.——-------

I 

\ Department of Health and Humm Services

OFFICE OF 

INSPECTOR GENERAL 

PATlENT ADVANCE DIRECTIVES: 

EARLY IMPLEMENTATION EXPERIENCE 

AUGUST 1993 o~ 06-91-o1130 

L 

. — 
EXECUTIVE SUMMARY 

PURPOSE 

To determine the extent of institutional compliance with the Omnibus Budget 

Reconciliation Act of 1990 advance directive provisions one year after enactment and 

determine the patients’ understanding of their rights as well as the information provided to 

them under the law. 

BACKGROUND 

On November 5, 1990 the Congress enacted advance directive provisions as part of the 

OBRA-90. These provisions, however, became effective December 1, 1991. The intent 

of this law is to provide an opportunity for adult patients to express their desires about 

medical treatment in a variety of settings. An additional intent is to educate the entire 

population on advance directives such as living wills and the durable power of attorney for 

health care. This law creates no new rights for patients, it simply requires health care 

providers to inform individuals of any rights they have under State law, regarding patient 

self-determination. 

It is important to evaluate early implementation efforts due to the law’s potential effect on 

all Americans health care decisions. For this evaluation, a facility level review was 

undertaken at 72 facilities, in six States in a total of 12 counties. We interviewed staff 

responsible for implementing the requirements of the law at each facility, obtained 

required written materials and reviewed necessary documentation. Whhin these facilities, 

1553 charts were reviewed and 348 patients or family members were contacted for phone 

interviews. 

FINDINGS 

MOST OF THE SAMPLE FACILITIES ARE COMPLYING WITH THE GENERAL 

LEGISLATIVE REQUIWMENTS. 

THE LACK OF CLEAR AND CONSISTENT DOCEMENTATION IN PATIENTS’ 

CHARTS INCREASES THE POSSIBILITY THAT THEIR TREATMENT WISHES 

MAY NOT BE FOLLOWED. 

�	 Many Sample Facilities had Missing Documentadon Regarding Whether or Not the 

Patient hud an Advance Directive. 

�	 Performance In Clearly and Consistency Documenting l%e Existence of an 

Advance Directive In lhe Chart Needs Improvement. 

�	 Only 60 Percent of the Pm”ents With Advance Directives had Copies of the 

Directive in Xheir Medical Chart. 

i 

——— 
TWENTY-ONE PERCENT OF THE PATIENTS IN HOSPITALS, NURSING 

FACILITIES AND HOME HEALTH AGENCIES HAVE ADVANCE DIRECTIVES. 

TWO-THIRDS OF THE INDIVIDUALS INTERVIEWED HAD SOME 

UNDERSTANDING OF ADVANCE DIRECTWES. 

� We Found No Evidence of Patients Being Pressured To Have Advance Directives. 

�	 Only 32 Percent of the Facilities Provided Additional Information In Materials To 

Promo~e Patient Understanding of and Comfort Wth Advance Directives. 

�	 Receiving Information on Advance Directives Appeared To Have Some Impact On 

Patient Interest in Obtaining A Directive. 

RECOMMENDATIONS 

HCFA should develop and issue specific regulatory guidelines clarifying acceptable 

documentation methods to assist providers in meeting the requirements of the Federal 

Statute. 

HCFA should encourage the Joint Co-ion for Accre~~tion of Hc@h 

Organizations (JCAHO) to examine if the chart for =ch patient documents whether 

or not the patient has an advance directhe, in addhion to the existiig JCAHO review 

item for advance d-ives. 

HCFA, along with other appropriate Health and Human Service departmental 

offices, should provide leadership to develop a coordinated plan for educating the 

general public on advance directives. 

AGENCY COMMENTS 

We solicited and received comments from the Health Care Financing Administration 

(HCFA) on our draft report. 

The HCFA did not concur with our recommendation regarding additional documentation 

guidelines in the regulations, believing that such changes would be overly prescriptive. 

However, because technical questions still remain for providers regardiig compliance with 

the law we continue to believe that additional guidance would be helpful to providers. 

This guidance need not be overly prescriptive. 

The HCFA generally concurred with our recommendation concerning the JCAHO review 

of medical record documentation but suggested that JCAHO’S current process, which 

determines if a copy of the advance directive is present in a sample of records, addresses 

our concerns. As a result of this comment, we refined our second recommendation to 

ii 
TABLE OF CONTENTS


. . i 

EXECU~S~Yc””o”.”. . . . . . . . . . . . . . . . . . . . . . . . . . 1 

. . . . . 1 

INTRODUCflON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A .U . . . . . . .

FINDINGS ....................................... 

FAC~Ty CO~H~CE WITH LEGISM~E REQ~S . . . . . . . 6

7 I 

CIWR’rDoC~AmoN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

. 11 

pA~~S-~V~CED~C~~. . . . . . . . . . . . . . . . . . . . . 12 

~~T~~GOF~V~CED~C~. . . . . . . . . . . . . . . . . . 

. ..16 

~CO~A~ONS........... . . . . . . . . . . . . . . . . . . . . . . . ..18 

AGENCYCO~S~OIG~~NSE . . . . . . . . . . . . . . . . . . . . . . . . . . 21 

ENDNO~ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

Appendices 

. . . . . . A-1 

ARe~ssion Results ..,.... . . . . . . . . . . . . . . . . . . . . . . . . . . .B-l 

B: Weightd adUnweightdCM DataRePofiedhText . . . . . . . . . . . . . . . .C-l . . . . . . 

C: Agency Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

—— —— 
INTRODUCTION 

PURPOSE 

To determine the extent of institutional compliance with the Omnibus Budget 

Reconciliation Act of 1990 advance directive provisions one year after enactment and 

determine the patients’ understanding of their rights as well as the information provided to 

them under the law. 

BACKGROUND 

On November 5, 1990 the Congress enacted advance directives provisions as part of 

OBIL4 19901. The intent of this portion of the law is to provide an opportunity for adult 

patients to express their desires about medical treatment in a variety of settingsz. An 

additional intent is to educate the entire population on advance directives such as living 

wills and the duxable power of attorney for health care. These provisions do not create 

any new rights for patients. The provisions simply require health care providers to inform 

individuals of any rights they now have under State law, regarding patient selfdetermination. 

Senators Danforth and Moynihan introduced the provisions as the Patient Self 

Determination Act in October of 1989, to afford ‘individuals the opportunity to participate 

in medical decisions affecting the condition and length of their lives4. Such an Act W= 

needed to offset an imbalance in the relationship between health care consumers and 

providers. Senator Danforth perceived that the caring component was beiig left out of 

medicine and patient rights were being trampled uponb. 

Because of the potential impact of these provisions on all Americans, it was important to 

determine if the spirit and letter of this law were being met. A facility level miew of the 

requirements was necessary to detenrd.ne if the provisions wem being implemented 

appropriately. It was also crucial to determine if patients were being educated and 

allowed to participate in the health care decision process, or if additional paperwork had 

simply been added to the administrative process. 

The Provisions 

The advance directive provisions are contained in the Omnibus Budget Reconciliation Act 

of 1990. This section of the law became effective December 1, 1991, approximately one 

year after enactment, in all f~y States. Dutig the interim year, health care providers 

participating in the Me&aid/Medicare programs were to develop both written policies and 

procedures and patient materials addressing dtives under State law. Participating 

health care providers covered by these provisions include, but are not limited to, 

1 
hospitals, nursing homes and home health care agencies. The materials develop~ ~ to 

be provided to all adults upon admission to a facility or in advance of beginning care. 

Policies and procedures, as well as materials provided, must ensure compliance with State 

legislation and/or court opinions addressing patient directives. A description of Snte law 

must be included in information provided to all adult patients. Finally, the patient’s 

record must state whether he/she repons having executed an advance directive’. 

While the advance directive provisions require health care providers to make this 

information available to all adult patients, certain activities are not required. The 

provisions do not require patients to complete any form of advance directive. In fact, the 

provisions expressly forbid requiring an advance directive as a requisite for treatment. In 

addition, the provisions do not override any State law allowing a provider to object to the 

implementation of an advance directive on the basis of conscience. However, in such a 

case policies on this topic should be included in the information provided upon admission. 

Evolution of the Advance Directive Provisions 

The advance directive provisions evolved both from case law and medico/legal 

considerations. The final legal decision drawing attention to the need to consider patient’s 

wishes in health m decision making was provided in the Supreme Court ruling in the 

Cruzan case*. This case recognized a patient’s right to accept or refuse treatment and 

endorsed the withbwal of life support and the withholding of medical treatment when a 

patient’s wishes were known9’10 . This ruling helped focus the need to inform patients of

their rights to state treatment preferences regarding life and death matters before 

undergoing medical treatment. 

The evolution of me&co/legal considerations over the past ftieen years also encouraged 

greater patient involvement in their medical care. These considerations took three forms: 

1.	 Do not resuscitate order (DNR), a written order documented in the patient’s 

medical chart to allow patients or family members to choose to forego 

further medkxd intervention in case of an event such as a cardiac arrest. 

2.	 LNing will, a document containing written instmctions pertaining to an 

individual’s treatment. 

3.	 Durable power of attorney for health care, empowers an individual to 

appoint an agent or surrogate to decide for them should they become 

incompetent or unconscious. 

Due to the patient’s lack of knowledge about these devices, communication between the 

patient and physician had not increased. In addition, despite the frequent use of DNR 

orders, they often were not discussed with the patient or even the family. Studies found 

patients were only asked their preference for life prolonging treatment between 14 and 22 

percent of the time*1*12s13, while family members were asked 33 to 86 percent of the 

time14’*s’lb.Further studies indicated the agreement between a potential proxy and 

the patient on preferences for life sustaining treatments ranged between 53 and 90 percent 

2 
for a family member17118,and between 38 and 89 percent for the patient’s 

physician19’20.Thus, the literature indicates the wishes of the patient were frequently 

not considered before placing an order to forgo resuscitation. This reinforced the n=d for 

the advance directive provisions, which include patient education about advance directives 

as an important component. 

Public and Institutional Response to Advance Directives. 

Research on patients’ interests in advanced care directives supports the need for the 

advance directive provisions. Studies have found between 89 and 9321percent of 

individuals surveyed desire at least one form of advance directive. However, two surveys 

indicate only 1422to 18D percent of individuals have either discussed their desires with 

their physicians or put them in writing, 

In the realm of hospital policies on advance directives, a 1988 study of randomly selected 

hospitals noted that 67 percent of the nxpondents reported having a formal policy 

regarding advance dmtives 24. However, of these hospitals, only 63X percent reported 

a policy r&@ring the patient to notify the physician if they had an advance directive. 

Oniy four percent of the hospitals had a policy of asking all patients whether they had 

ever completed an advance directive*. 

Concerns Regarding the Use of Advance Directives. . 

One concern addressed in the literature is the possibility that the advance directive 

provisions will have little impact. A study of New York State’s legislation requiring a 

patient discussion before issuing DNR orders found no signifkant change in the number of 

decisions being made by patients. Both before and after the legislation, 80% of cases 

involving DNR orders were based on decisions made by family members27. 

Another concern relating to the impact of the advance dmtive provisions is whether 

patients will fully understand the information contained in materials provided, as well as 

the importance of the information. Studies show many existing consent forms require 

reading skills at the advanced college leve12aand even well-educated individuals often 

fmd it dilllcult to understand terms explained in health care plans to which they 

subscribe29. Concern also exists that patients may view the information as just another 

form and choose not to read i~”. Another risk is that patients may be incorrectly 

informed of their rights due to discrepancies between State statutes and legal fmdings3]. 

Additional concerns surround the issue of patients making involuntmy or unreasoned 

decisions due to the initiation of the informational process upon admission, frequently a 

time of turmoi332. Finally, concern is expressed that facilities will encourage 

disadvantaged patients to sign a dtitive for financial masons, to limit costs of potential 

extended titmen?3Y. 

3

These concerns demonstrate a need to determine both the administrative compliance level, 

as well as compliance related to the level of patient understanding of advance directives. 

Researchers believe relying solely on a simple patient chart audit to determine compliance 

with the requirements of the provisions could be misleading. Such reviews do not 

measure patients’ understanding of their rights or the lack of a requirement to have a 

directive to obtain medical treatment3sJb. 

METHODOLOGY 

This inspection reviewed both institutional compliance with the requirements of the 

advance directive provisions, and patient understanding of the information presented to 

him/her at time of admission or commencement of services. Institutional compliance was 

divided into two components, administrative compliance and chart documentation. Since 

the advance directive provisions were Federal in nature and applied to all 

Medicaid/Medicare facilities, all States and all hospitals, nursing facilities and home health 

agencies were initially included in our sample. Individuals who received care within each 

of these settings were also interviewed to ascertain their understanding of the advance care 

directive information they received. 

While the content of State laws was not reviewed in deptl?’, consideration was given to 

the type of advance directives allowed in the sample State#a. Legislation in States 

generally allowed for the following advance directive possibilities: 

;: 

3. 

A four stage, 

was based on 

Living Wills only (9 States)


Durable Power of Attorney for Health Care only (6 States)


Living Will and Durable Power of Attorney for Health Care (33 States)


stmtifled random sample was utilized in this study. The initial stratifkation


the type of advance directive(s) legislation present in the State. Two States


were randomly selected from each group. The six sample States were, Arizona, Florida, 

Maryland, Massachusetts, Michigan and Washington. After sample States were selected, 

two counties/county units were randomly selected fmm each State with probability 

proportionate to size. Size was defined as the total number of Medicam/Nledicaid 

participating hospitals, nursing facilities and home health agencies in the county unit. 

County unit was deftned as two or more contiguous counties in which one or more has 

fewer than the required number (two), of at least one type of organization included in the 

sample. Within these county units, two of each type of provider were randomly selected 

and included in the sample. Within each facility, 25 charts were randomly selected for 

review from all the admissions for the period, March 1 to April 30, 1992. For the 

facilities with fewer than 25 admissions, all admissions during the sixty day period were 

reviewed. Finally, five charts of living patients were randomly selected and contacted for 

personal conversations regarding their understanding of the information they received on 

advance directives. If five or fewer patients we~ admitted during the time period, all 

living patients were contacted and 

June 4, 1992. 

interviewed. Data were collected between May 11 and 

4 
I Number of I Number of Number of 1 Number of 

Counties Facilities Charts Patient/Individuals 

Visited Reviewed Reviewed Interviewed 

Hospital 12 24 591 120 

Nursing Facility” 12 24 424 113 

Home Health Agency 12 24 t 538 115 

~TOTAL I 12 I 72 I 1553 I 348 

The data collected pertained to the presence or absence of specific materials and policies 

within the organization, the documentation of speciilc interactions and educational 

activities in the patient chart and elsewhere, and the patient understanding of information 

provided based on phone conversations with patients and other relevant individuals. In an 

effofl to understand facility/agency outcomes, information was also obtained regarding 

difficulties facilities encountered in implementing the requirements of the advance 

directive provisions. 

Information reported for the facilities and patient understanding are based on the sample 

data. Information presented on data from the charts is weighted and projected to the 

universe of all Medicaid/Medicare participating hospitals, nursing facilities and home 

health agencies. ‘l’his projection represents 6.8 million charts. While some of the 

projections have poor precision due to the limited number of facilities and the four stage 

sampling technique, it is still felt that they represent a reasonable estimate of initial 

implementation effom. Appendix B presents the unweighed and weighted sample data 

for the data presented on patient charts. Regression analysis was also undertaken on the 

sample data, with a cursory discussion included in the ~rt and a more complete 

discussion of the regression results in Appendix A. 

We conducted our review according to the Quality Standurds for Inspections issued by the 

President’s Council on Integrity and Efficiency. 

5

---- —-—----- -- ----

FINDINGS 

MOST OF THE SAMPLE FACILITIES ARE COMPLYING WITH THE GENERAL 

LEGISLATIVE REQ~TS. 

Measures of Compliance With the Advance Directive Provisions 

Used to Form The Legislative Requirements Index*. 

~o The facility has developed written policies and procedures 

explaining advance directives and the hospital’s requhvments 

pertaining to them. 

69 � The facility has developed writien materials regarding advance 

directives and provides them to each adult patient upon 

admission or commencing services (both must be answered yes 

to obtain credit for this item.) 

x.	 Materials provided to the patient clearly state that a patient 

does not require an advance directive to receive treatment. 

69 � Materials provided to the patient include a written explanation 

of the law pertaining to advance directives in that State. 

67 � The facility has provided staff education on the advance 

directive provisions, and has some form of documentation 

indicating education has been provided (both must be answered 

yes to obtain credh for this item.) 

fio The facility has planned or provided community education on 

advance directives. 

. -.–J..-..-i!-- ,.- ..... .. .. . . ..... --— numoefs presenteu m uaucs represent number 01 facmucs mccung uus fequmemem UUL0? a total ot /“2 

Figure 1 

Eighty-seven percent of the facilities demonstrate compliance in five or more of the index 

areas, and all facilities demonstrated compliance in at least four of the index areas. 

Forty-three percent of the facilities demonstrated 100 percent compliance in the legislative 

requirements index. When examining facility type, it is noted that hospitals have the 

highest mean index, 5.5, nursing facilities have a mean index of 5.3 and home health 

agencies scored the lowest, with 5.0 on the six point index. This demonstrates very little 

overall difference between facility types in complying with the gened legislative 

requirements. The index total was derived by assigning one point to each of the six 

legislative requirements listed in figure one.39’a 

6 
The Legislative Requirement Most Frequently Umnet Was The Facility Responsibility 

To Provide Community Education. 

Twenty-three of the 72 facilities in the sample, or 32 percent, had not planned or provided 

community education on the advance directive provisions. Home health agencies were the 

type of facility which most frequently had not provided community education. Twelve 

home health agencies, or half of the home health sample, had not provided this sexvice. 

While many facilities had not provided community education, half of the seventy-two 

facility contacts stated more information needs to be given to the pubIic. Such public 

information would increase awareness of advance directives before individuals became ill 

and improve understanding of the terms when directives were explained. Generally, 

contacts at the facilities called for public service announcements on this topic and said 

government agencies, such as HCFA and Social Security, should include information 

regarding the topic with current mailings. 

THE LACK OF CLEAR AND CONSISTENT DOCUMENTATION IN PATIENT 

CHARTS INCREASES THE POSSHKLITY THEIR TREATMENT WISHES MAY 

NOT BE FOLLOWED 

Many Sample Facilities Had Missing Documentation Regardkg Whether Or Not The 

Patient Had An Advance Directive. 

Only 19 facilities, or 26 percent of the sample, had clear documentation stating whether 

the patient did or did not have an advance dmtive in 100 percent of the medical rezords 

reviewed. By contrast, in 15 percent of facilities less than half of the charts were clearly 

documented, including one of four nursing homes and one of five home health agencies. 

PERCENTAGE OF CHARTS WITH DOCUMENTATION PRESENT: 

BY FACILITY 

Below 50 percent 50-75 percent 75-99 Percent 100 Percent 

# of % of #of % of #of % of #of % Row 

Facilities Total Facilities Total Facilities Total Facilities Total 

All Facilities 11 15.3 11 15.3 31 43.0 19 26.4 

Hospitals o 0 5 20.8 14 58.3 5 20.8 

Nursing 

Facilities 6 25.0 3 12.5 7 29.2 8 33.3 

Home 

Health 5 20.8 3 12.5 10 41.6 6 25.0 

Agencies 

7


.— 
While three facilities had no documentation in the medical chart as to whether a patient 

had an advance directive, two of these facilities did have documentation in the patient’s 

financial folder, located in the business office. Additionally, some facilities would clearly 

document that patients had received information regarding advance directives, but would 

not consistently document whether or not the individual had a directive. 

A statistical examination of the percent of charts with documentation present provided 

only limited insight (explaining 13.5 percent of the variation among facilities) into which 

factors affect the presence of clear chart documentation in each facility. The three factors 

having an impact on explaining the percentages of charts with documentation in each 

facility were: 

� The lack of staff education or documentation of staff education on the topic 

� The provision of staff education after the provisions were implemented 

� Status as a for-profit organization 

Facilities providing staff education on the topic tier, rather than before, implementation 

of the advance directive provisions had a lower percentage of charts with documentation 

present. This supports the effectiveness of employee education and its impact on 

improving employee awareness and attention to this new procedure, supporting the need 

for the education requirement. The effect of the for-profit variable was positive, when 

compared to not-for-prufit facilities, indicating a higher frequency of documentation in 

for-profit agencies. This finding could indicate for-profit organizations may be members 

of a chain and thus more likely to have received company-wide policies and materials that 

could be easily disseminated. 

After accounting for the States included in the sample, two additional variables, location 

in Florida and whether the facility was a nursing home, had a signifkant negative impact 

on the percent of charts with documentation present. By controlling for the individual 

States in the regression analysis, the variables examined explained 23.8 percent of the 

variation in documentation between the facilities. There was no signifkant effect of 

whether the facility was a hospital, or home health agency, location in one of the other 

sample States, or from having a higher score on the legislative index in either analysis. 

For a further discussion of the statistical findings, see Appendix A. 

In Sample Facilities, Information On Advance Directives Was Often Difficult To 

X.mate Due To A Lack of Standardized Methods of Documenting. 

Standardized methods of presenting chart documentation, within a facility, regarding 

advance directives may be an important issue in assuring the ability to locate information 

stating whether or not the patient has a directive. In an emergency situation, the ability to 

quickly locate this information would be important, as it could lead to dfierent treatment 

approaches. When examining documentation methods it was noted that sample facilities 

documented in a variety of ways. When documenting in the chart, facilities generally 

used a standard form (either computer generated or photocopied), a written note in the 

8 
J 

chart (generally in the social service section or nurses notes), or a standardized admissions 

assessment form utilized by the State in nursing facilities. Difficulties sometimes ~ose in 

locating the documentation since methods were not always consistent within the facility. 

In addition, several facilities may have kept documentation on a standardized form in the 

business office exclusively, or in the business office with a note appearing in the patient’s 

chart. Many facilities had utilized various methods of documentation and had moved 

toward a more standardized facility format during the early months of the implementation. 

Performance In Clearly And Consistently Documenting In The Chart Needs 

Improvement. 

STATUS OF DOCUMENTATION IN PATEiNT’S MEDICAL RECORD 

Facility Documentation No Chart Documentation “Unknown” “Comprehension a

Type ‘ in Chart Documentation Elsewhere Noted Poor” Noted 

All Types 80.5 % 14.0% 1.7% 3.3% .2%


Hospitals 86.2% 9.4% o 4.4% o


Nursing 46.0% 25.5% 26.7% o 1.8%
 Facilities


Home


Health 68.0% 31.5% o .03% .5%


= “


While the majority of chaxts had clear documentation stating “yes” the patient has an 

advance directive or “no” the patient does not have an advance directive, many charts 

lacked any documentation or contained ambiguous statements. In addition, some ch~s 

contained uncompleted directive forms, or only documentation that information on 

advance directives had been provided to the patient. 

When examining provider types and their documentation efforts, some dflerences become 

apparent. Almost one-thid of the charts in home health agencies and one-fourth in 

nursing facilities had no clear documentation indicating whether the patient dld or did not 

have a directive. Additionally, about one-fourth of the charts in nursing facilities had 

documentation regarding the status of the patient’s pmfenmce for a directive, but the 

documentation was in a location that was inaccessible after working hours. While this 

indicates the agencies have made some effort to document, documentation problems create 

situations where the wishes of the patient may not be followed, due to either the lack of or 

inaccessibility of information. 

Pregnant women were the largest category of patients in the sample lacking documentation 

of directives in their medical charts. Of the 116 women in the sample with dmgnoses of 

pmgn~cy or nAated to pregnancy, 41 had no documentation in the~ chart and 8 had 

notations stating “unknown” regardiig the presence of an advance directive. Two 

facilities stated they did not give information to pregnant women, since provisions of 

advance directives were not applicable while a woman was pregnant. Other facilities 

9 

11 
stated information was provided to pregnant women, but they could be missed, since they 

were often admitted through the emergency room or directly to the floor. Although many 

hospitals had a policy of following up, to determine if the patient had a directive, the 

information in the chart was often not updated to reflect the follow-up. 

Many State laws indicate advance directives do not apply during a woman’s pregnancy, if 

it appears that her baby may be able to go full term. However, the need to ~form 

pregnant women of advance directives is still important. If a pregnant woman, not 

informed of her right to an advance directive, should experience a tragic outcome, her 

wishes regarding continued life support, after the delivery of the baby, would be 

unknown. This could be equivalent to denying the pregnant woman an opportunity to 

make decisions regarding her medical treatment, which was the intent of the provisions. 

Another group of patients, whose charts frequently lacked clear documentation regarding 

advance directives, were those patients who were confused or very ill and were not 

accompanied by a friend or family member during admission. Without such assistance or 

counsel, it was dfilcult or impossible for the facility to obtain accurate information on 

patient’s advance directive preferences. 

In telephone interviews with individuals whose charts had been reviewed, several said they 

had a directive while the information in the chart did not indicate this. Thirteen 

individuals whose medkal charts lacked any documentation, stated they had an advance 

directive prior to being admitted for cam. In addition, 11 individuals with documentation 

that they did not have an advance directive, stated they did have one prior to being 

admitted. While there is no way of confirming this information, if true, it would be 

difficult to comply with these individuals’ treatment wishes, due to either the lack or 

inaccumcy of documentation in the chart. 

problems In Clearly Documenting patients’ Charts May Result From the Lack of 

Guidelines on Acceptable Documentation. 

All types of facilities included in the sample had some charts that did not clearly specify 

“yes” the patient has an advance directive or “no” the patient does not have an advance 

d~tive. Ambiguous documentation and documentation located outside of the patient’s 

chart accounted for approximately five percent of the documentation efforts. When 

examining documentation by facility type, about one-fourth of nursing facility charts had 

documentation located outside of the charts and approximately four-and-a-half percent of 

hospital charts had “unknown” specifkd. In addhion, a number of the over nine percent 

of hospital charts lacking any documentation were charts of pregnant women. In some 

facilities, persomel stated pregnant women were not asked whether they had a directive, 

as they understood the state law to spec@ directives were not applicable when a woman 

was pregnant. These results appear to indkate facilities are unsure of exactly what 

constitutes appropriate documentation of whether the patient does or does not have a 

directive. 

10

Comments made by sample facilities suppoxt this fmding4*. One facility stated that the 

lack of specific documentation guidelines was a problem. In addition, personnel in many 

facilities inquired about the appropriateness of their documentation efforts during the chart 

review undertaken for the study. Some facilities mentioned problems clearly documenting 

the required information due to the patient’s condition, admission of patients through the 

emergency room, clinics or after hours, and the dfilculty in obtaining information for day 

surgexy and short stay patients. Finally, some facilities mentioned the difllculty of 

obtaining clear information on advance directive preferences from confused or disoriented 

patients. In many of these cases, “u~own” or “comprehension poor” were noted. 

Only 60 Percent Of The Patients With Advance Directives Had Copies Of The 

Directive In Their Medical Chart. 

Of the charts with documentation (either in the chart or in the financial folder) indicating 

the patient has an advance directive, 57.5% have a copy of the directive in the chart. 

Approximately two-and-a-half percent of the charts with copies of advance directives did 

not have documentation in the chart stating the patient had a directive. A note was 

present in eight percent of the charts indicating where a copy of the advance directive 

could be found and 31.8 percent of the charts had neither a copy of the directive nor a 

note stating the location. 

The lack of copies of advance directives in patient charts is acknowledged as a problem by 

many facilities. During discussions regarding facilities’ problems or dfi~culties in 

implementing the advance directive provisions, 12 specifkd the difficulty in obtaining 

copies of the directive for placement in the chart. Problems in obtaining directives mnged 

from patients being requested to provide a copy of their directive but not doing so, 

patients not being able to obtain a copy due to lack of mobility and not wishing to give an 

original to the provider, patients not being aware that they should bring a copy of a 

directive to a facility upon commencing care, relatives having to be responsible for 

obtaining a copy or papers having to be sent out of State in order to obtain a copy of a 

directive from a relative. 

TWENTY-ONE PERCENT OF PATIENTS RECEIVING CARE FROM 

HOSP~AI& NURSING FACILITIES, AND HOME HEALTH AGENCIES HAVE 

ADVANCE DIRECTIVES. 

PATIENTS WITH ADVANCE DIRECTIVES* 

Total With Directives Average Age (sample) Female Male 

All facilities 21.2% 73 55.5% 42.7% 

Hospital 18.2% 63 48.3% 49.5 % 

Nursing Facility 47.7% 79 58.9% 40.2% 

Home Health 25.1% 76 77.1% 22.3% i 

*--numbers may not sum to 100% due to mlssmg sex and age mformauon 

11 

7 
Examination of the data indicates that nursing facility and female patients are more likely 

to have advance directives. The fact that a greater percentage of nursing facility patients 

have a directive is consistent with the common view that advance directives are documents 

that should be considered by people who may be approaching the end of their life. 

Examination of individuals from the sample with directives, by age group and diagnoses, 

provided some additional insight into the public perception of advance directives. Nine 

percent of the patients under age 30, 11 percent of the patients between the ages of 36 and 

45, and 20 percent of the patients between the ages 46 and 55 had a directive. The 

percentages continue to increase with age, with 34.7 percent of individuals over the age of 

85 having a directive. The diagnoses among individuals having a directive included 10 

percent with cancer, eight percent with a diagnosis of broken hip, seven percent with 

stroke and five percent having a diagnosis of congestive heart failure. While none of 

these diagnoses are exclusively related to the elderly, more older people tend to have these 

medical conditions. In addition, each of these has a higher likelihood of mortality than 

the other diagnoses in the sample. 

The sample findings indicate the public tends to perceive advance directives as only being 

appropriate for the very old and very ill. This is further supported by comments made by 

interviewed individuals such as, “I was only having a baby, ” or “I am too young to think 

about that. ” Unfortunately, many of the legal cases which brought this issue to the 

attention of the public involved young pemple. These individuals met with tragic 

experiences resulting in the extended use of life-sustaining measures, beyond what their 

family members felt the individual would have wanted. These findings also support the 

need to provide public education on the topic of advance directives. 

TWO THIRDS OF THE INDIVIDUALS INTERVDIWED HAD SOME 

UNDERSTANDING OF ADVANCE DIRECTIVES. 

Percent of Individuals Interviewed With Understandimz of Advance Directives 

a

E@w!L_Jl Patient Relative I Relevant Individual 

t 

Overall 

All Types 63% 74% 89% 67.5 % 

Hospital 61% 77% (not applicable) 64% 

Nursing Facility 71% 71% 83% 72% 

Home Health ~ 60% 77% 100% 6’7% 

Interviews were held with 348 individuals whose charts were randomly selected from each 

facility’s original sample, Of the individuals interviewed, 130 were former patients, 209 

were family members, and nine were friends, caretakers or lawyers. The interviews 

indicated that 235 of the individuals had some understanding of advance directives or 

related terms such as, living will, durable power of attorney for health care, proxy, 

12 
surrogate or patient advocate. Understanding was judged to be present if the individual 

could either give at least a simple definition of the term advance directive, living will or 

durable power of attorney, or if they volunteered information regarding their previous 

familiarity or experience with an advance directive. 

It is noteworthy that patients as a group included the smallest percentage of respondents 

with an understanding of advance directives. Only nursing home patients demonstrated 

understanding equivalent to that of family members. Facilities reported patient 

understanding often is very poor upon admission, due to the anxiety surrounding their 

health condition and the number of papers presented to them. Reinforcing this point is the 

fact that 10 percent of patients who could not recall what an advance directive was 

mentioned they were too ill, too upset or were bombarded by too many papers at 

admission. Furthermore, 12 percent of individuals stated they did not remember receiving 

information on the topic, and 16 percent stated they did not receive information on 

advance directives upon admission. This supports the suggestion of 17 facilities that the 

provision of information on advance directives should begin before the patient is admitted 

for care. 

Nursing facility patients had the highest understanding of advance directives among patient 

respondents. This might be a function of the generally long stays associated with nursing 

facilities which allow more time to explain and re-explain advance directives as necessary. 

It may also indicate that the average population in nursing homes, frail elderly people, 

have considered this topic prior to arriving at the nursing facility. Also, many individuals 

receiving care from a nursing facility may demonstrate greater knowledge and education 

on the topic because they view it as more relevant to their lives. 

Of the individuals with understanding of advance directives, 186 could provide at least a 

simple deftition of either “living will” or “durable power of attorney for health care” 

without prompting. A larger percentage recalled “living will. ” For example, 77 percent 

correctly defined a living will, while 55 percent defined a durable power of attorney for 

health care. Four percent of individuals provided an incorrect det”tition, although they 

thought they understood the term, and two percent of the individuals stated they had an 

advance directive, when they actually had a general or durable power of attorney with no 

health specifkations. 

Six facilities specifka.lly mentioned the problem of patient difilculty in understanding the 

information due to the different terminology used, or the similarity between advance 

directive terms and other legal terms. Facilities also noted some patients confuse living 

wills with wills and confuse durable power of attorney for health care with a durable 

power of attorney related to financial areas. This concern was reinforced by some 

respondents who when asked to define the terms gave the deftition of a will, or dumble 

power of attorney for financial affairs. Eight facilities suggestcxl using uniform language 

and simpler terms in an effort to encourage greater understanding of advance dmtives. 

The need for a public information campaign by the Secretary of Health and Human 

Semites, as called for in the legislation, was supported by comments made by facilities. 

13 
Many facilities cited the need to provide a greater opportunity for public education on the 

topic to improve patient understanding of advance directives. The.t also indicated that 

education should be provided at a variety of levels. Facilities cited early education in 

schools, providing information through large community and government organizations 

and using televised public service announcements as ways of reaching more people. 

Additionally, ten facilities felt physicians should be more involved in discussing this area, 

as they are generally the patient’s initial contact with the health system. 

We Found No Evidence Of Patients Being Pressured To Have Advance Directives. 

A concern voiced by Congress and others before the advanced directive provisions were 

enacted was that patients would either feel that they were required to have a directive to 

obtain treatment or this would be subtly communicated to patients. In addition, there was 

concern that poorer or more disadvantaged patients might be encouraged to have a 

directive. Two steps were taken to examine this concern. First, we reviewed materials 

provided to the patient by each facility to see if a clear statement that a directive was not 

required was present. Second, in interviewing patients and family members we 

specifically asked if they had to have a directive to receive treatment. Our review showed 

78 percent of the materials clearly stated that a patient was not required to have an 

advance directive to receive treatment. Similarly, our interviews detected only one person 

who felt they might have been required to have a directive to receive treatment. Finally, 

a review of the data indicated that Medicaid patients, genemlly poorer and more 

disadvantaged, consistently were the least likely to have a directive. ‘Ilk would indicate 

they were not more likely to be encouraged to have a directive when compared to other 

groups. 

Only 32 Percent of the Facilities Provided Additional Information ItI Materials To 

Promote Patient Understanding Of And Comfort With Advance Directives. 

An examination of facility efforts to alleviate the concern that patients might feel 

pressured to have an advance directive was also undertaken. This examination imokd 

reviewing the content of advance directive materials provided to patients upon admission. 

To determine if facilities were clarifying that advance directives were not required in 

order to receive care, could be revoked at any time and should be carefully considenxi, 

we developed an index to examine facility efforts in communicating this information. 

This index was called the quality index. The quality index contained three items and was 

used to check whether materials provided to patients: 

1.	 Mention the need to dkcuss treatment preferences w~th family and friends 

in case they should have to make medical decisions for the patient; 

2. State the patient has a right to revoke the advance directive at any time; and 

3.	 Advises patients that the facility has blank advance dmtive forms for their 

use upon request. 

14 
The data from sample facilities indicates there is a need to improve facility performance in 

providing information to increase patients’ understanding and level of comfort with 

advance directives. For example, 22 percent of the facilities met none or only one of the 

three items and only 32 percent of facilities met all three indices. Once again, including 

these items in materials could increase patient understanding of advance directives, an area 

which facilities noted as needing improvement. 

Percentage of Facilities Including Quality Information in Patient Materials 

Facilities Quality Index Scores for Facilities 

Zero One Two Three 

All Types 4.1% 18% 45.8% 31.9% 

Hospitals o 20.8% 54.1 % 25.0% 

Nursing Facilities 4.1% 16.6% 37.5 % 41.6% 

Home Health Agencies 8.3% 16.6% 45.8% 29.1 % 

Receiving Information On Advance Directives Appeared To Have Some Impact On 

Patients’ Interest In Obtaining A Directive. 

Being informed of the right to have an advance directive, and receiving information on the 

topic, did appear to influence some of the patients who were interviewed. Seventy-three, 

or 20.9 percent, of the individuals interviewed said they would consider getting a directive 

after hearing about them. In addition, 14 (or four percent of the individuals) actually 

executed a dinxtive after nxeiving treatment. 

This finding underscores the importance of discussing advance directives with patients 

before they become ill. The appropriate place to begin this process may be in the 

physician’s oftlce, since they are often the initial patient contact with the health care 

system. Once again, this lends support to the suggestion of ten facilities, that physicians 

become more involved in discussing advance directives with patients. Further, this 

finding also supports the need to provide general public education on the topic, to 

encourage people to both think about and discuss advance directives with relatives or 

friends. 

15


II 
RECOMMENDATIONS 

While the majority of facilities reviewed have met many of the requirements of the 

advance directive provisions within the first five months of implementation, some areas of 

concern exist regarding: 

� patient knowledge and understanding of advance directives 

� facilities documentation of advance directives and 

� the presence of the directive in the chart. 

Because advance directives are a complicated topic not falling neatly into one arena, a 

coordinated effort should be considered in addressing these concerns. This effort should 

involve the State agencies and intermediaries involved with the Medicaid and Medicare 

progmm, as well as involved outside agencies. Assistance for facilities participating in the 

Medicaid or Medicare programs should also be available from the HCFA, the agency 

writing the Federal rules and regulations pertaining to the advance directive provisions. 

This would increase the potential for consistent interpretation of the requirements. 

The coordinated effort should also include the Joint Commission for Accreditation of 

Health Organizations (JCAHO). Much of the determination of compliance with the 

provisions will be left to the JCAHO in facilities they accredit. While the JCAHO has 

specific review items pertaining to the provisions, including the presence of a dmtive in 

the chart, they do not include simple documentation of whether the patient has a directive. 

Since findings of this inspection indicate that 11 percent of patients with advance 

directives did not have this documented in their chart, and 20 percent of charts lacked 

CIW documentation, support is present for a geneml documentation item. The lack of 

such documentation weakens the ability to both know and comply with patient wishes. 

To assure patient participation in some of the most delicate issues confronted in health 

care, we make the following recommendations: 

The HCFA should develop and issue specillc regulatory guidelines clarifying 

acceptable documentation methods to assist providers in meeting the requirements of 

the Federal Statute. The guidelines could be incorporated in the Final Regulations 

which are currently pending, and should specifically address what constitutes 

acceptable documentation of whether a patient does or does not have a dmective. 

Alternatively, the HCFA could disseminate documentation guidelines through other 

options: 

� A program memorandum from HCFA to State Medicaid Agencies and Medicare 

Fkal Intenmidaries specifying documentation requirements. 

� Medicaid Agencies and Medicare Intermediaries could provide a notifkation letter 

to all participating facilities on documentation requirements. 

� Participating facilities could be informed of Medicaid and Medicare contacts who 

can provide technical assistance on specillc documentation requirements. 

16 
The HCFA should encourage the JCAHO to examine if the medical record for each 

patient documents whether or not the patient has an advance directive. l’bis would 

be in addition to the existing JCAHO review item regarding the presence of a copy of 

the advance directive in the chart. 

The HCFA, along with other appropriate departmental offices, should provide 

leadership to develop a coordinated Department of Health and Human Service plan 

for educating the general public on advance directives. 

The education plan should 1) address the statutory requirement for the Secretary to lead a 

national public information campaign on this topic, 2) incorporate a variety of means for 

conveying the message in a cost-effective manner and 3) should involve all appropriate 

DHHS components (The Social Security Administration (SSA), The public Health Service 

(PHS), The Administmtion On Aging (AOA), The Administmtion For Children and 

Families (ACF), The Assistant Secretary for Public Affairs (ASPA), etc.). Options for 

developing a public education plan might include: 

� A public information campaign to increase understanding of advance directives 

which could include: 

Encouraging the development of Public Semite Announcements regardiig 

advance directives. The department could consider providing such 

announcements in conjunction with national organizations of health care 

providers or advocacy groups. 

Encomaging professional organizations to provide community education on 

the topic in conjunction with local health care facilities. 

Developing generic informational materials which could be provided to a 

variety of agencies. 

�	 A coordinated effort involving all relevant agencies to provide uniform information 

on advance directives to individuals receiving program senices or benefits from 

the HCFA, SSA, PFIS, AOA, ACF, and the ASPA. Generic information, such as 

that included in the 1993 Me&are Handbook, could be used by other agencies in 

booklets, public materials and mass mailings. 

�	 Encou@.ng coordinated State and private efforts to provide the public with a 

means of canying information on their person to alert physicians or facilities that 

they have an advance directive including: 

Investigating the possibility of a check-off box on driver’s licenses for 

individuals with advance directives, in conjunction with the State Motor 

Vehicle Departments. 

Discussing the development of bracelets or neck chains, similar to those 

available to people with speci.flc health conditions, to indk.ate an individual 

has an advance directive, with various groups whose purposes are to 

promote hedthlmedieal awareness and provide public information. 

17 
SUMMARY OF AGENCY COMMENTS AND OIG RESPONSE 

We solicited and received comments from the HCFA on the draft report. The complete 

text of the HCFA comments are contained in Appendix C. 

The HCFA concurred with our recommendation to provide leadership in educating the 

public on advance directives, but suggested that the Assistant Secretary for Public Affairs 

(ASPA) take the lead role in coordinating this effort. The HCFA also concurred with our 

recommendation to work with JCAHO to include a spedlc review item to determine the 

presence of documentation in the medical record that indicates whether or not a patient 

has executed an advance directive. However, based on conversations with JCAHO, the 

HCFA believes this item has been addressed in the accreditation process. The HCFA did 

not concur with our recommendation to develop more specific guidance on chart 

documentation, expressing concerns that such guidance might be overly prescriptive and 

reduce provider flexibility. 

While we appreciate HCFA’S concerns about overly prescriptive guidance, we continue to 

believe that additional guidance is needed. Although we believe that HCFA’S interim 

final rule will assist facilities in complying with the law, some questions still remain. We 

found seveml situations in which it might be dfilcult to document whether or not patients 

had executed an advance directive. For example, some patients’ mental status may not 

allow them to provide the needed information upon admission and they may not be 

accompanied by an individual who is knowledgeable about their personal affairs. In other 

situations, State laws may lead to misunderstandings regarding the need to collect this 

information. For example some hospitals, in States where an advance directive may not 

be implemented during a woman’s pregnancy, do not even ask pregnant women whether 

or not they have an advance directive when they are admitted. In still other 

circumstances, nonstandard or emergency admissions may create problems in obtaining the 

necessary information. For example, when individuals are admitted either after hours or 

directly to a hospital unit they often bypass the process for obtaining information on 

advance directives. We believe that more spe.ciflc guidance would help facilities handle 

these situations and comply with the statute. This guidance need not be any more 

prescriptive than the guidance already contained in the interim final rule, but would only 

be more expansive in requiring that these subjects be addressed along with other topics. 

Based upon HCFA’S comments regarding our recommendation on JCAHO reviews, we 

have revised the wording of our recommendation. It was our intent to recommend that 

JCAHO, in their review of a sample of medical recotis, examine the records for 

documentation of whether or not patients have executed an advance directive, in addition 

to their current review of whether an advance dtitive is present in the chart. As HCFA 

states, currently the JCAHO reviews medical records to determine only if an advance 

directive is pment in the chart, an item that is not a Federal requirement. In contrast, the 

Federal statute requires that facilities “document... whether or not the individual has 

executed an advance directive.” The absence of an advance directive may indicate a 

number of possible scenarios. It may indicate that an individual does not wish to execute 

an advance directive, or that an individual was not informed that s/he has a right to have 

18 
an advance directive or that an individual has an advance directive but a copy has not been 

placed in the medical record. In fact, our study shows that 40 percent of persons with 

advance directives fell into this latter category. We believe that a speci.ilc documentation 

requirement to indicate whether or not an advance directive was executed, as the statute 

requires, would better ensure that medical records contain meaningfid information about a 

patient’s decision concerning an advance directive. Such documentation would also better 

ensure that a patient’s wishes are known to providers when making treatment decisions. 

We support the HCFA’S suggestion that other appropriate depalmental members should 

participate in the public education effort on advance directives. However, because 

primary authority for the advance directive provisions lies with the HCFA, and they have 

established relationships with the providers affected by the prevision, we feel the HCFA 

should be responsible for negotiating with the suggested departmental components, 

including ASPA, to decide who should coordinate and participate in this campaign. We 

have revised our recommendation accordingly. 

The HCFA also raised questions concerning: 

* whether we had reviewed facilities’ compliance too early in the process; 

�	 whether the reason for lack of documentation in medical charts arose from 

lack of understanding of State laws, the patient’s condition, or the mode of 

admission, rather than confusion about what constitutes acceptable 

documentation; and 

o	 whether the low level of documentation we found is consistent with our 

statement that most facilities are complying with legislative requirements. 

We recognize that we have reviewed facilities’ compliance with the statute 4 to 5 months 

after the effective date, and 1 month after HCFA issued its dmft regulations. It was 

indeed our intent to psesent information on facilities’ experiences and efforts as they f~st 

began to implement the statute’s requirements. While it is logical to assume that 

compliance increases with experience and knowledge on the part of providers, some of the 

problems that arise in the early stages of implementation--if addressed quickly--can best 

ensure smooth realization of new requirements over time. Additionally, we also =o@tie 

that the HCFA issued Program Memomn& in October and December of 1991 to inform 

all facilities and State Agencies of the requirement to implement the self determination 

legislation by December 1, 1992. 

Based on HCFA’S comments regarding the possibility that factors other than confusion 

about acceptable documentation might have contributed to poor documentation, we have 

refined our sub-fmdmg on this point. 

Finally, we appreciate HCFA’S point about whether facilities are generally complying with 

legislative requirements if they are not meeting documentation requirements. However, 

we indicate that in our review, facilities were in fact complying with many aspects of the 

19 
legislation, with the requirement regarding documen~tion being the most obvious 

exception. It is for this reason that these issues were separated and our first two 

recommendations are directed at strengthening guidance and technical assistance in this 

area. 

20

ENDNOTES


1. ~eadvmce dkective provisions wemenactti as S~tions42O6md475l of the 

Omnibus Budget Reconciliation Act of 1990, Public Law 101-508. The original bill, 

referred to as the Patient Self Determination Act, was introduced as S. 1766 by Senators 

Danforth and Moynihan and H.R. 5067 by Congressman Sander Levin. 

2.	 Levin, Sander, D. MI, Remarks in the House of Representatives on H.R. 5067: 

Patient Self-Determinationj Thursday, Jun 28, 1990, CR page E-2190. 

3. McCloskey, Elizabeth Leibold, “The Spirit of the PSDA”, Practicing fhe PSDA, 

Hastings Center, Sept-Ott 1991, pg S14. 

4.	 Rouse, Fenella, “Patients, Providers, and the PSDA”, Practicing the PSDA, Hastings 

Center Report, Sept-Ott 1991, pg S2. 

5. Rouse, Fenella, ibid. 

6. McCloskey, Elizabeth, “The Patient SeLf-Determination Act”, Kennedy Institute of 

Ethics Journal, I, no. 2, 1991, pg 163-69. 

7. OBRA 1990, P.L. 101-508, section 4206, Conference agreement, pg. 129. 

8. Rouse, Fenella, ibid. 

9. Nancy Beth Cruzan, by her Parents and Co-Guardians, Lester L. Cruzan, et UX, 

Petitioners V Di.nxtor, Mssouri Department of Health, et al., U.S. Supreme Court 

Reports, 1990, 497 US -, 111 L Ed 2d 224, 110 S Ct-, no. 88-1503. 

10. Legislative History, House Report No, 101-881, sec. 4122, pg. 88. 

11. Bedell, Susanna E., and Delbanco, Thomas L., “Choices Abut Cardiopulmonary 

Resuscitation in the Hospital, When Do Physicians Talk With Patients?”, Z7zeNew 

England Journal of Medicine, 1984, Vol 310, no. 17, pgs. 1089-1093. 

12. Jonsson, McNamee, and Carnpion, “ne ‘1)0 Not Resuscitate Order’ A Profde of Its 

Changing Use,” Archives of Internal Medicine, Nov 1988 pg. 2373. 

13. Bedell, Susanna E. et al., “Do Not Resuscitate Orders for Critically Ill Patients in the 

Hospital, How Am They Used and What is Their Impact”, Joumal of the America 

Medical Association, July 1986, vol. 256, no.2, pgs 233-237. 

14. Bedell & Delbanco, ibid. 

15. Jonsson, McNamee, & Campion, ibid. 

21 
--

16. Bedell et al,, Ibid. 

17. Uhlrnann, Richard F., et al., “Physicians and Spouses Predictions of Elderly Patients 

Resuscitation Preferences”, Journal of Gerontology, 1988, Vol 43, no. 5, Ml 15-121. 

18. Ouslander, Joseph, et al., “Health Care Decisions Among Elderly Long-term Care 

Residents and Their Potential Proxies”, Archives of Internal Medicine, June 1989, vol 

149, pgs 1367-1372. 

19. Uhlmann, et al., Ibid. 

20. Ouslander, et al., Ibid. 

21. Emanuel, Linda and Barry, Michael, et al., “Advance Directives For Medical Care 

A Case For Greater Use”, The New Englund Journal of Medicine, V01324, N0. 13, pgs. 

889-895, 

22, l?ze Righl To Die: Times Mirror Center forthe Pwplemd the press, 1990, 

23. Emanuel, &Barry, ibid. 

24. McCrary, Van and Bot.kin, Jeffrey, “Hospital Policy on Advance Directives, Do 

Institutions Ask Patients About Living Wills?”, Joumai of the American Medical 

Association, Nov. 1989, vol 262, no. 17, pgs 2411-2414. 

25. McCrary, ibid. 

26. McCrary, ibid. 

27. Kamer, R. S., et al., “Effect of New York States Do Not Resuscitate Legislation On 

III Hospital Cardiopulmonary Resuscitation Practice”, American Journal of Medicine, 

1990, VO188, pgs. 108-111. 

28.	 Tarnowski, K. J., et al., “Readability of Pediatric Biomedical Research Informed 

Consent Forms”, Pediti”cs, 1990, VOI85, pgs. 58-62. 

29.	 Berman H, Rose L., Choosing ~he&“ghtHealth are Plan, Mount Vernon N.Y.1, 

Consumers Union, 1990, 3. 

30. Annas, George J., “The Health Care Proxy and the Living Will”, ?%e New EngZand 

Journal of Medicine, April 1991, vol 324, no.1 17, pgs. 1210-1213. 

31. h Puma, John, et al., “Advance Directives on Admission, CliNcal Implications and 

Analysis of tie Patient Self-Detenni.nation Act of 1990”, Journal of the American Medical 

Association, July 1991, Vol 266, no. 3, pgs. 402-405. 

32. I& Puma, et al, ibid. 

22

33. La Puma, et al, ibid. 

34. White, Margot and Fletcher, John, “The Patient Self Determination Act, On Balance, 

More Help Than Hindrance (editorial)”, Journal of the American Medical Association, 

July 1991, vol. 266, no. 3, pgs 410-412. 

35. Puma, et al., “In Reply to Letter to the Editor”, Joumul of lhe American Medical 

Association, Dec 1991, vol. 266, vol. 24, pg. 3424. 

36. White & Fletcher, ibid. 

37. While individual State Laws regarding advanced directives were not reviewed, 

information prepared by Charles Sabatino of the Commission on Legal Problems of the 

EJderly within the American Bar Association (September 1991), Amy Rosenberg, Editor 

for the AAHA Leml Memo within the American Association of Homes for the Aging 

(Summer 1991) and a drafl article for Clearing House Review (October 1991) by Charles 

P. Sabatino and Vicki Gottlich, “Seeking Self Determination in the Patient SelfDetermination Act, ” were used as a guide to State Legislation on the topic. 

38. For initial sample selection, States were grouped strictly on the basis of existing 

legislation, although legal opinions and case law may also be considered when determining 

the types of advance directives allowed in each State. Based on this selection approach, 

one State, Nebraska, was excluded from the sample due to lack of legislation pertaining to 

advanced directives at the time of the study. Two additional States, Alaska and Hawaii, 

were excludcxl from the sample due to their distance and cost considemtions. Although 

Maryland did have an Attorney Gened’s opinion recognizing the legal effectiveness of 

the Durable Power of Attorney for Health Care, this opinion did not appear in Statute. 

Thus, the DPAHC in Maryland was not considered for grouping purposes. Only the 

living will was considered for grouping purposes. Washington has legislation mgard~g 

both living wills and DPAHC, and thus was grouped based on this infomnation. 

However, the legislation regarding DPAHC is very limited, allowing a named individual 

to only provide informed consent for those treatment decisions previously specifkd by a 

patient. Because both types of directives did appear in statute, Washington was grouped 

based on the presence of both types of advance directives, despite the limits placed on the 

DPAHC. Finally, at the time of the study design, Arizona was characterized as having 

only a living will statute and was grouped based on this information. However, at time of 

data collection it was noted that information was provided to patients on both living wills 

and DPAHC. Upon further clarifkation from David Iandreth of the Auizona Medical 

Association, it was determined that Arizona enacted a DPAHC statute during the summer 

of 1992, and both living wills and DPAHt2 are now officially recognized. For purposes 

of this study, the sample States selected were categorized as follows: 1) Florida and 

Washington, living will and DPAHC, 2) Maryland and Arizona, living will, and 3) 

Massachusetts and Michigan, DPAHC. 

39. The legislative index developed for use in this study was based on information 

provided in Public Law 101-508, section 4206, 1990 Budget Reconciliation, the draft 

interim rule, referred to in this report as draft regulations dated Febmary 6, 1992, the 

23 
Progxam Memorandum to Intermediaries dated December 1991, Program Memorandum to 

Medicaid State Agencies dated October, 1991, and information on page 2 number 690 of 

the Medicare and Medicaid Guide in the discussion of the issuance of the interim final 

rule on advanced directives. All six of the items are specillcally mentioned in the 

requirements and have been assigned the same weight of one. An additional item was 

clearly mentioned in the requirements, the need to document in the patient’s medical 

record whether or not they have a directive. Since data on this specific item was collected 

and discussed at length in other sections of this report, it was not included in the 

legislative index. 

40. Since the design of this study and the collection of the data, an additional item has 

been clariiled specifically as a requirement in complying with legislation on advanced 

directives, This information was provided in the Medicare Hospital Manual, transmittal 

number 641, date August 1992. The additional requirement is noted in parentheses on 

page 134 of the Medicare Hospital Manual. The requirement specifies that facilities must 

provide written information to the patients regarding any conscientious objection clause 

the facility might have regarding implementing advanced directives, to the extent it is 

allowed in State law. A conscientious objection clause refers to the ability of the hospital 

or any agent of the hospital to n%use to implement a directive as a matter of conscience. 

41. After the data collection for this inspection had been completed a hospital in 

Michigan contacted the project leader about the chart documentation issue. The individual 

calling was responsible for the Medical Records function in the hospital. She stated other 

individuals with this responsibility in Michigan hospitals had expressed their concerns 

about appropriate documentation in the charts of patients during dkcussions. She stated 

one of the individuals involved in the discussion worked in a hospital that had been 

included in the sample for this inspection, prompting her call. She wanted to express her 

interest in seeking guidance on documentation. She was referred to individuals in her 

regional office and HCFA. This indicates that other facilities have spe.ciflc concerns about 

documentation issues. 

24 
APPENDICES 

Appendw A Regression Results 

Appendti B Weightd and Unweighed Chafi DaU 

Appendm C Full Text of Agency Comments 
APPENDIX A


Regression analysis on the sample data was undertaken estimating two models. The 

dependent variable was the percent of charts in each facility with clear documentation 

stating whether or not the patient has an advance directive. Our regression analysis 

detected five factors (independent vtiables] that were statistically signillcant: 

1) status as a for-profit organization, 

2) the lack of staff education or documentation of staff education on the topic, 

3) the provision of staff education after the Act was implemented, 

4) location in the State of Florida, and 

5) the provider was a nursing home. 

There was no signitlcant effect of whether the provider was a hospital or home health 

agency, location in one of the other sample States, or from having a higher score on the 

administrative index. See Table 1 for regression results. 

The effect of status as a for-profit organization was positive in both models, meaning they 

were more likely to have a larger percentage of charts with documentation present when 

compared to not-for-profit facilities. In the second equation where States were controlled, 

this variable had the greatest impact. As many of the for-profit agencies were members 

of a multiple facility system, this could indicate efficiencies in central development and 

dissemination of information. This may allow the facilities in for-profit multi-facility 

systems to have more standardized procedures and forms which could impact the 

documentation in patient charts. 

The effects of both lack of staff education or having no documentation that education was 

provided and providing education after the Act became effective we= negative in both 

models. This indicated that the facilities which provided education after the requirements 

were implemented, had a lower percentage of charts with documentation present than dld 

facilities which provided education before the implementation of the Act. The staff 

education variables had the greatest effect of the signifkant factors in the f~ regression 

model. This could indicate that the education did affect employee awareness and attention 

to this new procedure, and reinforces the importance of the education requirement. It 

could also indkate that facilities that document, document well. 

In model two, variables were included to account for the effect of each State. When 

controlling for each State in the sample, the effect of a facility located in the State of 

Florida was negative and sigrdfkxmt when compared to the omitted category (which was 

Washington). Location in any of the other sample States did not result in any signifkant 

changes. This indicated that facilities in Florida had a lower percentage of charts with 

documentation present. In addition, when controlling for States in the sample, the effect 

of whether the provider was a nursing home became statistically signiflca.nt and negative. 

This indicated &at nursing facilities were more likely to have a lower percentage of charts 

with documentation present when compared to hospitals, after looking at individual States. 

A -1

Table 1 

1


R.EGRESSION RESULTS: Percent of Chalts in Facil@ 

Independent 

Variable 

INDEX 

For Profit 

Public 

Numi.ngFacility 

Home Health Agency 

Ed After Implemen@tion 

No Education 

A-izona 

Florida 

Massachusetts 

Maryland 

Michigan 

Constant 

R Square 

Adjusted R Square 

F = 

(.Model 1) 

percent Chti 

Compliance 

per Facility 

8.77 

(5.29) 

8.82* 

(4.12) 

6.15 

(5.13) 

-7.46 

(4.37) 

-2.84 

(2.91) 

-10.85** 

(3.83) 

-10.38* 

(3.96) 

24.78 

.220 

.135 

2.585* 

With Document&”on 

(Model 2) 

percent Chti 

Compliance 

per Facility 

5.18 

(5.67) 

12.75** 

(4.28) 

4.49 

(4.97) 

-9.05* 

(4.15) 

-3.82 

(2.77) 

-8.08* 

(3.73) 

-11.35** 

(3.85) 

1.21 

(6.00) 

-9.36* 

(4.00) 

-3.35 

(2.81) 

.56 

(2.33) 

1.91 

(2.05) 

38.21 

.366 

.238 

2.84*” 

*	 = sig. .05 ** = ‘ig. “01


(stantid error presentd in Parentheses)


A -3


_— 
APPENDIX B


WEIGHTED AND UNWEIGHED CHART DATA REPORTED IN THE TEXT 

STATUS OF DOCUMENTA~ON IN PATIENTS MEDICAL RECORD:


Sample/Weighted 

Facility 

Type 

n 

All TWeS 

Hospitals 

Nursing 

Facilities 

Home 

Health 

Documented Not 

in Chart Documented 

in Chart 

76 0%/80.5% 18.0%/14.0% 

81.7%/86.2% 14.2%/9.4% 

69.1%/46.0% 16.0%/25.5% 

74.7%/68.0% 23.8%/31.5% 

Documented, 

But Filed 

Elsewhere 

3.2%/1.7% 

o 

12.0%/26.7% 

o 

“U~own” 

noted in 

Chart 

1.7%/3.3% 

4.1%/4.4% 

o 

.5%/.03% 

PATIENTS WITH ADVANCE DIRECTIV=: 

Sample/Weighted* 

rype of Facility Total Patients With Average 

Unable to 

Comprehend 

Noted in Chart 

1.1%/.2% 

o 

2.8%/1.8% 

1.0%/.5% 

Male 

35.9%42.7% 

39.1%/49.5% 

32.1%/40.2% 

37.8%122.3% 

AUFacilities 

Hospital 

Nursing 

Facility 

Home 

Health 

Advance 

Directives 

26.6%/21.2% 

20.8%/18.2% 

40.3%/47.7% 

22.4%/25.1% 

Age 

(sample) 

73 

63 

79 

76 

Female 

64.1%/55.5% 

60.6%/48.3% 

67.8%/58.9% 

62.1%/77.1% 

1

--numbers may not sum to 100% due to md.ng 

B-1 

sex and age mtormatlon 
APPENDIX C 

AGENCY COMMENTS: 

HEALTH CARE FINANCING ADmSTRA~ON 

c-1 

—.. 
DATE 

FROM 

SUBJECT 

TO 

u 30= /b@c&;L -

Bruce C. Vladeck


Administrator


Office of Inspector General (OIG) Draft Reports: “Early


Implementation of the Patient Self-Determination Act”


(OEI-06-91-01130), and “Facility and Patient Responses to the Patient


Self-Determination Act” (OEI-06-91-01131)


Bryan B. Mitchell


P~ncipal Deputy Inspector General


We have reviewed the draft reports which present OIG findings on the extent of 

institutional compliance with the advance directive provisions of the Omnibus 

Budget Reconciliation Act of 1990 and patients’ understanding of their rights and 

information provided to them in regard to this provision. Our specific comments are 

attached for your consideration. 

Thank you for the opportunity to review and comment on these reports. Please 

advise us if you agree with our position on the report’s recommendations at your 

earliest convenience. 

Attachment 
Comments of the Health Care Financirw Administration (HCFA) on 

the Office of InsDector General (OIG) Draft Reuorts: 

Earlv Implementation of the Patient Self-Determination Act, 

(OEI-06-91-01130)1 

and


Facilitv and Patient Rest)onses to~e Patient Self-Determination Act,


~OE1-06-91-01 131)


Recommendation 1 

The HCFA should develop and issue specific regulato~ guidelines clarifying 

acceptable documentation practices to meet requirements of the Patient SelfDetermination Act. Guidelines could be incorporated in the Final Regulations which 

are currently pending and specifically address what constitutes acceptable 

documentation of whether a patient does or does not have a directive. The HCFA 

could further disseminate documentation guidelines in the manner used in 

disseminating initial information on the r~quirements. For example: 

o	 Program memorandum from HCFA could be provided to State Medicaid 

agencies and State Medicare fiscal intermediaries on specific documentation 

requirements. 

o	 Medicaid agencies and Medicare intermediaries could provide a letter to all 

participating facilities on documentation requirements. 

o	 Participating facilities should be informed of Medicaid and Medicare contacts 

who can provide technical assistance on specific documentation requirements. 

HCFA Resrmnse 

HCFA nonconcurs. We do not believe that it is prudent to be overly perscriptive in 

this area. Existing Medicare and Medicaid regulations include specific requirements 

governing medical record documentation. Hospital medical records standards 

(42 CFR 48224) require the record to b~ accurate, legible, complete, and 

authenticated. If the records this study identified as ambiguous had been properly 

authenticated, staff could easily have contacted the author for clarification. HCFA 

regulations also include medical records requirements for nursing facilities 

[42 _ 483.75(1): Records must be in accordance with accepted professional 

standards, complete, accurately documented, and readily accessible], and home health 

agencies [42 CFR 484.48: Records must be in accordance with accepted professional 

standards]. We believe these requi.ranents are sufficient to accommodate 

_ ——
Page 2 

the advance directive requirement; therefore, we do not agree that specific regulatory 

guidelines are needed. If these facilities are not meeting existing standards, 

promulgation of new standards will not solve the problem. 

The interim final regulation stated that there may be various ways to effectively obtain 

the information needed to document the medical record, but did not address the 

specifics of how this documentation should be done. The flexibility contained in our 

regulation is appropriate because it encourages innovation and avoids potentially 

unnecessa~ recordkeeping burden. We believe the focus should be on ensuring that 

providers comply with the documentation requirement, instead of prescn%ing the 

method for documenting the existence of an advance directive. Additionally, while 

we understand that many providers will collect copies of advance directives, we do not 

believe that the statute authorizes a regulatory requirement to do so. 

The OIG study notes that the Joint Commission for Accreditation of Health 

Organizations (JCAHO) requires that aiy advance directive be included in the 

patient’s chart. We would also like to point out that the States also typically include 

records requirements among conditions for licensure for health facilities. It appears 

that the report did not review the content of State advanced directive laws. ~ese 

laws may contain additional documentation requirements. 

Recommendation 2 

HCFA should encourage the JCAHC) to include a specific review item to determine 

the presence of documentation of advance directives in each patient’s chart, in 

addition to the existing review items regarding directives. 

HCFA Resnonse 

HCFA concurs to the extent that JCAHO agrees to any additional information 

collection requirement. It is a longstanding practice between HCFA and JCAHO to 

coordinate efforts, where possible, on the rules and regulations issued by each. 

We have had discussions with the JCAI-IC) regarding advance directive rules and the 

documentation of such in the medical records, and it appears that they have . 

addressed this issue. Specifically, the JCAHO’S Accreditation Manual for Hospitals, 

standard RI.1.1.3.2.3., states that “any advance directive(s) is in the patient’s medical 

record . . .“ and the scoring process includes review of medical records. 
Page 3 

Recommendation 3 . 

The HCFA should provide leadership in developing a coordinated Department of 

Health and Human Services plan for educating the general public on advance 

directives. 

HCFA Resuonse 

HCFA concurs. We recognize that additional work remains in educating the general 

public on advance directives and that HCI?A should play a key role in developing a 

coordinated plan for carrying out that educational activity. Since this effort will 

involve several agencies within the Department, we believe responsibility for this 

action should rest with the Office of the Assistant Secretary for Public #dfairs 

(OASPA), in order that tasks can be directed through the Department’s chain of 

command. HCFA is nevertheless willing to provide staff support in working closely 

with the OASPA in carrying out this actitity. 

Technical Comments 

We believe it is contradictory to assert that most facilities are complying with the 

legislattie requirements, but at the same time find that only 26 percent of facilities 

clearly and consistently document whether the patient has an advance directive. 

Significantly, this report measured initial implementation efforts only 1 month after 

the regulation was in place. 

On page 5, the report notes that some of the samples “have poor precision” due to 

the small number of samples, but concludes that “it is still felt that they represent a 

reasonable estimate of initial implementation efforts.” Further explanation of this 

conclusion would strengthen the repo~ particularly in light of the contradictory 

findings in the Facilitv and Patient Resnonses report. 

Most of the findings cited in the section entitled “Lack of Guidelines” of the Early 

Imdementation of the Patient Self-Determination Act report (pages 10 and 11) do 

not support the section’s cmtchsion. These findings. indicate that facilities failed to 

document whether an advanced directive existed because personnel did not 

understand State laws, because of a patient’s condition, or because the patient was 

admitted after hours or through the emergency room - not due to confision 

regarding what constitutes acceptable documentation. The Facili~ and patient 

Resuonses report also indicates that the condition of the patient and the 

circumstances of admission were the reasons given for lack of documentation. 

Marginal notes have been added to your draft report. A copy is attached.