The Omnibus Budget Reconciliation Act of 1987 (OBRA 87) introduced major reforms in the federal regulation of nursing homes that responded to growing concerns about the quality of care that residents received. Among other things, these reforms revised care requirements that facilities must meet to participate in the Medicare or Medicaid programs, modified the survey process for certifying a home’s compliance with federal standards, and introduced additional sanctions and decertification procedures for homes that fail to meet federal standards. The federal responsibility for overseeing nursing facilities belongs to HCFA, an agency of the Department of Health and Human Services (HHS). Among other tasks, HCFA defines federal requirements for nursing home participation in Medicare and Medicaid and imposes sanctions against homes failing to meet these requirements. The law requires HCFA to contract with state agencies to survey nursing homes participating in Medicare and Medicaid. In California, DHS performs nursing home oversight, and its authority is specifically defined in state and federal laws and regulations. As part of this role, DHS (1) licenses nursing homes to do business in California; (2) certifies to the federal government, by conducting reviews of nursing homes, that the homes are eligible for Medicare and Medicaid payment; and (3) investigates complaints about care provided in the licensed homes. To assess nursing home compliance with federal and state laws and regulations, DHS relies on two types of reviews—the standard survey and the complaint investigation. The standard survey, which must be conducted no less than once every 15 months at each home, entails a team of state surveyors spending several days on site conducting a broad review of care and services with regard to meeting the assessed needs of the residents. The complaint investigation entails conducting a targeted review with regard to a specific complaint filed against a home. California state law mandates that a complaint must be investigated within 2 to 10 days, depending on the seriousness of the infraction being alleged. HCFA requires that any complaint involving immediate jeopardy to a resident’s health or safety be investigated within 48 hours. The state and HCFA each has its own enforcement system for classifying deficiencies that determines which remedies, sanctions, or other actions should be taken against a noncompliant home. During standard surveys, California’s DHS typically cites deficiencies using HCFA’s classification and sanctioning scheme; for complaint investigations, it generally uses the state’s classification and penalty scheme, which allows the imposition of penalties and other actions under state enforcement criteria. Table 1 shows HCFA’s classification of deficiencies and their accompanying levels of severity and compliance status. HCFA guidance also classifies deficiencies by their scope, or extent, as follows: (1) isolated, defined as affecting a limited number of residents; (2) pattern, defined as affecting more than a limited number of residents; and (3) widespread, defined as affecting all or almost all residents. HCFA guidance on citing a deficiency’s scope as “widespread” states that “‘the universe’ is the entire facility,” not just those who, by their condition, would have been affected by the deficiency cited. The example provided explains that if a facility was deficient in appropriately treating all of a facility’s tube-fed residents—but the number of tube-fed residents was less than the facility’s total number of residents—surveyors must cite the deficiency’s scope as “pattern” and not widespread. Whether a deficiency is judged by surveyors to be isolated, a pattern, or widespread has implications for enforcement. For example, under HCFA regulations, a home is to be cited for “substandard quality of care” when it has certain deficiencies exceeding a particular severity and scope level. Receiving a substandard rating is significant because, depending on a home’s past performance, such a rating can prompt stronger enforcement actions than are typically taken under HCFA policy. The deficiencies that can warrant a substandard rating involve federal requirements related to quality of care, quality of life, and resident behavior and facility practices. Any of these types of deficiencies involving immediate jeopardy to resident health and safety results in a substandard rating. In addition, these types of deficiencies lead to a substandard rating if they are of the following severity and scope combinations: a pattern of or widespread actual harm that is not immediate jeopardy; or a widespread potential for more than minimal harm that is not immediate jeopardy, with no actual harm. The work of our expert nurses indicates that some of California’s nursing home residents who died in 1993 received unacceptable care that, in certain cases, endangered their health and safety. We also found evidence that serious care problems exist today in California nursing homes. Data from standard and complaint surveys indicate that nearly a third of California’s nursing homes experience serious care problems. We examined medical records of residents who died in 1993 from such causes as malnutrition, dehydration, pressure sores, and urinary tract infections with sepsis (the presence of bacteria and toxins in the blood or tissue). Their deaths were alleged to have been caused by unacceptable nursing home care. The 3,113 cases of alleged unacceptable care were distributed across nearly three-fourths of California’s nursing homes in 1993. However, to avoid selecting isolated instances of such deaths, our cases were drawn from about 5 percent of California’s homes that had at least five of the allegedly avoidable deaths. Our review suggests that 34 residents—more than half of the 62 cases reviewed—received unacceptable care. Our expert nurses concluded that, in some of these cases, unacceptable care endangered residents’ health and safety. Care problems included dramatic, unplanned weight loss, failure to properly treat pressure sores, and failure to manage pain. The examples in figure 1 illustrate the nature of the care problems we identified. In other cases we reviewed from 1993, the care documented in the medical record was acceptable. For example, when nursing home staff recognized that a resident was having difficulty swallowing food, they changed her diet to pureed food and placed the resident in a restorative feeding program, where she received additional help in eating. Although the resident later refused all food and liquid and eventually died of dehydration, our expert reviewers concluded that the nursing home staff provided acceptable care during the resident’s 4-month stay in the home. The cause of death listed on her death certificate might raise questions about the care she received, but only medical record review could determine whether the care was acceptable. DHS surveyors identified a substantial number of homes with serious care problems through their annual standard surveys of nursing homes and through ad hoc complaint investigations. Through examining the most recent two surveys from homes that had at least two standard surveys conducted between July 1995 and February 1998, and that may have had complaint investigations in 1996 or 1997, we found that surveyors cited 407 homes—nearly a third of the 1,370 homes included in our analysis—for serious violations classified under the federal deficiency categories, the state’s categories, or both. These homes were cited for violations that caused death, seriously jeopardized residents’ health and safety, or were considered by state surveyors to have constituted substandard care. Figure 2 shows the distribution of the nursing homes included in our analysis by the seriousness of the federal and state violations cited. Caused Death or Serious Harm (407 Homes) Caused Less Serious Harm (449 Homes) The four wedges in figure 2 correspond to federal deficiency categories shown in table 1 and include comparable-level deficiencies cited using the state’s separate classification scheme, as follows: “Caused death or serious harm” represents any federal deficiency that surveyors classified as constituting immediate jeopardy or substandard care and California deficiencies of improper care leading to death, imminent danger or probability of death, intentional falsification of medical records, or material omission in medical records. “Caused less serious harm” represents federal violations constituting actual harm but not immediate jeopardy or substandard care and California violations that have a direct or immediate relationship to the health, safety, or security of a resident. “More than minimal deficiencies” represents federal violations that could cause more than minimal harm to residents if not corrected. “Minimal or no deficiencies” represents either no violations or federal violations that could have resulted in minimal harm to residents if not corrected. Figure 3 shows the distribution of types of deficiencies in the category called “caused death or serious harm” and gives examples of each type. The category “improper care leading to death” does not include all residents who died in homes cited for violations related to residents’ care, because the category “life-threatening harm” can also include such violations and associated deaths. We also found examples of poor care that were ranked by state surveyors as causing less serious harm under the federal and state classification systems. For example, the cases described in figure 4 were not classified in the group of “most serious” violations. Deficiencies classified as “potential for more than minimal harm”—corresponding to the “more than minimal deficiencies” category in figure 2—can also include problems more serious than their classification implies, as figure 5 shows. Homes with deficiencies classified as having “potential for minimal harm”—corresponding to the “minimal or no deficiencies” category in figure 2—are considered by HCFA to be in substantial compliance, as shown in table 1. However, figure 6 shows examples of deficiencies that California surveyors classified in this category in which the harm could be considered by some to be greater than minimal. The deficiencies that state surveyors identified and documented very likely capture part but not the full extent of care problems in California’s homes, for several reasons. Some homes can mask problems because they are able to predict the timing of annual reviews or because medical records sometimes contain inaccurate information that overstates the care provided, given the resident’s observed condition. In addition, state surveyors can miss identifying deficiencies because of limitations on the methods used in the annual review—methods established in HCFA guidance on conducting surveys—to identify potential areas of unacceptable care. The extent of care problems is likely to be masked because of the predictability of homes’ standard surveys. The law requires that a standard survey be unannounced, that it begin no later than 15 months after the last day of the previous standard survey, and that the statewide average interval between standard surveys not exceed 12 months. Because many California homes were reviewed in the same month—sometimes almost the same week—year after year, homes could often predict the timing of their next survey and, if inclined, prepare to cover up problems that may normally exist at other times. For example, a home that may routinely operate with too few staff could temporarily augment its staff during the period of the survey in order to mask an otherwise serious deficiency in staffing levels. Advocates and residents’ family members told us they believe that such staffing adjustments are common, given their own observations in homes they visited. At two homes we visited, we saw that the homes’ officials had made advance preparations—such as making a room ready for survey officials—indicating that they knew the approximate date and time of their upcoming oversight review. When we discussed these observations with California DHS officials, they acknowledged that a review of survey scheduling showed that the timing of some homes’ surveys had not varied by more than a week or so for several cycles. DHS officials have since instructed district office managers to schedule surveys in a way that reduces their predictability. The issue of the predictable timing of surveys is long-standing. In the mid-1980s, the Institute of Medicine recommended adjusting the timing of surveys to make them less predictable and maximize the element of surprise. It suggested that standard surveys be conducted between 9 and 15 months after the previous standard survey. In OBRA 87, the Congress established a civil monetary penalty to be levied against an individual who notifies a nursing home about the time or date of an impending survey. In 1995, HCFA issued guidance to states to keep the timing of the standard survey unpredictable by ensuring that all surveys are unannounced. However, the guidance is silent on varying the survey cycle as a way to reduce the predictability of these reviews. Since the guidance was issued, two studies have found that regular timing of surveys is still a problem. The National State Auditors Association found that in nine states it studied, the timing of inspections in some states was around the same date every year, which allowed nursing homes to predict when their survey would occur. Similarly, nursing home advocates in 41 states and the District of Columbia polled by HCFA noted that the predictability of surveys was a continuing problem. One state’s advocate noted that a home’s care, food, and environment change dramatically as the time of the home’s standard survey nears. Another reason quality problems in nursing homes escape detection is the questionable accuracy of some resident medical records. When conducting on-site reviews, surveyors screen residents’ medical records for indicators of improper care; if information in the records is misleading or omitted, surveyors may fail to identify care deficiencies. Studies of nursing home quality cite questionable accuracy of resident medical records as a problem. For example, one study found that nursing home staff often incorrectly record the amount of food consumed by residents, thus calling into question the information maintained on the adequacy of residents’ nutrition. Another study examined records on the use of restraints compared with actual restraint use. In this study, although nursing home records showed that staff had removed residents’ restraints every 2 hours as required, researcher observation revealed that, in fact, 56 percent of the residents had been continuously restrained for 3 hours or longer. In the course of reviewing the 1993 medical records, we also found inaccuracies and otherwise misleading information. The examples in figure 7, abstracted from the 1993 California records we reviewed, illustrate the implausibility or suspicious omissions of information contained in some residents’ records. We found discrepancies in about 29 percent of the 1993 California records we reviewed. Through medical record reviews as well as direct observation at two homes, we found that the standard surveys at these facilities failed to identify a number of serious care problems. In our visits to two facilities during their annual surveys, we arranged for our team of registered nurses to accompany the state surveyors and conduct concurrent surveys designed specifically to identify quality-of-care problems. Our survey methodology differed from the methodology specified by HCFA guidance and used by state surveyors in three major ways: (1) we selected a stratified, random sample of a much larger number of cases to review, including vulnerable populations such as new admissions and those at risk for pressure sores; (2) we collected uniform information on those cases using a structured protocol for observations, chart review, and staff interviews; and (3) we compared the results from those cases at each facility with data collected under the same sampling method at more than 60 other nursing homes nationwide, and then targeted our case review in areas where we identified a facilitywide pattern that could denote poor care. Using this methodology, we were able to spot cases in which the homes had not intervened appropriately for residents experiencing weight loss, dehydration, pressure sores, and incontinence—cases the state surveyors either missed or identified as affecting fewer residents. At the two homes where our nurses conducted their quality-of-care surveys, the findings of our team and those of DHS surveyors were similar in some respects and different in others. For example, state surveyors cited one of the homes (home A) for a high medication error rate that was not found by our surveyors. However, problems state surveyors missed included unaddressed nutrition and weight loss, failure to prevent pressure sores, and poor management of resident incontinence—cases in which the homes had not intervened appropriately. (See fig. 8 for examples of such problems in home A.) DHS surveyors classified home A’s violations as posing potential for more than minimal harm to residents and, according to standard practice for deficiencies classified at this level, required the home to produce a corrective action plan. In contrast, we determined, on the basis of the problems shown in figure 8, that this home had a pattern of poor care and classified this home’s care for unaddressed nutrition and weight-loss problems, pressure sore problems, and incontinence problems as conditions demonstrating actual harm. At home B, we noted that the state surveyors had found a considerable number of problems, including some that were similar to those we found. For example, both teams found pressure sore treatment and infection control deficiencies. The state surveyors also found problems we did not identify, including the home’s failure to provide oral hygiene to residents and to appropriately administer an intravenous medication to one resident. However, the state surveyors overlooked quality-of-care problems that we detected and considered serious. Among those missed were problems in the category of “failure to provide appropriate personal and preventive care.” (See fig. 9.) DHS surveyors classified home B’s violations as resulting in actual harm but determined that the harm was isolated rather than systemic. By defining the extent of the deficiencies as isolated, DHS followed its standard practice—for a deficiency cited at this level—of requiring the home to submit a corrective action plan. In contrast, by using a larger sample, we were able to establish a frequency of cases demonstrating a pattern of actual harm. Several factors account for the different assessments of care between the two survey teams. First, in reviewing medical records to identify areas with potential for poor care, our surveyors took random samples of cases from several types of residents, including the most vulnerable residents. Second, the number of cases our surveyors drew was large enough to estimate how common the problems were in the homes. Third, the information our surveyors collected from medical record reviews, staff interviews, and data analyses was entered into a structured format and compared with similar information from more than 60 other homes nationwide. This allowed our surveyors to pinpoint areas where care seemed problematic and review those cases thoroughly. HCFA policy establishes the procedures, or protocol, that state surveyors must follow in conducting a home’s standard survey. Selecting cases for review is an activity that occurs early in the standard survey of a home to identify potential instances of poor care. At the beginning of a standard survey, the nursing home administrator must supply surveyors with documents that specify, among other things, a census of residents by medical condition, such as numbers of individuals with pressure sores, indwelling catheters, and physical restraints. The state surveyors use this information to select the majority of cases for particular scrutiny during the survey. They may add to the list of cases after observing residents and talking with nursing home staff. HCFA’s protocol for selecting cases does not call for taking a random sample of sufficient size, however, and relies primarily on the use of professional expertise and judgment, based on numerous criteria that HCFA offers as guidance. While professional judgment is an essential component in identifying poor care, the nonrandom nature of the sample and its insufficient size precludes the state surveyor from easily determining the prevalence of the problems identified. The protocol our surveyors used for sampling allowed them to cast a wider net. Specifically, they took random samples of three groups of residents to target cases in which poor care would be most likely to surface. The three groups sampled were classified as “new admissions,” “long stays” (residents more than 105 days into their stay), and “sentinel events” (residents whose medical conditions put them at the greatest risk for poor outcomes). By stratifying the sample and taking a random selection of a sufficient number of each group, our surveyors could project the results of the samples to all residents in the home, thus assessing the potential prevalence of their initial review findings. For each resident in the sample, the survey team collected information from observations, chart reviews, and staff interviews assessing 75 elements reflecting quality-of-care outcomes. Our surveyors then profiled these findings—that is, they compared the data from the sampled cases with data collected under the same sampling method at more than 60 nursing homes in other states. Analyzing data collected from the cases sampled, our survey team compared a home’s rate of poor outcomes against the rates determined for the homes in other states. For example, they found that, at the two homes discussed, the rate of pressure sores was 27 percent and 21 percent of each home’s total residents, whereas the comparison homes’ average rate was roughly 8 percent. Being able to compare rates of medical conditions in a nursing home, such as the percentage of residents with pressure sores, allows the surveyor to determine whether the home is an outlier in comparison with other homes. Our surveyors then used this information to review residents’ care regarding specific conditions to determine whether the poor outcome rates were due to unacceptable care or were justifiable because of other factors. HCFA has just begun to implement a requirement for all nursing homes participating in Medicare and Medicaid to transmit electronically certain data they maintain on residents’ health and functional status. Having this information in computerized form could provide surveyors better access to residents’ outcome data, thus potentially enhancing surveyors’ ability to select cases for review more systematically and quickly. Access to information in this form could also facilitate assessing a home’s performance with regard to residents’ outcomes against an established average or norm. These benefits will depend, however, on ensuring that these data are valid and reliable reflections of residents’ status and care. Once surveyors find deficiencies through nursing home surveys, their next step is to have the homes correct their deficiencies and return to compliance with federal requirements. Despite HCFA’s goal to have nursing homes sustain compliance with federal requirements over time, our work in California showed that 1 in 11 California homes—serving thousands of residents—were cited twice in a row for “actual harm” violations. Relatively few disciplinary actions were taken against such homes because of HCFA’s forgiving stance on enforcement. HCFA’s termination policy is likewise generous—allowing California homes terminated from the program for serious problems to be easily reinstated—even though they often have serious care violations in subsequent surveys. Recognizing these and other weaknesses in the current process, California’s DHS has begun a “focused enforcement” effort and has implemented procedures to strengthen its use of available nursing home enforcement authority for facilities with the poorest past performance records. OBRA 87 requires the HHS Secretary to ensure that the enforcement of federal care requirements for nursing homes is adequate to protect the health, safety, welfare, and rights of residents. In the background to its final regulations, HCFA stated that its system of requirements implementing OBRA 87 reforms “was built on the assumption that all requirements must be met and enforced” and that its enforcement actions will encourage “sustained compliance.” In addition, HCFA noted that “our goal is to promote facility compliance by ensuring that all deficient providers are appropriately sanctioned.” However, our data suggest that current enforcement efforts in California are not reaching the stated goal to ensure that all requirements are met and deficient providers are appropriately sanctioned, and also may not fulfill the OBRA 87 promise to protect the health, safety, welfare, and rights of residents. National data indicate this problem is not limited to California. A significant number of homes in our analysis had repeated violations in categories that HCFA classifies as “serious” or “most serious.” Specifically, 122 homes—representing over 17,000 resident beds—were cited in both of their last two surveys for conditions causing actual harm or conditions that put residents in immediate jeopardy or caused death. The repeated deficiencies included, among others, problems with infection control, pressure sore treatment, and bladder continence care. Preliminary analysis of national data indicates that repeating serious deficiencies is more common nationally than in California. One in nine nursing homes in the United States—representing more than 232,000 resident beds—were cited in both of their last two surveys for conditions that caused actual harm or put residents in immediate jeopardy or caused death. Relatively few disciplinary actions have been taken against homes cited for repeated harm violations. Before OBRA 87, the only sanction available to HCFA and the states to impose against such noncompliant homes, short of termination, was to deny federal payments for new admissions. Because this sanction afforded HCFA and the states an opportunity to defer the decision to terminate, it was considered an “intermediate” sanction. OBRA 87 provided for additional intermediate sanctions, such as denial of payment for all admissions, civil monetary penalties, and on-site oversight by the state (“state monitoring”). Nevertheless, between July 1995 and May 1998, nearly three-quarters of those 122 homes—cited in at least 2 consecutive years for serious deficiencies—had no federal intermediate sanctions that actually took effect. Our review of federal actions taken against California’s noncompliant homes indicates that HCFA’s policies, as implemented by California’s DHS, have not led to sustained compliance, either for some homes immediately referred for sanctioning or for others given a grace period to correct their deficiencies. In addition, HCFA has reinstated California homes terminated for serious deficiencies that became problem homes soon after reinstatement. HCFA guidance instructs state agencies to immediately refer for federal sanctioning homes that meet HCFA criteria for posing the greatest danger to residents. The immediate referral contrasts with the practice of first granting homes a grace period to correct cited deficiencies. To qualify for immediate referral, homes must be cited for violations in the immediate jeopardy category or be rated as a “poor performer.” HCFA’s definition of poor performer itself is circumscribed such that the definition applies to relatively few homes. A home must have been cited on its current standard survey for substandard quality of care and have been cited in one of its two previous standard surveys for substandard quality of care or immediate jeopardy violations. Homes cited for cases of actual harm to residents—if assessed at the isolated level—do not satisfy HCFA’s criteria for the substandard quality-of-care classification. Since July 1995, when the federal enforcement scheme established in OBRA 87 took effect, about 25 California homes have been designated as poor performers and 59 homes have been cited for immediate jeopardy deficiencies. HCFA guidance permits the state to broaden the definition of poor performer, but California has chosen not to do so. Even homes immediately referred for sanctioning do not necessarily receive sanctions that take effect. Among California homes HCFA considers to have the most serious deficiencies that immediately jeopardize resident health and safety, only about half had any sanctions that actually took effect. If homes come into substantial compliance before sanctioning is scheduled to take effect, HCFA rescinds the sanction. In principle, sanctions imposed against a home remain in effect until the home corrects the deficiencies cited and until state surveyors find, after an on-site review (called a “revisit”) that the home has resumed substantial compliance status. HCFA’s guidance on revisits allows states to forgo an on-site visit and accept a home’s report of resumed compliance status if the home’s deficiencies are not more serious than the “potential for harm” range and do not constitute substandard care. HCFA officials told us this policy was put into place because of resource constraints. In California, however, this policy has been applied even to some of the immediate referral homes that continue to have deficiencies that put them out of substantial compliance upon revisit. Thus, our review of certain enforcement cases showed that HCFA failed to ensure that homes with a record of posing the greatest danger to residents had, in fact, resumed substantial compliance. For example, in the case of one home immediately referred for sanctioning, DHS surveyors made a few on-site reviews, but HCFA twice accepted the home’s self-reported statement of compliance without requesting DHS to revisit and independently verify that the home had fully corrected its deficiencies. Specifically, in an October 1996 survey, DHS cited the home for immediate jeopardy and actual harm violations, including improper pressure sore treatment, medication errors, insufficient nursing staff, and an inadequate infection control program. By early November 1996, however, surveyors had found in an on-site review that the problems had abated but had not fully ceased. A week later, the home reported itself to HCFA as resuming substantial compliance. HCFA accepted this report without further on-site review. About 6 months later (May 1997), in the home’s next standard survey, DHS found violations that warranted designating the home a poor performer. On a revisit to check compliance in July 1997, surveyors found new but less serious deficiencies. In August 1997, however, when the home reported itself in compliance, HCFA accepted the report without further verification. Between October 1996 and August 1997, HCFA imposed several sanctions but lifted them each time it accepted the home’s unverified report of resumed compliance. According to HCFA guidance, noncompliant homes that are not classified in the immediate jeopardy or poor performer categories do not meet HCFA’s criteria for immediate referral for sanctioning, even though residents may have suffered actual harm. Following this guidance, California’s DHS first notifies these homes of the sanctions it will recommend imposing unless the home resumes compliance. DHS revisits the homes where residents have suffered actual harm or worse to ensure that compliance has been achieved. In practice, on the basis of HCFA’s guidance, the state will forward notification of the recommended sanctions to HCFA only if the home fails to correct the deficiencies cited within a 30- to 45-day grace period allowed by HCFA. Although California’s DHS regulators have the option of referring the home immediately for disciplinary action, the accepted practice under HCFA’s guidance is to first allow the home to return to compliance status within the specified grace period. HCFA policy permits granting a grace period to this group of noncompliant homes, regardless of their past performance. Between July 1995 and May 1998, California’s DHS gave about 98 percent of noncompliant homes a grace period to correct deficiencies. For nearly the same period (July 1995 to April 1998), the rate of noncompliant homes receiving a grace period nationwide was 99 percent, indicating that the practice of granting a grace period to nearly all noncompliant homes is common across all states. Moreover, data we analyzed on actions taken against California homes cited repeatedly for harming residents suggest that DHS does not take into account a home’s compliance history when determining whether to impose intermediate sanctions. Of the 122 homes in our analysis cited repeatedly for harming residents, 73 percent were not federally sanctioned. In the case of such homes—cited in consecutive surveys for actual harm or immediate jeopardy violations—granting a grace period with no further disciplinary action appears to be a highly questionable practice. Table 2 illustrates a home with the same violations cited 4 years in a row—thus not sustaining compliance from one standard survey to the next—and still receiving a grace period to correct its deficiencies after each survey. Although HCFA has the authority to terminate homes from participation in Medicare and Medicaid if they fail to resume compliance, termination rarely occurs and is not as final as the term implies. In the recent past, California’s terminated homes have rarely closed for good. Of the 16 homes terminated in the 1995 to 1998 time period, 14 have been reinstated. Eleven have been reinstated under the same ownership they had before termination. Of the 14 reinstated homes, at least six have been cited since their reinstatement with new deficiencies that harmed residents, such as failure to prevent avoidable accidents, failure to prevent avoidable weight loss, and improper treatment of pressure sores. A home that reapplies for participation is required to have two consecutive on-site reviews—called reasonable assurance surveys—within 6 months to determine whether it is in substantial compliance with federal regulations before its eligibility to bill federal programs can be reinstated. However, HCFA has not always ensured that homes are in substantial compliance before reinstatement. For example, one home terminated on April 15, 1997, had two reasonable assurance surveys on April 25 and May 28, 1997. Although the nursing home was not in substantial compliance at the time of the second survey, HCFA considered the deficiencies minor enough to reinstate the home on June 5, 1997. The consequence of termination—stopping reimbursement for the home’s Medicare and Medicaid beneficiaries—was in effect for no longer than 3 weeks. About 3 months after reinstatement, however, the home was cited for harming residents. DHS surveyors investigating a complaint found immediate jeopardy violations as a result of a dangerously low number of nursing home staff. In addition, surveyors cited the facility for providing substandard care. Residents who could not move independently, some with pressure sores, were left sitting in urine and feces for long periods of time; some residents were not getting proper care for urinary tract infections; and surveyors cited the home’s infection control program as inadequate. By 1997, California DHS officials recognized that the state, in combination with HCFA’s regional office, had not dealt effectively with persistently and seriously noncompliant nursing homes using the OBRA 87 enforcement process. The process discouraged immediate application of enforcement actions. It allowed nursing homes to come back into compliance for a short period of time, escaping enforcement action altogether. In many instances, though, homes did not sustain compliance for a significant period of time. Therefore, in July 1998 and with HCFA’s agreement, DHS began a “focused enforcement” process that combines state and federal authority and action, targeting providers with the worst compliance records for special attention. As a start, DHS has identified about 34 homes with the worst compliance histories—generally two in each of its districts. Officials intend to conduct standard surveys of these homes about every 6 months rather than every 9 to 15 months. In addition, DHS intends to conduct more complete on-site reviews of facilities for all complaints received about these homes. DHS and HCFA told us that they do not intend to accept such homes’ self-reports of compliance without a revisit. DHS officials told us that the agency is developing procedures—consistent with HCFA regulations implementing OBRA 87 reforms—to ensure that, where appropriate, the state will immediately recommend and HCFA will impose civil monetary penalties and other strong sanctions to bring such homes into compliance and keep them compliant. For focused enforcement homes unable to sustain compliance, state officials plan to revoke their state licenses and recommend termination from the Medicare and Medicaid programs. In addition, DHS plans to screen the compliance history of facilities by owner—both in California and nationally—before granting new licenses to operate nursing homes in the state. State officials told us that they will require all facilities with the same owner to be in substantial compliance before any new licenses are granted. The responsibility to protect nursing home residents, among the most vulnerable members of our society, rests with nursing homes and with HCFA and the states. In a number of cases, this responsibility has not been met in California. We and state surveyors found cases in which residents who needed help were not provided basic care—not helped to eat or drink; not kept dry and clean; not repositioned to prevent pressure sores; not monitored for the development of urinary tract infections; and not given pain medication when needed. When such basic care is not provided, residents may suffer unnecessarily. As serious as the identified care problems are, weaknesses in federal and state oversight of nursing homes raise the possibility that many care problems escape the scrutiny of surveyors. Homes can prepare for surveyors’ annual visits because of the visits’ predictable timing. Homes can also adjust resident records to improve the overall impression of the home’s care. In addition, DHS surveyors may overlook significant findings because the federal survey protocol they follow does not rely on an adequate sample for detecting potential problems and their prevalence. Together, these factors can mask significant care problems from the view of federal and state regulators. Furthermore, HCFA needs to reconsider its enforcement approach toward homes with serious, recurring violations. Federal policies allowing a grace period to correct deficiencies and to accept a home’s report of compliance without an on-site review can be useful policies, given resource constraints, when applied to homes with less serious problems. However, even with resource constraints, HCFA and DHS need to ensure that their enforcement efforts are directed to homes with serious and recurring violations and that policies developed for homes with less serious problems are not applied to them. Under current policies and practices, noncompliant homes that DHS identifies as having harmed or put residents in immediate danger have little incentive to sustain compliance, once achieved, because they may face no consequences for their next episode of noncompliance. Our findings regarding homes that repeatedly harmed residents or were reinstated after termination suggest that the goal of sustained compliance has not been met. Failure to bring such homes into compliance limits the ability of federal and state regulators to protect the welfare and safety of residents. In order to better protect the health, safety, welfare, and rights of nursing home residents and ensure that nursing homes sustain compliance with federal requirements, we recommend that the HCFA Administrator revise federal guidance and ensure state agency compliance through taking the following actions: Stagger or otherwise vary the scheduling of standard surveys to effectively reduce the predictability of surveyors’ visits; the variation could include segmenting the standard survey into more than one review throughout the 12- to 15-month period, which would provide more opportunities for surveyors to observe problematic homes and initiate broader reviews when warranted. Revise federal survey procedures to instruct surveyors to take stratified random samples of resident cases and review sufficient numbers and types of resident cases so that surveyors can better detect problems and assess their prevalence. Eliminate the grace period for homes cited for repeated serious violations and impose sanctions promptly, as permitted under existing regulations. Require that for problem homes with recurring serious violations, state surveyors substantiate, by means of an on-site review, every report to HCFA of a home’s resumed compliance status. We sought comments on a draft of this report from HCFA and DHS (whose written comments are reproduced in appendixes II and III), experts on nursing home care, and representatives from the nursing home industry. The reviewers generally agreed that the findings were troubling and that improvements were needed in the federal survey and enforcement process to better protect residents’ health and safety. Reviewers also suggested technical changes, which we included in the report as appropriate. HCFA officials informed us that they are planning to make significant modifications in their survey and enforcement processes, which they believe will address our recommendations. HCFA concurred with the recommendation to eliminate the grace period for homes with repeated serious violations and agreed that having a more scientifically selected and larger case review sample would improve the ability of surveyors to detect poor care in nursing homes. HCFA also agreed to change its revisit policy for homes that are seriously noncompliant. HCFA agreed in principle that quality of care needs to be monitored outside the bounds of an annual, standard survey and acknowledged that certain factors can affect the predictability of surveys. These factors include the time of day and day of week the survey begins as well as the timing of surveys for homes in a given locale. Based on its analysis of certain OSCAR data, however, HCFA disagreed that states are not varying their survey schedules. We believe that basing a conclusion about the predictability of the annual survey primarily on analysis of OSCAR data is problematic, given weaknesses we identified in the classification of surveys entered into the database. Given these questions we raised, HCFA agreed to review the validity of the OSCAR data. HCFA also raised concerns—as did DHS—that segmenting the survey into two or more reviews would make it less effective and more expensive. We believe that segmenting the survey could largely eliminate concern about predictability and, by increasing the frequency of surveyors’ visits to homes, could provide more opportunity to observe problematic homes and initiate broader reviews when warranted. These advantages should be evaluated relative to the potential disadvantages that concern HCFA. DHS officials generally agreed with our findings and recommendations. They attributed many of the problems in the current survey and enforcement process to federal policy directives that, they maintain, have weakened states’ ability to oversee quality of care and quality of life in nursing homes. In its comments, DHS has also suggested a number of additional changes it believes would improve the federal survey and enforcement process. These include adding a waiting period before homes terminated from Medicare and Medicaid could be reinstated in the programs, changing HCFA’s definitions of scope of violations and of substandard care to more realistically reflect the seriousness of poor care, changing HCFA’s revisit policy for homes that are not in substantial compliance, developing a peer review of survey and enforcement practices in different regions, improving the database used for enforcement tracking, and more fully funding survey and enforcement activities for the state. Some reviewers questioned whether the scope of our clinical review of 1993 records and concurrent review of nursing homes was sufficient to permit drawing conclusions about the current condition of all California nursing homes. These aspects of our methodology—while important—were not the primary basis for reaching our conclusions. The most comprehensive and compelling evidence we analyzed was recent standard survey reports of California’s own surveyors, the statewide database DHS maintains on complaint investigations, and the nationwide database HCFA maintains on nursing home deficiencies. In response to these comments, we modified the report to better clarify our methodology and the primary basis for our findings. As agreed with your offices, unless you publicly announce its contents earlier, we plan no further distribution of this report until July 28, 1998. At that time, we will make copies of this report available to interested parties upon request. Please contact me or Kathryn Allen, Associate Director, at (202) 512-7114 if you or your staff have any further questions. This report was prepared by Jack Brennan, Scott Berger, Mary Ann Curran, C. Robert DeRoy, Gloria Eldridge, and Hannah Fein, under the direction of Sheila Avruch. Concerned about the life-threatening potential of the recent allegations, you asked us to determine whether the allegations had any merit and whether the monitoring of California’s nursing homes has been adequate to protect residents. More specifically, we assessed (1) whether, as alleged, residents who died in 1993 from certain causes had received unacceptable care that could have endangered their health and safety, and whether serious care problems currently exist; (2) the adequacy of federal and state efforts in monitoring nursing home care through annual surveys; and (3) the effectiveness of federal and state efforts to enforce sustained compliance with federal nursing home requirements. We reviewed the medical records of a sample of the 3,113 residents alleged to have died avoidable deaths in 1993 in 971 California nursing homes from malnutrition, dehydration, urinary tract infection (UTI), bowel obstruction, or bedsores (pressure sores). We met with those making the allegations, and from them we obtained copies of the death certificates of the 3,113 residents. To select our sample, we eliminated residents with UTI who did not also suffer from septicemia (the presence of bacteria and toxins in the blood), because if these conditions are not present, UTI is generally not lethal. We assumed that if care was a problem in a home, more than one resident would have been affected. We therefore excluded death certificates for residents of homes with (1) fewer than five such deaths and (2) for such deaths, a deaths-to-total-beds ratio of less than 5 percent. That left a universe of 546 residents at 72 homes. In addition, we eliminated residents who died in counties having few nursing homes. After these exclusions, our universe became 446 residents at 59 homes, from which we selected a preliminary sample of 75 residents from 15 homes. Fourteen of these homes were freestanding and one was a hospital-based nursing home. Because we selected from residents of homes with five or more such deaths in certain counties, our results cannot be generalized to the universe of all residents in California nursing homes who died of the same causes in 1993. To review the medical records, we used two registered nurses with advanced degrees in gerontological nursing and with expertise in clinical nursing home care and data abstraction. To guide them, another registered nurse on our staff developed a detailed structured data collection instrument. The nurses’ work was reviewed by the registered nurse on our staff, who has experience working in nursing homes and judging whether care met acceptable clinical standards. This second review focused on a critical examination of all cases where the first team of registered nurses identified residents as having unacceptable care, in order to exclude any cases that might be questionable rather than unacceptable. The registered nurse on our staff also discussed some of the cases with physicians and additional registered nurses specializing in geriatric care to further clarify whether care was acceptable. We excluded all questionable cases from the unacceptable care group. Because of the time needed to thoroughly review each resident’s complete clinical history (some were more than 600 pages), the nurses reviewed 62 of the 75 records initially selected from 1993. To determine the extent of deficiencies identified by state surveyors in California nursing homes since July 1995, and to identify enforcement actions taken in response to the deficiencies, we used two databases. The first, HCFA’s On-Line Survey, Certification, and Reporting (OSCAR) System, contains information about violations of federal requirements that a home has received in its last four surveys. The second, the Automated Certification and Licensing Administrative Information Management System (ACLAIMS) database, is maintained by California’s DHS and contains information on each home’s violations of state requirements. In addition, we used data that HCFA’s San Francisco regional office maintains separately from OSCAR on federal sanctions imposed. In OSCAR, we identified 1,445 California homes that had survey data after July 1, 1995—the date the new OBRA 87 scope and severity system went into effect. If a nursing home at a particular address had more than one provider number, we included in our analysis only one of the provider numbers to represent that home. Of the 1,445 California homes, 1,370 of those homes (95 percent) had at least two surveys entered into the OSCAR database since July 1995. Information in the OSCAR database is constantly being updated. We downloaded OSCAR data on February 26, 1998, to get a fixed database for our analysis of 1,370 homes. We also continued to work with OSCAR on-line as necessary, for example, to download survey reports on particular homes. The nursing homes we analyzed included Medicare and Medicaid dually certified facilities, Medicare-only facilities, Medicaid-only facilities, and both freestanding and hospital-based facilities. To develop information shown in figures 2 and 3, we combined information from both the OSCAR and ACLAIMS databases. We did not conduct a thorough assessment of the validity or reliability of either OSCAR or ACLAIMS. We did determine, however, that OSCAR excludes data that could be useful in obtaining a complete picture of a nursing home’s history of deficiencies. For example, serious violations of state requirements discovered during complaint investigations are not routinely shown as federal deficiencies in OSCAR. Other information, such as the seriousness and extent of identified deficiencies, were missing from OSCAR in some cases. We found instances of missing information in 282 of the 1,370 homes in our analysis. The effect of these omissions from the database, we believe, is an understatement of documented deficiencies in OSCAR. To assess the effectiveness of the survey process, we accompanied California state surveyors on annual standard surveys conducted at two homes. To do this, we arranged for a team of registered nurses to accompany the DHS surveyors and conduct concurrent surveys using a protocol developed under a HCFA research contract designed specifically to identify quality-of-care problems. These nurses work with Andrew M. Kramer, M.D., of the University of Colorado’s Center on Aging Research Section of the Health Sciences Center, who developed the survey protocol for HCFA. Before conducting the concurrent surveys at these homes, we accompanied a state survey team to a third home to gather information on survey procedures. To better understand survey deficiencies, complaints, and enforcement, we reviewed selected records. We determined the types of problems being identified by surveyors by obtaining and analyzing annual standard surveys for 18 homes we visited. We also obtained and analyzed information about the number and type of complaints investigated by two district offices. To better understand enforcement efforts, we reviewed selected enforcement files and enforcement data kept by HCFA. We also interviewed responsible officials from HCFA headquarters in Baltimore and HCFA’s San Francisco regional office. We met with officials from California DHS in Sacramento and two district offices; the California Association of Health Facilities; the American Health Care Association; the American Association of Homes and Services for the Aging; the California Association of Homes and Services for the Aging; the California Advocates for Nursing Home Reform; California’s Office of Ombudsman; nursing home administrators and directors of nursing; geriatricians and registered nurses with expertise in nursing home issues; and families of nursing home residents. The first copy of each GAO report and testimony is free. Additional copies are $2 each. 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Summary: Pursuant to a congressional request, GAO reviewed allegations that residents in California nursing homes are not receiving acceptable care, focusing on: (1) examining, through a medical record review, whether these allegations had merit and whether serious care problems currently exist; (2) reviewing the adequacy of federal and state efforts in monitoring nursing home care through annual surveys; and (3) assessing the effectiveness of federal and state efforts to enforce sustained compliance with federal nursing home requirements. GAO noted that: (1) despite the federal and state oversight infrastructure currently in place, certain California nursing homes have not been and currently are not sufficiently monitored to guarantee the safety and welfare of their residents; (2) GAO reached this conclusion primarily using data from federal surveys and state complaint investigations conducted by California's Department of Health Services (DHS) on 1,370 California homes, supplemented with more in-depth analysis of certain homes and certain residents' care; (3) GAO found that surveyors can miss problems that affect the safety and health of nursing home residents and that even when such problems are identified, enforcement actions do not ensure that they are corrected and do not recur; (4) with regard to allegations made about avoidable deaths in 1993, GAO's expert nurses' review of the 62 resident cases sampled found that residents in 34 cases received care that was unacceptable and that sometimes endangered their health and safety; (5) in the absence of autopsy information or other additional clinical evidence, GAO cannot be conclusive about the extent to which this unacceptable care may have contributed directly to individual deaths; (6) unacceptable care continues to be a problem in many homes; (7) GAO believes that the extent of serious care problems portrayed in federal and state data is likely to be understated; (8) GAO found that homes could generally predict when their annual on-site reviews would occur and, if inclined, could take steps to mask problems otherwise observable during normal operations; (9) GAO found irregularities in the homes' documentation of the care provided to their residents; (10) in visiting homes selected by California DHS officials, GAO found multiple cases in which DHS surveyors did not identify certain serious care problems; (11) surveyors missed these care problems because federal guidance on conducting surveys does not include sampling methods that can enhance the spotting of potential problems and help establish their prevalence; (12) the Health Care Financing Administration's (HCFA) enforcement policies have not been effective in ensuring that the deficiencies are corrected and remain corrected; (13) California's DHS grants all noncompliant homes, with some exceptions, a 30- to 45-day grace period, during which they may correct the deficiencies without penalty; (14) a substantial number of California's homes that have been terminated and later reinstated have soon thereafter been cited again for serious deficiencies; and (15) the problems GAO identified are indicative of systemic survey and enforcement weaknesses.