present) and nutritional product. Whether staff provide the type, rate, volume and duration of the feeding as ordered by the practitioner and consistent with the manufacturer’s recommendations, and Whether staff implement interventions to minimize the negative psychosocial impact that may occur as a result of tube feeding.
Slide 39
If possible, the surveyor will interview the resident or the resident’s representative to determine whether they were involved in the process, for example; Do the interventions reflect the resident’s choices and preferences, was the resident given information about risks and benefits and possible alternatives to the use of the feeding tube? Has the resident had any significant new or worsening physical, functional or psychosocial changes?
Slide 40
Facility staff interviews are also part of the investigative protocol. During interviews with staff who provide direct care the surveyor will ask questions to determine if there have been any complaints from the resident, or symptoms of complications associated with the tube feeding. For example; has the resident been nauseated, had abdominal discomfort or been hesitant to be in social interaction? Does the resident have specific care needs such as special positioning, personal care, and insertion site care? The surveyor may also ask how the staff and/or practitioner determined the cause(s) of decreased oral intake/weight loss or impaired nutrition and what interventions were attempted to maintain oral intake prior to the insertion of a feeding tube. Did staff collaborate with the physician to identify medical causes of decreased appetite or try to help the resident eat enough food such as cueing or hand feeding; changing food consistency, texture, form; seeking and addressing causes of anorexia or providing assistive devices?
Slide 41
Surveyors may interview to determine if resident problems or complaints have been addressed and to whom staff reports signs or symptoms of complications.
Page 9 of 14
F322 – Feeding Tubes Script Slide 42
Surveyors may also interview health care professionals and practitioners responsible for overseeing or training staff to determine: Is the resident periodically reassessed for the continued appropriateness/necessity of the feeding tube? Was the care plan revised and implemented, as necessary, with input from the resident or his/her legal representative, to the extent possible? If the feeding tube was placed in another facility did the physician and staff attempt to identify the circumstances that led to the placement of the feeding tube?
Slide 43
Record review involves looking for evidence of clinical rationale for the tube feeding such as physician orders, tube feeding records, multidisciplinary progress notes and RAI/MDS information to determine: Were there attempts at alternatives? What was the rationale for the feeding tube? Do staff verify that the feeding tube was properly placed? Do staff monitor the resident for possible complications related to a feeding tube and the tube feeding? Are staff assigned responsibilities for various aspects of enteral feedings consistent with their position and training such as administering the feeding, determining and verifying correct formula; calculating the amount of formula, feeding intervals and flow rate? Has the resident been periodically reassessed and the care plan revised and implemented as necessary with input from the resident or legal representative to the extent possible?
Slide 44
There may be related concerns identified regarding facility practices, staffing, staff training and functional responsibilities such as the procurement of necessary equipment
Slide 45
If there is a pattern of residents with issues related to feeding tubes, the surveyor will determine through interview, whether the facility has incorporated the appropriateness and management of tube feedings into their quality assurance program.
Slide 46
To summarize: The regulation at F322 requires that the facility: Determine that the use of a feeding tube is clinically unavoidable, and; Provide services to prevent complications and restore normal eating skills as possible.
Page 10 of 14
F322 – Feeding Tubes Script Slide 47
The facility is in compliance with F322 if staff: Use a feeding tube to provide nutrition and hydration only when the resident’s clinical condition makes this intervention necessary based on adequate assessment and after other efforts to maintain or improve the resident’s nutritional status have failed
Slide 48
The facility is in compliance with F322 if staff: Manage all aspects of a feeding tube and enteral feeding consistent with current clinical standards of practice in order to meet the resident’s nutritional and hydration needs and to prevent complications ; and if staff Identify and address the potential risks and/or complications associated with feeding tubes, and provide treatment and services to restore, if possible, adequate oral intake.
Slide 49
Noncompliance with F322 may include, but is not limited to: Failure to appropriately assess a resident’s clinical needs and rationale for the use of a feeding tube. Is it unavoidable? Or failure to identify the resident’s nutritional requirements, and ensure the enteral feeding would meet those needs.
Slide 50
The facility is not in compliance if there is failure to: Adequately address the nutritional aspects of enteral feeding and the management of the feeding tube, including prevention of related complications; or failure to Use and monitor a feeding tube per facility protocol and clinical standards of practice, provide services to attempt to restore, if possible, normal eating skills, or identify and manage tube-related or enteral feeding related complications The investigative protocol also identifies other requirements which may need further investigations if concerns are noted.
Slide 51
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.
Page 11 of 14
F322 – Feeding Tubes Script Slide 52
Actual or potential harm may include for example: Failure to adequately assess a resident’s nutritional status and the care and services needed to maintain or improve the resident’s nutritional status and the resident is experiencing malnutrition and/or dehydration. Or failure to use, maintain, and monitor the feeding tube properly resulting in complications such as aspiration.
Slide 53
The survey team must evaluate the harm or potential for harm based upon the following levels of severity for F-tag 322. 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, following the guidance in Appendix Q.
Slide 54
Does the situation require immediate correction to prevent serious harm?
Slide 55
The survey team will determine the level of severity using the scope and severity grid. We will review each severity level. Please note that severity level one; no actual harm with potential for minimal harm, does not apply to F322.
Slide 56
Severity level 4 is immediate jeopardy resulting in, or is likely to cause serious injury, harm, impairment or death to a resident, and
Slide 57
Severity level 4 requires immediate correction.
Slide 58
One example of severity level 4 would be a situation where the facility routinely kept a resident lying almost flat in bed while administering the resident’s tube feeding. As a result the resident aspirated some of the tube feeding and developed aspiration pneumonia. Another example of severity level 4 would include a situation where the facility failed to train staff about how to ensure proper placement of a feeding tube, and/or to ensure that staff were checking for tube placement consistently and correctly. As a result of staff failure to verify tube placement, a resident developed peritonitis, (an infection of the lining of the abdominal cavity) and died following the administration of tube feeding.
Page 12 of 14
F322 – Feeding Tubes Script Slide 59
Severity level 3 is actual harm that is not immediate jeopardy. A negative outcome to the resident has occurred.
Slide 60
An example of severity level 3 would be an instance where the facility failed to monitor for complications related to a resident’s feeding tube and tube feeding. As a result, the resident experienced significant but not life-threatening tube feedingrelated complications. Another example would be, as a result of facility failure to assess the resident’s nutritional needs and to continue to administer, monitor, and adjust tube feeding accordingly, a resident experienced significant weight loss that cannot be otherwise attributed to a medically unavoidable cause.
Slide 61
Severity level 2 is the potential for more than minimal harm that is not immediate jeopardy, resulting in no more than minimal discomfort and/or has the potential to compromise the resident’s ability to reach their highest practicable well being.
Slide 62
Severity level two examples include: As a result of staff failure to manage a tube feeding pump properly, the resident did not receive the calculated amount of tube feeding, without resulting in significant weight loss or other GI complications. As a result of staff failure to anchor a feeding tube properly, the resident had leakage and irritation around the tube insertion site that required topical treatment and resolved without complications.
Slide 63
With this regulation at F322, the failure to provide appropriate care and services places the resident at risk for more than minimal harm. Therefore severity level 1 does not apply here.
Page 13 of 14
F322 – Feeding Tubes Script Slide 64
As I mentioned earlier, surveyors will use the QIS critical element pathway for tube feeding if that area is triggered for stage 2 investigation, or due to identified concerns, an investigation into tube feedings is initiated by the survey team. As with all the critical element pathways, the surveyor focuses their investigation on observation, interview and document review. The critical element pathway contains many of the same observation, interview and document review directions as in the investigative protocol. This CE Pathway is posted on our MDH website as well as the QTSO website, where all CE Pathways are available for review.
Slide 65
As part of the document review, the surveyor will review the resident’s orders, multidisciplinary notes, MDS, and any other available assessments regarding the rationale for the use of a feeding tube. Has there been a thorough assessment of the resident’s nutritional status? Has a care plan for tube feeding been developed with specific details of the resident’s risks, needs and preferences? If the care plan references a facility protocol, is this readily available to caregivers? Is care of the feeding tube and enteral nutrition provided by qualified staff? Are there any concerns with associated requirements such as resident choice, dignity, written policies and procedures? If so, these areas must also be investigated.
Slide 66
In conclusion, the federal regulatory language for feeding tubes has not changed, it has been incorporated into one tag, F322. Definitions have been added and the interpretive guidelines and investigative protocol details have been expanded and revised. This WebEx and additional resources and information can be found at the MDH clinical web window. Thank you for your attention during this presentation.
Page 14 of 14
