Regulation and Enforcement-The health care sector has been the object of numerous regulations, for two main reasons

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Regulation and Enforcement-The health care sector has been the object of numerous regulations, for two main reasons

Regulation and Enforcement
The health care sector has been the object of numerous regulations, for two main reasons: (1)
The government is a major payer for individuals receiving health care services under Medicare,
Medicaid, and other public programs. By committing a significant amount of tax dollars to the
delivery of health care, the government retains a vested interest in how the money is spent by
private organizations that deliver health care. (2) Health care in general, and long-term care in
particular, provide services to the frailest and most vulnerable individuals in society. Many of
them are physically and/or mentally incapacitated and have no one else to act on their behalf.
The regulatory system is deemed obligated to protect vulnerable populations against negligence
and abuse, to ensure that they receive needed services for which they are eligible, and to
ensure that the services provided meet at least certain defined minimum standards of quality.
Administrative agencies have the power to enforce the rules and regulations that they
formulate. The most important federal agency regulating nursing facilities certified as skilled
nursing facilities (SNF) or nursing facilities (NF) is the Centers for Medicare and Medicaid
Services (CMS), an administrative agency under the U.S. Department of Health and Human
Services (DHHS). The U.S. Department of Justice enforces compliance with the accessibility
standards for the disabled. Workplace safety rules are enforced by the Occupational Safety and
Health Administration (OSHA), an agency of the U.S. Department of Labor.
Nursing Home Oversight
Regulatory oversight for clinical care delivered in certified nursing homes is authorized under
the Nursing Home Reform Act (OBRA-87). States can use their enforcement powers to take
action against facilities that do not comply with federal and state standards. Regulatory
oversight, however, has its weaknesses. Monitoring for compliance is based on periodic
inspections and complaint investigations. Inspections of a nursing home may take place as much
as 15 months apart. This sporadic system of monitoring does not guarantee that compliance
with standards is continuous. Complaint investigations can be conducted any time, but they take
place only when a complaint is filed against the nursing home by a patient, family member,
friend, or employee.
Nursing home oversight begins with state licensing regulations. Second, the Nursing Home
Reform Act prescribes regulations, referred to as Requirements of Participation, that govern
federal certification. Although the CMS is responsible for overseeing compliance, the actual task
of monitoring for compliance is delegated to each state. The agency responsible in each state
(generally the health department or department of human services, under contract from the
CMS) to carry out monitoring and compliance with the state licensure standards and the federal
Requirements of Participation is referred to as the State Survey Agency. Monitoring is carried
out through an annual inspection, called a survey, of the facility.
Requirements of Participation The Requirements of Participation (also referred to as conditions of participation) are standards
that are widely regarded as minimum standards of quality for nursing facilities. There are 185
regulatory standards, which are classified under 15 major categories. A summary of the 15
broad requirements appears in Exhibit 5–1, which is meant for illustrative purposes only. The
actual regulations can be found in the Code of Federal Regulations (CFR), Title 42, Part 483.
Exhibit 5–1 Requirements of Participation for SNF, NF, and Dual Certification (Illustrative Only)
1. Resident rights. These include the right to see a physician of one’s choice, to be fully
informed of one’s medical condition and treatments, to refuse treatment, to formulate advance
directives, to authorize the facility to manage personal funds and require accounting for the
funds, to have personal privacy and confidentiality, and to voice grievances without fear of
retaliation. In addition, residents cannot be prevented, coerced, or discriminated against in the
course of exercising their rights as citizens of the facility or citizens of the United States.
2. Admission, transfer, and discharge rights. These rights provide residents certain safeguards
against transfer or discharge from a facility and allow one to return to the same facility after
brief periods of hospitalization or therapeutic leave. It also requires equal access and delivery of
services regardless of the source of payment.
3. Resident behavior and facility practices. It limits the facility’s use of physical and chemical
restraints and prohibits mistreatment, neglect, or abuse of residents.
4. Quality of life. The facility must promote each resident’s individuality, dignity, and respect.
Exercise of choice and self-determination must be allowed. Residents have the right to interact
with the community. Residents can organize resident and family groups for mutual support and
planned activities, or to air grievances. The facility must make reasonable accommodation for
individual preferences, such as meals and roommates. The facility must provide an ongoing
program of recreational activities and medically related social services. The standard also
requires a clean, safe, comfortable, and homelike environment that will promote maintenance
or enhancement of the quality of life of each resident.
5. Resident assessment. Within 14 days of admission and at least annually thereafter the
facility must undertake a comprehensive assessment of each patient’s functional capacity and
medical needs. The assessment must be reviewed at least quarterly. Based on the need
assessment, the facility must develop a comprehensive plan of care for each resident and
provide the services necessary to provide that care.
6. Quality of care. Each resident must receive and the facility must provide the necessary care
and services to attain or maintain the highest practicable physical, mental, and psychosocial
well-being in accordance with the comprehensive assessment and plan of care. The facility must
provide appropriate treatments to maintain or improve a resident’s functioning and range of
motion, unless it is unavoidable. The facility must ensure that residents receive proper
treatment and assistive devices to maintain vision and hearing abilities. Other patient care requirements include adopting measures to prevent pressure sores, providing appropriate
treatment for pressure sores, ensuring adequate nutrition and hydration, providing special
treatments as necessary, limiting use of antipsychotic drugs, and confining medication error
rates to less than 5%. Indwelling urinary catheters should not be used unless necessary.
Treatment and services must be provided to prevent urinary tract infections and to restore
bladder function to the extent possible. The environment must be free from accident hazards
and each resident should receive adequate supervision to prevent accidents. Facility must
ensure that residents maintain acceptable parameters of nutritional status.
7. Nursing services. The facility must have sufficient nursing staff, including licensed nurses, to
provide necessary care on a 24-hour basis.
8. Dietary services. The facility must provide a nourishing, palatable, and well-balanced diet
that meets the daily nutritional and special dietary needs of each resident. Sanitary conditions
must be maintained in the storage, preparation, and serving of food.
9. Physician services. A physician must approve each admission, and each resident must
remain under the care of a physician. Unless otherwise prohibited, the physician may delegate
tasks to a physician assistant, nurse practitioner, or clinical nurse specialist.
10. Specialized rehabilitative services. The facility must provide specialized rehabilitative
therapies by qualified personnel under written orders of a physician.
11. Dental services. The facility must assist residents in obtaining routine and 24-hour
emergency dental services.
12. Pharmacy services. The facility must provide pharmaceutical services with consultation
from a licensed pharmacist. If state law permits it, unlicensed personnel may administer drugs,
but only under the general supervision of a licensed nurse. The standard also requires monthly
review of drug regimen for each resident and appropriate labeling and storage of drugs.
13. Infection control. The facility must have an infection control program and maintain records
of incidents and corrective actions.
14. Physical environment. The facility must comply with the Life Safety Code® of the National
Fire Protection Association. The facility should provide for emergency electrical power in case of
power failure. The building must have adequate space and equipment for dining, health
services, and recreation. Resident rooms must meet certain requirements as to size and
15. Administration. The facility must operate in compliance with all applicable federal, state,
and local regulations and must be licensed by the state. The governing body has legal
responsibility for the management and operation of the facility. The governing body must
appoint a licensed nursing home administrator to manage the facility. Nurse aides working at the facility must receive required training, a competency evaluation, periodic performance
review, and needed inservice education. The facility must also designate a physician to serve as
medical director. The facility must provide or obtain needed laboratory, radiology, and other
diagnostic services. The facility must maintain clinical records on each resident, have detailed
written plans and procedures to meet all potential emergencies and disasters, have a written
transfer agreement with a hospital that participates in the Medicare and Medicaid programs,
and maintain a quality assessment and assurance committee.
Interpretive Guidelines
The CMS has formulated interpretive guidelines to clarify and explain each standard in detail.
Interpretive guidelines also spell out the procedures the surveyors would use to verify
compliance. Although the guidelines provide directions to personnel conducting surveys, they
also assist nursing home personnel in understanding what practices they must implement to
comply with each standard. The standards are identified by F-tags. Interpretive guidelines are
furnished for each F-tag. For example, the requirement, Quality of Life (Item 4 in Exhibit 5–1),
has 19 standards from F240 to F258. As an example, Exhibit 5–2 provides a portion of the
interpretive guidelines for F241–Dignity.
Exhibit 5–2 Partial Interpretive Guidelines for F241–Dignity
The facility must promote care for residents in a manner and in an environment that maintains
or enhances each resident’s dignity and respect in full recognition of his or her individuality.
Interpretive Guidelines: §483.15(a)
“Dignity” means that in their interactions with residents, staff carries out activities that assist
the resident to maintain and enhance his/her self-esteem and self-worth. Some examples
include (but are not limited to):
• Grooming residents as they wish to be groomed (e.g., hair combed and styled, beards
shaved/trimmed, nails clean and clipped)
• Encouraging and assisting residents to dress in their own clothes appropriate to the time of
day and individual preferences rather than hospital-type gowns
• Assisting residents to attend activities of their own choosing
• Labeling each resident’s clothing in a way that respects his or her dignity (e.g., placing
labeling on the inside of shoes and clothing) • Promoting resident independence and dignity in dining such as avoidance of:
• Day-to-day use of plastic cutlery and paper/plastic dishware
• Bibs (also known as clothing protectors) instead of napkins (except by resident choice)
• Staff standing over residents while assisting them to eat
• Staff interacting/conversing only with each other rather than with residents while assisting
• Respecting residents’ private space and property (e.g., not changing radio or television station
without resident’s permission, knocking on doors and requesting permission to enter, closing
doors as requested by the resident, not moving or inspecting resident’s personal possessions
without permission)
• Respecting residents by speaking respectfully, addressing the resident with a name of the
resident’s choice, avoiding use of labels for residents such as “feeders,” not excluding residents
from conversations or discussing residents in community settings in which others can overhear
private information
• Focusing on residents as individuals when they talk to them and addressing residents as
individuals when providing care and services
• Maintaining an environment in which there are no signs posted in residents’ rooms or in staff
work areas able to be seen by other residents and/or visitors that include confidential clinical or
personal information (such as information about incontinence, cognitive status). It is allowable
to post signs with this type of information in more private locations such as the inside of a closet
or in staff locations that are not viewable by the public. An exception can be made in an
individual case if a resident or responsible family member insists on the posting of care
information at the bedside (e.g., do not take blood pressure in right arm). This does not prohibit
the display of resident names on their doors nor does it prohibit display of resident memorabilia
and/or biographical information in or outside their rooms with their consent or the consent of
the responsible party if the resident is unable to give consent.
(This restriction does not include the Centers for Disease Control and Prevention isolation
precaution transmission-based signage for reasons of public health protection, as long as the
sign does not reveal the type of infection)
• Grooming residents as they wish to be groomed (e.g., removal of facial hair for women,
maintaining the resident’s personal preferences regarding hair length/style, facial hair for men,
and clothing style) NOTE: For issues of failure to keep dependent residents’ faces, hands, fingernails, hair, and
clothing clean, refer to Activities of Daily Living (ADLs), Tag F312.
Procedures: §483.15(a)
For a sampled resident, use resident and family interviews as well as information from the
Resident Assessment Instrument (RAI) to consider the resident’s former lifestyle and personal
choices made while in the facility to obtain a picture of the resident’s individual needs and
Throughout the survey, observe: Do staff show respect for residents? When staff interact with a
resident, do staff pay attention to the resident as an individual? Do staff respond in a timely
manner to the resident’s requests for assistance? Do they explain to the resident what care they
are doing or where they are taking the resident? Do staff groom residents as they wish to be
Reproduced from CMS. 2011. State Operations Manual. Appendix PP – Guidance to Surveyors
for Long Term Care Facilities. Available at: Accessed January
Survey and Enforcement
Enforcement of the standards is based on substantial compliance rather than “zero tolerance”
because perfect compliance sets expectations that are unrealistic in most instances.
Enforcement of zero tolerance could disqualify most nursing facilities from providing services to
Medicare and Medicaid patients. The law defines substantial compliance as “a level of
compliance with requirements of participation such that any identified deficiencies pose no
greater risk to patient health and safety than the potential for causing minimal harm.” In simple
language, it means that violation of a certification standard should not endanger the health and
safety of a patient. The law also emphasizes the need for continued rather than cyclical
compliance with the standards. To achieve this, the facility must implement policies and
procedures for continuous monitoring to sustain compliance.
In each state, the designated State Survey Agency is responsible for inspecting nursing facilities
and making recommendations to the CMS to determine the provider’s eligibility to participate
in the Medicare and Medicaid programs. Two types of surveys are currently in use. Nursing
homes in approximately half of the states are inspected under the traditional survey. A new
survey process, called the Quality Indicator Survey (QIS), is gradually being phased in to replace
the traditional survey over the next few years.
Types of Survey The State Operations Manual provides for four types of surveys: standard, abbreviated
standard, extended, and postsurvey revisit. This section gives an overview of the traditional
survey. The QIS is discussed subsequently.
Standard Survey
A standard survey is the most common type of survey. This periodic, unannounced survey is
conducted for the purpose of certification renewal, generally no later than 15 months after a
previous survey. The lapse of time between two surveys depends on the facility’s history of
compliance. Timing of the survey is not confined to weekdays and normal business hours;
surveys may also be conducted in the evening (after 6 p.m.), early in the morning (before 8
a.m.), or on weekends. Composition of the survey team and length of the survey depend on the
size and layout of the facility to be surveyed and the complexity of issues to be investigated.
Besides nurses, the team may include social workers, dietitians, pharmacists, activity
professionals, or rehabilitation specialists when feasible. Other professionals, such as
sanitarians, engineers, physicians, or physician assistants, may be called upon as consultants.
According to federal law, surveyors must be trained and they are required to declare any
possible conflicts of interest. A conflict of interest may disqualify a surveyor from inspecting a
particular nursing facility.
Abbreviated Standard Survey
An abbreviated standard survey is a standard survey of shorter duration and of a limited scope.
This survey focuses on particular tasks that relate, for instance, to complaints received or to a
change of ownership, administrator, or director of nursing. During the survey, however, a
determination can be made to investigate any area of concern.
Extended Survey
An extended survey, in which the scope and duration of a standard survey is expanded, may
become necessary when indications are present that quality of care may be substandard. An
extended survey requires a more detailed investigation of problems and a closer review of the
facility’s policies and procedures. A partial extended survey may follow an abbreviated survey
on the grounds of substandard quality of care.
Postsurvey Revisit
The state survey agency, at its discretion, may do a survey revisit. It involves a follow up survey
to confirm that the facility is in compliance and has the ability to remain in compliance. The
follow-up survey reevaluates the specific care and services that were cited as noncompliant
during the original standard, abbreviated, or extended survey. The nature of noncompliance
dictates the scope of the revisit.
Quality Indicator Survey In many respects the QIS is similar to the traditional survey, but there are two main differences
(General Accountability Office, 2012): (1) the QIS is computer based, whereas the traditional
method is paper based; and (2) the QIS draws an expanded sample of residents to enable a
more thorough review of care delivery whereas the traditional survey is based on the surveyors’
judgment in the sampling of residents.
The QIS is a two-stage process. The computerized process guides surveyors through a structured
investigation intended to allow surveyors to systematically and objectively review all regulatory
areas and subsequently focus on selected areas for further review:
• Stage I: A preliminary investigation of all regulatory areas to identify potential issues for indepth review in stage II.
• Stage II: In-depth review of issues triggered in Stage I. Identification of deficient areas and the
seriousness of deficiencies.
The QIS was designed to produce a standardized resident-centered, outcome-oriented quality
review. Although the survey process has been revised under the QIS, the federal regulations and
interpretive guidelines remain unchanged (CMS, 2007). The electronic system is also expected
to improve the consistency of the surveys.
Survey Process and Protocols
Regulations governing survey and enforcement procedures are published in the Code of Federal
Regulations, Title 42, Part 488. The State Operations Manual contains a detailed description of
the survey protocols and procedures (CMS, 2009). This section provides a brief overview of the
survey process. A standard survey consists of seven successive tasks; in principle, the QIS also
incorporates these steps:
• Offsite preparation
• Entrance conference
• Initial tour
• Resident sample selection
• Information gathering
• Determination of compliance
• Exit conference Task 1: Offsite Preparation
Offsite preparation before the actual visit to the facility includes potential areas of concern at
the targeted facility based on the facility’s compliance history. During the actual visit, surveyors
will initially focus on determining whether the previously identified concerns indeed exist.
Offsite preparation is based primarily on reports generated by the state’s database. Each facility
is required by law to use a patient assessment instrument called the minimum data set (MDS),
and to electronically transmit the MDS information to the state in which the facility is licensed.
The MDS information is used by the state to compile three main facility-specific reports that are
available to the surveyors:
1. Facility Characteristics Report, which provides demographic information about the patient
population in the facility. It includes information on gender, age, payment source, diagnostic
characteristics, type of assessment, stability of conditions, and discharge potential.
2. Facility Quality Measure/Indicator (QM/QI) Report, which ranks the facility on quality
indicators that apply to both chronic care (long-stay) and postacute care (short-stay) patients in
the facility. The percentile ranking of the facility indicates how it compares with other facilities
in the state.
3. Resident Level QM/QI Report, which provides resident-specific information. The report
indicates whether a given resident has a particular condition, such as pressure ulcers or
behavioral problems, or whether a given resident is at a high or low risk of developing a
Other sources of information include (1) areas of noncompliance on the previous survey, (2) any
patterns of noncompliance based on the past four surveys (OSCAR Report 3, where states are
required to maintain comprehensive information about past and current surveys and complaint
investigations in CMS’s OSCAR database), (3) findings from complaints that were investigated
and complaints that have not been investigated, and (4) any areas of concern reported by the
State Ombudsman Office. Information about any other potential areas of concern, such as
events reported in the news media, may also be included.
Task 2: Entrance Conference
The survey team coordinator has an on-site meeting with the administrator (or other person in
charge of the facility in the administrator’s absence) to provide introductions and explain the
purpose of the visit. The surveyors depend on the administrator for various types of information
that would help facilitate the survey. For example, surveyors will need copies of the actual work
schedules for licensed and registered nursing staff; a copy of the written information that is
provided to patients regarding their rights; copies of admission contracts for all patients;
whether the facility has any special care units, such as dementia care units; and where the
surveyors could find key personnel when needed. The administrator is given copies of the QM/QI and other reports used in the off-site preparation. Signs are posted in the facility to
notify the residents, employees, and the general public that a survey is in progress and that the
surveyors are available to meet with any concerned individual.
Task 3: Initial Tour
In an average-size nursing home of approximately100 beds, the tour may take about 2 hours.
Members of the survey team may go around independently, with or without members of the
facility’s staff accompanying them. However, the suggested protocol is to have a facility staff
person accompany the surveyors to answer questions and provide introductions to residents or
family. The surveyors talk to residents, employees, and visitors in the facility; visi…

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