42 USC 1320a-7j - Accountability requirements for facilities

U.S Code last checked for updates: May 01, 2024

§ 1320a–7j.

Accountability requirements for facilities

(a)

Definition of facility

In this section, the term “facility” means—

(1)

a skilled nursing facility (as defined in section 1395i–3(a) of this title); or

(2)

a nursing facility (as defined in section 1396r(a) of this title).

(b)

Effective compliance and ethics programs

(1)

Requirement

(2)

Development of regulations

(A)

In general

(B)

Design of regulations

(C)

Evaluation

(3)

Requirements for compliance and ethics programs

In this subsection, the term “compliance and ethics program” means, with respect to a facility, a program of the operating organization that—

(A)

has been reasonably designed, implemented, and enforced so that it generally will be effective in preventing and detecting criminal, civil, and administrative violations under this chapter and in promoting quality of care; and

(B)

includes at least the required components specified in paragraph (4).

(4)

Required components of program

The required components of a compliance and ethics program of an operating organization are the following:

(A)

The organization must have established compliance standards and procedures to be followed by its employees and other agents that are reasonably capable of reducing the prospect of criminal, civil, and administrative violations under this chapter.

(B)

Specific individuals within high-level personnel of the organization must have been assigned overall responsibility to oversee compliance with such standards and procedures and have sufficient resources and authority to assure such compliance.

(C)

The organization must have used due care not to delegate substantial discretionary authority to individuals whom the organization knew, or should have known through the exercise of due diligence, had a propensity to engage in criminal, civil, and administrative violations under this chapter.

(D)

The organization must have taken steps to communicate effectively its standards and procedures to all employees and other agents, such as by requiring participation in training programs or by disseminating publications that explain in a practical manner what is required.

(E)

The organization must have taken reasonable steps to achieve compliance with its standards, such as by utilizing monitoring and auditing systems reasonably designed to detect criminal, civil, and administrative violations under this chapter by its employees and other agents and by having in place and publicizing a reporting system whereby employees and other agents could report violations by others within the organization without fear of retribution.

(F)

The standards must have been consistently enforced through appropriate disciplinary mechanisms, including, as appropriate, discipline of individuals responsible for the failure to detect an offense.

(G)

After an offense has been detected, the organization must have taken all reasonable steps to respond appropriately to the offense and to prevent further similar offenses, including any necessary modification to its program to prevent and detect criminal, civil, and administrative violations under this chapter.

(H)

The organization must periodically undertake reassessment of its compliance program to identify changes necessary to reflect changes within the organization and its facilities.

(c)

Quality assurance and performance improvement program

(1)

In general

(2)

Regulations

(f)

 So in original. No subsecs. (d) and (e) have been enacted.

Standardized complaint form

(1)

Development by the Secretary

(2)

Complaint forms and resolution processes

(A)

Complaint forms

The State must make the standardized complaint form developed under paragraph (1) available upon request to—

(i)

a resident of a facility; and

(ii)

any person acting on the resident’s behalf.

(B)

Complaint resolution process

The State must establish a complaint resolution process in order to ensure that the legal representative of a resident of a facility or other responsible party is not denied access to such resident or otherwise retaliated against if they have complained about the quality of care provided by the facility or other issues relating to the facility. Such complaint resolution process shall include—

(i)

procedures to assure accurate tracking of complaints received, including notification to the complainant that a complaint has been received;

(ii)

procedures to determine the likely severity of a complaint and for the investigation of the complaint; and

(iii)

deadlines for responding to a complaint and for notifying the complainant of the outcome of the investigation.

(3)

Rule of construction

(g)

Submission of staffing information based on payroll data in a uniform format

Beginning not later than 2 years after March 23, 2010, and after consulting with State long-term care ombudsman programs, consumer advocacy groups, provider stakeholder groups, employees and their representatives, and other parties the Secretary deems appropriate, the Secretary shall require a facility to electronically submit to the Secretary direct care staffing information (including information with respect to agency and contract staff) based on payroll and other verifiable and auditable data in a uniform format (according to specifications established by the Secretary in consultation with such programs, groups, and parties). Such specifications shall require that the information submitted under the preceding sentence—

(1)

specify the category of work a certified employee performs (such as whether the employee is a registered nurse, licensed practical nurse, licensed vocational nurse, certified nursing assistant, therapist, or other medical personnel);

(2)

include resident census data and information on resident case mix;

(3)

include a regular reporting schedule; and

(4)

include information on employee turnover and tenure and on the hours of care provided by each category of certified employees referenced in paragraph (1) per resident per day.

Nothing in this subsection shall be construed as preventing the Secretary from requiring submission of such information with respect to specific categories, such as nursing staff, before other categories of certified employees. Information under this subsection with respect to agency and contract staff shall be kept separate from information on employee staffing.

(h)

Notification of facility closure

(1)

In general

Any individual who is the administrator of a facility must—

(A)

submit to the Secretary, the State long-term care ombudsman, residents of the facility, and the legal representatives of such residents or other responsible parties, written notification of an impending closure—

(i)

subject to clause (ii), not later than the date that is 60 days prior to the date of such closure; and

(ii)

in the case of a facility where the Secretary terminates the facility’s participation under this subchapter, not later than the date that the Secretary determines appropriate;

(B)

ensure that the facility does not admit any new residents on or after the date on which such written notification is submitted; and

(C)

include in the notice a plan for the transfer and adequate relocation of the residents of the facility by a specified date prior to closure that has been approved by the State, including assurances that the residents will be transferred to the most appropriate facility or other setting in terms of quality, services, and location, taking into consideration the needs, choice, and best interests of each resident.

(2)

Relocation

(A)

In general

(B)

Continuation of payments until residents relocated

(3)

Sanctions

Any individual who is the administrator of a facility that fails to comply with the requirements of paragraph (1)—

(A)

shall be subject to a civil monetary penalty of up to $100,000;

(B)

may be subject to exclusion from participation in any Federal health care program (as defined in section 1320a–7b(f) of this title); and

(C)

shall be subject to any other penalties that may be prescribed by law.

(4)

Procedure

(Aug. 14, 1935, ch. 531, title XI, § 1128I, as added and amended Pub. L. 111–148, title VI, §§ 6102, 6105(a), 6106, 6113(a), Mar. 23, 2010, 124 Stat. 702, 711, 712, 718.)

cite as: 42 USC 1320a-7j

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