The New Survey Initiatives

The information contained herein and through the subsequent section herein entitled "Additional Survey Considerations" enhances the information provided in Section I of Achieving Substantial Compliance entitled, "The Surveys." If you are placing this information in your manual, it is suggested you insert it at page 32.

Historically and especially since the advent of the current OBRA regulations in 1995, survey teams have met in the pre-survey conference forum for the purpose of offsite survey preparation. These conferences have entailed the surveyors reviewing the facility’s compliance and survey history, the OSCAR reports, complaints, and a number of other factors. Now, with the advent of new survey protocols designed to be implemented effective July 1, 1999, offsite survey preparation becomes an even more critical task. Surveyors will now have access to three new reports generated as a result of data provided by facilities via MDS transmittal. Those reports are the Facility Characteristics report, the Facility Quality Indicator Profile report, and the Resident Level Summary report (see Manual Update section, "The New Quality Indicators.") By reviewing these documents, surveyors will now be better able to target both specific areas of concern and specific residents to address during the survey. In the newly designed procedures for offsite preparation, the survey teams will be able to easily access information about a facility via computer modem. In addition, prominence will be given to the quality indicator reports and thus the survey process further matures in its quality based design.

As part of these new survey protocols, a newly designed roster sample matrix will also be put into use. This will replace the previous roster sample matrix used by the survey teams and enable team members to more easily highlight areas of concern for Phase I of the survey process. With the advent of these new resources, residents selected for inclusion in a survey sample will now most likely be taken from the Resident Level Summary report. HCFA asserts that the newly designed roster sample matrix form will be available via the internet on HCFA’s website by mid-June, 1999.

One concession HCFA has made regards those surveys to be conducted during off hours. The survey teams will place priority on promptly touring the facility. Additionally, as off hour surveys can occur at any time, surveyors have been advised that entrance conferences can be delayed until "daylight" hours when most administrative staff will have arrived at the facility.

The Initial Tour
Including Subtask 5: Initial Kitchen/Food Service Observation
Including Investigative Protocol: Nursing Services, Sufficient Staffing

As in the past, once a survey team arrives at a facility they will quickly commence an initial tour. These tours will still be aimed at meeting all residents and identifying quality issues, but additional steps have been added to the initial tour procedures. Now, survey teams will conduct an immediate, brief kitchen observation. They will check the offsite roster to determine if residents and concerns identified thereon are still present. HCFA has also implied that as part of the initial tour the survey team members will identify those residents who are deemed interviewable. This is a significant change from past practices. Previously, the identification of those residents who were interviewable was reserved for facility staff. Now, the survey team will identify those residents and select those considered interviewable from the survey sample. HCFA’s statistical survey profile indicates that approximately 5 residents in every 100 is interviewable and, therefore, if an adequate number of residents is not in the sample, the survey team may go outside of the sample to select additional interviewable residents. It is not clear whether facilities will still provide survey teams with information about interviewable residents, but is does appear as if the decision as to interviewability now rests with the surveyors.

The kitchen/food service observation done as part of the initial tour is now categorized as survey subtask 5B. The general objective of this dietary observation is to determine if the facility is storing, preparing, distributing, and serving food to prevent food borne illness (corresponds to F-371). One survey team member is assigned to complete this task and that surveyor will begin with a visit to the kitchen as part of the initial facility tour. Observations will be conducted to see if potentially dangerous foods have been left on countertops, are improperly in steam tables, are not properly prepared, and the manner in which food is being thawed. Cleanliness and sanitary practices will also be observed, as well as the appearance of the staff. Dietary staff will be expected to be dressed in clean, appropriate attire and be wearing proper hair restraints. The surveyor will also determine whether the food prepared is consistent with the written, planned menu, and whether the availability of food in relation to the number of residents is adequate. If concerns are identified during the initial tour, according to the draft language for the newly revised State Operations Manual, the surveyor may also observe for any of the following:

"If recipes are available and consistent with the menu and followed by employees
If appropriate equipment is available and used to prepare and serve food
If the food is being held for more than thirty minutes prior to food service (e.g., in the steam table, oven, refrigerator rather than freezer for frozen foods, etc.)
If cooked leftovers used during food preparation were stored and used within the appropriate time frames and reheated to at least 165 degrees F."

While not necessarily included as part of the initial tour, the survey team will also continue to conduct other observations of the facility’s dining and food service. During the dining and food service investigative protocol, the survey team will attempt to determine if each resident is provided with nourishing, attractive, and palatable meals that meet the resident’s dietary or special regimen needs; whether each resident is provided with services designed to maintain or improve eating skills; if the dining experience enhances the resident’s quality of life and is supportive of resident need; and if adequate food service and support staff are present during mealtime.

At a minimum, the dining and food protocol will be used to investigate sampled residents identified with malnutrition, unintended weight loss, mechanically altered diets, pressure ulcers, and hydration concerns. Food complaints received from residents, families, or others will also be investigated as part of this protocol. Surveyors are going to be required to observe at least two complete meal servings during the course of the survey. Moreover, survey team members will be observing whether or not facility med passes occur during the meal time. If so, unless specifically ordered to be given just prior to or with meals, the passing of meds at meal time will likely result in a deficiency citation(s).

During the initial survey, if problems regarding care concerns have been identified, then the surveyors are to implement an investigative protocol for nursing services and sufficient staffing. This essentially expands the province of F-353 beyond simply staffing in accordance with numerical ratios. Surveyors will now base judgments regarding the sufficiency of staffing levels on a variety of concerns which the draft State Operations Manual identifies as including:

Care problems including unintended weight loss, hydration issues, adequate skin care and the presence of pressure ulcers, lack of care and services to prevent declines in condition(s) and ADL functioning
Complaints received from residents, families, or other resident representatives concerning a lack of services such as care not being provided, unanswered call lights, lack of assistance in eating and other tasks
Whether registered and/or licensed nurses are available to monitor and supervise the delivery of care in accordance with each resident plan of care and to:

a. supervise the delivery of care by the nursing assistants
b. assess resident condition changes
c. respond to the requests of nursing assistants for assistance
d. correct inappropriate or unsafe nursing assistant technique(s)
e. identify training needs for the nursing assistants

Discuss with supervisory nursing personnel those situations that led to the use of the staffing protocol and determine how they assure adequate staff to meet resident need
How does supervisory nursing personnel assure the staff is knowledgeable about the needs of resident(s) and whether they are capable of delivering care
What orientation methods are used for new and temporary staff to inform them about resident care need
How is staff kept apprised of changes in resident condition and changes in the care plan
Are the nursing assistants and other nursing staff knowledgeable about resident care needs such as food and fluid intake, turning and positioning, toileting and incontinence care, etc.
Do the nursing assistant assignments correspond to care plans and resident need
What does the resident or family say about staff response(s) to requests for assistance and the timeliness of answering call lights
If staffing problems are identified, are they facility-wide, do they extend to all shifts, or are they limited to certain shifts or units
If applicable, does the facility meet the minimum staffing requirements established in individual State rule or regulation

One additional area of significance the survey team will review regarding staffing will be those measures or procedures a facility has in place to increase staffing ratios when changes in care require such increases. Facilities should note that such changes in care might refer to overall resident census acuity, or they might simply refer to a change or changes in the care plan of an individual resident. Nevertheless, a facility should devise a system to insure adequate staffing levels at all times. Moreover, it could realistically become an expectation of the survey process that if a system or mechanism to increase staff due to changes in condition(s) or care plans cannot be followed or implemented, there could be an expectation that a facility reduces its census until adequate staffing levels are reached and maintained.

One mechanism that can be readily used to insure adequate staffing levels is an acuity scale which bases staffing ratios in accordance with resident acuity. Once such example is found in this manual in Section X entitled, "Staffing for Acuity." HCFA is currently developing acuity staffing standards and it would be wise for facilities to develop similar mechanisms for their own purposes. If a facility can show that it has an active system by which it provides staff based on acuity level and it can show that staffing levels meet or exceed the staffing requirements indicated in the acuity system, then the facility has a strong position from which to defend itself and from which to avoid citation under F-353.

While there are a number of issues that comprise the new survey protocols, facilities should keep in mind that survey histories and regulatory compliance information are now available to the general public via the internet. While many survey issues may require clinical knowledge beyond the scope of the general layperson, one deficiency can be understood by all. That deficiency is one for shortage of staff and that is one area that has historically plagued the long term care industry. Facilities would be wise to do all they can to avoid such deficiencies.

The New Emphasis on Medications/Drugs
Including Investigative Protocol: Adverse Drug Reactions

The impetus for HCFA’s decision to concentrate on drug issues comes as a result of a report compiled by the Office of the Inspector General in 1997 and subsequent Congressional recommendations that drugs in long term care facilities be reduced and that new lists of inappropriate drugs be developed. As a result, HCFA has developed new interpretive guidelines for those F-tags regarding medication usage and administration. These interpretive guidelines correspond to F-tags F-329 and F-331 through F-333. While there are significant changes in these interpretive guidelines, it should be noted that all of the former guidelines have not been deleted and that there is no change to the language of the regulation. The author makes the assumption that facilities will make the effort to obtain copies of the new interpretive guideline language.

In general terms, the new survey process emphasizing drug issues will concentrate on potentially ineffective drugs, expand the definition of medication error(s), and make additions to the listings of antipsychotic dosages. HCFA takes the position that there is a lack of communication between those who start a medication and those who see the residents daily and monitor the success or failure of the drug.

The new interpretive guidelines will establish a level of evidence and explanation expected to validate the use of certain medications. Surveyors will pay particular attention to a resident’s medication regimen when specific medications present known substantial risks. The surveyor’s purpose will theoretically be to establish a reasonable balance between assuring residents are protected from risk from potential harm from those medications with substantial risk(s). It will be the surveyor’s task to make sure the resident is truly at potential risk or actual risk before intervention is taken.

While the methodology for calculating the medication error rate has not changed and the definitions for significant and non-significant errors have not changed (see Manual Section VI, "Analyzing the F-tags," page 174), the guidelines for determining a medication error have been greatly expanded. Now, a medication error is generally defined as the observed preparation or administration of a drug or biological that is not in accordance with (1) the physician’s order, (2) the manufacturer’s specifications (not recommendations) regarding preparation and/or administration, and (3) accepted professional standards of practice (see Manual Section VI, "Analyzing the F-tags," page 157, F-281 for further discussion regarding professional standards of practice; refer also to the newly worded interpretive guidelines found at F-333 which describe professional standards and principles as including those various state regulations which might govern professional practice and commonly held and accepted practices established by national credentialing bodies, professional organizations, boards, and councils.)

Examples of medication error will now include but may not be limited to:

unauthorized drugs
incorrect dosage
incorrect route of administration
incorrect time of administration
failure to follow the manufacturer’s specifications such as:

failure to "shake well" when the product is so labeled
Crushing medications that should not be crushed
insulin suspensions must be properly mixed and without air bubbles
medications must be administered with adequate fluid intake
medications that should be taken with food should be administered accordingly

proper administration of medications with enteral nutritional formulae
properly administered tube feedings (although some facets may be cited as a failure to follow standards and practices rather than a medication error)
proper flushing of tube feedings
simultaneously administering enteral nutritional formula with dilantin (administration should be separated and resident monitored for seizure activity)
proper administration of eye drops including insuring proper eye contact and adequate contact time
failure by the facility to find alternatives to residents who persist in swallowing sublingual medications
proper administration of medication via metered dose inhalers (MDI)

The general observation of the medication pass has also been expanded under the new interpretive guidelines. Now, surveyors will be required to observe residents during several different med passes. The surveyor will also now interview the person passing medication to assure that person is aware of the facility’s system for the administration of drugs.

While these new interpretive guidelines and survey protocols do not prohibit the use of certain drugs (nor are they intended to prohibit use), the expectations placed upon a facility have certainly broadened and increased. Facilities will now have to develop systems for all facets of their medication administration programs. A procedure for passing meds coupled with a check of the resident’s medication regimen by the pharmacist are no longer going to be adequate to satisfy survey expectations. For example, facilities shall now have to have in place systems designed to monitor medications. Facility staff will be expected to prove why certain medications are necessary and are more helpful than harmful. While the newly revised quality indicators include domains for clinical management (nine or more meds) and antipsychotic drug use, it would behoove facilities to develop additional quality indicators for use as internal tools to monitor their medication system(s).

In the broadest sense, drug therapy issues will concentrate on the effectiveness of drug therapy. Simplistically, the surveyor will determine whether a drug was administered to the right person; once administered, did the drug have benefit; and was the drug effective without too much harm. As part of HCFA’s drug initiative, surveyors will watch for potentially ineffective drugs, will utilize an expanded definition of medication error, and will also consider additions that have been made to current antipsychotic dosages.

HCFA has concluded that there exists a great lack of communication between those who start the drug and those who see the resident daily and monitor the success or failure of the drug therapy. Moreover, further conclusions by HCFA assert a lack of awareness and knowledge by caretakers of both the effectiveness or expected goal of a medication and consideration for what unwanted side effects should be noticed. The drug therapy initiative, through newly revised interpretive guidelines, now establishes a level of evidence and explanation expected to validate the use of certain medications. Facilities will be especially scrutinized for these validation efforts when medications present known substantial risk.

During the survey process the survey team will specifically review all medication taken by a sampled resident for the previous seven days. In so doing, the surveyor will evaluate for the presence of unnecessary drugs, the presence of a drug regimen review, and the presence of possible adverse drug reactions. More specifically, for each resident the surveyor will be checking to determine the presence of the proper indications for drug use and the drug’s effectiveness; correct dosage amount; the presence of duplicative therapy (2 or more medications normally given for the same reason); the presence of monitoring; and the presence of possible adverse drug reactions.

It is an expectation of the survey process that adverse drug reactions be identified by the facility. In fact, the foundation for medication guidelines specifically designate the provider and the practitioner as those responsible for identifying an adverse drug reaction and determining its significance. As disease symptomology and adverse drug reactions may be similarly manifested, the survey process is bound to become controversial when the surveyor alleges the presence of an adverse drug reaction the facility asserts is a normal manifestation of the disease process. In identifying an adverse drug reaction the surveyor will watch for several levels of change and these will include major, apparent symptoms or condition changes; suspicious symptoms or changes (the significance of which may or may not be readily apparent); and more subtle, intermittent or fluctuating symptoms or condition changes.

While a drug regimen review performed by licensed pharmacist has been a regulatory requirement for twenty five years, the new survey guidelines include an investigative survey protocol for adverse drug reaction(s). Facilities should note that adverse drug reactions are not synonymous with side effects. While the term "side effect" is often used interchangeably with adverse drug reaction, a side effect is but one of five categories of adverse drug reaction. The other four are hypersensitivity, idiosyncratic response, toxic reaction, and adverse drug interaction. An adverse drug reaction is defined in the draft State Operations Manual as, "…any response to a drug that is noxious and unintended and occurs in doses for prophylaxis, diagnosis, or therapy.

Before examining the details of the investigative protocol for adverse drug reactions, facilities should be aware of how ADR’s are defined and categorized. As stated previously, a side effect and an ADR are not interchangeably synonymous. A side effect is simply one type of adverse drug reaction. In addition to the categories mentioned above, adverse drug reactions are also categorized by type. The types of adverse drug reactions are (1) drug-drug interaction; (2) hypersensitivity (allergic) reaction; (3) drug side effect; (4) drug toxicity; (5) idiosyncratic reaction; and (6) complication.

Presumably the ADR survey protocol is not designed or intended to instruct surveyors to determine if a resident outcome is an actual adverse drug reaction (except in obvious circumstances). The protocol and new interpretive guidelines are intended to guide surveyors to find pertinent facts that will assist them in determining compliance. Facilities should be apprised that drug listings found in the interpretive guidelines are not all inclusive and other sources may be used by surveyors as reference tools.

As part of the ADR protocol, drugs will be categorized as those with a potential for severe problems and as those with a potential for less than severe problems. If the surveyor finds citation is necessary for medications with the potential for severe problems, the citation will be written to correspond to F-329 (unnecessary drugs). If the determination regards a drug that has potential for less than severe adverse outcomes, then the citation is written to correspond to F-429 (drug regimen review by the pharmacist). One of the significant factors in this differentiation is that a citation for F-329 is a quality of care issue and could result in a citation of substandard quality of care, while F-429 is not included in the quality of care F-tag groupings and thus cannot result in a finding of substandard quality of care.

Facilities should note that the survey protocol does not indicate a surveyor needs to identify an adverse drug reaction to issue a finding of deficient practice, only that the potential for the adverse drug reaction exists. This further emphasizes the importance of a facility developing a comprehensive system by which drug use can be both monitored and evaluated. Surveyors will be evaluating the usage of a drug(s) for its impact upon the resident’s quality of life. The existence of a viable drug use system for monitoring and evaluation will provide the tool by which the facility can show the surveyor that drug therapy is monitored for reason and benefit. The survey team will be seeking to discover if the facility has considered and monitors the reason and benefit of a resident’s drug regimen and that a goal of minimal harm to the resident is maintained along with the individual’s quality of life.

The criteria for the implementation of the ADR protocol is by definition limited to (1) only residents over the age of 65, (2) residents who have been in the facility more than seven days, and (3) the resident is receiving one of the drugs in the ADR lists found in the interpretive guidelines corresponding to F-329 and F-429. The exception to the criteria is that resident who appears to be experiencing or having a noticeable adverse drug reaction.

The ADR protocol has four specified steps for the surveyor to follow and these are:

screening
analysis
review of facility response
additional considerations (e.g., documentation that provides a valid justification for the drug use; the comparative benefits of certain medications whose benefits might outweigh the adverse reaction, i.e. pain relief as opposed to causing constipation, etc.)

Therefore, a deficiency citation under F-329 (unnecessary drugs) may be made not only because the drug is evaluated by the surveyor as specifically unnecessary or it is being administered in an excessive dose or for an excessive duration, a citation under F-329 may also be issued because the facility fails to adequately monitor the reason for use and, especially in the presence of adverse consequences, fails to indicate the need to reduce or eliminate the drug.

In addition to the potential for citation due to excessive dose or duration, adverse consequences, failure to monitor, and/or failure to reduce or eliminate a drug causing or having the potential to cause an adverse reaction, facilities will continue to have the potential for citation for the inappropriate use of antipsychotic medications. While this general provision is not new to the interpretive guidelines, some "flag" doses have been either revised or newly added to the list requiring further review. A "flag" dose is not necessarily the maximum daily dose, it is a level at which HCFA identifies the need for further review.

Theoretically, the purpose of the overall drug review and all of its component procedures and/or protocols is to validate the appropriateness of the facility’s method of drug delivery and to insure the facility’s drug delivery and monitoring systems provide for the resident to receive optimal drug therapy as intended by the prescriber. The review is supposedly designed to be resident centered and protect against and/or minimize risk, maintain comfort and dignity, and maintain functional status and health. In that regard, one of the more controversial aspects of both the drug and food service reviews is the strong probability that survey teams will no longer tolerate medication passes that occur at meal times (exceptions being the obvious, medications prescribed to be administered with food or at meals).

Investigative Protocol: Pressure Sore/Ulcer

As stated in the draft State Operations Manual, the primary objectives of the investigative protocol for pressure ulcers are for the survey team to determine if the identified pressure ulcer was or was not avoidable and to determine the adequacy of the facility’s treatment and prevention interventions. In accomplishing this task, the surveyors are instructed to select at least one sampled resident who appears on the Resident Level Summary report as having a pressure ulcer. It does not matter if the resident selected is identified as being at high or low risk, but facilities should remain cognizant that pressure ulcers occurring with low risk residents is a sentinel event. Consequently, if a facility has residents who have been "flagged" as sentinel events, chances are highly inevitable that not only will all so identified be investigated, but those at high risk with pressure ulcers are also likely to be investigated.

In conducting the investigative review which comprises this investigative protocol, the surveyors will follow a number of survey procedures. These will include, but may not necessarily be limited to:

Observations and interviews
A review of the resident’s assessment and care plan
Observing care delivery to insure the interventions in the care plan have been implemented
Evaluate whether the facility’s assessment identifies factors or conditions which may place the resident at risk for the development of pressure ulcers
Review all related information and documentation for evidence of identified causes of the resident’s condition
Interview applicable facility staff and health care practitioners who, by their level of knowledge of the resident and professional training, should be aware of or be able to provide information about the causal factors contributing to the resident’s condition
Determine if the facility developed a care plan with interventions for prevention of pressure ulcer development for residents identified as at risk
Determine if the facility has maintained an ongoing evaluation of the care plan and its interventions so that the effectiveness of the care plan can be determined and revised as necessary
Determine whether the facility identified, assessed, and intervened appropriately to address those changes in a low risk resident that contributed to the development of a pressure ulcer
Determine if the facility has aggressively designed a plan of care for the resident admitted with a pressure ulcer
Determine if the care plan is consistently implemented, then evaluated and subsequently revised based upon the response, outcomes, and needs of the resident
Determine if a causal factor to the condition was the refusal of treatment by the resident and, if so, determine if the facility both counseled the resident about alternatives and the ramifications of refusal and did the facility reevaluate and attempt alternative interventions

Facilities should remain aware that surveyors will also be investigating whether or not the development of the pressure ulcer did or did not trigger a significant change in condition and result in an appropriately changed resident assessment instrument (MDS and new care plan). Regardless of whether or not the pressure ulcer has, in fact, been identified by the facility as a significant change in condition, a care plan addressing the pressure ulcer is necessary. Moreover, just because a facility has identified factors which may classify the resident as being at risk, this does not necessarily indicate the pressure ulcer was unavoidable. If a facility is contending that the development of a pressure ulcer was unavoidable it must not only identify those risk factors present, it must also show that it provided ongoing, consistent preventive care to no avail. If so, then the facility would also be wise to provide an explanation in the clinical record documentation providing and/or describing the justification for categorizing a pressure ulcer as unavoidable. If a facility is to prevent a deficiency citation, these steps are strongly advised.

Investigative Protocol: Hydration

According to the draft State Operations Manual, the objectives of the investigative protocol regarding hydration are to determine if the facility identified those risk factors which lead to dehydration, if the facility developed a care plan to address dehydration, and if the facility provided the resident with adequate fluid intake to maintain proper hydration and health.

This protocol will most obviously be used in those instances when a resident has been "flagged" on the Resident Level Summary report for the sentinel event of dehydration. Additionally, surveyors may also investigate sampled residents for hydration status if one or more quality indicator conditions have been identified on the Summary report. These conditions would include fecal impaction (also a sentinel event), urinary tract infections, weight loss, tube feeding, decline in ADL functioning, and residents who have been observed or discovered to have conditions or risk factors that are not part of quality indicator identification. These conditions or risk factors would include vomiting or diarrhea resulting in fluid loss; elevated temperature; infectious process; dependence upon staff for fluid intake; use of certain medications including diuretics, laxatives, and cardiovascular agents; renal disease; dysphasia; a resident history of fluid refusal; limited fluid intake; or lacking the sensation of thirst.

In conducting the review that comprises this investigative protocol, surveyors will follow a number of investigative procedures. These procedures may include, but not necessarily be limited to:

Determine if the facility has adequately assessed the resident to identify risk factors for dehydration
Determine if the resident’s clinical record reflects laboratory test results indicating possible dehydration
Determine if an interdisciplinary care plan was developed which addressed those identified risk factors and/or clinical conditions
Determine if the care plan addresses the amount of fluid the resident requires and provides appropriate intervention(s) to insure the resident receives the fluid
Determine for those residents receiving tube feedings whether the tube feeding orders include a sufficient amount of free water and whether the tube feeding is being administered in accordance with the physician’s order
Determine via observation whether the care delivery corresponds to those interventions delineated in the resident’s plan of care

Determine the resident’s response to the intervention

Determine if staff provides adequate fluids and fluids in accordance with the care plan

Determine if the type of fluids (i.e., caffeine, alcohol) contribute to rather than resolve dehydration

For residents with dysphasia, determine whether the proper type of fluid was provided

Determine if the resident can reach and serve fluids without assistance or whether staff is required for assistance and that assistance is indicated on and provided in accordance with the plan of care

Determine if the resident’s beverage preferences are provided and if the resident refuses a beverage (including water), are alternate beverages provided and offered and are these factors included in the care plan

Determine if staff is aware of the resident’s fluid needs and whether they encourage the resident to drink

Determine if fluids are provided and offered both during and between meals

Determine how the facility monitors the resident to insure adequate fluid intake and if the fluid intake goals or calculated fluid needs have been met

Review all related information and documentation to insure evidence of identified causes of the problem or the risk factors.
Interview applicable facility staff and health care practitioners who, by their knowledge of the resident and professional training, should know of or be able to provide information about the resident’s condition or causes of the condition
Determine if the care plan is evaluated and revised as necessary according to the response, outcomes, and needs of the resident.

Facilities should note that residents who may be at the end stage of a terminal illness and have an advance directive may have dehydration as an expected outcome. Surveyors, under these circumstances, will review to insure appropriate measures have been taken to encourage fluid intake and observe and review to insure the facility is providing palliative care. While these circumstances may limit the surveyor’s ability to allege a deficiency for dehydration, a facility could face the risk of citation under F-309 (quality of care) if it is not providing such comfort measures and has not included palliative care as part of the resident’s care plan. As with any plan of care, those that indicate palliative care will also be reviewed to insure they are being evaluated and revised as necessary.

In instances where residents have been identified as at risk for dehydration or have been identified with dehydration, facilities will be expected to utilize some formula to determine necessary and adequate daily fluid intake. Facilities should note the State Operations Manual includes such a formula as part of the investigative protocol for dehydration. That formula multiplies the resident’s body weight in kilograms (one kilogram equals 2.2 pounds) by thirty milliliters (weight in kg. X 30ml = fluid need). Unless a facility has adopted another generally accepted formula, the surveyors will apply this formula to facility residents during the survey process. A facility’s registered dietitian should be aware of those formulae available and generally accepted for calculating fluid need. It should also be noted that physicians may not always be aware of these calculations and may order fluids in a lesser amount than the calculations would indicate. In these cases, the physician should be asked to either adjust his order(s) accordingly or provide a written progress note justifying the reason the physician has prescribed less than the calculated amount determined to be the resident’s fluid need.

Investigative Protocol: Unintended Weight Loss

While this investigative protocol is intended to review unintended weight loss, it is curious that the objectives stated in the draft State Operations Manual do not instruct the surveyors to identify if resident weight loss was planned or intended. The stated objectives are for the surveyors to determine if the identified weight loss was avoidable or unavoidable and if the facility’s response to the weight loss was adequate. While the casual reader may initially think this noted discrepancy is not material, facilities should consider the ramifications.

If a resident is placed on a regimen of planned or intended weight loss, the quality indicator found on the Resident Level Summary report cannot differentiate that resident from the resident who has experienced an unintended weight loss. Consequently, that resident who has a planned weight loss could very well be designated as a sample resident during the survey. If so, the facility should make sure its clinical documentation is in place and that it identifies the resident as having the need for the weight loss, gives reasons or justification for planned interventions, provides proper dietary and other clinical assessment information justifying a planned weight loss, includes a care plan with interventions for a planned weight loss, has an evaluative tool in place to monitor the effectiveness of the weight loss program, revises the care plan as necessary and so forth. Without the proper documentation in place, the surveyors will have the latitude to identify that resident as having an unintended weight loss.

In conducting the review that comprises this investigative protocol, the surveyors will use a number of procedures. These procedures will include, but not necessarily be limited to:

Determine if the resident has been assessed to identify those factors or clinical conditions that might place the resident at risk for unintended weight loss. Included among those factors are cancer; renal disease; Parkinson’s disease; Alzheimer’s disease; malnutrition; infection; dehydration; constipation; diarrhea; Body Mass Index (BMI) below 19; dysphasia; other chewing or swallowing problems; dental problems such as ill fitting dentures, missing teeth, or edentulousness; mouth pain; taste or sensory changes; bedfast; dependence for eating; pressure ulcers; abnormal laboratory values; use of certain medications.
Determine if the facility has assessed the resident’s nutritive and fluid requirements, the need for assistance during meals or while eating, the need for assistive devices, food preferences and allergies, and frequency of meals.
Review all documentation and related information to determine the presence of evidence that the facility has identified the causes of weight loss.
Interview applicable facility staff and health care practitioners who should have knowledge of the resident and who, by their level of training, can provide information about the resident’s problem(s) and the causes of same
Determine if the care plan was developed addressing the clinical conditions and risk factors for unintended weight loss.
Determine if aggressive interventions such as oral supplements, enteral feeding, alternative eating schedules, liberalized diet regimens, adaptive equipment, allotting additional time for meals, and so forth have been included in the plan of care
Determine if the delivery of care and services is being provided in accordance with the interventions listed on the care plan and whether the care plan interventions have been implemented
Determine if the plan of care has been reviewed and evaluated for effectiveness based on the response, outcomes, and needs of the resident and revised if necessary

As with the investigative protocol for dehydration which addresses fluid intake, the investigative protocol for unintended weight loss also takes into consideration those residents who are terminal and at the end stage of life. Those residents with advanced directives may not be subject to citation under this investigative protocol for weight loss is an expected outcome. Moreover, if the facility is implementing palliative measures and can document those measures, it may avoid citation for unintended weight loss. Again, if comfort measures are not readily apparent or not documented, evaluated, and revised properly, the facility may face citation under F-309 (quality of care).

In addition to the procedures the surveyors will follow as part of this investigative protocol, the State Operations Manual also includes a formula for determining Body Mass Index. This index estimates total body mass and is theoretically highly correlated with the amount of body fat. By providing information about body composition, it can be an indicator of nutritional status. The BMI may be calculated by:

Dividing the weight in kilograms by the height in meters squared or by

Dividing the weight in pounds by the height in inches squared and then multiplying by 705

Unless a facility wants to defer to this formula, it is wise to have in place an alternative method by which to determine body mass or a similar index which would provide the facility with information regarding the resident’s nutritional status. What the purpose of using the BMI seems to be is to determine the resident’s body composition and thus quantifying body fat. What the BMI does not consider, however, is the quantification of all of the various components of the body which include, in addition to fat, water, protein, and bone mineral. There are accepted alternative methods by which a facility can determine the resident’s percentage of body fat. One simpler way might be to utilize an instrument that determines body fat by measuring skin fold thickness. A facility’s registered dietitian would be most familiar with these alternatives and it is suggested that, considering this investigative protocol, a facility adopt a means by which body fat or specific gravity is determined and include that information as part of any dietary assessment.

Investigative Protocol: Dining and Food Service

The stated objectives in the draft State Operations Manual for the investigative protocol for dining and food service are to determine if each resident is provided with nourishing, palatable, attractive meals that meet daily nutritional and/or special dietary needs; determine if each resident is provided services which allow the resident to maintain or improve eating skills; and determine if the dining experience enhances quality of life, while being supportive of resident need(s) including food service and staff support during dining. Specifically, the surveyors are to apply this protocol to a sampled residents identified with malnutrition, unintended weight loss, mechanically altered diets, pressure ulcers, and hydration concerns. The protocol will also investigate food complaints received from residents, family members, or others.

When conducting this particular protocol, surveyors are required to observe at least two meals during the course of a survey, preferably one noon and one evening meal. Surveyor observations are supposed to be conducted discreetly, with questions held to a minimum so as not to disturb the meal service. For each sampled resident the surveyor is to observe, the needs of that resident are to be identified as well as the interventions planned to meet those needs. The surveyor is also to use the facility menu to record what is planned in writing to be served to each sampled resident to be observed. Obviously, discrepancies which occur between those things in writing (care plan interventions, written menu) and the actual delivery of service expose the facility to the possibility of citation.

This protocol also calls for the surveyors to make general observations of the facility which apply to the dining service and meal time. Surveyors will observe food preparation and the quality of meals, but they will also follow procedures that will include:

Observing the dining room and/or resident’s room at meal time for comfortable sound levels, adequate lighting, adequate and appropriate furnishings, ventilation, absence of odors, sufficient space, and appropriate accommodations for wheelchairs and so forth.
Determine whether each resident has been properly prepared for meal time by observing resident hygiene, the presence of spectacles, dentures, hearing aides if required, proper positioning in the chair an appropriate distance from the table and at the appropriate height, and determine the use of assistive devices as indicated in the plan of care or as needed
General food service observations will further include insuring the use of proper dishes and flatware (disposables are not to be used except in the event of an emergency or a planned special event, i.e., a picnic); determining that each resident has a proper place setting that includes water and a napkin; determining that meals are delivered in a timely fashion (within thirty minutes of the scheduled meal time), were palatable, attractive, and served at the appropriate temperature(s); determine if needed or requested substitutes arrived within 15 minutes of the request; and determine if diet cards, portion sizes, preferences, and condiment requests are honored
Determine whether residents needing assistance are being provided assistance (including necessary cueing) in a timely fashion after the serving of the meal with particular attention to be paid to insuring residents seated together (i.e., at the same table) are receiving needed assistance concurrently
Determine if the meals served were attractive, palatable, nutritious, and met the needs of the resident while also noting whether the resident has voiced concerns about taste, temperature, quality, quantity, or appearance; whether mechanically altered items were prepared and served as separate entrees; whether attempts were made to determine the reason for a resident’s refusal of food and, if refused, was a equally nutritious substitute provided; and whether the placement, color, and texture of the food all were in keeping with the resident’s needs or deficits (i.e., vision, swallowing)
If concerns are noted by the surveyors which involve the meal service, meal preparation, and quality, the surveyors are to conduct interviews with the staff responsible for dietary services to determine how staff are assigned to insure proper meal service (i.e., as per menus, timeliness, temperature, service in the dining room, resident room or other locale)

There are two additional procedures the surveyors are to follow as part of the investigative protocol for dining and food service. Because these two procedures are likely to be quite controversial, they will be discussed individually and apart from the above listing.

The first of these procedures is the observation to be conducted by the surveyors to determine the presence or absence of "institutionalized practices" during the meal time. The focal point of this observation is the routine med pass which occurs in the dining room during meal time and with med carts present. If the facility chooses to conduct routine medication administration at meal times it must be able to show the survey team that it has made attempts to provide medications at times and in a manner to better support the dining experience of the resident. It is anticipated the facility’s ability to justify scheduling a med pass at meal times will be most difficult.

Additionally, the facility must also verify to the surveyors it has attempted to and does pass meds at a time(s) other than meal time in order to enhance the dining experience. Applicable examples that will be investigated to verify these facility efforts will include the administration of pain medication prior to meal time so the meal may be enjoyed in maximum comfort and that foods served at meals are not routinely used as a vehicle by which to pass meds (i.e., mixing the med in mashed potatoes).

While the routine passing of medications at meal time will be discouraged and could likely be subject to deficiency citation, this investigative protocol does not strictly prohibit passing meds at meal time. Exceptions to such a prohibition would include those meds ordered by the physician to be administered at meals, those meds which have manufacturer’s specifications instructing they be administered with food or at meals, and meds administered with small portions of food in order to facilitate swallowing. With each exception, the resident’s plan of care should specify the intervention and assessment information should be present in the clinical record (if necessary) justifying the intervention. For example, if a medication is given with a small amount of food to facilitate swallowing, there should be present in the clinical record an applicable swallowing evaluation and accompanying physician order regarding this intervention.

The second procedure that will likely be subject to controversy is the requirement that the surveyor determine if sampled residents are receiving and consuming adequate amounts of food as may be planned for that resident. The surveyor is to determine whether the facility is adequately and appropriately monitoring those foods and fluids which are consumed.