Department of Health and Human Services
 

OFFICE OF 

INSPECTOR GENERAL 

NURSING FACILITY ASSESSMENTS 


AND CARE PLANS FOR RESIDENTS 


RECEIVING ATYPICAL 


ANTIPSYCHOTIC DRUGS 


Daniel R. Levinson
 

Inspector General
 

July 2012 

OEI-07-08-00151 
 

EXECUTIVE SUMMARY: NURSING FACILITY ASSESSMENTS AND CARE 

PLANS FOR RESIDENTS RECEIVING ATYPICAL ANTIPSYCHOTIC DRUGS 

OEI-07-08-00151 

WHY WE DID THIS STUDY 

Nursing facilities must meet Federal quality and safety standards to participate in the 

Medicare and/or Medicaid programs. The standards require extra protections for nursing 

facility residents receiving antipsychotic drugs. Nursing facility staff are required to 

assess each resident’s functional capacity upon admission to the facility and periodically 

thereafter. Staff must specify in a written care plan, based on these assessments, the 

services that each resident needs. The Centers for Medicare & Medicaid Services (CMS) 

contracts with State agencies to ensure that nursing facilities comply with the standards 

for resident assessments and care plans. 

HOW WE DID THIS STUDY 

This study used a random sample of records from a previous Office of Inspector General 

(OIG) study of elderly nursing facility residents with Medicare claims for atypical 

antipsychotic drugs between January and June 2007 (OEI-07-08-00150). We reviewed 

the records for evidence of compliance with Federal requirements for resident 

assessments and documentation of decisionmaking. We also reviewed the records for 

evidence of compliance with Federal requirements for care plan development and 

implementation. 

WHAT WE FOUND 

Nearly all records reviewed (99 percent) failed to meet one or more Federal requirements 

for resident assessments and/or care plans. The resident assessment and care plan process 

involves four steps. One-third of records reviewed did not contain evidence of 

compliance with Federal requirements regarding resident assessments, the first step. 

Further, for 4 percent of records, nursing facility staff did not document consideration of 

the Resident Assessment Protocol for psychotropic drug use as required, the second step. 

Ninety-nine percent of records did not contain evidence of compliance with Federal 

requirements for care plan development, the third step. Finally, 18 percent of records 

reviewed did not contain evidence to indicate that planned interventions for antipsychotic 

drug use—the fourth step—actually occurred. 

WHAT WE RECOMMEND 

We recommend that CMS: (1) improve the detection of noncompliance with Federal 

requirements for resident assessments and care plans for residents receiving antipsychotic 

drugs, (2) take appropriate action to address noncompliance with these requirements, and 

(3) provide methods for nursing facilities to enhance the development and usefulness of 

resident assessments and care plans. CMS concurred with all of our recommendations. 
TABLE OF CONTENTS 

Objective......................................................................................................1 

Background..................................................................................................1 

Methodology................................................................................................7 

Finding .......................................................................................................12 

Nearly all records reviewed failed to meet one or more Federal 

requirements for resident assessments and/or care plans ...............12 

Conclusion and Recommendations ............................................................17 

Agency Comments and Office of Inspector General Response .................19 

Appendixes ................................................................................................20 

A: Changes to the Minimum Data Set, Version 3.0, That May 

Affect the Assessment of Residents Receiving Antipsychotic 

Drugs..............................................................................................20 

B: Triggers for the Resident Assessment Protocol for Psychotropic 

Drug Use ........................................................................................21 

C: Example of How a Resident Assessment Is Used To Develop a 

Care Plan Intervention for Antipsychotic Drug Use ......................22 

D: State Certification of Nursing Facilities ..................................23 

E: Sample Selection ......................................................................26 

F: Professionals Involved in Resident Assessments 

and Care Plans................................................................................27 

G: Agency Comments...................................................................28 

Acknowledgments......................................................................................31 
 

 

 

 

 

 

 

 

OBJECTIVE 

To determine the extent to which nursing facilities follow Federal 

assessment and care plan requirements designed to ensure quality of care 

for elderly residents receiving atypical antipsychotic drugs. 

BACKGROUND 

Elderly nursing facility residents (residents) receiving atypical 

antipsychotic drugs are a particularly vulnerable population because of an 

increased risk of death associated with these drugs.1, 2 A previous Office 

of Inspector General (OIG) study found that when this population received 

these drugs, about half of the drugs were not given for medically accepted 

indications as required for Medicare coverage3 and one-fifth of the drugs 

were not given in accordance with Federal safeguards to protect nursing 

facility residents from unnecessary antipsychotic drug use.4 This study 

uses records collected for the previous study to assess the quality of the 

care provided by nursing facilities to residents receiving atypical 

antipsychotic drugs. 

Nursing facilities must meet Federal quality and safety standards to 

participate in the Medicare and/or Medicaid programs.5 To ensure quality 

of care for residents, the regulations require that nursing facilities provide 

residents with the services they need to achieve the highest practicable 

level of well-being.6 To identify these services, nursing facility staff must 

assess each resident’s functional capacity upon admission to the facility 

and periodically thereafter.7 Staff must then specify in a written care plan, 

based on these assessments, the services that each resident needs.8 

1 Antipsychotic drugs were developed to treat psychoses and/or mood disorders. Atypical antipsychotic drugs 

are second-generation antipsychotic drugs.
 

2

 Food and Drug Administration (FDA), Public Health Advisory: Deaths With Antipsychotics in Elderly 

Patients With Behavioral Disturbances, April 2005. Accessed at http://www.fda.gov on February 22, 2008.
 

3

 Medically accepted indications include both the uses approved by FDA and those uses supported by statutorily 

named compendia. Social Security Act § 1927(g)(1)(B)(i), 42 U.S.C. 1396r-8(g)(1)(B)(i). Medically accepted 

indications for atypical antipsychotic drugs generally include mental health conditions, such as bipolar disorder,
 

schizophrenia, depression, and psychotic features.
 

4 Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents (OEI-07-08-00150), 

May 2011. 

5

 We use the term “nursing facilities” to refer to both skilled nursing facilities and nursing facilities. The former 

operate under Medicare and the latter under Medicaid; however, both must comply with nearly all of the same 

requirements. Requirements for the provision of nursing facility services are contained in Social Security Act 

§§ 1819 and 1919. Federal regulations at 42 CFR pt. 483 and the Centers for Medicare & Medicaid Services 

(CMS) State Operations Manual (SOM), Pub. No. 100-07, provide further interpretation. 

6

 42 CFR § 483.25. 

7

 42 CFR § 483.20(b). 

8

 42 CFR § 483.20(k). 

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Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 2 

 

 

CMS contracts with State agencies to survey nursing facilities and certify 

those that comply with Federal standards.9 

Protection for Residents Receiving Antipsychotic Drugs 

In addition to providing information about the services that residents need, 

periodic assessments protect residents from receiving services that they do 

not need. For residents receiving antipsychotic drugs, nursing facilities 

must ensure, on the basis of comprehensive resident assessments, that: 

	 residents who have not previously taken antipsychotic drugs are not 

given them unless it is necessary to treat a specific condition as 

diagnosed and documented in the residents’ clinical records and 

	 when antipsychotic drugs are given, residents must receive gradual 

dose reductions and behavioral interventions in an effort to discontinue 

the drugs’ use, unless clinically contraindicated.10 

Resident Assessments and Care Plans 

Resident assessments and care plans are critical in providing care. 

Graphic 1, the “Quality of Care Pathway,” illustrates the importance of 

each of the four phases involved in providing care. The activities along 

the pathway can be regarded as a proxy measure for the quality of care 

provided to nursing facility residents. 

Graphic 1: Quality of Care Pathway 

1. Assessment 

2. Decisionmaking 

3. Care Plan 

Development 

4. Care Plan 

Implementation 

Source: Adapted from CMS, Long-Term Care Facility Resident Assessment Instrument (RAI) User’s 

Manual, version 2.0, December 2002. 

9

 42 CFR § 488.10.
 

10 42 CFR § 483.25(l)(2).
 
 

 

 

 

 

 

 

 

Phase One: Assessment. Federal regulations require nursing facility staff 

to conduct a comprehensive assessment at the following times: upon 

resident admission, whenever there has been a significant change in the 

resident’s physical or mental condition, and at least once per year.11 The 

initial comprehensive assessments provide baseline information for use in 

the ongoing assessment of residents’ progress.12 

To ensure that residents are accurately assessed, a qualified health 

professional correctly documents each resident’s medical, functional, and 

psychosocial issues.13 The resident’s condition determines the appropriate 

level of involvement of physicians; nurses; rehabilitation therapists; 

activities professionals; medical social workers; dietitians; and other 

professionals, such as developmental disabilities specialists.14 For 

example, a resident receiving atypical antipsychotic drugs for a mental 

health condition should be assessed by a mental health professional who is 

qualified in this specific care area. 

A registered nurse (RN) is required to conduct or coordinate each 

assessment with the participation of other health professionals.15 In 

addition, an RN is required to certify that resident assessments are 

completed.16 

The Resident Assessment Instrument (RAI) is the tool that nursing 

facilities must use for preliminary screening to identify potential resident 

problems, strengths, and preferences.17 It must contain standardized core 

items, called the Minimum Data Set (MDS).18 On October 1, 2010, CMS 

implemented a new version of the MDS—version 3.0—to improve the 

MDS’s reliability, accuracy, and usefulness; to include the resident in the 

assessment process; and to use standard protocols used in other settings.19 

See Appendix A for information about changes in MDS 3.0 that may affect 

assessments of residents receiving antipsychotic drugs. 

11 42 CFR § 483.20(b)(2). A significant change is a major improvement or decline in the resident's status that 

will not normally resolve itself without further intervention by staff or by implementing standard disease-related
 

clinical interventions; that has an impact on the resident’s health status; and that requires interdisciplinary 

review, revision of the care plan, or both.
 

12 CMS, SOM, Pub. No. 100-07, Appendix PP, interpretive guidelines of 42 CFR § 483.20(g).
 

13 Ibid. 

14 CMS, SOM, Pub. No. 100-07, Appendix PP, interpretive guidelines of 42 CFR § 483.20(h).
 

15 42 CFR § 483.20(h). CMS, SOM, Pub. No. 100-07, Appendix PP, interpretive guidelines of 

42 CFR § 483.20(h).
 

16 42 CFR § 483.20(i). 

17 42 CFR § 483.20(b)(1).
 

18 42 CFR § 483.20(b)(1)(xvii).
 

19 CMS, MDS 3.0 for Nursing Homes and Swing Bed Providers. Accessed at https://www.cms.gov on 

September 30, 2011. 

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In addition to performing comprehensive assessments, nursing facilities 

are required to perform quarterly assessments for each resident at least 

once every 3 months.20 These quarterly assessments are designed to 

ensure that residents’ needs are periodically assessed and that their care 

plans are updated to reflect any identified changes in needs. Each State’s 

quarterly assessment instrument must contain certain mandatory MDS 

items.21 

The MDS provides a standard format for Federal documentation 

requirements and allows nursing facilities to summarize the information in 

residents’ records.22 Relevant details that are not part of MDS should be 

documented by nursing facilities elsewhere in resident records, using 

additional tools for assessment as necessary.23 The information in nursing 

facility records should support, rather than conflict with, MDS data 

reported to CMS.24 

Phase Two: Decisionmaking. Certain combinations of responses to MDS 

items alert nursing facility staff to potential resident problems, known as 

“triggered conditions.” These triggered conditions guide nursing facility 

staff to conduct an additional assessment(s) through Resident Assessment 

Protocols (RAP). Nursing facility staff use RAPs and other clinically 

relevant assessments to determine whether a triggered condition represents 

an actual problem for the resident that needs to be addressed in the care 

plan. Using the assessment information, staff must document in care plans 

their decisions about whether to proceed with interventions to address 

triggered conditions.25 

For residents who receive atypical antipsychotic and other psychotropic 

drugs,26 the coding of certain items on the MDS should “trigger” the RAP 

for psychotropic drug use.27 For example, if a resident taking an atypical 

20 42 CFR § 483.20(c). A minimum of three quarterly assessments are required for each 12-month period, as 

there are a maximum of 92 days in any 3-month interval.
 

21 CMS, SOM, Pub. No. 100-07, Appendix PP, 42 CFR § 483.20(c) interpretive guidelines; and CMS,
 

Long-Term Care Facility RAI User’s Manual, version 2.0, December 2002.
 

22 CMS, Long-Term Care Facility RAI User’s Manual, version 2.0, December 2002, pp. 1-23. This version of 

the manual was revised in December 2008; however, we used the 2002 version, as our review period involves 

nursing facility records from 2007. RAPs were termed “Care Area Assessments” (CAA) in the MDS 

version 3.0, released in October 2010.
 

23 Ibid. 

24 Ibid. 

25 CMS, SOM, Pub. No. 100-07, Appendix PP, 42 CFR § 483.20(k) interpretive guidelines.
 

26 Psychotropic drugs include antipsychotic, antidepressant, and antianxiety medications for the purposes of 

MDS 2.0. 

27 Appendix B contains the list of triggers for the Psychotropic Drug Use RAP at the time our data were
 

collected. MDS 3.0, released in October 2010, requires only that a resident received psychotropic drugs prior to 

the assessment in order to trigger the Psychotropic Drug Use CAA. CMS, Long-Term Care Facility RAI User’s 

Manual, version 3.0, September 2010, pp. 4-37.
 

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antipsychotic drug experiences periods of lethargy according to MDS, that 

observed state should trigger the RAP for psychotropic drug use.28 

Facility staff should then use the RAP to collect additional information 

about the resident’s status to determine whether the lethargy represents a 

problem related to antipsychotic drug use that should be addressed in the 

resident’s care plan. 

Phase Three: Care Plan Development. Nursing facilities are required to 

develop a care plan for each resident within 7 days after the completion of 

the comprehensive assessment and to review it after all subsequent 

(comprehensive and quarterly) resident assessments.29 Care plans should 

describe the services that the nursing facility will provide to residents to 

assist them in attaining or maintaining the highest practicable functional 

status.30 Care plans include measurable objectives and timeframes to meet 

residents’ physical, mental, and psychosocial needs.31 

Interdisciplinary teams composed of the attending physician, the RN 

overseeing the resident’s care, and “other appropriate staff in disciplines as 

determined by the resident’s needs” must prepare a care plan for each 

resident.32 Care plan development also requires participation, to the extent 

practicable, of the resident or the resident’s family or legal 

representative.33 Appendix C provides an example of how a resident 

assessment is used to help develop a care plan intervention for 

antipsychotic drug use. 

Phase Four: Care Plan Implementation. In general, care plans list several 

physical, medical, and psychosocial objectives based on resident strengths 

or problems; interventions to address risks related to those objectives; and 

periodic evaluations of progress towards the goal. Figure 1 shows an 

example of what might be included in a care plan to address risks 

associated with antipsychotic drug use. 

28 Appendix B indicates signs, symptoms, and conditions for using the RAP for psychotropic drug use. CMS,
 

Long-Term Care Facility RAI User’s Manual, version 2.0, December 2002, pp. C-87.
 

29 42 CFR § 483.20(k)(2).
 

30 42 CFR § 483.20(k)(1).
 

31Ibid. 

32 Ibid. 

33 42 CFR § 483.10(d)(3), 42 CFR § 483.20(k)(2)(ii), and interpretive guidelines at CMS, SOM,
 

Pub. No. 100-07, Appendix PP. The facilities are responsible for assisting residents and/or their representatives 

with participation in care plans.
 

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Figure 1. Care Plan Example 

Problem/Objective Intervention Evaluation 

Resident is at risk for 

side effects of 

antipsychotic drug use. 

Goal: Reduce risk of 

side effects. 

 Attempt gradual dose reduction 

of antipsychotic drug at least 

once per quarter. 

 Monitor resident for side effects, 

especially lethargy. 

 Dose reduction occurred 2 months ago 

and was well tolerated. 

 Resident experienced lethargy only 2 of 

the last 30 days. 

 Action: Continue interventions as stated. 

Source: OIG analysis of nursing facility records, 2011. 

Federal regulations require that nursing facilities provide necessary care 

and services to each resident in accordance with the resident’s 

comprehensive assessment and care plan.34 To achieve this, the facility 

staff must continually implement and update the care plan.35 Interpretive 

guidelines state that nursing facilities must ensure that each resident 

“obtains optimal improvement or does not deteriorate” within the limits of 

the normal aging process.36 That is, care plans can be used to correct 

physical or emotional problems, if possible, or ensure that a resident does 

not experience an avoidable decline in health. Nursing facility staff 

reevaluate the resident’s status using the RAI and then modify the care 

plan as necessary.37 

State Certification Process 

To participate in Medicare and Medicaid, nursing facilities must be 

certified.38 States certify nursing facilities through a process that 

determines compliance with Federal standards, including standards for 

resident assessments and care plans.39 In this process, State surveyors 

identify deficiencies and score them using severity and scope. The 

deficiencies identified on State surveys have implications for nursing 

facilities’ participation in Medicare.40 To rate the quality of each nursing 

facility on its publicly available Nursing Home Compare Web site CMS 

uses health inspection ratings from State surveys, nursing facility staffing 

information, and quality measures from MDS.41 Consumers can compare 

34 42 CFR § 483.25 and § 483.20(k)(3)(ii). 

35 CMS, SOM, Pub. No. 100-07, Appendix PP, interpretive guidelines for 42 CFR § 483.25.
 

36 Ibid. 

37 CMS, Long-Term Care Facility RAI User’s Manual, version 2.0, December 2002, pp. 4-27.
 

38 Requirements for the provision of nursing facility services are contained in Social Security Act §§ 1819 

and 1919. Federal regulations at 42 CFR § 483 and the CMS SOM, Pub. No. 100-07, provide further
 

interpretation.
 

39 CMS, SOM, Pub. No. 100-07, ch. 1 § 1016—Approval and Correction of Deficiencies. 

40 42 CFR § 488.330
 

41 CMS, “Five-Star Quality Rating System.” Accessed at https://www.cms.gov on December 22, 2011.
 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 6 
 

 

 

 

 

these quality ratings to evaluate how nursing facilities may differ from one 

another.42 

When identifying deficiencies, State surveyors determine the accuracy of 

residents’ comprehensive (MDS) assessments and the adequacy of care 

plans using those assessments. However, no guidance explains 

specifically how deficiencies in resident assessments and care plans should 

be scored. See Appendix D for more information about the State 

certification process for nursing facilities. 

Previous Office of Inspector General Reports 

Previous OIG studies used medical review to examine the accuracy of the 

MDS in resident assessments and care plans at skilled nursing facilities.43 

Medical reviewers identified inconsistencies between responses in MDS 

and documentation in residents’ medical records. For example, medical 

reviewers identified documentation in nursing facility records representing 

triggered conditions; however, staff did not indicate in the MDS that these 

conditions were present. Thus, MDS did not “trigger” RAPs and staff did 

not consider triggered conditions in care plans. 

Additional OIG work has focused on the timeliness of resident 

assessments and submission of required MDS data.44 OIG found that 

nursing facilities generally performed resident assessments and submitted 

MDS data within required timeframes, but did not always code MDS data 

accurately. In contrast to previous OIG reports, this report does not 

examine the accuracy of MDS data. 

METHODOLOGY 

We selected a random sample of nursing facility records for elderly 

residents receiving atypical antipsychotic drugs. We reviewed the records 

for evidence of compliance with Federal requirements for resident 

assessments and care plans. 

Data Collection 

Scope. This study used a sample of records from a previous OIG study of 

elderly nursing facility residents with Medicare claims for atypical 

antipsychotic drugs during the first 6 months of 2007.45 During the 

42 CMS, “Understanding Nursing Home Quality Measures.” Accessed at http://www.medicare.gov on 

December 22, 2011.
 

43 Nursing Home Resident Assessment Quality of Care (OEI-02-99-00040), January 2001; Supplemental Data 

on the Minimum Data Set (OEI-02-02-00831), August 2005; and Questionable Billing by Skilled Nursing 

Facilities (OEI-02-09-00202), December 2010.
 

44 Facility Performance in Assessing Residents and Submitting MDS Records (OEI-06-02-00730), April 2005.
 

45 Medicare Claims for Atypical Antipsychotic Drugs in Nursing Homes (OEI-07-08-00150), May 2011.
 

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previous study, geriatric psychiatrists reviewed these residents’ records to 

determine facility compliance with Medicare requirements for 

administering atypical antipsychotic drugs. Because all previously 

sampled residents had Medicare claims for atypical antipsychotic drugs, 

this study used those residents’ records to focus on nursing facility use of 

the RAP for psychotropic drug use during resident assessments and care 

plans. 

Sample Selection. For this study, we reviewed 375 records randomly 

selected from the 640 nursing facility records collected for the previous 

study. During the previous study, we requested nursing facility records 

corresponding to a sample of 700 Medicare claims (from a universe of 

1,678,874 claims) for atypical antipsychotic drugs for elderly residents 

from January 1 through June 30, 2007 (our review period).46 These 

prescription drug claims from the previous study were associated with 

304,983 elderly nursing facility residents, representing 14 percent of the 

total elderly nursing facility population during the review period.47 

We did not project our results for this study to the universe of residents 

from the previous study because the basis for sampling for the previous 

study was claims rather than residents. We also did not project our results 

for this study to the original universe of claims corresponding to the 

nursing facility records, as the nursing facility regulatory requirements that 

we reviewed in this study are not applicable to prescription drug claims. 

Record Review. We used the Medicare beneficiary nursing facility records 

for the 6 months before and after the date of the sampled Medicare claims, 

which were collected for the previous study. We developed a data 

collection instrument to determine the extent to which nursing facilities 

met Federal requirements for resident assessments and for care plans, 

according to documentation in the nursing facility records. We reviewed 

the records for comprehensive assessments, quarterly assessments, and 

care plans. We determined whether the records indicated that nursing 

facility staff complied with Federal requirements for (1) resident 

assessments, (2) decisionmaking, (3) care plan development, and (4) care 

plan implementation. 

Resident Assessments. We determined whether the requisite number of 

comprehensive and quarterly assessments were present in the record. We 

adjusted our analysis, when applicable, according to residents’ dates of 

46 See Appendix E for detailed information about how the sampling methodology for the previous study affects 

this study. 

47 The previous study excluded payments for atypical antipsychotic drugs provided under the Medicare Part A 

Prospective Payment System for short-term stays in skilled nursing facilities because they are not individually 

quantifiable on the basis of claims data. 
 

death during our review period. For example, if a resident’s date of death 

occurred 4 months before the end of our 12-month review period, we did 

not expect to see at least one comprehensive assessment and all three 

quarterly assessments in the record, nor did we consider those records to 

be noncompliant. Similarly, if a resident was admitted to the nursing 

facility in the middle of our review period, we adjusted our analysis of 

timeliness accordingly. 

We also reviewed assessments for staff involvement. We noted the 

credentials of staff listed as participants in completing comprehensive and 

quarterly assessments. When the MDS had a location for an RN to sign 

indicating RN coordination of the comprehensive assessment or of the 

RAP assessment process, we assumed the signatures to be those of RNs 

even if the individual signing the form did not list his or her credentials. If 

the signature was missing from the relevant assessment section or the 

relevant assessment section was missing entirely, we considered the record 

noncompliant. 

Decisionmaking. We reviewed comprehensive assessments to determine 

whether the nursing facility staff documented their care plan decisions 

when the RAP for psychotropic drug use was triggered. For example, if 

this RAP was triggered because a resident taking an atypical antipsychotic 

drug experienced an unsteady gait, we reviewed the RAP summary to 

determine whether nursing facility staff (1) attributed the unsteady gait to 

antipsychotic drug use or another cause and (2) determined whether the 

unsteady gait represented a problem for the resident that needed to be 

addressed in the care plan. When staff documented a decision, we noted 

the facility’s intention to proceed (or not to proceed) with inclusion of an 

intervention in the care plans. 

Care Plan Development. We reviewed care plans for timeliness 

(i.e., developed within 7 days of each comprehensive assessment) and 

evidence that they were developed by an interdisciplinary team composed 

of at least a physician and an RN and that the resident or the resident’s 

family or legal representative was involved. We noted the credentials of 

staff listed as participants in developing the care plan, including mental 

health professionals, such as psychologists or psychiatric or geriatric 

specialty-trained physicians. When involvement of the resident or the 

resident’s family or legal representative was not documented within the 

care plan, we reviewed care plan information, intake forms, social work 

notes, and nursing notes to determine whether nursing facility staff 

documented why their involvement was not practicable. For example, if 

the intake form indicated that the resident was incompetent and the social 

worker noted that he or she was not successful in contacting the resident’s 

family or legal representative regarding a care plan update, we determined 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 9 
 

that the involvement of the resident or the resident’s family or legal 

representative was not practicable and that the nursing facility complied 

with this requirement. 

Care Plan Implementation. We reviewed mental health assessments, 

medication administration records, and logs of behavior and drug side 

effects to determine whether interventions occurred as stated in the care 

plans. For example, if a care plan stated that the nursing facility would 

monitor the resident for side effects, such as unsteady gait, and would 

attempt gradual dose reductions, we reviewed the record for evidence of 

those interventions. We reviewed care plans for evidence of interventions 

to address psychotropic drug use regardless of whether the RAP for 

psychotropic drug use was triggered and/or considered in the development 

of the care plan. We also reviewed records for evidence of interventions to 

address psychotropic drug use regardless of whether they were listed in the 

care plans. 

Data Analysis 

Using SAS (a statistical analysis software package), we analyzed data 

collected during our record review. We calculated the proportion of 

sampled records that included evidence indicating that: 

	 comprehensive and quarterly assessments were conducted during the 

time intervals required and by qualified health professionals; 

	 care plans included consideration of interventions for triggered RAPs; 

	 care plans were created timely, were prepared by an interdisciplinary 

team, and involved the resident or the resident’s family or legal 

representative; and 

	 care plans were implemented as described with respect to interventions 

for antipsychotic drug use. 

Given the nature of our study population, our review of the involvement of 

health professionals in resident assessments and care plans focused on 

those most qualified to assess complex mental health and medical 

conditions, including physicians, psychologists, social workers, and RNs. 

We did not review the involvement of other staff, such as activities 

professionals, nutritionists, licensed practical nurses, or nurse’s aides. 

Additionally, our review determined whether assessments were present in 

records during the general time intervals required rather than the precise 

timeliness of such items. For example, we determined how many 

quarterly and annual assessments were present rather than whether each 

quarterly assessment was performed exactly 92 days from the previous 

assessment date. This method may have overestimated nursing facility 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 10 
 

 

compliance with Federal requirements for timeliness of resident 

assessments. 

Limitations 

Our analysis was limited by the information available in the nursing 

facility records and interpretation of those records provided previously by 

medical reviewers. Neither the medical reviewers nor the study team 

members conducted in-person observations of the residents or interviews 

with the residents, residents’ families or legal representatives, or clinical 

staff to evaluate compliance with Federal requirements. 

To determine compliance with the requirement that care plan development 

include the resident, the resident’s family, or the resident’s legal 

representative “to the extent practicable,” we reviewed whether attempts at 

inclusion were documented. While no explicit requirement exists that a 

nursing facility document its efforts to include the resident, family, or legal 

representative, documentation was the most feasible way to assess 

compliance with the requirement. 

We did not determine whether comprehensive assessments were conducted 

when a significant change in resident status occurred, because the medical 

reviewers did not note those occurrences.48 

We determined the extent to which the RAP for psychotropic drug use was 

used to create care plans. However, we did not determine the medical 

appropriateness of care plans or of the antipsychotic drugs prescribed for 

residents. 

Although the medical records we reviewed are from a period prior to 

implementation of MDS 3.0, we are unaware of any MDS changes or 

other changes in nursing facility practice that materially affect the findings 

in this report. 

Standards 

This study was conducted in accordance with the Quality Standards for 

Inspection and Evaluation issued by the Council of the Inspectors General 

on Integrity and Efficiency. 

48 42 CFR § 483.20(b)(2). 

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Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 12 

FINDING 

Nearly all records reviewed failed to meet one or more 

Federal requirements for resident assessments and/or 

care plans 

Overall, 373 of the 375 records reviewed for elderly nursing facility 

residents receiving atypical antipsychotic drugs during the first 6 months 

of 2007 lacked evidence to indicate that they met all Federal 

requirement(s) for nursing facility resident assessments and care plans. 

The resident assessment and care plan process involves four steps. 

One-third of records did not contain evidence of staff compliance with 

Federal requirements regarding resident assessments, the first step. For 

4 percent of records, nursing facility staff did not document consideration 

of the RAP for psychotropic drug use as required, the second step. 

Additionally, 99 percent of records did not contain evidence that Federal 

requirements for care plans—the third step—were met. Finally, 

18 percent of records that listed care plan interventions for antipsychotic 

drug use did not contain evidence that those interventions—the fourth 

step—actually occurred. Forty-eight percent of records did not meet two 

or more Federal requirements, resulting in 205 overlapping errors.49 

Table 1 summarizes records that did not meet Federal requirements for 

resident assessments and care plans. Further details regarding each type of 

requirement follow the table. 

Table 1: Records That Did Not Contain Evidence That Federal 

Requirements Were Met 

Federal Requirements Not Documented 

Resident Assessments 

Decisionmaking 

(Consideration of RAP for psychotropic drug use) 

Care Plan Development 

Care Plan Implementation 

Records 

(n=375) 

125 

15 

371 

67 

Percentage 

33.3% 

4.0% 

98.9% 

17.9% 

Overlapping (205) (54.6%)

 Total (net) 373 99.5% 

Source: OIG analysis of nursing facility records, 2011. 

49 Note that a single record may have multiple errors and thus the percentage overlap would be equal to or 

greater than the percentage of records with overlapping errors. 
 

 

 

One-third of records reviewed did not contain evidence of 

compliance with Federal requirements regarding resident 

assessments 

To meet Federal requirements, 

nursing facility staff must conduct at 

least one comprehensive resident and 

three quarterly assessments per year. 

Comprehensive assessments and RAP 

assessments must be coordinated by 

1. Assessment 

2. Decisionmaking 

3. Care Plan 

Development 

4. Care Plan 

Implementation 

an RN. Overall, 125 of 375 records 

did not meet Federal requirements 

regarding resident assessments, 

according to the documentation 

provided. Nine percent of records did not meet more than one Federal 

requirement for resident assessments, resulting in 34 overlapping errors. 

Table 2 shows the number and percentage of records that did not comply 

with Federal requirements for resident assessments. 

Table 2: Records That Did Not Contain Evidence That 

Federal Requirements for Resident Assessments Were Met 

Federal Requirements Not Documented 

Lacked required quarterly assessments 

Lacked required comprehensive assessments 

Comprehensive assessments not coordinated by RN 

RAP assessments not coordinated by RN 

Records 

(n=375) 

106 

43 

0 

10 

Percentage 

28.3% 

11.5% 

0.0% 

2.7% 

Overlapping (34) (9.1%)

 Total (net) 125 33.3% 

Source: OIG analysis of nursing facility resident records, 2011. 

As listed in Table 2, 28 percent of records did not include required 

quarterly assessments and 12 percent of records did not include required 

comprehensive assessments. No records that contained the required 

assessments lacked evidence of an RN’s coordination of comprehensive 

assessments; however, 10 such records lacked evidence of an RN’s 

coordination of the RAP assessment. 

Although RN involvement in resident assessments was generally evident, 

records contained little evidence of involvement by a professional who 

was qualified in the relevant care area, such as a mental health 

professional. Despite the fact that residents had mental health conditions 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 13 
 

that needed to be assessed by qualified health professionals, no 

psychiatrists or geriatricians were involved with resident assessments and 

only one record contained evidence that a psychologist was involved. In 

fact, 46 percent of records indicated that an RN was solely responsible for 

conducting the resident assessment. See Appendix F for a listing of 

professionals involved in the comprehensive resident assessments for this 

population, illustrating the lack of involvement of mental health 

professionals. 

For 4 percent of records reviewed, nursing facility staff did not 

document consideration of the RAP for psychotropic drug use 

as required 

Nursing facility staff must document 

their decisionmaking regarding 

whether triggered conditions for RAPs 

require care plans. Nursing facility 

staff did not document consideration 

of the RAP for psychotropic drug use 

1. Assessment 

2. Decisionmaking 

3. Care Plan 

Development 

4. Care Plan 

Implementation 

for 15 of the 375 records reviewed. 

Additionally, of the 277 records that 

indicated that the staff intended to 

develop care-plan interventions for 

psychotropic drug use, 14 percent (39 of 277) did not contain evidence 

that the staff actually did so. Of the 98 records that indicated that staff did 

not intend to develop care-plan interventions for psychotropic drug use, 

54 percent (53 of 98) contained evidence that the staff developed such 

interventions, further illustrating a disconnection in the decisionmaking 

process between resident assessments and care plans. 

Ninety-nine percent of records reviewed did not contain 

evidence of compliance with Federal requirements for care 

plan development 

To meet Federal requirements, a care 

plan must (1) be developed within 

7 days after the completion of a 

comprehensive assessment, (2) be 

prepared by an interdisciplinary team 

consisting of at least a physician and 

1. Assessment 

2. Decisionmaking 

3. Care Plan 

Development 

4. Care Plan 

Implementation 

an RN, and (3) include involvement 

of the resident or the resident’s 

family or legal representative to the 

extent practicable. Table 3 shows the 

number and percentage of records that did not contain evidence of 

compliance with Federal requirements for care plans. Sixty-six percent of 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 14 
 

 

records did not contain evidence for more than one Federal requirement 

for care plans, resulting in 271 overlapping errors. 

Table 3: Records That Did Not Contain Evidence That Federal 

Requirements for Care Plan Development Were Met 

 Federal Requirements Not Met 

 No care plan documentation was provided 

Care plans were not developed timely 

Care plans did not include evidence of 

resident/family/representative involvement or 

documentation as to why it was impracticable 

Care plans were not developed by 

interdisciplinary team (physician and RN) 

Records 

(n=375) 

23 

35 

221 

363 

Percentage

6.1% 

9.3% 

58.9% 

96.8% 

Overlapping (271) (72.2%)

 Total (net) 371 98.9% 

Source: OIG analysis of nursing facility resident records, 2011. 

Six percent of records did not include care plans, and 9 percent of records 

contained care plans that were not developed or updated within the 

required 7 days from the completion of comprehensive assessments. Less 

than 5 percent of records contained care plans developed by the required 

interdisciplinary team of at least a general physician and an RN. 

A psychiatrist, geriatrician, or psychologist should also be involved in 

developing care plans, given that they are the appropriate, qualified 

practitioners to assess the mental health conditions among our study 

population. However, only two care plans involved such practitioners. 

Moreover, 20 percent of records indicated that an RN, a social worker, or a 

licensed practical nurse was solely responsible for developing the care 

plan.50 Of the 12 records that involved a physician, 2 records indicated 

that the physician signed the care plan but did not actually attend the care 

plan development conference. See Appendix F for a listing of the 

professionals that were involved in care plans for our study population, 

showing the lack of mental health professionals. 

Though the participation of the resident, family, or legal representative in 

developing care plans is required only “to the extent practicable,” such 

participation is important to ensure that residents receive quality care. 

Overall, 91 percent of records did not contain evidence that the resident, 

the resident’s family, or the resident’s legal representative participated in 

50 These records are included in the measure of care plans not developed by an interdisciplinary team. 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 15 
 

the care plan process. Nearly two-thirds of those records, or 59 percent of 

all records, also lacked documentation as to why such participation did not 

occur (i.e., why participation was not practicable). 

Eighteen percent of records reviewed did not contain evidence 

to indicate that planned interventions for antipsychotic drug 

use occurred 

Nursing facilities must provide 

necessary services to residents in 

accordance with their written care 

plans. Interventions for psychotropic 

drug use listed in care plans included 

monitoring for side effects and 

1. Assessment 

2. Decisionmaking 

3. Care Plan 

Development 

4. Care Plan 

Implementation 

effectiveness of the drugs and 

attempting gradual dose reductions. 

For 18 percent of records reviewed, 

nursing facility staff listed such 

interventions in residents’ care plans, but the records contained no 

evidence that those interventions occurred. For example, one resident’s 

care plan listed as an intervention a gradual dose reduction for the 

antipsychotic drug within a certain quarter, but the record contained no 

evidence in the medication log, pharmacist’s review, or elsewhere that a 

dose reduction was attempted. Also, in several of these cases, the facilities 

had forms—such as side-effect logs or behavioral logs—designed to 

measure the intervention, but those forms were either blank or incomplete. 

An additional 23 percent of records reviewed did not list any interventions 

for psychotropic drug use. Overall, of the records we reviewed of elderly 

nursing facility residents receiving atypical antipsychotic drugs, 

41 percent contained no indications that the residents received relevant 

interventions. 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 16 
 

 

 

 

CONCLUSION AND RECOMMENDATIONS 

In striving to ensure quality of care for residents, nursing facilities must provide 

residents with the services they need to achieve their highest practicable level of 

well-being. Nursing facilities identify services through periodic assessments of 

each resident’s functional capacity and specify these services in a written care 

plan for each resident. Facility noncompliance with the requirements for 

resident assessments and care plans may negatively affect the services that 

residents receive, thereby placing their quality of care at risk. 

Overall, 99.5 percent of records reviewed for elderly nursing facility residents 

receiving atypical antipsychotic drugs did not contain evidence that all Federal 

requirements for nursing facility resident assessments and care plans were met. 

For one-third of records, nursing facility staff did not complete resident 

assessments in accordance with Federal requirements. For 4 percent of records, 

nursing facility staff did not document consideration of the RAP for 

psychotropic drug use as required. Ninety-nine percent of records did not 

contain evidence that care plans were developed in accordance with Federal 

requirements. Finally, for 18 percent of records, records contained no evidence 

that interventions for antipsychotic drug use listed in the care plans actually 

occurred. Forty-eight percent of records did not meet more than one type of 

requirement. The extent of the noncompliance identified suggests increased 

risks for this already vulnerable population. 

To ensure that nursing facilities take actions designed to provide high-quality 

care to elderly residents in nursing facilities, we recommend that CMS: 

Improve the detection of noncompliance with Federal requirements 

for resident assessments and care plans 

Although this study targeted residents receiving antipsychotic drugs, CMS 

should aim to eliminate nursing facility deficiencies in resident assessments and 

care plans for all residents. CMS should also consider modifying the survey 

process to target a small subsample of residents receiving antipsychotic drugs, 

focusing on the quality of care for these particularly vulnerable residents. 

In addition, CMS should consider strengthening guidance in the SOM for issues 

for which Federal regulations for resident assessment and care plans do not 

explicitly require documentary evidence. For example, CMS could require that 

nursing facilities document any efforts to include the participation of residents, 

their families, or their legal representatives in the development of care plans. 

Surveyors’ determination of compliance with requirements for care plan 

development may be more expeditious and reliable if based on documentation 

rather than on the recollection of residents, their families or legal 

representatives, or nursing facility staff. 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 17 
 

Take appropriate action to address noncompliance with Federal 

requirements for resident assessments and care plans 

CMS should ensure that both the rate of detection and the sanctions for survey 

deficiencies are significant enough to deter noncompliance. CMS could 

accomplish this by clarifying in the SOM which deficiency determinations and 

enforcement remedies are most appropriate for deficiencies in resident 

assessments and care plans. For example, CMS could indicate whether 

residents are placed in an “immediate jeopardy” status when interventions listed 

in care plans are not provided. 

To promote nursing facility compliance, CMS should also explore alternative 

methods beyond the State survey and certification process. CMS could consider 

incentive programs for nursing facilities and/or prescribing physicians for 

providing high-quality resident assessment and care plan services. To bring 

consumer awareness to this issue, CMS could also consider adding to the 

publicly available Nursing Home Compare Web site one or more quality 

measures reflecting deficiencies in resident assessment and care plans. 

Provide methods for nursing facilities to enhance the development 

and usefulness of resident assessments and care plans for 

residents receiving antipsychotic drugs 

CMS could accomplish this by: 

	 forming a task force of qualified health professionals (e.g., geriatric 

psychiatrists, psychologists, social workers) to recommend best practices for 

resident assessments and care plans for nursing facility residents receiving 

antipsychotic drugs; 

	 exploring novel ways to ensure that nursing facilities have access to the 

expertise of qualified mental health professionals (e.g., through remote 

consultations or interactive informational Web sites) when assessing and 

developing care plans for residents receiving antipsychotic drugs; 

	 providing nursing facility staff with training on the importance of care plan 

interventions, especially for residents receiving antipsychotic drugs; and 

	 encouraging nursing facilities to complete the applicable forms when 

providing care plan interventions, such as monitoring residents’ moods, 

behaviors, and drug side effects. 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 18 
 

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

CMS concurred with all of our three recommendations. CMS has recently 

launched a national initiative to improve behavioral health and dementia care 

and to reduce the use of antipsychotic drugs in nursing homes by 15 percent by 

the end of 2012. CMS noted that that the information in this report will be 

helpful in its efforts to improve the care of all individuals residing in nursing 

homes, not only those receiving antipsychotic medications. 

With regard to our first recommendation, CMS plans to strengthen guidance for 

surveyors in the SOM to improve the detection of noncompliance with Federal 

requirements for resident assessments and care plans. CMS also recently 

expanded the sampling strategy for the Quality Indicator Survey to ensure 

sufficient representation of residents receiving antipsychotic drugs. If resources 

permit, CMS plans to test a focused review of resident assessments, care plans, 

and medication use in a sample of nursing facilities. 

With regard to our second recommendation, CMS plans to clarify guidance in 

the SOM on which deficiency determinations and enforcement remedies are 

most appropriate for deficiencies in resident assessments and care plans and to 

include this clarification in upcoming surveyor training programs. CMS plans 

to develop—through a partnership with consumer organizations—educational 

materials to increase consumer awareness of antipsychotic drug use in nursing 

facilities. CMS also plans to post a new quality indicator on the publicly 

available Nursing Home Compare Web site regarding the prevalence of 

antipsychotic drug use among long-term residents with dementia who have not 

been diagnosed with specific psychotic disorders. 

With regard to our third recommendation, CMS has a multidisciplinary 

approach to reduce the unnecessary use of antipsychotic drugs that includes 

public-private partnerships; research; technical assistance and education (for 

nursing homes, physicians/prescribers, pharmacists, nurses, and others); 

consumer engagement; public reporting; and updates to surveyor guidance and 

training. A technical expert panel recently advised CMS regarding provider 

training and technical assistance, quality indicators, surveyor training, and 

improvements to surveyor guidance. 

The full text of CMS’s comments is provided in Appendix G. We did not make 

any changes to the report based on CMS’s comments. 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 19 
 

 

APPENDIX A 

Changes to the Minimum Data Set, Version 3.0, That May Affect the Assessments of Residents 

Receiving Antipsychotic Drugs 

Cognitive Assessment: 

 The Brief Interview for Mental Status (BIMS) structured test replaces the staff 

assessment for residents who can understand the interview questions and respond. 

 Facilities complete the staff assessment for mental status only for residents who cannot 

complete the BIMS. 

 The Validated Confusion Assessment Method (CAM) replaces the MDS 2.0 delirium 

items, which were not reliable. 

Mood Assessment: 

 The Patient Health Questionnaire nine-item depression scale (PHQ-9) resident 

interview replaces staff observations for residents who can report mood symptoms. 

 This scale is based on well-established diagnostic criteria for depression. 

Behavior Items: 

	 Items regarding hallucinations and psychosis were moved from a list of several other 

behaviors to a subsection about psychosis where definitions for hallucinations and 

delusions were added to the form. 

 Language describing physical and verbal behavioral symptoms was revised for 

clarification. 

 “Wandering” is now rated separately from the other behavioral symptom groups. 

Resident Assessment Protocol (RAP) for psychotropic drug use: 

 The RAP is now called the Psychotropic Drug Use Care Area Assessment (CAA). 

 Whereas the RAP was triggered by combination triggers in MDS 2.0 (listed in 

Appendix B), the CAA—its successor—is triggered simply by use of an antipsychotic, 

antianxiety, antidepressant, or hypnotic medication administered to the resident in the 

7 days preceding the assessment. 

Source: Centers for Medicare & Medicaid Services (CMS), Long-Term Care Facility Resident Assessment Instrument User’s 

Manual, version 3.0, September 2010; CMS, Minimum Data Set (MDS), accessed at https://www.cms.gov on May 14, 2011; and 

CMS, MDS 3.0: The Why & How (presentation from MDS 3.0 National Training Conference), August 2010, accessed at 

https://www.cms.gov on May 11, 2011. 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 20 
 

APPENDIX B 

Triggers for the Resident Assessment Protocol for Psychotropic Drug Use 

[FOR THE RESIDENT ASSESSMENT PROTOCOL (RAP)] TO BE TRIGGERED, 

RESIDENT MUST FIRST USE A PSYCHOTROPIC DRUG (antipsychotic, antidepressant, 

or antianxiety). If used, go to Resident Assessment Protocol review if one or more of the 

following [is] present:* 

Potential for drug-related hypotension or Potential for drug-related 

gait disturbances if: cognitive/behavioral impairment if: 

 Repetitive Physical Movement  Delirium/Disordered Thinking 

 Balance While Sitting o Easily Distracted 

 Hypotension o Periods of Altered Perception or 

 Dizziness/Vertigo Awareness of Surroundings 

o Episodes of Disorganized Speech  Syncope 

o Periods of Restlessness  Unsteady Gait 

o Periods of Lethargy  Fell in Past 30 Days 

o Mental Function Varies Over the  Fell in Past 31-180 Days Course of the Day  Hip Fracture  Deterioration in Cognitive Status  Swallowing Problem  Deterioration in Communication 

 fort if: Deterioration in Mood Potential for drug-related discom  Deterioration in Behavioral Symptoms  Constipation  Depression  Fecal Impaction  Hallucinations  Lung Aspiration 

Source: Centers for Medicare & Medicaid Services (CMS), Long-Term Care Facility Resident Assessment Instrument [RAI] 

User’s Manual, version 2.0, December 2002. 

*Minimum Data Set 3.0, released October, 2010, now uses Care Area Assessments (CAA) for triggered conditions instead of 

RAPs. The only condition to trigger the Psychotropic Drug Use CAA is that the resident received psychotropic drugs in the 

7 days prior to the assessment. CMS, Long-Term Care Facility RAI User’s Manual, version 3.0, September 2010. 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 21 
(This is an iterative process: staff should 

evaluate interventions, reassess the 

resident, and modify the care plan as 

necessary.) 

4. Care Plan 

Implementation 

The care plan lists this 

intervention:
 

"Monitor resident for drug 

side effects and efficacy. 

Evaluate for gradual dose 

reduction."
 

1. Assessment 

•The Mimimum Data Set 

(MDS) notes antipsychotic 

drug use in the last 7 days 

and unsteady gait. 

•These items trigger the 

Resident Assessment 

Protocol (RAP) for 

psychotropic drug use. 

2. Decisionmaking 

The facility staff note this 

in the RAP summary: 

"Antipsychotic drug use 

may contribute to unsteady 

gait. Proceed to care 

plan." 

3. Care Plan 

Development 

The care plan lists this 

problem:

"The resident is at risk of 

side effects of
 

antipsychotic drug use, 

especially unsteady gait."
 

 

 

APPENDIX C 

Example of How a Resident Assessment Is Used To Develop a Care Plan Intervention for 

Antipsychotic Drug Use 

Source: Office of Inspector General analysis of nursing facility records, 2011. 

Note: MDS 3.0, released October, 2010, now uses Care Area Assessments (CAA) for triggered conditions instead of RAPs. The 

only condition to trigger the Psychotropic Drug Use CAA is that the resident received psychotropic drugs in the 7 days prior to the 

assessment. Centers for Medicare & Medicaid Services, Long-Term Care Facility Resident Assessment Instrument User’s 

Manual, version 3.0, September 2010. 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 22 
 

APPENDIX D 

State Certification of Nursing Facilities 

General Process 

State agencies certify nursing facilities as compliant or noncompliant with Federal 

standards for health and safety. This determination is based on a survey conducted by 

qualified health professionals that verifies whether and how each standard is met. Surveys 

are generally unannounced and must be conducted at a minimum of every 15 months for 

each facility. If deficiencies are identified, they are categorized by severity (i.e., effect on 

resident outcome) and scope (i.e., number of residents potentially or actually affected), and 

the State sends the facility a Statement of Deficiencies. Facilities have 10 days to respond 

with a Plan of Correction for each cited deficiency. If an acceptable plan is not submitted 

or if a facility does not correct deficiencies, the State and/or the Centers for Medicare 

& Medicaid Services (CMS) may impose remedies, such as civil money penalties, 

temporary managers, directed plans of correction, in-service training, denial of payment for 

new admissions, and State monitoring. 

Survey tasks. State surveys generally include: offsite survey preparation, an entrance 

conference and onsite preparation, an initial tour of the facility, and a sample selection of 

residents. Information for the sampled residents is gathered through activities such as 

observations; informal and formal interviews with residents, staff, family, and others; and 

record review. Surveyors analyze this information to identify any deficiencies and then 

hold an exit conference with the facility. 

Deficiency determinations. When a facility is not in substantial compliance with Federal 

standards, the facility may have the opportunity to correct deficiencies before remedies are 

imposed. This depends on the severity and scope of the deficiencies. Severity levels 

should reflect pyschosocial (i.e., mood and behavior) outcomes as well as physical 

outcomes. There are four severity levels, ranging from no actual harm with potential for 

minimal harm (Level 1) to immediate jeopardy to resident health or safety (Level 4). 

Immediate jeopardy requires immediate corrective action because of actual or potential 

serious injury, harm, impairment, or death to a resident. When determining scope, 

surveyors consider the cause of the deficiency. Scope has three levels: isolated, pattern, 

and widespread. If a facility lacks an adequate system to meet a requirement and this 

failure has the potential to affect a large number of residents, the deficiency is likely to be 

widespread. 

Remedy Categories. There are three categories of enforcement remedies (see Table D-1). 

Denial of payment for new admissions must be imposed when a facility is not in substantial 

compliance within 3 months of being found out of compliance. Denial of payment and 

State monitoring must be imposed when a facility provides substandard quality of care as 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 23 
 

 

 

determined by three consecutive standard surveys. See Table D-2 for a matrix of 

enforcement remedies for deficiencies based on severity and scope. 

Table D-1: Remedy Categories 

Category 1 Category 2 Category 3 

Directed plan of correction Denial of payment for new 

admissions 

Temporary management 

State monitor; and/or Denial of payment for all 

individuals imposed by CMS; 

and/or 

Termination 

Directed in-service training Civil money penalties: 

$50 - $3,000/day 

$1,000 - $10,000/instance 

Optional: 

Civil money penalties 

$3,050 - $10,000/day 

$1,000 - $10,000/instance 

Source: CMS, State Operations Manual, Pub. No. 100-07, ch. 7. 

Table D-2: Enforcement Remedies Based on Severity and Scope of Deficiencies 

Deficiency

 Severity 

Remedy 

Category 

Deficiency Scope 

Isolated Pattern Widespread 

Actual or potential for 

death or serious injury 

(immediate jeopardy) 

Required 3 3 3 

Optional 1, 2 1, 2 1, 2 

Actual harm that is not 

immediate jeopardy 

Required 2 2 2 

Optional 1 1 1 

Potential for more 

than minimal harm 

Required 1 1 2 

Optional 2 2 1 

Potential for minimal 

harm; substantial 

compliance exists 

Required None Plan of 

Correction 

Plan of 

Correction 

Source: CMS, State Operations Manual, Pub. No. 100-07, ch. 7. 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 24 
 

Resident Assessments and Care Plans* 

Surveyors are instructed to evaluate assessments, care plans, and outcomes of care 

interventions for sampled residents. Surveyors determine whether the facility has properly 

assessed its residents through the completion of the Resident Assessment Instrument (RAI) 

and has appropriately developed, implemented, and evaluated care plans. They use 

observations, interviews, and record review to conduct a comprehensive review, including 

the following: 

	 a check of specific items on the Minimum Data Set (MDS) for accurate coding of the 

resident’s condition; 

	 a review of the facility’s completion of the RAI process, including use of the Resident 

Assessment Protocols (RAP), evaluation of assessment information not covered by the 

RAPs, identification of risks and causes of resident conditions, completion of the RAP 

summary sheet, and development of a care plan that meets the identified needs of the 

resident; 

	 a review of the implementation of the care plan and resident response; and 

	 a review of the relationship of the resident’s drug regimen to the resident’s condition, 

including whether the effectiveness of the regimen is being monitored and assessed. 

When reviewing the RAIs and care plans, surveyors: 

	 review the RAP summary sheet to determine: 

o	 where the assessment documentation is located for triggered RAPs and 

o	 whether the facility used the RAPs and considered necessary information when 

deciding to proceed or not proceed with care plans and 

	 review the care plan to identify: 

o	 whether the facility used the RAI to make sound care plan decisions and 

o	 whether the facility implemented the interventions listed in the care plan. 

Surveyors use this information to determine whether a resident’s decline or failure to 

improve was avoidable or unavoidable. Surveyors also determine whether a reassessment 

based on a significant change should have been conducted and whether the absence of a 

reassessment contributed to the resident’s decline or lack of improvement. Record reviews 

of information, of care plans, of implementation of care plans, and of evaluations of care 

enable surveyors to determine whether there has been a decline, an improvement, or 

maintenance in identified focus areas. 

The State Operations Manual does not provide specific guidance to surveyors regarding 

how deficiencies in resident assessments and care plans should be scored and/or when they 

might place residents in immediate jeopardy. 

Source: CMS, State Operations Manual, Pub. No. 100-07, chs.1 and 7, Appendixes P and Q. 

* MDS 3.0, released October, 2010, now uses Care Area Assessments (CAA) for triggered conditions instead of RAPs. 

As a result, State surveyors now use CAAs instead of RAPs during their reviews. 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 25 
 

 

 

 

 

 

 

APPENDIX E 

Sample Selection 

The sample size for the original study (700) was chosen to accommodate stratification by 

resident diagnoses. (For additional information, see Medicare Claims for Atypical 

Antipsychotic Drugs in Nursing Homes, OEI-07-08-00150, May 2011). This 

stratification scheme was not relevant to the current study. Therefore, we randomly 

selected fewer records from the original sample to expedite our review for this study 

while allowing for adequate precision when reporting results. 

We reviewed a subset of 375 records for this study that were originally collected for the 

previous study. The original sample of 700 claims included 59 cases from facilities that 

did not respond to our record request, which are not represented in this study. The 

original sample also included 40 cases with records that were not submitted timely and 

were therefore not submitted for medical review. Twenty-four of those 40 cases were 

included in this review but did not contain data from the previous medical record review. 

Table E-1 shows how the original sample for the previous study relates to the sample for 

this study. 

Table E-1: Characteristics of Current Sample Based on 

Previous Study 

Study Sample 

Size Nonrespondents 

Did Not Receive 

Medical Review 

Previous 700 59 40 

Current 375 n/a 24 

Source: Office of Inspector General selection of study sample, 2010. 

We conducted analysis to determine whether the errors in this study correlated with the 

errors in the previous study. There were no statistically significant correlations between 

the two sets of variables. Therefore, our results for this study do not appear to be biased 

by the absence of information from those records that did not previously undergo medical 

review. 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 26 
 

APPENDIX F 

Professionals Involved in Resident Assessments and Care Plans 

Table F-1: Professionals Involved in Resident Assessments 

Professionals 

Psychiatric Physician 

Geriatric Physician 

Psychologist 

General Physician 

Social Worker 

Registered Nurse 

Number 

(Exclusive*) 

0 

0 

0 

0 

15 

172 

Percentage 

0.0% 

0.0% 

0.0% 

0.0% 

4.0% 

45.9% 

Number 

(Inclusive**) 

0 

0 

1 

4 

103 

261 

Percentage 

0.0% 

0.0% 

0.3% 

1.1% 

27.5% 

69.6% 

*The indicated staff member was solely responsible for resident assessments. 

**The indicated staff member was responsible for resident assessments as part of a group including one or more staff 

members from other disciplines. 

Source: Office of Inspector General (OIG) analysis of nursing facility resident records, 2011.
 

Table F-2: Professionals Involved in Care Plans 

Professionals 

Psychiatric Physician 

Geriatric Physician 

Psychologist 

General Physician 

 Licensed Practical 

Nurse 

Social Worker 

Registered Nurse 

Number 

(Exclusive*) 

0 

0 

0 

0 

13 

13 

50 

Percentage 

0.0% 

0.0% 

0.0% 

0.0% 

3.5% 

3.5% 

13.3% 

Number 

(Inclusive**) 

0 

0 

2 

12 

49 

160 

195 

Percentage 

0.0% 

0.0% 

0.5% 

3.2%

13.1% 

42.7% 

52.0% 

*The indicated staff member was solely responsible for resident assessments. 

**The indicated staff member was responsible for resident assessments as part of a group including one or more staff 

members from other disciplines. 

Source: OIG analysis of nursing facility resident records, 2011. 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 27 
APPENDIX G 

Agency Comments 

J 1.'/ .•J-".~"""' .. .''''. DEf'ARTMEr-;r Or HEAtnl & IIUMAN SERVICES 

", 	 " _'''-.'_,.m,.."..., ,,_". .. , __ 

""""" 	 dmffli~ttlltl1" 

W.W1iflOlt)l).OC 2«/.01 

MAY 302012 

TO: 	 Damel It. Levin:,on 


Insp~l(If ( iclt¢t'ill 


FROM: 	 fvP.u~!1l1t..1.Itlllt't 


Acting .. in~,.,'tol 

Sl!fUE<'''r: 	 OffiCt' "(~)«i!:lr <kn<:r41 (010) Dmlt Report Nuntng facility "~t~!<l'l'IenlS and 

(",3!C ?tlll1$ (If Ri:SU!elll'l Rrteiviftg Atypical Antip;lIychoti(; Dmhls 

{Off·v?·08.00 I S I I 

Thank you fUT (hi: ofJp,(JrtW¥ily \Q review the subje<:t 010 dr4!\~pOrt un nUTlling fadlhy 

asse~fI'le t' and care pltlM k t rC$idcnt$ receiving utypi.cnl antip$ydwlic drugs. The Centers for 

\ ..tedi.:are &. !<.ledienid Service~ (eMS} appre<;t1ltes the OIG's valuable contribullnos tnward 

improving tilt' !lve, (If nursin); home midenls. eMS has taken action lhr\)\lgh Il fUU)vMi 

inilwliv¢ h} Improve behavioral henlthand dementia care and 10 reduce tile nf antipsycholic 

drugs 'm nursi ng hamcs by 15 perH'!ol by Ihe end of Cillt:ndar )'car 2(H2. St,me detail! {.fC}.!S' 

initiative arc included in the NCOlll'trendatJon sections below.. \VellppM.:iatc fhAl the 

inforlm'lIiiln in thill 010 dral\ t'C'pOf1 will be helpful in our ~rrtIW u> lmpruw rhe ~e vf aU 

indh'idunls residing In !lu.n;ing hottleS. not only those on amipsychoti;; nwd;iC\1ti.t'!I;!l, 

To en~u~ that nUflufliI l'4!n l!tles i{lke lIICtiom dcsiSl1i!d tt) provide high-quahty c<vc to elderly 

Tes1d..'1lts in mming t'aeilitit'$. "'It ret::ommend that C~l'" Improve tilt' dc\{':Clwr\ ofnNleOmpliltJ'1(;(: 

with f¢tkra! re'l tl iR'm~ nl$ for tt""ident usS<."'Ssments and care plans. 

eMS ~"oncur'l. eMS plmu to 51 reng,lhcn the Slate OperatifHtf Mannal dit¢t1ioos fur survt.'yOT'S to 

fcvic\'\' cKlI:umentation of rClIident and family involvement in tlsscsstnent ll!ld can: planning.. tiS 

well as as!o(",~sing wmplltlnc¢ " ith regulations through intervieWl; with f'eSidenu and families. 

pl<ij1h<r. we recently imph.1lllcnted the new Minimum Data Sel (MDs) .l .G $)'stem, as (I system 

which inCQtpOl'llleS hnpruvcruefllll that were O(ot present. illlllC MOS 2.U{lInd hence not lIvai\abk: 

for the OlG study). 1» p.mticul:Sf. MOS ) .0 rcquiresfa(;;iUtil.7$ lOinlcJ'Vlew n:sidenl$ and staff 

rather than sotcly lool.:inl,l lit pUl'er records. eMS believes tltat im}'lro'l<i:w, of 

noncompliam:ce durin.g the survi:Y prOCC$li mould also rely on bath lheme.dlcal ~cord and Sill 

and ~sident or farolly intefv~, New SUTve}Xlt 1,?uiliancc in devel()pt1"W:'tU \\1U Cll1phasilC . 

rrlm~iplm. 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08·00151) 28 
 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 29 
 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 30 
 

ACKNOWLEDGMENTS 

This report was prepared under the direction of Brian T. Pattison, Regional 

Inspector General for Evaluation and Inspections in the Kansas City 

regional office, and Brian T. Whitley, Deputy Regional Inspector General. 

Julie Dusold Culbertson served as the team leader for this study. Other 

principal Office of Evaluation and Inspections staff from the Kansas City 

regional office who conducted the study include Rae Hutchison and 

Dennis Tharp. Central office staff who provided support include 

Kevin Farber, Sandy Khoury, and Christine Moritz. 

Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151) 31 
Office of Inspector General 

http://oig.hhs.gov 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as amended, is 

to protect the integrity of the Department of Health and Human Services (HHS) programs, as well as the 

health and welfare of beneficiaries served by those programs. This statutory mission is carried out through 

a nationwide network of audits, investigations, and inspections conducted by the following operating 

components: 

Office of Audit Services 

The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting audits with 

its own audit resources or by overseeing audit work done by others. Audits examine the performance of 

HHS programs and/or its grantees and contractors in carrying out their respective responsibilities and are 

intended to provide independent assessments of HHS programs and operations. These assessments help 

reduce waste, abuse, and mismanagement and promote economy and efficiency throughout HHS. 

Office of Evaluation and Inspections 

The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide HHS, Congress, 

and the public with timely, useful, and reliable information on significant issues. These evaluations focus 

on preventing fraud, waste, or abuse and promoting economy, efficiency, and effectiveness of 

departmental programs. To promote impact, OEI reports also present practical recommendations for 

improving program operations. 

Office of Investigations 

The Office of Investigations (OI) conducts criminal, civil, and administrative investigations of fraud and 

misconduct related to HHS programs, operations, and beneficiaries. With investigators working in all 

50 States and the District of Columbia, OI utilizes its resources by actively coordinating with the 

Department of Justice and other Federal, State, and local law enforcement authorities. The investigative 

efforts of OI often lead to criminal convictions, administrative sanctions, and/or civil monetary penalties. 

Office of Counsel to the Inspector General 

The Office of Counsel to the Inspector General (OCIG) provides general legal services to OIG, rendering 

advice and opinions on HHS programs and operations and providing all legal support for OIG’s internal 

operations. OCIG represents OIG in all civil and administrative fraud and abuse cases involving HHS 

programs, including False Claims Act, program exclusion, and civil monetary penalty cases. In 

connection with these cases, OCIG also negotiates and monitors corporate integrity agreements. OCIG 

renders advisory opinions, issues compliance program guidance, publishes fraud alerts, and provides other 

guidance to the health care industry concerning the anti-kickback statute and other OIG enforcement 

authorities.