Federal Ethics and Compliance Mandates for Nursing Homes

Federal Nursing Home Ethics and Compliance Regulations
Federal Nursing Home Ethics and Compliance Regulations

Nursing Home Ethics and Compliance Federal Regulations

Pursuant to federal regulations 42 CFR § 483.85, compliance and ethics program (a) Definitions. For purposes of this section, the following definitions apply:

Compliance and ethics program means, with respect to a facility, a program of the operating organization that—

(1) Has been reasonably designed, implemented, and enforced so that it is likely to be effective in preventing and detecting criminal, civil, and administrative violations under the Act and in promoting quality of care; and

(2) Includes, at a minimum, the required components specified in paragraph (c) of this section.
High-level personnel means individual(s) who have substantial control over the operating organization or who have a substantial role in the making of policy within the operating organization.
Operating organization means the individual(s) or entity that operates a facility.

(b) General rule. Beginning on November 28, 2017, the operating organization for each facility must have in operation a compliance and ethics program (as defined in paragraph (a) of this section) that meets the requirements of this section.

Additional Nursing Home Ethics Requirements

(c) Required components for all facilities. The operating organization for each facility must develop, implement, and maintain an effective compliance and ethics program that contains, at a minimum, the following components:

(1) Established written compliance and ethics standards, policies, and procedures to follow that are reasonably capable of reducing the prospect of criminal, civil, and administrative violations under the Act and promote quality of care, which include, but are not limited to, the designation of an appropriate compliance and ethics program contact to which individuals may report suspected violations, as well as an alternate method of reporting suspected violations anonymously without fear of retribution; and disciplinary standards that set out the consequences for committing violations for the operating organization’s entire staff; individuals providing services under a contractual arrangement; and volunteers, consistent with the volunteers’ expected roles.

(2) Assignment of specific individuals within the high-level personnel of the operating organization with the overall responsibility to oversee compliance with the operating organization’s compliance and ethics program’s standards, policies, and procedures, such as, but not limited to, the chief executive officer (CEO), members of the board of directors, or directors of major divisions in the operating organization.

(3) Sufficient resources and authority to the specific individuals designated in paragraph (c)(2) of this section to reasonably assure compliance with such standards, policies, and procedures.

(4) Due care not to delegate substantial discretionary authority to individuals who the operating organization knew, or should have known through the exercise of due diligence, had a propensity to engage in criminal, civil, and administrative violations under the Social Security Act.

(5) The facility takes steps to effectively communicate the standards, policies, and procedures in the operating organization’s compliance and ethics program to the operating organization’s entire staff; individuals providing services under a contractual arrangement; and volunteers, consistent with the volunteers’ expected roles. Requirements include, but are not limited to, mandatory participation in training as set forth at §483.95(f) or orientation programs, or disseminating information that explains in a practical manner what is required under the program.

(6) The facility takes reasonable steps to achieve compliance with the program’s standards, policies, and procedures. Such steps include, but are not limited to, utilizing monitoring and auditing systems reasonably designed to detect criminal, civil, and administrative violations under the Act by any of the operating organization’s staff, individuals providing services under a contractual arrangement, or volunteers, having in place and publicizing a reporting system whereby any of these individuals could report violations by others anonymously within the operating organization without fear of retribution, and having a process for ensuring the integrity of any reported data.

(7) Consistent enforcement of the operating organization’s standards, policies, and procedures through appropriate disciplinary mechanisms, including, as appropriate, discipline of individuals responsible for the failure to detect and report a violation to the compliance and ethics program contact identified in the operating organization’s compliance and ethics program.

(8) After a violation is detected, the operating organization must ensure that all reasonable steps identified in its program are taken to respond appropriately to the violation and to prevent further similar violations, including any necessary modification to the operating organization’s program to prevent and detect criminal, civil, and administrative violations under the Act.

(d) Additional required components for operating organizations with five or more facilities. In addition to all of the other requirements in paragraphs (a), (b), (c), and (e) of this section, operating organizations that operate five or more facilities must also include, at a minimum, the following components in their compliance and ethics program:

(1) A mandatory annual training program on the operating organization’s compliance and ethics program that meets the requirements set forth in §483.95(f).

(2) A designated compliance officer for whom the operating organization’s compliance and ethics program is a major responsibility. This individual must report directly to the operating organization’s governing body and not be subordinate to the general counsel, chief financial officer or chief operating officer.

(3) Designated compliance liaisons located at each of the operating organization’s facilities.

(e) Annual review. The operating organization for each facility must review its compliance and ethics program annually and revise its program as needed to reflect changes in all applicable laws or regulations and within the operating organization and its facilities to improve its performance in deterring, reducing, and detecting violations under the Act and in promoting quality of care.

Common areas of cases I see include:  Falls from Beds, Hoyer Lifts and in the Bathroom; Sexual Abuse; Medication Errors and Others.  STOP ELDER ABUSE AND NEGLECT!

For more information about nursing home ethics requirements or other questions about elder abuse and neglect contact Nursing Home Neglect Attorney Kenneth LaBore for a free consultation at 612-743-9048 or by email at KLaBore @ MNnursinghomeneglect.com.

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Infection Control Requirements for Nursing Homes

Nursing Home Federal Regulations on Infection Control
Nursing Home Federal Regulations on Infection Control

Federal Nursing Home Infection Control Regulations

Pursuant to 42 CFR § 483.80, infection control, the facility must establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.

(a) Infection prevention and control program. The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements:

(1) A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to §483.70(e) and following accepted national standards;

(2) Written standards, policies, and procedures for the program, which must include, but are not limited to:

(i) A system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;

(ii) When and to whom possible incidents of communicable disease or infections should be reported;

(iii) Standard and transmission-based precautions to be followed to prevent spread of infections;

(iv) When and how isolation should be used for a resident; including but not limited to:

(A) The type and duration of the isolation, depending upon the infectious agent or organism involved, and

(B) A requirement that the isolation should be the least restrictive possible for the resident under the circumstances.

(v) The circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and

(vi) The hand hygiene procedures to be followed by staff involved in direct resident contact.

(3) An antibiotic stewardship program that includes antibiotic use protocols and a system to monitor antibiotic use.

(4) A system for recording incidents identified under the facility’s IPCP and the corrective actions taken by the facility.

Additional Infection Control Requirements

(b) Infection preventionist. The facility must designate one or more individual(s) as the infection preventionist(s) (IPs) who are responsible for the facility’s IPCP. The IP must:

(1) Have primary professional training in nursing, medical technology, microbiology, epidemiology, or other related field;

(2) Be qualified by education, training, experience or certification;

(3) Work at least part-time at the facility; and

(4) Have completed specialized training in infection prevention and control.

(c) IP participation on quality assessment and assurance committee. The individual designated as the IP, or at least one of the individuals if there is more than one IP, must be a member of the facility’s quality assessment and assurance committee and report to the committee on the IPCP on a regular basis.

(d) Influenza and pneumococcal immunizations—(1) Influenza. The facility must develop policies and procedures to ensure that—

(i) Before offering the influenza immunization, each resident or the resident’s representative receives education regarding the benefits and potential side effects of the immunization;

(ii) Each resident is offered an influenza immunization October 1 through March 31 annually, unless the immunization is medically contraindicated or the resident has already been immunized during this time period;

(iii) The resident or the resident’s representative has the opportunity to refuse immunization; and

(iv) The resident’s medical record includes documentation that indicates, at a minimum, the following:

(A) That the resident or resident’s representative was provided education regarding the benefits and potential side effects of influenza immunization; and

(B) That the resident either received the influenza immunization or did not receive the influenza immunization due to medical contraindications or refusal.

(2) Pneumococcal disease. The facility must develop policies and procedures to ensure that—

(i) Before offering the pneumococcal immunization, each resident or the resident’s representative receives education regarding the benefits and potential side effects of the immunization;

(ii) Each resident is offered a pneumococcal immunization, unless the immunization is medically contraindicated or the resident has already been immunized;

(iii) The resident or the resident’s representative has the opportunity to refuse immunization; and

(iv) The resident’s medical record includes documentation that indicates, at a minimum, the following:

(A) That the resident or resident’s representative was provided education regarding the benefits and potential side effects of pneumococcal immunization; and

(B) That the resident either received the pneumococcal immunization or did not receive the pneumococcal immunization due to medical contraindication or refusal.

(e) Linens. Personnel must handle, store, process, and transport linens so as to prevent the spread of infection.

(f) Annual review. The facility will conduct an annual review of its IPCP and update their program, as necessary.

Common areas of cases I see include:  Falls from Beds, Hoyer Lifts and in the Bathroom; Sexual Abuse; Medication Errors and Others.  STOP ELDER ABUSE AND NEGLECT!

For more information about nursing home infection disease requirements or other questions about elder abuse and neglect contact Nursing Home Neglect Attorney Kenneth LaBore for a free consultation at 612-743-9048 or by email at Klabore@MNnursinghomeneglect.com.

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Quality Assurance Regulations in Nursing Homes

Quality Assurance Requirements for Nursing Homes
Quality Assurance Requirements for Nursing Homes

Nursing Home Quality Assurance Requirements in Nursing Homes

Pursuant to federal regulations in 42 CFR § 483.75, quality assurance and performance improvement.

(a) Quality assurance and performance improvement (QAPI) program. Each LTC facility, including a facility that is part of a multiunit chain, must develop, implement, and maintain an effective, comprehensive, data-driven QAPI program that focuses on indicators of the outcomes of care and quality of life. The facility must—

(1) Maintain documentation and demonstrate evidence of its ongoing QAPI program that meets the requirements of this section. This may include but is not limited to systems and reports demonstrating systematic identification, reporting, investigation, analysis, and prevention of adverse events; and documentation demonstrating the development, implementation, and evaluation of corrective actions or performance improvement activities;

(2) Present its QAPI plan to the State Survey Agency no later than 1 year after the promulgation of this regulation;

(3) Present its QAPI plan to a State Survey Agency or Federal surveyor at each annual recertification survey and upon request during any other survey and to CMS upon request; and

(4) Present documentation and evidence of its ongoing QAPI program’s implementation and the facility’s compliance with requirements to a State Survey Agency, Federal surveyor or CMS upon request.

(b) Program design and scope. A facility must design its QAPI program to be ongoing, comprehensive, and to address the full range of care and services provided by the facility. It must:

(1) Address all systems of care and management practices;

(2) Include clinical care, quality of life, and resident choice;

(3) Utilize the best available evidence to define and measure indicators of quality and facility goals that reflect processes of care and facility operations that have been shown to be predictive of desired outcomes for residents of a SNF or NF.

(4) Reflect the complexities, unique care, and services that the facility provides.

(c) Program feedback, data systems and monitoring. A facility must establish and implement written policies and procedures for feedback, data collections systems, and monitoring, including adverse event monitoring. The policies and procedures must include, at a minimum, the following:

(1) Facility maintenance of effective systems to obtain and use of feedback and input from direct care staff, other staff, residents, and resident representatives, including how such information will be used to identify problems that are high risk, high volume, or problem-prone, and opportunities for improvement.

(2) Facility maintenance of effective systems to identify, collect, and use data and information from all departments, including but not limited to the facility assessment required at §483.70(e) and including how such information will be used to develop and monitor performance indicators.

(3) Facility development, monitoring, and evaluation of performance indicators, including the methodology and frequency for such development, monitoring, and evaluation.

(4) Facility adverse event monitoring, including the methods by which the facility will systematically identify, report, track, investigate, analyze and use data and information relating to adverse events in the facility, including how the facility will use the data to develop activities to prevent adverse events.

(d) Program systematic analysis and systemic action. (1) The facility must take actions aimed at performance improvement and, after implementing those actions, measure its success, and track performance to ensure that improvements are realized and sustained.

Requirements for Quality Assurance Policies and Procedures

(2) The facility will develop and implement policies addressing:

(i) How they will use a systematic approach to determine underlying causes of problems impacting larger systems;

(ii) How they will develop corrective actions that will be designed to effect change at the systems level to prevent quality of care, quality of life, or safety problems ; and

(iii) How the facility will monitor the effectiveness of its performance improvement activities to ensure that improvements are sustained.

(e) Program activities. (1) The facility must set priorities for its performance improvement activities that focus on high-risk, high-volume, or problem-prone areas; consider the incidence, prevalence, and severity of problems in those areas; and affect health outcomes, resident safety, resident autonomy, resident choice, and quality of care.

(2) Performance improvement activities must track medical errors and adverse resident events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the facility.

(3) As a part of their performance improvement activities, the facility must conduct distinct performance improvement projects. The number and frequency of improvement projects conducted by the facility must reflect the scope and complexity of the facility’s services and available resources, as reflected in the facility assessment required at §483.70(e). Improvement projects must include at least annually a project that focuses on high risk or problem-prone areas identified through the data collection and analysis described in paragraphs (c) and (d) of this section.

(f) Governance and leadership. The governing body and/or executive leadership (or organized group or individual who assumes full legal authority and responsibility for operation of the facility) is responsible and accountable for ensuring that—

(1) An ongoing QAPI program is defined, implemented, and maintained and addresses identified priorities.

(2) The QAPI program is sustained during transitions in leadership and staffing;

(3) The QAPI program is adequately resourced, including ensuring staff time, equipment, and technical training as needed;

(4) The QAPI program identifies and prioritizes problems and opportunities that reflect organizational process, functions, and services provided to resident based on performance indicator data, and resident and staff input, and other information.

(5) Corrective actions address gaps in systems, and are evaluated for effectiveness; and

(6) Clear expectations are set around safety, quality, rights, choice, and respect.

(g) Quality assessment and assurance. (1) A facility must maintain a quality assessment and assurance committee consisting at a minimum of:

(i) The director of nursing services;

(ii) The Medical Director or his or her designee;

(iii) At least three other members of the facility’s staff, at least one of who must be the administrator, owner, a board member or other individual in a leadership role; and

(iv) The infection control and prevention officer.

(2) The quality assessment and assurance committee reports to the facility’s governing body, or designated person(s) functioning as a governing body regarding its activities, including implementation of the QAPI program required under paragraphs (a) through (e) of this section. The committee must:

(i) Meet at least quarterly and as needed to coordinate and evaluate activities under the QAPI program, such as identifying issues with respect to which quality assessment and assurance activities, including performance improvement projects required under the QAPI program, are necessary; and

(ii) Develop and implement appropriate plans of action to correct identified quality deficiencies; and

(iii) Regularly review and analyze data, including data collected under the QAPI program and data resulting from drug regimen reviews, and act on available data to make improvements.

(h) Disclosure of information. A State or the Secretary may not require disclosure of the records of such committee except in so far as such disclosure is related to the compliance of such committee with the requirements of this section.

(i) Sanctions. Good faith attempts by the committee to identify and correct quality deficiencies will not be used as a basis for sanctions.

Common areas of cases I see include:  Falls from Beds, Hoyer Lifts and in the Bathroom; Sexual Abuse; Medication Errors and Others.  STOP ELDER ABUSE AND NEGLECT!

For more information about quality assurance requirements or other questions about elder abuse and neglect contact Nursing Home Neglect Attorney Kenneth LaBore for a free consultation at 612-743-9048 or by email at KLaBore @ MNnursinghomeneglect.com.

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Fall Prevention in Nursing Homes

Information on Falls and Fracture Prevention
Information on Fall Prevention and Fracture Prevention

Fall Prevention and Fractures in Nursing Homes

According to the Center for Disease Control and Prevention: Fall Prevention – Each year, an average nursing home with 100 beds reports 100 to 200 falls. About 1,800 older adults living in nursing homes die each year from fall-related injuries. Those who experience non-fatal falls can suffer injuries, have difficulty getting around and have a reduced quality of life.

How big is the problem?

How serious are these falls?

Why do falls occur more often in nursing homes?

What are the most common causes of nursing home falls?

How can we prevent falls in nursing homes?

Do physical restraints help prevent falls?

Preventing Falls in Nursing Homes- How big is the problem?

• In 2003, 1.5 million people 65 and older lived in nursing homes.3 If current rates continue, by 2030 this number will rise to about 3 million.
• About 5% of adults 65 and older live in nursing homes, but nursing home residents account for about 20% of deaths from falls in this age group.
• Each year, a typical nursing home with 100 beds reports 100 to 200 falls. Many falls go unreported.
• As many as 3 out of 4 nursing home residents fall each year. That’s twice the rate of falls for older adults living in the community.
• Patients often fall more than once. The average is 2.6 falls per person per year.
• About 35% of fall injuries occur among residents who cannot walk.
How serious are these falls?
• About 1,800 people living in nursing homes die each year from falls.
• About 10% to 20% of nursing home falls cause serious injuries; 2% to 6% cause fractures.
• Falls result in disability, functional decline and reduced quality of life. Fear of falling can cause further loss of function, depression, feelings of helplessness, and social isolation.

Why do falls occur more often in nursing homes?

Falling can be a sign of other health problems. People in nursing homes are generally more frail than older adults living in the community. They are generally older, have more chronic conditions, and have difficulty walking. They also tend to have problems with thinking or memory, to have difficulty with activities of daily living, and to need help getting around or taking care of themselves.  All of these factors are linked to falling.

What are the most common causes of nursing home falls?

• Muscle weakness and walking or gait problems are the most common causes of falls among nursing home residents. These problems account for about 24% of the falls in nursing homes.
• Environmental hazards in nursing homes cause 16% to 27% of falls among residents.  Such hazards include wet floors, poor lighting, incorrect bed height, and improperly fitted or maintained wheelchairs.
• Medications can increase the risk of falls and fall-related injuries. Drugs that affect the central nervous system, such as sedatives and anti-anxiety drugs, are of particular concern.
• Other causes of falls include difficulty in moving from one place to another (for example, from the bed to a chair), poor foot care, poorly fitting shoes, and improper or incorrect use of walking aids.

Steps towards preventing falls in nursing homes

Fall prevention takes a combination of medical treatment, rehabilitation, and environmental changes. The most effective interventions address multiple factors. Interventions include:

• Assessing patients after a fall to identify and address risk factors and treat the underlying medical conditions.
• Educating staff about fall risk factors and prevention strategies.
• Reviewing prescribed medicines to assess their potential risks and benefits and to minimize use.
• Making changes in the nursing home environment to make it easier for residents to move around safely. Such changes include putting in grab bars, adding raised toilet seats, lowering bed heights, and installing handrails in the hallways.
• Providing patients with hip pads that may prevent a hip fracture if a fall occurs.
• Using devices such as alarms that go off when patients try to get out of bed or move without help.

Exercise programs can improve balance, strength, walking ability, and physical functioning among nursing home residents. However, it is unclear whether such programs can reduce falls.

Do physical restraints help prevent falls?

• Routinely using restraints does not lower the risk of falls or fall injuries. They should not be used as a fall prevention strategy.
• Restraints can actually increase the risk of fall-related injuries and deaths.
• Limiting a patient’s freedom to move around leads to muscle weakness and reduces physical function.
• Since federal regulations took effect in 1990, nursing homes have reduced the use of physical restraints.
• Some nursing homes have reported an increase in falls since the regulations took effect, but most have seen a drop in fall-related injuries.

For more information see the rest of this article at: http://www.cdc.gov/ncipc/factsheets/nursing.htm

For more information about elder abuse and neglect contact Attorney Kenneth LaBore for a free consultation at 612-743-9048 or by email at KLaBore@MNnursinghomeneglect.com.

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Emergency Plans Required at Nursing Homes

 

Nursing Homes Must Have an Emergency Plan
Nursing Homes Must Have an Emergency Plan

Emergency Plan is Required in Nursing Homes

Pursuant to 42 CFR § 483.73, a LTC facility must comply with all applicable Federal, State and local emergency preparedness requirements. The LTC facility must establish and maintain a preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:

(a) Emergency plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following:

(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents.

(2) Include strategies for addressing emergencies identified by the risk assessment.

(3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.

(4) Include a process for cooperation and collaboration with local, tribal, regional, State, or Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the LTC facility’s efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.

Emergency Plan Policies and Procedure Regulation

(b) Policies and procedures. The LTC facility must develop and implement preparedness policies and procedures, based on the plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:

(1) The provision of subsistence needs for staff and residents, whether they evacuate or shelter in place, include, but are not limited to the following:

(i) Food, water, medical, and pharmaceutical supplies.

(ii) Alternate sources of energy to maintain—

(A) Temperatures to protect resident health and safety and for the safe and sanitary storage of provisions;

(B) Emergency lighting;

(C) Fire detection, extinguishing, and alarm systems; and

(D) Sewage and waste disposal.

(2) A system to track the location of on-duty staff and sheltered residents in the LTC facility’s care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the LTC facility must document the specific name and location of the receiving facility or other location.

(3) Safe evacuation from the LTC facility, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.

(4) A means to shelter in place for residents, staff, and volunteers who remain in the LTC facility.

(5) A system of medical documentation that preserves resident information, protects confidentiality of resident information, and secures and maintains the availability of records.

(6) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.

(7) The development of arrangements with other LTC facilities and other providers to receive residents in the event of limitations or cessation of operations to maintain the continuity of services to LTC residents.

(8) The role of the LTC facility under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified officials.

Common areas of cases I see include:  Falls from Beds, Hoyer Lifts and in the Bathroom; Sexual Abuse; Medication Errors and Others.  STOP ELDER ABUSE AND NEGLECT!

For more information about federal nursing home requirements or other questions about elder abuse and neglect contact Nursing Home Neglect Attorney Kenneth LaBore for a free consultation at 612-743-9048 or by email at KLaBore @ MNnursinghomeneglect.com.

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