Department of Health and Human Services 

OFFICE OF 

 
INSPECTOR GENERAL 

 
 
 
 
 
 
 
 
N F A
URSING  ACILITY  SSESSMENTS 

 
 
C P R
AND  ARE  LANS FOR  ESIDENTS 

 
  R A  
ECEIVING  TYPICAL 

A D  
NTIPSYCHOTIC  RUGS 

 
 
 
 
 
 
 
 
 
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 residents 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 usethe fourth stepactually 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 residents 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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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 
4. Care Plan 
2. Decisionmaking 
Implementation 
3. Care Plan 
Development 
 
Source:  Adapted  from CMS, Long-Term Care Facility Resident Assessment Instrument (RAI) Users  
Manual, version 2.0, December 2002.   
 
 
9 42 CFR  488.10. 
  
10 42 CFR  483.25(l)(2).
  
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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 
residents 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 residents medical, functional, and 
psychosocial issues.13   The residents 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 MDSversion 3.0to improve the 
MDSs 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 residents 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 States  
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 Users Manual, version 2.0, December 2002. 
   
22 CMS, Long-Term Care Facility RAI Users 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 Users 

Manual, version 3.0, September 2010, pp. 4-37. 
   
Nursing Facility  Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151)   4 
   
   
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 residents status to determine whether the lethargy represents a 
problem related to antipsychotic drug use that should be addressed in the 
residents 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 residents care, and other appropriate staff in disciplines as  
determined by the residents 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 residents 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 Users 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     Attempt gradual dose reduction     Dose reduction occurred 2 months ago 
side effects of   of antipsychotic drug at least  and was well tolerated.  
antipsychotic drug use.   once per quarter.      Resident experienced lethargy only 2 of 
Goal: Reduce risk of     Monitor resident for side effects,  the last 30 days. 
side effects.   especially lethargy.      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 residents  
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 residents 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 Users 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  1016Approval 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. 

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death during our review period. For example, if a residents 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 facilitys 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 residents  
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 
residents 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 residents  
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 residents 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 residents 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 nurses 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 residents family, or the residents 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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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 plansthe third stepwere met.  Finally, 
18 percent of records that listed care plan interventions for antipsychotic 
drug use did not contain evidence that those interventionsthe fourth 
stepactually 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 
Records  
Federal Requirements Not Documented   Percentage  
(n=375)  
Resident Assessments  125  33.3%  
Decisionmaking 
15  4.0%  
(Consideration of RAP for psychotropic drug use)  
Care Plan Development   371  98.9%  
Care Plan Implementation   67  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. 
Nursing Facility  Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151)  12 
   
   
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  1. Assessment 
least one comprehensive resident and 
three quarterly assessments per year.  
Comprehensive assessments and RAP   4. Care  Plan 
2. Decisionmaking  
Implementation 
assessments must be coordinated by 
an RN.  Overall, 125 of 375 records 
did not meet Federal requirements 
3. Care  Plan 
regarding resident assessments,  Development 
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 

Records  
Federal Requirements Not Documented   Percentage  
(n=375) 
Lacked required quarterly assessments  106  28.3%  
Lacked required comprehensive assessments   43  11.5%  
Comprehensive assessments not coordinated by  RN   0  0.0%  
RAP assessments not coordinated by RN    10  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 RNs coordination of comprehensive 
assessments; however, 10 such records lacked evidence of an RNs  
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  1. Assessment 
whether triggered conditions for RAPs 
require care plans. Nursing facility 
staff did not document consideration  4. Care  Plan 
2. Decisionmaking  
Implementation 
of the RAP for psychotropic drug use 
for 15 of the 375 records reviewed. 
Additionally, of the 277 records that 
3. Care  Plan 
indicated that the staff intended to  Development 
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  1. Assessment 
7 days after the completion of a 
comprehensive assessment, (2) be 
prepared by an interdisciplinary team   4. Care  Plan 
2. Decisionmaking  
Implementation 
consisting of at least a physician and 
an RN, and (3) include involvement 
of the resident or the residents  
3. Care  Plan 
family or legal representative to the  Development 
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 
Records  
  Federal Requirements  Not Met    Percentage 
(n=375)    
 
 No care plan documentation was provided      23  6.1%  
 
 
Care plans were not developed timely  35  9.3%  
Care plans did not include evidence of 
resident/family/representative involvement or  221  58.9%  
 
documentation as to why it was impracticable 
Care plans were not developed by  
363  96.8%  
interdisciplinary team (physician and RN)    
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 residents family, or the residents 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  1. Assessment 
accordance with their written care 
plans. Interventions for psychotropic 
drug use listed in care plans included  4. Care  Plan 
2. Decisionmaking  
Implementation 
monitoring for side effects and 
effectiveness of the drugs and 
attempting gradual dose reductions.  
3. Care  Plan 
For 18 percent of records reviewed,  Development 
nursing facility staff listed such 
interventions in residents care plans, but the records contained no 
evidence that those interventions occurred.  For example, one residents  
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, pharmacists review, or elsewhere that a 
dose reduction was attempted.  Also, in several of these cases, the facilities  
had formssuch as side-effect logs or behavioral logsdesigned 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.  
 
 
 
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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 residents 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.   
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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. 
 
   
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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 developthrough a partnership with consumer organizationseducational 
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 CMSs comments is provided in Appendix G.  We did not make 
any changes to the report based on CMSs comments. 
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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 CAAits successoris 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 Users  
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.  
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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 
   Syncope  o   Episodes of Disorganized Speech
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  
 
   Deterioration in Mood
Potential for drug-related discomfort if: 
   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] 
Users  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 Users  Manual, version 3.0, September 2010.   
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APPENDIX C 
 
Example of How  a Resident Assessment Is Used To Develop a Care Plan Intervention for  
Antipsychotic Drug Use  
 
 
1. Assessment 
The Mimimum Data Set 
(MDS) notes antipsychotic 
drug use in the last 7 days 
and unsteady gait. 
These items trigger the 
(This is an iterative process:  staff should   Resident Assessment 
evaluate interventions, reassess the  Protocol (RAP) for 
resident, and modify the care plan as   psychotropic drug use. 
necessary.) 
4. Care Plan 
2. Decisionmaking 
Implementation 
The facility staff note this 
The care plan lists this 

in the RAP summary:  
intervention: 

"Antipsychotic drug use 
"Monitor resident for drug 

may contribute to unsteady 
side effects and efficacy.  

gait. Proceed to care 
Evaluate for gradual dose 

plan." 
reduction."
 
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." 

 
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 Users  
Manual, version 3.0, September 2010.   
 
 
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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  
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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  Temporary management  
admissions 
State monitor; and/or  Denial of payment for all  Termination 
individuals imposed by CMS; 
and/or 
Directed in-service training   Civil money penalties:   Optional: 
$50 - $3,000/day  Civil money penalties  
$1,000 - $10,000/instance   $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 Scope  
Deficiency  Remedy  
 Severity   Category   Isolated   Pattern  Widespread  
Actual or potential for 
Required  3  3  3  
death or serious injury 
(immediate jeopardy)  
Optional   1, 2  1, 2  1, 2 
Actual harm that is not  Required  2  2  2  
immediate jeopardy  
Optional  1  1  1 
Potential for more  Required  1  1  2  
than minimal harm  
Optional  2  2  1 
Potential for minimal 
Plan of  Plan of 
harm; substantial  Required  None 
Correction  Correction  
compliance exists   
Source: CMS, State Operations Manual, Pub. No. 100-07, ch. 7.   
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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 
residents condition;  
	   a review of the facilitys 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 residents drug regimen to the residents 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 residents 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 residents 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. 
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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 
Sample  Did Not Receive   
Study   Nonrespondents 
Size  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.  
 
   
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APPENDIX F 
Professionals Involved in Resident Assessments and Care Plans 
Table F-1:  Professionals Involved in Resident Assessments  
 
Number  Number 
Professionals   Percentage   Percentage  
(Exclusive*)   (Inclusive**) 
Psychiatric Physician  0  0.0%   0  0.0%  
Geriatric Physician  0  0.0%   0  0.0%  
Psychologist  0  0.0%   1  0.3%  
General Physician  0  0.0%   4  1.1%  
Social Worker  15  4.0%   103  27.5%  
Registered Nurse  172  45.9%   261  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  
Number  Number 
Professionals   Percentage   Percentage  
(Exclusive*)   (Inclusive**) 
Psychiatric Physician  0  0.0%   0  0.0%  
Geriatric Physician  0  0.0%   0  0.0%  
Psychologist  0  0.0%   2  0.5%  
General Physician  0  0.0%   12  3.2% 
  Licensed Practical 
13  3.5%   49  13.1%  
Nurse  
Social Worker  13  3.5%   160  42.7%  
Registered Nurse  50  13.3%   195  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".~"""'- 	
J1. .'/ ..  .''''.  DEf'ARTMEr-;r Or HEAtnl & IIUMAN SERVICES 
", 	 " _'''-.'_,.m,.."...,,,_". .. ,_  _ 
""""" 	
Admffli~ttlltl1" 
W.W1iflOlt)l).OC 2/.01 
MAY 302012 
TO: 	 Damel It. Levin:,on 

Insp~l(If ( icltt'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 
{Offv?08.00 I S I I 
Thank you fUT (hi: ofJp,(JrtWily \Q review the subje<:t 010 dr4!\~pOrt un nUTlling fadlhy 
asse~fI'lent' and care pltlM kt 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 nursing 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 ~evf 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!nl!tles i{lke lIICtiom dcsiSl1i!d tt) provide high-quahty c<vc to elderly 
Tes1d..'1lts in mming t'aeilitit'$. "'It ret::ommend that C~l'" Improve tilt' dc\{':Clwr\ ofnNleOmpliltJ'1(;(: 
with ftkra! re'ltl.iR'm~'nl$ for tt""ident usS<."'Ssments and care plans. 
eMS ~"oncur'l. eMS plmu to 51 reng,lhcn the Slate OperatifHtf Mannal ditt1ioos 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 ~cordand 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-07-0800151) 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 OIGs 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.