Nursing Home Quality Standards

Transcription

1 Nursing Home Quality Standards A Primer for Managed Care Organizations By Richard J. Mollot The Long Term Care Community Coalition One Penn Plaza, Suite 6252, New York, NY Funding for this report was provided by The Robert Sterling Clark Foundation The Long Term Care Community Coalition

2 2 Nursing Home Quality Standards: A Primer for Managed Care Organizations Important Note: How to Use This Report This report provides general and specific information on the law and regulatory standards relating to nursing home quality. All of the standards discussed in the report are listed in the Table of Contents, below, with a brief descriptive title. The Table of Contents has imbedded links, to assist in quickly locating the provision of interest. Thus, it is highly recommended to use this report as a resource in electronic form. Table of Contents Why Does Nursing Home Quality Matter?... 4 How to Assess Nursing Home Quality Using Nursing Home Compare... 4 The 5-Star Rating System...5 Digging Deeper...5 Digging (Even) Deeper Collecting & Analyzing Historical Performance Data...5 A Note on the Accuracy of Nursing Home Compare Data...6 Other Resources to Assess a Nursing Home s Quality...7 Summary of Federal Law... 7 Government Regulation & Oversight... 8 Transparency...8 Enforcement Organization...8 Enforcement Implementation...8 Selected Standards Relevant to Quality Care F-151 General Residents Rights CFR F-154 Right to be Fully Informed - 42 CFR (b)(3) and (d)(2) F-155 Right to Refuse: Formulate Advance Directives CFR (b)(4) F-163 Right to Choose a Personal Attending Physician CFR (d)(1) F-164 Personal Privacy CFR (e) F-172 Right to/facility Provision of Visitor Access CFR (j)(1)&(2) F-201 Reasons for Transfer/Discharge of Resident CFR (a)(2) F-222 Right To Be Free From Chemical Restraints - 42 CFR (a) F Free From Abuse/Involuntary Seclusion CFR (b) F-225 Investigate & Report Allegations of Mistreatment, Neglect or Abuse CFR (c) F-240 Facility Promotes/Enhances Quality of Life - 42 CFR F-241 Dignity - 42 CFR (a) F-242 Self-Determination-Right to Make Personal Choices CFR (b) F-246 Reasonable Accommodation of Needs/Preferences CFR (e) F-248 Activity Program Meets Individual Needs - 42 CFR (f)(1) F-250 Medically Related Social Services - 42 CFR (g) F-252 Safe/Clean/Comfortable/Homelike Environment CFR (h)(1) F-272 Resident Assessment 42 CFR and 42 CFR (b)(1) F-279 Develop Comprehensive Care Plans CFR (d), (k)(1) F-280 Resident Participation in Development of Comprehensive Care Plan 42 CFR (d)(3) and 42 CFR (k)(2)... 24

3 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 3 F-281 Services Provided Meet Professional Standards of Quality CFR (k)(3)(i) F-282 Care Provided by Qualified Persons in Accordance with Plan of Care 42 CFR (k)(3)(ii) F-309 Necessary Care for Highest Practicable Well Being - 42 CFR F-310 ADLs Do Not Decline Unless Unavoidable CFR (a)(1) F-311 Treatment/Services to Improve/Maintain ADLs CFR (a)(2) F-312 ADL Care for Dependent Residents CFR (a)(3) F-314 Treatment/Services to Prevent/Heal Pressure Sores CFR (c) F-315 No Catheter, Prevent UTI, Restore Bladder CFR (d) F-317 No Reduction in Range of Motion Unless Unavoidable - CFR (e) F-318 Treatment for Range of Motion Problems - CFR (e) F-319 Mental/Psychosocial Treatment 42 CFR (f)(1) F-320 No Development of Mental Problems 42 CFR (f)(2) F-325 Maintain Nutrition Status Unless Unavoidable CFR (i) F-329 Free from Unnecessary Drugs - 42 CFR (l) F-332 Facility Free of Medication Errors of 5% or Greater CFR (m)(1) F-333 Residents Free of Significant Med Errors CFR (m)(2) F-353 Sufficient 24-Hr Nursing Staff Per Care Plans CFR (a) F-364 Food CFR (d)(1)-(2) F-385 Residents Care Supervised by Physician 42 CFR (a)(1, 2) F-411 Routine/Emergency Dental Services CFR (a) F-428 Drug Regimen Reviewed Monthly 42 CFR (c)(1) F-490 Facility Administered Effectively 42 CFR F-498 Proficiency of Nurse Aides 42 CFR (f) F-501 Responsibilities of Medical Director 42 CFR (i)(1, 2)(i, ii) F-514 Clinical Records Meet Professional Standards 42 CFR (l) F-520 Quality Assessment and Assurance 42 CFR (o)(1) and (o)(2) Appendix I: F-tag List Appendix II: Scope & Severity Grid Appendix III: CMS Summary of Certification & Compliance for Nursing Homes Appendix IV: Useful Terms, Acronyms & Internet Resources National & General Resources New York State Resources Additional Terms... 44

4 4 Nursing Home Quality Standards: A Primer for Managed Care Organizations Why Does Nursing Home Quality Matter? There are three principal reasons why nursing home quality is important to Managed Care Organizations (MCOs): 1. Good care and treatment with dignity is valuable to your members and to their families. Simply put, it makes for a happy customer and helps sustain and build an MCO s reputation among consumers and in the community. 2. Good care makes good financial sense, especially for MCOs that are responsible for all of the costs incurred in a member s care including paying for the costs resulting from poor care. In addition to the indirect financial benefits of providing good and reputable nursing home services, good nursing home care saves money. For instance, good quality nursing home care reduces re-hospitalizations (which are costly in and of themselves and may have additional financial repercussions, such as on eligibility for government quality incentive programs) As detailed in the following sections, good care meaning care that is centered on the needs and preferences of the individual residents, and which helps each resident attain and maintain his or her highest practicable physical, emotional and social well-being is required by federal law. Providers that provide Medicaid/Medicare services agree to meet or exceed these standards. Failure to do this leaves providers vulnerable to penalties, prosecution for fraud or for the provision of worthless services and civil lawsuits by residents (or their families) who have suffered due to poor or inadequate care. How to Assess Nursing Home Quality Using Nursing Home Compare While it is not perfect, Nursing Home Compare (NHC), is by far the most reliable and complete resource for information on a nursing home. NHC provides a searchable database for all licensed facilities in the country. It includes the results of the most recent inspection reports, as well as self-reported information on staffing levels and a facility s performance on a range of quality measures. It also includes ownership information, including type of ownership (for profit, not for profit and government). 2 One can search for facilities by state, city or name and compare up to three nursing homes at the same time. 1 Thomas, K., Rahman, M., Mor., V. and Intrator, O., Am J Manag Care. 2014;20(11):e523-e531, Influence of Hospital and Nursing Home Quality on Hospital Readmissions (February 2015). Accessed at Hospital-and-Nursing-Home-Quality-on-Hospital-Readmissions. This study found that [p]atients discharged from higher-quality hospitals (as indicated by higher scores on their accountability process measures and high nurse staffing levels) and patients who received care in higher-quality NHs (as indicated by high nurse staffing levels and lower deficiency scores) were less likely to be rehospitalized within 30 days. 2 Staffing and quality measure data are self-reported and unaudited as of April 2015, though CMS has begun developing and implementing processes to improve the accuracy of these data.

5 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 5 The 5-Star Rating System The 5-Star Rating System in NHC is an important tool for assessing a nursing home. Facilities are assigned a star rating in each of three categories: (1) Health Inspections: Based on the facility s inspection results; (2) Staffing: Based on licensed nurses (RNs, LPNs and LVNs) and nurse aides (CNAs); and (3) Quality Measures: Based on data on residents needs and the provision of services to meet those needs. 3 Based on its scores in these three categories, facilities also receive an overall star rating. In all categories, more stars are better. Three stars are average. To assess a nursing home, it is useful to first look at the star rating to identify whether a facility is at the lower or upper end. Consumers, particularly those in more populace areas, may have a number of facilities in their area, or in the area in which they would like to receive nursing home care (for instance, in a community close to family). In addition to geographic limitations, individuals may face significant limitations based on the numbers of facilities with which their Managed Care Organization contracts. We recommend that consumers choose from the highest rated facilities possible (based on these or other limitations) those which they are interested in exploring further online and/or in person. Wherever possible, we recommend avoiding a facility with less than three stars. Digging Deeper NHC provides significantly more information on nursing homes than just star ratings. Each listing for a nursing home provides the results of the most recent inspections, including a downloadable copy of Statements of Deficiencies (SoDs, the records of inspection results). NHC allows the reader to easily compare a facility s staffing rates, citation rates and performance on quality measures with state and national averages. For consumers, and those who work with them, we recommend using this information to determine which facilities they wish to visit (to make critical in-person assessments) and to formulate questions to ask when visiting a facility. For example, if a facility looks good but has a high pressure ulcer or antipsychotic drugging rate, one can ask why that is the case. Digging (Even) Deeper Collecting & Analyzing Historical Performance Data There are times when it is useful, especially for MCOs, to gain further insights into how one (or more) facility compares on different criteria. NHC also has a database that can be accessed directly at The database is easy to access and useful for collecting and assessing data on nursing home performance over the last three years. The data include: 3 See the section below, A Note on the Accuracy of Nursing Home Compare Data, for important information about the accuracy of these data.

6 6 Nursing Home Quality Standards: A Primer for Managed Care Organizations (1) Deficiencies ( A list of all deficiencies currently listed on Nursing Home Compare, including the nursing home that received the deficiency, the associated inspection date, deficiency tag number, scope and severity, the current status of the deficiency and the correction date. ); (2) Penalties ( The total dollar amount of fines, the number of fines, and the number of payment denials for each nursing home. ) Note: CMS and the states can and do impose other penalties against nursing homes besides fines and payment denials. However, CMS does not (as of April 2015) post them on its website. These data are available from CMS via FOIA request.; (3) Quality Measures ( A list of the quality measure scores currently displayed on Nursing Home Compare for each nursing home. Each row contains a specific quality measure for a specific nursing home and includes the three-quarter score average and the score for each individual quarter. ); (4) Staffing ( Staffing ratings and reported, expected, and adjusted staffing values. ); and (5) Star Ratings ( Overall, Health Inspection, Staffing, and Quality Measure Ratings for all active providers. ) A Note on the Accuracy of Nursing Home Compare Data While NHC is by far the most useful and accurate resource for assessing a nursing home and comparing its quality of care against that of other facilities, there are a number of significant issues about which it is important to be aware. These include: (1) Under-Identification of Nursing Home Deficiencies: Numerous studies, including several by LTCCC over the years, have indicated that state surveyors often fail to identify substandard nursing home care, including serious abuse and neglect. In addition, those deficiencies that are identified are often under-rated in terms of the scope of the problem (number of residents effected) and its severity (degree to which residents have been harmed). As a 2007 study found, nursing home rating systems are generally better at identifying poor performers than they are at identifying superior ones. 4 (2) Self-Reported Staffing Data: The staffing information posted on NHC is entirely selfreported and unaudited for accuracy by either CMS or the State Agencies. As a result, it is widely considered to be, generally speaking, inflated by facilities and not reflective of typical, day-to-day staffing patterns. In February 2015 CMS announced that it would be developing a system to address this problem by collecting and publish auditable, payroll-based staffing data. (3) Self-Reported Quality Measures: Like the staffing data, nursing home quality measure data are self-reported and unaudited. As a result, they are also widely considered to be inflated by nursing homes. In October 2014 CMS announced that it will be implementing improvements to these data, including the addition (beginning in 2015) of antipsychotic drugging rates to the Quality Measure star rating and that it had been piloting special surveys of nursing homes that 4 Phillips, C, Hawes, C, Lieberman, T and Koren, M, Where should Momma go? Current nursing home performance measurement strategies and a less ambitious approach, BMC Health Services Research 2007, 7:93. This article is available at

7 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 7 focused on investigating the coding of the Minimum Data Set (MDS), which are based on resident assessments and are used in the quality measures. 5 (4) Redacted Statements of Deficiencies: Though not a failure in accuracy, per se, it is important to note that the Statements of Deficiencies are heavily redacted before they are posted on NHC. As a result, many of them are rendered virtually useless, since it is often impossible to learn any relevant details surrounding a deficiency due to zealous removal of vital information, such as identification of diagnoses and names of drugs used or misused to treat residents conditions. Other Resources to Assess a Nursing Home s Quality ProPublica Nursing Home Inspect This web-based tool enables users to compare nursing homes in a state based on the deficiencies cited by regulators and the penalties imposed in the past three years. One can also search over 60,000 nursing home Statements of Deficiencies to look for trends or patterns. Unlike NHC, the Statements of Deficiencies on the ProPublica website are not redacted. State Nursing Home Websites & Contact Information CMS website page with each state s website and contact information. It is critical to note that the state websites vary greatly in their quality. NYS Nursing Home Profile NY State website with information on all nursing homes in the state. Quality data are the same as those reported on Nursing Home Compare, though the format of information provided is somewhat different. The NYS website utilizes an independent and more extensive star rating system. Most importantly, it posts Statements of Deficiencies that have not been redacted. Summary of Federal Law All nursing homes that contract to provide Medicaid and/or Medicare services are required to meet federal standards of care for all of the patients in their facilities (whether or not the individual is a beneficiary of one of those programs). These standards were promulgated in the 1987 Omnibus Budget Reconciliation Act (aka OBRA 87 ), which contains the Nursing Home Reform Law. 6 The Reform Law requires skilled nursing facilities receiving federal funding to conform to specific standards of care, including the requirement that nursing staff help residents attain or maintain their highest practicable physical, mental, and psychosocial wellbeing as individuals. The emphasis on individualized, patient-centered care was intended to reduce widespread problems in long term care facilities, including abuse and neglect, and 5 CMS Announces Two Medicare Quality Improvement Initiatives (press release) (October 2014). Available at 6 Nursing Home Reform Law, 42 U.S.C. 1395i-3(a)-(h), 1396r(a)-(h) (Medicare and Medicaid, respectively) (December 1987). The Reform Law s text is available at:

8 8 Nursing Home Quality Standards: A Primer for Managed Care Organizations improve quality of life. Unfortunately, many of the reforms have not been fully implemented and, as a result, nursing homes are often poor places to live. For example, the widespread inappropriate use of antipsychotics in nursing homes (which has received considerable news media, public and government attention in recent years) is, in many ways, emblematic of weaknesses in implementation of the Reform Law, such as in its standards regarding freedom from unnecessary drugging; freedom from chemical restraints; and rights to be informed about, participate in and refuse treatment. Government Regulation & Oversight Transparency Nursing Home Compare, 7 part of the medicare.gov website, contains information about every Medicaid and Medicare-certified nursing home in the United States. The public can view information about individual facilities such as the facility s staffing levels (self-reported, as of April 2015), measures that indicate a facility s qualities in certain categories (also self-reported), the dates and results of recent inspections, and the level and frequency of penalties against a specific facility. The public can also compare these statistics against statewide and national averages. [See above chapter, How to Assess Nursing Home Quality, for more on how to use the website, as well as its strengths and weaknesses.] Enforcement Organization The State Survey Agencies (often referred to as the SAs) contract with the federal government to monitor and oversee care in nursing homes and respond to complaints about care. In New York State, the Department of Health (DOH) is the SA. State agencies are required to operate in accordance with the CMS State Operations Manual (SOM) and also receive periodic updates from CMS on how to improve identification of nursing home care and quality issues. They are expected to conduct a survey of each facility approximately annually and respond in a timely and efficacious manner to complaints about quality of care. Enforcement Implementation CMS provides state and federal nursing home surveyors with a system to help them identify relevant criteria for evaluating whether a nursing home is meeting quality of care, quality of life, safety and other standards. Based on the law and regulations, this system is comprised of F-Tags (data tags used to identify specific federal nursing home regulations) and guidance to help surveyors understand the regulatory requirements and how to evaluate for compliance with them. F-Tags are cited in the Statements of Deficiencies (SODs, also known as Form 2567) that are the written record of a surveyor s findings when a facility fails to comply with one or more standards. The SODs for every nursing home are now posted on Nursing Home Compare (as 7 Nursing Home Compare website available at:

9 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 9 noted above, under Transparency ) and on many of the state nursing home websites (including New York s, at Following are the regulatory standards which we have identified as being particularly relevant to quality of care. For each standard we have included the corresponding F-tag, brief descriptive title and citation in the Code of Federal Regulations (CFR). This is followed by the relevant text from the code and explanatory information.

10 10 Nursing Home Quality Standards: A Primer for Managed Care Organizations Selected Standards Relevant to Quality Care 8 Editor s Notes: The heading for each standard includes the relevant F-tag, a descriptive title and the applicable section of the federal code (CFR). A short discussion is provided for each section, including: (1) Bulleted text with excerpts of language from the code; (2) A brief narrative description; (3) Excerpts from CMS Interpretive Guidelines; and/or (3) Illustrative examples. The F-tag is important because it is how problems are signified on the Statements of Deficiencies (SoDs) for each nursing home. These SoDs are posted at (for NY State nursing homes) and Thus, the F-tags can be used as a way to find out about deficiencies that have been identified in the past for a given facility. All excerpts from the Interpretive Guidelines are from the State Operations Manual, Appendix PP - Guidance to Surveyors for Long Term Care Facilities (Rev. 107, ), available at F-151 General Residents Rights CFR The resident has a right to a dignified existence, self-determination, and communication with and access to persons and services inside and outside the facility. A facility must protect and promote the rights of each resident, including each of the following rights: Exercise of rights. (1) The resident has the right to exercise his or her rights as a resident of the facility and as a citizen or resident of the United States. (2) The resident has the right to be free of interference, coercion, discrimination, and reprisal from the facility in exercising his or her rights. (3) In the case of a resident adjudged incompetent under the laws of a State by a court of competent jurisdiction, the rights of the resident are exercised by the person appointed under State law to act on the resident's behalf. (4) In the case of a resident who has not been adjudged incompetent by the State court, any legal-surrogate designated in accordance with State law may exercise the resident's rights to the extent provided by State law. (d) Free choice. The resident has the right to o Choose a personal attending physician; 8 For the CMS guidance for all of the F-Tags, see State Operations Manual, Appendix PP Guidance to Surveyors for Long Term Care Facilities (Hereinafter CMS Guidance ). Available at: Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf.

11 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 11 o Be fully informed in advance about care and treatment and of any changes in that care or treatment that may affect the resident's well-being; and o Unless adjudged incompetent or otherwise found to be incapacitated under the laws of the State, participate in planning care and treatment or changes in care and treatment. (e) Privacy and confidentiality. The resident has the right to personal privacy and confidentiality of his or her personal and clinical records. Personal privacy includes accommodations, medical treatment, written and telephone communications, personal care, visits, and meetings of family and resident groups. This section includes detailed information on a range of resident rights and how those rights are to be implemented through the provision of notice to the resident and other required policies and procedures. The excerpts above provide the major components in the CFR relating to quality of life and care. Many of the F-tags below also relate to resident rights provisions of the CFR. F-154 Right to be Fully Informed - 42 CFR (b)(3) and (d)(2) (b)(3): The resident has the right to be fully informed in language that he or she can understand of his or her total health status, including, but not limited to, his or her medical condition. (d)(2):the resident has the right to be fully informed in advance about care and treatment and of any changes in that care or treatment that may affect the resident s well-being. A resident is fully informed when he or she receives information, in a manner he or she can understand, on (1) the benefits and reasonable risks of treatment, (2) potential changes to his or her medical condition, and (3) information about reasonably available alternatives. Note: Being appropriately informed, and in particular having the opportunity to provide informed consent, is increasingly seen as a critical component of good and appropriate care. For example, it has been a significant focus in efforts to improve dementia care and reduce antipsychotic drugging. Facility policies should include processes for providing informed consent and residents records should reflect implementation of these policies. F-155 Right to Refuse: Formulate Advance Directives CFR (b)(4) The resident has the right to refuse treatment, to refuse to participate in experimental research, and to formulate an advance directive. Importantly, just like citizens who do not reside in a facility, nursing home residents have the right to refuse treatment even if doing so is detrimental (or perceived as detrimental by their caregivers).

12 12 Nursing Home Quality Standards: A Primer for Managed Care Organizations F-163 Right to Choose a Personal Attending Physician CFR (d)(1) Residents have free choice in choosing their physician but are not required to do so. In addition, the CMS Interpretive Guidelines state: If a physician of the resident s choosing fails to fulfill a given requirement, such as (l)(1), Unnecessary drugs; (l)(2), Antipsychotic drugs; or , frequency of physician visits, the facility will have the right, after informing the resident, to seek alternate physician participation to assure provision of appropriate and adequate care and treatment. A facility may not place barriers in the way of residents choosing their own physicians. For example, if a resident does not have a physician, or if the resident s physician becomes unable or unwilling to continue providing care to the resident, the facility must assist the resident in exercising his or her choice in finding another physician. F-164 Personal Privacy CFR (e) The resident has the right to personal privacy and confidentiality of his or her personal and clinical records. (1) Personal privacy includes accommodations, medical treatment, written and telephone communications, personal care, visits, and meetings of family and resident groups, but this does not require the facility to provide a private room for each resident; (2) Except [when required by law or a resident is transferred to a different facility], the resident may approve or refuse the release of personal and clinical records to any individual outside the facility. The Interpretive Guidelines state: Facility staff must examine and treat residents in a manner that maintains the privacy of their bodies. A resident must be granted privacy when going to the bathroom and in other activities of personal hygiene. If an individual requires assistance, authorized staff should respect the individual s need for privacy. Only authorized staff directly involved in treatment should be present when treatments are given. People not involved in the care of the individual should not be present without the individual s consent while he/she is being examined or treated. Staff should pull privacy curtains, close doors, or otherwise remove residents from public view and provide clothing or draping to prevent unnecessary exposure of body parts during the provision of personal care and services. F-172 Right to/facility Provision of Visitor Access CFR (j)(1)&(2) Residents have numerous access and visitation rights, including to their physician, family, LTC Ombudsmen and any entity or individual that provides health, social, legal, or other services to the resident. Importantly, these rights pertain to the resident, and she or he can withdraw such consent at any time (including in regard to family members).

13 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 13 F-201 Reasons for Transfer/Discharge of Resident CFR (a)(2) The facility must permit each resident to remain in the facility, and not transfer or discharge the resident from the facility unless-- o The transfer or discharge is necessary for the resident s welfare and the resident s needs cannot be met in the facility; o The transfer or discharge is appropriate because the resident s health has improved sufficiently so the resident no longer needs the services provided by the facility; o The safety of individuals in the facility is endangered; o The health of individuals in the facility would otherwise be endangered. The Interpretive Guidelines state: If transfer is due to a significant change in the resident s condition, but not an emergency requiring an immediate transfer, then prior to any action, the facility must conduct the appropriate assessment to determine if a new care plan would allow the facility to meet the resident s needs. Conversion from a private pay rate to payment at the Medicaid rate does not constitute non-payment. Refusal of treatment would not constitute grounds for transfer, unless the facility is unable to meet the needs of the resident or protect the health and safety of others. Documentation of the transfer/discharge may be completed by a physician extender unless prohibited by State law or facility policy. F-222 Right To Be Free From Chemical Restraints - 42 CFR (a) Resident has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat medical symptoms. A facility may be in violation of F-222 if an antipsychotic or other drug is administered and not required to treat medical symptoms. While in practice this most often is done to make care of behaviors associated with dementia easier for the caregivers, it is important to note that the prohibition exists whether or not the antipsychotic is given for convenience or disciplinary purposes. 9 Conversely, even if the antipsychotic is required to treat a particular medical symptom, pursuant to F-222 the drug should not be administered for convenience or 9 CMS, in its May 24, 2013 Survey & Certification memo, specifically noted that if a survey team identifies a concern that an antipsychotic medication may potentially be administered for discipline, convenience and not being used to treat a medical symptom, the survey team should review F222.

14 14 Nursing Home Quality Standards: A Primer for Managed Care Organizations disciplinary purposes. F-222 is deliberately broad in this sense. Facilities sometimes rely on antipsychotic drugs as a means of treating residents deemed to be difficult or uncooperative. For example, if a resident is behaving in a manner that the facility determines is difficult to treat, a staff member could claim that the resident is exhibiting a behavioral problem and administer an antipsychotic drug to sedate the resident. This treatment may be easier for the staff member but it is not necessarily therapeutic for the resident; masking behavioral symptoms of dementia is not an appropriate substitute for care that responds to a resident s needs. 10 F Free From Abuse/Involuntary Seclusion CFR (b) As noted in the Intent description of the State Operations Manual, Each resident has the right to be free from abuse, corporal punishment, and involuntary seclusion. Residents must not be subjected to abuse by anyone, including, but not limited to, facility staff, other residents, consultants or volunteers, staff of other agencies serving the resident, family members or legal guardians, friends, or other individuals. The Interpretive Guidelines state: Abuse means the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish. (42 CFR ) This also includes the deprivation by an individual, including a caretaker, of goods or services that are necessary to attain or maintain physical, mental, and psychosocial well-being. This presumes that instances of abuse of all residents, even those in a coma, cause physical harm, or pain or mental anguish. Verbal abuse is defined as the use of oral, written or gestured language that willfully includes disparaging and derogatory terms to residents or their families, or within their hearing distance, regardless of their age, ability to comprehend, or disability. Examples of verbal abuse include, but are not limited to: threats of harm; saying things to frighten a resident, such as telling a resident that he/she will never be able to see his/her family again. Sexual abuse includes, but is not limited to, sexual harassment, sexual coercion, or sexual assault. Physical abuse includes hitting, slapping, pinching and kicking. It also includes controlling behavior through corporal punishment. Mental abuse includes, but is not limited to, humiliation, harassment, threats of punishment or deprivation. Involuntary seclusion is defined as separation of a resident from other residents or from her/his room or confinement to her/his room (with or without 10 California Advocates for Nursing Home Reform, No Surprises: Chemical Restraints Sedate and Subdue the Elderly with Dementia (January 3, 2012). Available at:

15 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 15 roommates) against the resident s will, or the will of the resident s legal representative. Emergency or short term monitored separation from other Residents will not be considered involuntary seclusion and may be permitted if used for a limited period of time as a therapeutic intervention to reduce agitation until professional staff can develop a plan of care to meet the resident s needs. [Emphases added.] F-225 Investigate & Report Allegations of Mistreatment, Neglect or Abuse CFR (c) (c)(2) The facility must ensure that all alleged violations involving mistreatment, neglect, or abuse, including injuries of unknown source and misappropriation of resident property are reported immediately to the administrator of the facility and to other officials in accordance with State law through established procedures (including to the State survey and certification agency) (c)(3) The facility must have evidence that all alleged violations are thoroughly investigated, and must prevent further potential abuse while the investigation is in progress (c)(4) The results of all investigations must be reported to the administrator or his designated representative and to other officials in accordance with State law (including to the State survey and certification agency) within 5 working days of the incident, and if the alleged violation is verified appropriate corrective action must be taken. The Interpretive Guidelines state: The facility s reporting requirements under (c)(2) and (4) include reporting both alleged violations and the results of investigations to the State survey agency. Injuries of unknown source An injury should be classified as an injury of unknown source when both of the following conditions are met: The source of the injury was not observed by any person or the source of the injury could not be explained by the resident; and The injury is suspicious because of the extent of the injury or the location of the injury (e.g., the injury is located in an area not generally vulnerable to trauma) or the number of injuries observed at one particular point in time or the incidence of injuries over time. Immediately means as soon as possible, but ought not exceed 24 hours after discovery of the incident, in the absence of a shorter State time frame requirement. Conformance with this definition requires that each State has a means to collect reports, even on off-duty hours (e.g., answering machine, voice mail, fax).

16 16 Nursing Home Quality Standards: A Primer for Managed Care Organizations As detailed in the CFR and guidelines, nursing homes have specific standards with which they are required to comply to (1) ensure that residents are safe and free from abuse and neglect and (2) investigate and report any instances or suspicion of abuse, neglect or mistreatment. In addition to these requirements, the 2010 federal Affordable Care Act established important requirements for the reporting of suspicion of a crime against a nursing home resident. 11 F-240 Facility Promotes/Enhances Quality of Life - 42 CFR A facility must care for its residents in a manner and in an environment that promotes maintenance or enhancement of each resident s quality of life. The Interpretive Guidelines state: The intention of the quality of life requirements is to specify the facility s responsibilities toward creating and sustaining an environment that humanizes and individualizes each resident. [Emphasis added.] F-241 Dignity - 42 CFR (a) Facility must promote care for residents in a manner that maintains or enhances each resident s dignity and respect in full recognition of his/her individuality. The Interpretive Guidelines state: Dignity means that in their interactions with residents, staff carries out activities that assist the resident to maintain and enhance his/her self-esteem and self-worth. Some examples include (but are not limited to): Grooming residents as they wish to be groomed (e.g., hair combed and styled, beards shaved/trimmed, nails clean and clipped); Encouraging and assisting residents to dress in their own clothes appropriate to the time of day and individual preferences rather than hospital-type gowns; Assisting residents to attend activities of their own choosing; Labeling each resident s clothing in a way that respects his or her dignity (e.g., placing labeling on the inside of shoes and clothing); Promoting resident independence and dignity in dining such as avoidance of: o Day-to-day use of plastic cutlery and paper/plastic dishware; o Bibs (also known as clothing protectors) instead of napkins (except by resident choice); o Staff standing over residents while assisting them to eat; 11 For more information, see LTCCC s synopsis of the Affordable Care Act requirements at Oct2012.pdf or the CMS Letter to State Survey Agency Directors, Reporting Reasonable Suspicion of a Crime in a Long-Term Care (LTC) Facility: Section 1150B of the Social Security Act (June 17, 2011), available at

17 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 17 o Staff interacting/conversing only with each other rather than with residents. while assisting residents; Respecting residents private space and property (e.g., not changing radio or television station without resident s permission, knocking on doors and requesting permission to enter, closing doors as requested by the resident, not moving or inspecting resident s personal possessions without permission); Respecting residents by speaking respectfully, addressing the resident with a name of the resident s choice, avoiding use of labels for residents such as feeders, not excluding residents from conversations or discussing residents in community settings in which others can overhear private information; Focusing on residents as individuals when they talk to them and addressing residents as individuals when providing care and services; Maintaining an environment in which there are no signs posted in residents rooms or in staff work areas able to be seen by other residents and/or visitors that include confidential clinical or personal information (such as information about incontinence, cognitive status). It is allowable to post signs with this type of information in more private locations such as the inside of a closet or in staff locations that are not viewable by the public. An exception can be made in an individual case if a resident or responsible family member insists on the posting of care information at the bedside (e.g., do not take blood pressure in right arm). This does not prohibit the display of resident names on their doors nor does it prohibit display of resident memorabilia and/or biographical information in or outside their rooms with their consent or the consent of the responsible party if the resident is unable to give consent. (This restriction does not include the CDC isolation precaution transmission-based signage for reasons of public health protection, as long as the sign does not reveal the type of infection); Maintaining resident privacy of body including keeping residents sufficiently covered, such as with a robe, while being taken to areas outside their room, such as the bathing area (one method of ensuring resident privacy and dignity is to transport residents while they are dressed and assist them to dress and undress in the bathing room). Refraining from practices demeaning to residents such as keeping urinary catheter bags uncovered, refusing to comply with a resident s request for toileting assistance during meal times, and restricting residents from use of common areas open to the general public such as lobbies and restrooms, unless they are on transmission-based isolation precautions or are restricted according to their care planned needs. An exception can be made for certain restrooms that are not equipped with call cords for safety. [Emphases added.]

18 18 Nursing Home Quality Standards: A Primer for Managed Care Organizations Dignity is a critical issue for nursing home residents, one which is both important in itself and also significantly affects a resident s physical and mental health. To aid in understanding and identifying dignity issues, following are some relevant excerpts from the survey procedure section of the State Operations Manual. Throughout the survey, observe: Do staff show respect for residents? When staff interact with a resident, do staff pay attention to the resident as an individual? Do staff respond in a timely manner to the resident s requests for assistance? Do they explain to the resident what care they are doing or where they are taking the resident? Do staff groom residents as they wish to be groomed? In group activities, do staff members focus attention on the group of residents? Or, do staff members appear distracted when they interact with residents? For example, do they continue to talk with each other while doing a task for a resident(s) as if the resident were not present? Are residents restricted from using common areas open to the public such as the lobby or common area restrooms? Are there signs regarding care information posted in view in residents rooms? If these are observed, determine if such signs are there by resident or family direction. If so, these signs are allowable. If a particular resident has been restricted from common areas by the care team, confer with staff to determine the reason for the restriction. Do staff members communicate personal information about residents in a way that protects the confidentiality of the information and the dignity of residents? This includes both verbal and written communications such as signage in resident rooms and lists of residents with certain conditions such as incontinence and pressure ulcers (or verbal staff reports of these confidential matters) at nursing stations in view or in hearing of residents and visitors. This does not include clinical information written in a resident s record. Determine if staff members respond in a dignified manner to residents with cognitive impairments, such as not contradicting what residents are saying, and addressing what residents are trying to express (the agenda) behind their behavior. For example, a resident with dementia may be attempting to exit the building in the afternoon, but the actual intent is a desire to meet her children at the school bus, as she did when a young mother. Allowing the behavior under supervision such as walking with the resident without challenging or disputing the resident s intent and conversing with the resident about the desire (tell me about your children) may assist the behavior to dissipate, and the staff member can then invite the resident to come along to have a drink or snack or participate in a task or activity. For more information about agenda behavior, see Rader, J., Tornquist, E, Individualized Dementia Care: Creative, Compassionate Approaches, 1995, New York: Springer Publishing Company, or Fazio, S. Seman, D., Stansell, J., Rethinking Alzheimer's Care. Baltimore: Health Professions Press, 1999.

19 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 19 F-242 Self-Determination-Right to Make Personal Choices CFR (b) The resident has the right to-- o Choose activities, schedules, and health care consistent with his or her interests, assessments, and plans of care; o Interact with members of the community both inside and outside the facility; and o Make choices about aspects of his or her life in the facility that are significant to the resident. According to the intent statement in the State Operations Manual, nursing homes must create an environment that is respectful of the right of each resident to exercise his or her autonomy regarding what the resident considers to be important facets of his or her life. This includes actively seeking information from the resident regarding significant interests and preferences in order to provide necessary assistance to help residents fulfill their choices over aspects of their lives in the facility. The Interpretive Guidelines state: Many types of choices are mentioned in this regulatory requirement. The first of these is choice over activities. It is an important right for a resident to have choices to participate in preferred activities, whether they are part of the formal activities program or self-directed. The second listed choice is schedules. Residents have the right to have a choice over their schedules, consistent with their interests, assessments and plans of care. Choice over schedules includes (but is not limited to) choices over the schedules that are important to the resident, such as daily waking, eating, bathing, and the time for going to bed at night. Residents have the right to choose health care schedules consistent with their interests and preferences, and the facility should gather this information in order to be proactive in assisting residents to fulfill their choices. For example, if a resident mentions that her therapy is scheduled at the time of her favorite television program, the facility should accommodate the resident to the extent that it can. If the resident refuses a bath because he or she prefers a shower or a different bathing method such as in-bed bathing, prefers it at a different time of day or on a different day, does not feel well that day, is uneasy about the aide assigned to help or is worried about falling, the staff member should make the necessary adjustments realizing the resident is not refusing to be clean but refusing the bath under the circumstance provided. The facility staff should meet with the resident to make adjustments in the care plan to accommodate his or her preferences. According to this requirement at (b)(3), residents have the right to make choices about aspects of their lives that are significant to them. One example includes the right to choose to room with a person of the resident s choice if

20 20 Nursing Home Quality Standards: A Primer for Managed Care Organizations both parties are residents of the facility, and both consent to the choice. [Emphases added.] F-246 Reasonable Accommodation of Needs/Preferences CFR (e) (e)(1) - Reside and receive services in the facility with reasonable accommodation of individual needs and preferences, except when the health or safety of the individual or other residents would be endangered. The Interpretive Guidelines state: Reasonable accommodations of individual needs and preferences, means the facility s efforts to individualize the resident s physical environment. This includes the physical environment of the resident s bedroom and bathroom, as well as individualizing as much as feasible the facility s common living areas. The facility s physical environment and staff behaviors should be directed toward assisting the resident in maintaining and/or achieving independent functioning, dignity, and well-being to the extent possible in accordance with the resident s own needs and preferences. F-248 Activity Program Meets Individual Needs - 42 CFR (f)(1) The facility must provide for an ongoing program of activities designed to meet, in accordance with the comprehensive assessment, the interests and the physical, mental, and psychosocial well-being of each resident. F-248 emphasizes the importance of patient-appropriate activities as a component of good care. Activities should be tailored to meet the physical, mental, and psychosocial needs of each resident, including those with dementia. Example of failure to meet this standard: a facility is not identifying and providing appropriate activities to engage residents with dementia and, instead, is treating so-called Behavioral and Psychological Symptoms of Dementia with antipsychotics drugs. F-250 Medically Related Social Services - 42 CFR (g) The facility must provide medically-related social services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident. The guidelines for F-250 requires that facilities aggressively identify the need for medicallyrelated social services, and pursue the provision of these services. The guidelines also enumerate numerous examples of services that may be employed, as appropriate, for meeting this requirement. Following are several relevant examples: Providing alternatives to drug therapy or restraints by understanding and communicating to staff why residents act as they do, what they are attempting to communicate, and what needs the staff must meet. Through the assessment and care planning process, identifying and seeking ways to support residents individual needs. - -

21 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 21 Finding options that most meet the physical and emotional needs of each resident. Assisting staff to inform residents and those they designate about the resident s health status and health care choices and their ramifications The guidance also provides important information on relevant factors that may be having a negative effect on physical, emotional or psychosocial well being, such as [n]eed for a homelike environment, control, dignity, privacy, and some of the conditions that facilities should be responding to with social services (by their staff or referral to an outside source), including: Lack of an effective family/support system; Behavioral symptoms; If a resident with dementia strikes out at another resident, the facility should evaluate the resident s behavior. For example, a resident may be re-enacting an activity he or she used to perform at the same time everyday. If that resident senses that another is in the way of his re-enactment, the resident may strike out at the resident impeding his or her progress. The facility is responsible for the safety of any potential resident victims while it assesses the circumstances of the resident s behavior); Presence of a chronic disabling medical or psychological condition (e.g., multiple sclerosis, chronic obstructive pulmonary disease, Alzheimer s disease, schizophrenia); [and] A physical or chemical restraint. F-252 Safe/Clean/Comfortable/Homelike Environment CFR (h)(1) The Interpretive Guidelines state: A homelike environment is one that de-emphasizes the institutional character of the setting, to the extent possible, and allows the resident to use those personal belongings that support a homelike environment. A personalized, homelike environment recognizes the individuality and autonomy of the resident, provides an opportunity for self- - - expression, and encourages links with the past and family members. The intent of the word homelike in this regulation is that the nursing home should provide an environment as close to that of the environment of a private home as possible. This concept of creating a home setting includes the elimination of institutional odors, and practices to the extent possible. Some good practices that serve to decrease the institutional character of the environment include the elimination of:

22 22 Nursing Home Quality Standards: A Primer for Managed Care Organizations Overhead paging and piped-in music throughout the building; Meal service in the dining room using trays (some residents may wish to eat certain meals in their rooms on trays); Institutional signage labeling work rooms/closets in areas visible to residents and the public; Medication carts (some innovative facilities store medications in locked areas in resident rooms); The widespread and long-term use of audible (to the resident) chair and bed alarms, instead of their limited use for selected residents for diagnostic purposes or according to their care planned needs; Mass purchased furniture, drapes and bedspreads that all look alike throughout the building (some innovators invite the placement of some residents furniture in common areas); and Large, centrally located nursing/care team stations. Many facilities cannot immediately make these types of changes, but it should be a goal for all facilities that have not yet made these types of changes to work toward them. A homelike or homey environment is not achieved simply through enhancements to the physical environment. It concerns striving for person-centered care that emphasizes individualization, relationships and a psychosocial environment that welcomes each resident and makes her/him comfortable. [Emphases added.] F-272 Resident Assessment 42 CFR and 42 CFR (b)(1) The facility must conduct initially and periodically a comprehensive, accurate, standardized reproducible assessment of each resident s functional capacity. A facility must make a comprehensive assessment of a resident s needs, using the resident assessment instrument (RAI) specified by the State. The assessment must include at least the following: o Identification and demographic information. o Customary routine. o Cognitive patterns. o Communication. o Vision. o Mood and behavior patterns. o Psychosocial well-being. o Physical functioning and structural problems. o Continence. o Disease diagnoses and health conditions.

23 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 23 o Dental and nutritional status. o Skin condition. o Activity pursuit. o Medications. o Special treatments and procedures. o Discharge potential. o Documentation of summary information regarding the additional assessment performed through the resident assessment protocols. o Documentation of participation in assessment. A facility is expected to primarily rely on direct observation and communication with the resident in order to assess his or her functional capacity when completing a resident s RAI. According to the CMS Guidance, In addition to direct observation and communication with the resident, the facility should use a variety of other sources, including communication with licensed and non-licensed staff members on all shifts. F-279 Develop Comprehensive Care Plans CFR (d), (k)(1) The facility must develop a comprehensive care plan for each resident that includes measurable objectives and timetables to meet a resident s medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment. The care plan must describe the following: o The services that are to be furnished to attain or maintain the resident s highest practicable physical, mental, and psychosocial well-being as required under ; and o Any services that would otherwise be required under but are not provided due to the resident s exercise of rights under , including the right to refuse treatment under (b)(4). The care plan is critical because it provides or should provide a written record of the care that the resident should be receiving. The Interpretive Guidelines state: An interdisciplinary team, in conjunction with the resident, resident s family, surrogate, or representative, as appropriate, should develop quantifiable objectives for the highest level of functioning the resident may be expected to attain, based on the comprehensive assessment. The interdisciplinary team should show evidence in the CAA summary or clinical record of the following: The resident s status in triggered CAA areas; The facility s rationale for deciding whether to proceed with care planning; and Evidence that the facility considered the development of care planning interventions for all CAAs triggered by the MDS.

24 24 Nursing Home Quality Standards: A Primer for Managed Care Organizations The care plan must reflect intermediate steps for each outcome objective if identification of those steps will enhance the resident s ability to meet his/her objectives. Facility staff will use these objectives to monitor resident progress. The requirements reflect the facility s responsibilities to provide necessary care and services to attain or maintain the highest practicable physical, mental and psychosocial well-being, in accordance with the comprehensive assessment and plan of care. [Emphasis added.] F-280 Resident Participation in Development of Comprehensive Care Plan 42 CFR (d)(3) and 42 CFR (k)(2) 42 CFR (d)(3): The resident has the right to unless adjudged incompetent or otherwise found to be incapacitated under the laws of the State, participate in planning care and treatment or changes in care and treatment. 42 CFR (k)(2): A comprehensive care plan must be: o Developed within 7 days after the completion of the comprehensive assessment; o Prepared by an interdisciplinary team, that includes the attending physician, a registered nurse with responsibility for the resident, and other appropriate staff in disciplines as determined by the resident s needs, and, to the extend practicable, the participation of the resident, the resident s family or the resident s legal representative; and o Periodically reviewed and revised by a team of qualified persons after each assessment. CMS defines participate in planning care and treatment as meaning that the resident is afforded the opportunity to select from alternative treatments, in both the initial decisions about treatment options and when revisions are made throughout the course of the resident s care, and that the attending physician, among other qualified staff members, must be a part of the interdisciplinary team that prepares the care plan. CMS s guidance instructs surveyors to investigate how the facility and its staff involved residents, families and representatives in care planning meetings, including whether or not (and, if so, how) they reached out to them, made the meetings accessible and made the process understandable. Without the opportunity to participate in the planning or developmental stages of a care plan, the resident or his or her representative may not know that alternative methods of treatment might be viable options; conversely, without appropriate personnel comprising the interdisciplinary team, alternative treatment options may never be properly considered during the initial planning stage or developed throughout the course of a treatment plan. F-281 Services Provided Meet Professional Standards of Quality CFR (k)(3)(i) The services provided or arranged by the facility must-- o (i) Meet professional standards of quality The Interpretive Guidelines state: Professional standards of quality means services that are provided according to accepted standards of clinical practice. Standards may apply to care

25 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 25 provided by a particular clinical discipline or in a specific clinical situation or setting. Standards regarding quality care practices may be published by a professional organization, licensing board, accreditation body or other regulatory agency. Recommended practices to achieve desired resident outcomes may also be found in clinical literature. Possible reference sources for standards of practice include: Current manuals or textbooks on nursing, social work, physical therapy, etc. Standards published by professional organizations such as the American Dietetic Association, American Medical Association, American Medical Directors Association, American Nurses Association, National Association of Activity Professionals, National Association of Social Work, etc. Clinical practice guidelines published by the Agency of Health Care Policy and Research. Current professional journal articles. This standard is important to quality of care because it makes clear that nursing homes are required to be aware of, and provide care in accordance with, accepted standards of practice. Thus, as noted above, professional guidelines and other literature can serve as a reference point to determine if a nursing home is providing appropriate and sufficient care. For example, if antipsychotic drugs are given to a resident with dementia including situations where an individual was put on antipsychotics in a hospital before coming to the facility the record should show that the facility utilize(d) both gradual dose reduction and non-pharmacological approaches to reduce and eliminate use of these drugs (particularly if the resident s medical history does not indicate a condition for which these drugs might be appropriate: schizophrenia, Tourette s Syndrome or Huntington s Disease). F-282 Care Provided by Qualified Persons in Accordance with Plan of Care 42 CFR (k)(3)(ii) The services provided or arranged by the facility must be provided by qualified persons in accordance with each resident s written plan of care. The implementation of an individual resident s care plan is a crucial aspect of appropriate, resident-centered care. Unfortunately, some facilities fail to adhere to the federal standards when carrying out a care plan: a July 2012 report issued by the Office of the Inspector General found, in a review of 375 records from 640 nursing homes, that these facilities failed to meet federal requirements in care plan implementation 17.9% of the time Office of the Inspector General: Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs. July Available at: Importantly, the OIG s assessment also found that 99 percent of records did not contain evidence that Federal requirements for care

26 26 Nursing Home Quality Standards: A Primer for Managed Care Organizations F-309 Necessary Care for Highest Practicable Well Being - 42 CFR Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well being, in accordance with the comprehensive assessment and plan of care. Importantly, highest practicable physical, mental, and psychosocial well-being is defined as the highest possible level of functioning and well-being, limited by the individual s recognized pathology and normal aging process. Highest practicable is focused on the resident, not on the facility; the facility is required to provide what the resident needs to attain and maintain the highest level of functioning of which she is capable. It is determined through the comprehensive resident assessment and by recognizing and competently and thoroughly addressing the physical, mental or psychosocial needs of the individual. According to the Interpretive Guidelines: In any instance in which there has been a lack of improvement or a decline, the survey team must determine if the occurrence was unavoidable or avoidable. A determination of unavoidable decline or failure to reach highest practicable wellbeing may be made only if all of the following are present: An accurate and complete assessment (see ); A care plan that is implemented consistently and based on information from the assessment; and Evaluation of the results of the interventions and revising the interventions as necessary. This section of the federal code details a range of requirements related to highest practicable well-being, from activities of daily living (such as toileting, eating and communicating with others), to ensuring that pressure sores do not develop ( unless the resident s clinical demonstrates that they were unavoidable ) to ensuring that residents are not given antipsychotics or other drugs inappropriately. F-309 is also one of the key F-tags identified by CMS is relation to the national campaign to improve dementia care and reduce inappropriate antipsychotic drugging. Following is an excerpt of the CFR related to drugging. (l) Unnecessary drugs-- General. Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used: In excessive dose (including duplicate drug therapy); or For excessive duration; or Without adequate monitoring; or Without adequate indications for its use; or plans were met [and] 18 percent of records that listed care plan interventions for antipsychotic drug use did not contain evidence that those interventions actually occurred.

27 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 27 In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or Any combinations of the reasons above. Antipsychotic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that-- Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs. Following is an excerpt from a 2012 CMS Survey & Cert Letter on F-309 and end of life care. Medications/Drugs. It is important that use of medications be consistent with the goals for comfort, control of symptoms, and for the individual s desired level of alertness. Review the continued need for any routine administration of medication and adjust or discontinue, as appropriate. Routes of administering medications may also need modification. Medication doses may need adjustment to attain desired symptom relief, while still considering whether side effects (such as sedation and nausea) are tolerable and consistent with the resident s wishes or that of his/her legal representative. Anecdotal reports indicate that nursing homes maybe be under treating terminal restlessness because of the fear of being accused of using a chemical restraint. 13 F-310 ADLs Do Not Decline Unless Unavoidable CFR (a)(1) A resident s abilities in activities of daily living do not diminish unless circumstances of the individual s clinical condition demonstrate that diminution was unavoidable. This includes the resident s ability to -- (i) Bathe, dress, and groom; (ii) Transfer and ambulate; (iii) Toilet; (iv) Eat; and (v) Use speech, language, or other functional communication systems. The facility is responsible for ensuring that each resident s ability to perform activities of daily living does not decline unless such decline is unavoidable due to factors that are impervious 13 Centers for Medicare and Medicaid Services, F tag 309 Quality of Care- Advance Copy, Survey and Certification Letter, (2012). Available at Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter pdf.

28 28 Nursing Home Quality Standards: A Primer for Managed Care Organizations to treatment, such as the natural and unavoidable progression of disease or the resident s refusal of care or treatment. F-311 Treatment/Services to Improve/Maintain ADLs CFR (a)(2) A resident is given the appropriate treatment and services to maintain or improve his or her abilities. According to the State Operations Manual, [t]he intent of this regulation is to stress that the facility is responsible for providing maintenance and restorative programs that will not only maintain, but improve, as indicated by the resident s comprehensive assessment to achieve and maintain the highest practicable outcome. F-312 ADL Care for Dependent Residents CFR (a)(3) A resident who is unable to carry out activities of daily living receives the necessary services to maintain good nutrition, grooming, and personal and oral hygiene. The intent of this regulation is to ensure that nursing home residents who need extensive or total assistance with maintenance of nutrition, grooming and personal and oral hygiene, receive this assistance from the facility. 14 F-314 Treatment/Services to Prevent/Heal Pressure Sores CFR (c) Based on the comprehensive Assessment of a resident, the facility must ensure that-- o A resident who enters the facility without pressure sores does not develop pressure sores unless the individual s clinical condition demonstrates that they were unavoidable; and o A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing. Pressure ulcers or sores are one of the most significant nursing home care problems. The CMS Intent states: The intent of this requirement is that the resident does not develop pressure ulcers unless clinically unavoidable and that the facility provides care and services to: Promote the prevention of pressure ulcer development; Promote the healing of pressure ulcers that are present (including prevention of infection to the extent possible); and Prevent development of additional pressure ulcers. According to the Centers for Disease Control and Prevention, Pressure ulcers, also known as bed sores, pressure sores, or decubitus ulcers, are wounds caused by unrelieved pressure on the skin. They usually develop over bony prominences, such as the elbow, heel, hip, shoulder, back, and back of the head. Pressure ulcers are serious medical conditions and one of the important 14 Quoted from Interpretive Guidelines.

29 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 29 measures of the quality of clinical care in nursing homes. 15 [Endnotes deleted from original.] While some pressure ulcers are unavoidable, research and experience indicate that, [i]n the vast majority of cases, appropriate identification and mitigation of risk factors can prevent or minimize pressure ulcer (PU) formation. 16 In fact, the need to reduce pressure ulcers in nursing homes has been one of the key areas identified for quality improvement by the nursing home industry s quality improvement campaign, Advancing Excellence. 17 F-315 No Catheter, Prevent UTI, Restore Bladder CFR (d) Based on the resident s comprehensive assessment, the facility must ensure that (d) (1) A resident who enters the facility without an indwelling catheter is not catheterized unless the resident s clinical condition demonstrates that catheterization was necessary; and (d) (2) A resident who is incontinent of bladder receives appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible. Loss of bladder (and bowel) control is a significant problem for nursing home residents that often results from poor or inadequate care. The State Operations Manual states: The intent of this requirement is to ensure that: Each resident who is incontinent of urine is identified, assessed and provided appropriate treatment and services to achieve or maintain as much normal urinary function as possible; An indwelling catheter is not used unless there is valid medical justification; An indwelling catheter for which continuing use is not medically justified is discontinued as soon as clinically warranted; Services are provided to restore or improve normal bladder function to the extent possible, after the removal of the catheter; and 15 NCHS Data Brief, No. 14 (February 2009), which incorporates Pressure Ulcers Among Nursing Home Residents: United States, Accessed in March 2015 from (PDF). 16 Edsberg, L; Langemo, D; Baharestani, M; Posthauer, M; and Goldberg, M, Unavoidable Pressure Injury: State of the Science and Consensus Outcomes, Journal of Wound, Ostomy & Continence Nursing: July/August Volume 41 - Issue 4 - p Abstract accessed in March 2015 at St ate_of_the_science.6.aspx. 17 Advancing Excellence in America s Nursing Homes,

30 30 Nursing Home Quality Standards: A Primer for Managed Care Organizations A resident, with or without a catheter, receives the appropriate care and services to prevent infections to the extent possible. F-317 No Reduction in Range of Motion Unless Unavoidable - CFR (e) F-318 Treatment for Range of Motion Problems - CFR (e) [F-317] A resident who enters the facility without a limited range of motion does not experience reduction in range of motion unless the resident s clinical condition demonstrates that a reduction in range of motion is unavoidable. [F-318] A resident with a limited range of motion receives appropriate treatment and services to increase range of motion and/or to prevent further decrease in range of motion. The CMS State Operations Manual states The intent of this regulation is to ensure that the resident reaches and maintains his or her highest level of range of motion and to prevent avoidable decline of range of motion. According to the Interpretive Guidelines: Examples of clinical conditions that are the primary risk factors for a decreased range of motion are: Immobilization (e.g., bedfast); Deformities arising out of neurological deficits (e.g., strokes, multiple sclerosis, cerebral palsy, and polio); and Pain, spasms, and immobility associated with arthritis or late state Alzheimer s disease. This clinical condition may demonstrate that a reduction in ROM is unavoidable only if adequate assessment, appropriate care planning, and preventive care was provided, and resulted in limitation in ROM or muscle atrophy. F-319 Mental/Psychosocial Treatment 42 CFR (f)(1) - Based on the comprehensive assessment of a resident, the facility must ensure that a resident who displays mental or psychosocial adjustment difficulty receives appropriate treatment and services to correct the assessed problem. F-319 may be particularly relevant when a resident displays mental or psychosocial adjustment difficulties and is administered antipsychotics inappropriately. As noted in the discussion below for F-329, an antipsychotic must be clinically appropriate for the resident and not used for convenience or disciplinary purposes, for instance as a means to address a resident s mental or psychosocial adjustment difficulties in a manner that is most convenient for medical and/or care staff, rather than what is most appropriate for the resident. F-320 No Development of Mental Problems 42 CFR (f)(2) A resident whose assessment did not reveal a mental or psychosocial adjustment difficulty does not display a pattern of decreased social interaction and/or increased

31 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 31 withdrawn, angry, or depressive behaviors, unless the resident s clinical condition demonstrates that such a pattern was unavoidable. The Probes for surveyor assessment in the guidance provides useful insights for this standard: Did the facility attempt to evaluate whether this behavior was attributable to organic causes or other risk factors not associated with adjusting to living in the nursing facility? What care did the resident receive to maintain his/her mental or psychosocial functioning? Were individual objectives of the plan of care periodically evaluated, and if progress was not made in reducing, maintaining, or increasing behaviors that assist the resident to have his/her needs met, were alternative treatment approaches developed to maintain mental or psychosocial functioning? F-325 Maintain Nutrition Status Unless Unavoidable CFR (i) Based on a resident s comprehensive assessment, the facility must ensure that a resident-- o 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 o Receives a therapeutic diet when there is a nutritional problem. F-329 Free from Unnecessary Drugs - 42 CFR (l) 1. General. Each resident s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used: o (i) In excessive dose (including duplicate therapy); or o (ii) For excessive duration; or o (iii) Without adequate monitoring; or o (iv) Without adequate indications for its use; or o (v) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or o (vi) Any combinations of the reasons above. (2)(i): Residents who haven t used antipsychotics are not given them unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed/documented in the clinical record, and (2)(ii): Residents who use antipsychotics receive gradual dose reductions, and behavioral interventions (unless clinically contradicted) in an effort to discontinue these drugs. F-329 signifies an important standard and is perhaps the most important F-Tag for inappropriate antipsychotic drugging, a serious and widespread problem in nursing homes that is receiving increasing attention by both the public and regulators. The first purpose of F-329 related to antipsychotic drug use is to prevent nursing home staff from giving a resident an unnecessary antipsychotic drug. Despite the FDA s black box warning of the potentially fatal side effects of antipsychotics for people suffering from dementia, these powerful drugs are too often used as a means of sedating elderly nursing home residents with dementia, as a

32 32 Nursing Home Quality Standards: A Primer for Managed Care Organizations substitute for appropriate care. 18 This is contrary to the Nursing Home Reform Law s requirement of promoting patient-centered care that enables each individual to maintain his or her highest practicable physical, emotional and social well-being. It is often evidenced by a failure to try non-pharmacological approaches to dementia care, such as when a resident becomes agitated and is subdued with an antipsychotic drug without first trying other, nondrugging options. The second purpose of this F-Tag relating to antipsychotics is to ensure that facilities take steps to wean residents off of antipsychotics drugs whenever the drugs are given. This goal is accomplished through either the implementation of behavioral interventions (unless diagnoses do not call for such interventions) or through recorded and monitored gradual dose reductions (GDR) (or, most likely, a combination of the two). A facility s systematic failure to implement GDRs could be an example of staff relying on antipsychotics as a primary treatment mechanism, rather than attempting to discontinue the use of the drugs. F-332 Facility Free of Medication Errors of 5% or Greater CFR (m)(1) F-333 Residents Free of Significant Med Errors CFR (m)(2) The Interpretive Guidelines for these two requirements define medication errors as the administration, or observed preparation to administer, of drugs or biologicals which is not in accordance with: 1. Physician s orders; 2. Manufacturer s specifications (not recommendations) regarding the preparation and administration of the drug or biological; 3. Accepted professional standards and principles which apply to professionals providing services. Accepted professional standards and principles include the various practice regulations in each State, and current commonly accepted health standards established by national organizations, boards, and councils. [Emphases added.] F-353 Sufficient 24-Hr Nursing Staff Per Care Plans CFR (a) The facility must have sufficient nursing staff to provide nursing and related services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, as determined by resident assessments and individual plans of care. Staffing levels have repeatedly been identified as one of the most (if not the most) significant indicators of a nursing home s quality of care and safety. Federal guidelines require that there be sufficient staff to meet the needs of resident. While this requirement lacks numerical specificity, it is straightforward on what outcomes are expected: facilities are required to have sufficient staff to provide both care and related services necessary for each resident to attain and maintain her highest practicable physical, emotional and social well-being. 18 The Boston Globe, A Rampant Prescription, A Hidden Peril (April 29, 2012). Available at:

33 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 33 To assess whether staffing is sufficient, the guidelines provide surveyors with the following probes to determine compliance with minimum regulatory standards: Determine nurse staffing sufficiency for each unit: Is there adequate staff to meet direct care needs, assessments, planning, evaluation, supervision? Do work loads for direct care staff appear reasonable? Do residents, family, and ombudsmen report insufficient staff to meet resident needs? Are staff responsive to residents needs for assistance, and call bells answered promptly? Do residents call out repeatedly for assistance? Are residents, who are unable to call for help, checked frequently (e.g., each half hour) for safety, comfort, positioning, and to offer fluids and provision of care? Are identified care problems associated with a specific unit or tour of duty? Is there a licensed nurse that serves as a charge nurse (e.g., supervises the provision of resident care) on each tour of duty (if facility does not have a waiver of this requirement)? What does the charge nurse do to correct problems in nurse staff performance? Does the facility have the services of an RN available 8 consecutive hours a day, 7 days a week (if this requirement has not been waived)? How does the facility assure that each resident receives nursing care in accordance with his/her plan of care on weekends, nights, and holidays? How does the sufficiency (numbers and categories) of nursing staff contribute to identified quality of care, resident rights, quality of life, or facility practices problems? F-364 Food CFR (d)(1)-(2) Each resident receives and the facility provides: o Food prepared by methods that conserve nutritive value, flavor, and appearance; o Food that is palatable, attractive, and at the proper temperature. Poor food quality, palatability and choice are among the most often cited resident complaints. In addition to affecting quality of life, the absence of food that is both enjoyable and nutritious can have a serious negative effect on a resident s physical health.

34 34 Nursing Home Quality Standards: A Primer for Managed Care Organizations F-385 Residents Care Supervised by Physician 42 CFR (a)(1, 2) The facility must ensure that the medical care of each resident is supervised by a physician, and another physician supervises the medical care of residents when their attending physician is unavailable. F-385 relates to an important distinction between supervision of a resident s care, which must be provided by a physician, and the carrying out of certain tasks, some of which must be carried out by a physician and some of which may be carried out by designated staff or others with appropriate training and/or licensure. For example, this standard is relevant when there are indications that a resident has been given antipsychotic drugs inappropriately or if there are patterns of extensive off-label use of antipsychotics or extensive reliance on PRNs (pro re nata) which allow nursing home staff to give a resident drugs on an as needed basis, at their own discretion. Any of these situations should trigger an inquiry into whether the physician(s) supervised their residents care in a meaningful way when these drugs were used, as the law requires. 19 F-411 Routine/Emergency Dental Services CFR (a) A facility-- o Must provide or obtain from an outside resource, in accordance with (h) of this part, routine and emergency dental services to meet the needs of each resident; o May charge a Medicare resident an additional amount for routine and emergency dental services; o Must if necessary assist the resident-- In making appointments; and By arranging for transportation to and from the dentist s office; and o Promptly refer residents with lost or damaged dentures to a dentist. The Interpretive Guidelines state: This requirement makes the facility directly responsible for the dental care needs of its residents. The facility must ensure that a dentist is available for residents, i.e., employ a staff dentist or have a contract (arrangement) with a dentist to provide services. For Medicare and private pay residents, facilities are responsible for having the services available, but they may impose an additional charge for the services. Routine dental services means an annual inspection of the oral cavity for signs of disease, diagnosis of dental disease, dental radiographs as needed, dental cleaning, fillings (new and repairs), minor dental plate adjustments, smoothing of broken teeth, and limited prosthodontic procedures, e.g., taking impressions for dentures and fitting dentures. 19 For a discussion of roles and tasks that physicians may delegate in LTC settings see Wilson, Kathleen M., PhD, Physicians May Delegate Tasks, Not Supervision, Caring For the Ages, Vol. 9, No. 11 (November 2008). Available at

35 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 35 Emergency dental services includes services needed to treat an episode of acute pain in teeth, gums, or palate; broken, or otherwise damaged teeth, or any other problem of the oral cavity by a dentist that required immediate attention. [First emphasis added.] F-428 Drug Regimen Reviewed Monthly 42 CFR (c)(1) The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist. The purpose of F-428 is to improve oversight and accountability in drug prescribing practices in nursing facilities. The pharmacist is charged with identifying potential medication-related problems such as: use of a medication without adequate indication for its use, use of a medication without identifiable evidence that safer alternatives (including more clinically appropriate medications) have been considered and use of an appropriate medication that is not reaching treatment goals. 20 According to the guidance: It may be necessary for the pharmacist to conduct the MRR [Medication Regimen Review] more frequently, for example weekly, depending on the resident s condition and the risks for adverse consequences related to current medications. Generally, MRRs are conducted in the facility because important information about indications for use, potential medication irregularities or adverse consequences (such as symptoms of tardive dyskinesia, dizziness, anorexia, or falls) may be attainable only by talking to the staff, reviewing the medical record, and observing and speaking with the resident. For example, given the critical safeguards that an independent pharmacist s review provides, cases where inappropriate use of antipsychotics have been identified should trigger a review of whether these requirements were met. F-490 Facility Administered Effectively 42 CFR A facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident. This requirement relates to the ultimate responsibility of the facility administration to ensure that the nursing home is providing sufficient appropriate services to ensure that each resident attain, and maintain, his or her highest practicable physical, emotional and social well-being. 20 For more examples and further information on F-428 see presentation by Maher, Robert L. Jr., Pharm.D, BCPS, CGP, F-Tag 428 Medication Regimen Review Drug Use Problems in Long Term Care Residents and Key Elements to Performing a Drug Regimen Review (October 2007). Available at

36 36 Nursing Home Quality Standards: A Primer for Managed Care Organizations For example, inappropriate antipsychotic drug use is often associated with systemic problems in a facility, such as insufficient staffing and a lack of knowledge and/or use of nonpharmacological treatment options for dementia care. F-498 Proficiency of Nurse Aides 42 CFR (f) The facility must ensure that nurse aides are able to demonstrate competency in skills and techniques necessary to care for residents needs, as identified through resident assessments, and described in the plan of care. Facilities are required to ensure that nurse aides have the knowledge and ability necessary to meet the various needs of their residents. The Interpretive Guidelines for F-498 note the need for competency in a range of skills, including the ability to provide sufficient and appropriate care to (1) meet residents mental health and social service needs and (2) uphold residents rights. F-501 Responsibilities of Medical Director 42 CFR (i)(1, 2)(i, ii) The facility must designate a physician to serve as medical director. The medical director is responsible for: o Implementation of resident care policies o The coordination of medical care in the facility The medical director has an important role in ensuring that a nursing home s residents have access to appropriate care that reflects current standards of practice. The CMS Guidance for this F-tag has a section that specifically addresses the intent of this requirement, including: providing clinical guidance and oversight regarding the implementation of resident care policies, collaborating with the facility leadership, staff, and other practitioners and consultants to help develop, implement and evaluate resident care policies and procedures that reflect current standards of practice, and helping the facility identify and address clinical concerns and issues affecting resident care, medical care or quality of life. F-514 Clinical Records Meet Professional Standards 42 CFR (l) The facility must maintain clinical records on each resident in accordance with accepted professional standards and practices. The guidance requires that surveyors: Determine whether the clinical records: Accurately and completely document the resident's status, the care and services provided in accordance with current professional standards and practices; and Provide a basis for determining and managing the resident's progress including response to treatment, change in condition, and changes in treatment. Accurate, timely and complete records of a resident s needs, care plan and implementation thereof are important in assuring that a resident s needs and desires are appropriately identified and addressed by the facility. For example, in the context of dementia care and antipsychotic drugging, this F-tag is relevant in respect to determining whether the nursing

37 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 37 home staff described the so-called behavioral symptoms of dementia (onset, duration, intensity, possible precipitating events or environmental triggers, etc ) and related factors (appearance, alertness) in the medical record with enough detail of the actual situation to permit cause identification, to the extent possible, and provided appropriate, individualized interventions. F-520 Quality Assessment and Assurance 42 CFR (o)(1) and (o)(2) A facility must maintain a quality assessment and assurance committee consisting of o (i) The director of nursing services; o (ii) A physician designated by the facility; and o (iii) At least 3 other members of the facility s staff. (2) The quality assessment and assurance committee o (i) Meets at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary; and o (ii) Develops and implements appropriate plans of action to correct identified quality deficiencies. F-520 states that a facility is responsible for finding out what problem areas it may have and is responsible for fixing problems that have been identified. Facilities should not only be relying on surveyors, complaints or other external catalysts to identify quality of care and quality of life problems. The quality assessment and assurance (QAA) committee should be identifying the problems in the facility and then developing and implementing policies and procedures to correct these problems. The QAA committee is also supposed to monitor the policies they have implemented to ensure that their implementation actually corrects the problem and that the problem stays corrected. Repeated citations for the same deficiency may be an indication that a facility does not have an appropriately functioning QAA committee. Important Note: The 2010 federal Affordable Care Act requires that nursing homes have a Quality Assurance & Performance Improvement (QAPI) program. As of April 2015, requirements for QAPI programs have not been promulgated. Nevertheless, the requirement has garnered significant attention by both the industry and regulators.

38 38 Nursing Home Quality Standards: A Primer for Managed Care Organizations Appendix I: F-tag List F-tags are used to identify the specific compliance standard for nursing homes set forth in the Code of Federal Regulations (CFR). The following list provides short descriptions of all the F- tags, many of which are covered in this primer. [See the Table of Contents for the list of F-tags covered.] Note: The list is in two parts, on this and the following page. Figure 1 - F-tag List Part 1

39 Long Term Care Community Coalition Nursing Home Quality Standards: A Primer for Managed Care Organizations 39 Figure 2 - F-tag List Part 2

40 40 Nursing Home Quality Standards: A Primer for Managed Care Organizations Appendix II: Scope & Severity Grid Scope and Severity is the system used by CMS and the state Survey Agencies for rating the seriousness of nursing home deficiencies, i.e., of violations in minimum standards of care or other requirements. For each deficiency identified, the surveyor is charged with identifying the level of harm to the resident or resident(s) involved and the scope of the problem within the nursing home. The surveyor then assigns an alphabetical scope and severity value to the deficiency. "A" is the least serious and "L" is the most serious rating. Information on deficiencies for all licensed nursing homes is available on Nursing Home Compare. It is important to note, when assessing a facilities survey performance, that numerous studies have found that surveyors often fail to adequately identify nursing home problems, including serious care problems. 21 The following chart is from the CMS Nursing Home Data Compendium 2013 Edition See, for example, US Government Accountability Office, Nursing Homes: Some Improvement Seen in Understatement of Serious Deficiencies, but Implications for the Longer-Term Trend Are Unclear, GAO R (April 2010). Available at 22 Available at Certification/CertificationandComplianc/downloads/nursinghomedatacompendium_508.pdf.