Quality Assurance and Quality Management
Safety Solutions is committed to your business quality assurance and quality management. This program specializes in the Health Care Industry. The main goal is to provide care and service to attain or maintain the highest practicable physical, mental, and psychosocial well-being of residents.
The Organizational Architecture for Quality
Residents
2008 OIG Work Plan
OBRA Regulations
DRA/Medi
State Specific Regulations
Under the ACA, the Secretary shall establish standards relating to quality assurance and performance improvement with respect to facilities and provide technical assistance to facilities on the development of best practices in order to meet such standards.  As noted above, these regulations have not been completed.

However, CMS has released guidance as to the five key elements of a QAPI. They are as follows:

Design and Scope – A QAPI program must be ongoing and comprehensive, dealing with the full range of services offered by the facility, including the full range of departments. When fully implemented, the program should address clinical care, quality of life, resident choice, and care transitions. It aims for safety and high quality with all clinical interventions while emphasizing autonomy and choice in daily life for residents (or resident’s agents). It utilizes the best available evidence to define and measure goals. Nursing facilities will have in place a written QAPI plan adhering to these principles.
Governance and Leadership – The governing body and/or administration of the nursing home develops and leads a QAPI program that involves leadership working with input from facility staff, as well as from residents and their families and/or representatives. The governing body assures the QAPI program is adequately resourced to conduct its work. This includes designating one or more persons to be accountable for QAPI; developing leadership and facility-wide training on QAPI; and ensuring staff time, equipment, and technical training as needed for QAPI. They are responsible for establishing policies to sustain the QAPI program despite changes in personnel and turnover. The governing body and executive leadership are also responsible for setting priorities for the QAPI program and building on the principles identified in the design and scope. The governing body and executive leadership are also responsible for setting expectations around safety, quality, rights, choice, and respect by balancing both a culture of safety and a culture of resident-centered rights and choice. The governing body ensures that while staff are held accountable, there exists an atmosphere in which staff are not punished for errors and do not fear retaliation for reporting quality concerns.
Feedback, Data Systems and Monitoring – The facility puts in place systems to monitor care and services, drawing data from multiple sources. Feedback systems actively incorporate input from staff, residents, families, and others as appropriate. This element includes using Performance Indicators to monitor a wide range of care processes and outcomes, and reviewing findings against benchmarks and/or targets the facility has established for performance. It also includes tracking, investigating, and monitoring Adverse Events that must be investigated every time they occur, and action plans implemented to prevent recurrences.
Performance Improvement Projects (PIPs) – The facility conducts Performance Improvement Projects (PIPs) to examine and improve care or services in areas that are identified as needing attention. A PIP project typically is a concentrated effort on a particular problem in one area of the facility or facility wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements. PIPs are selected in areas important and meaningful for the specific type and scope of services unique to each facility.
Systematic Analysis and Systemic Action – The facility uses a systematic approach to determine when in-depth analysis is needed to fully understand the problem, its causes, and implications of a change. The facility uses a thorough and highly organized/ structured approach to determine whether and how identified problems may be caused or exacerbated by the way care and services are organized or delivered. Additionally, facilities will be expected to develop policies and procedures and demonstrate proficiency in the use of Root Cause Analysis. Systemic Actions look comprehensively across all involved systems to prevent future events and promote sustained improvement. This element includes a focus on continual learning and continuous improvement.
      Section 6102 of the Affordable Care Act also requires HHS to establish and implement a quality assurance and performance improvement program (“QAPI program”) for facilities, including multi-unit chains of facilities. The ACA required that the regulations for the QAPI program be completed by December 31, 2011.  Here too, it does not appear that CMS met this deadline.  However, CMS’s webpage indicates that a national rollout of the QAPI program is set for summer 2012.  Here, CMS will post early prototypes of some of the tools and resources it has been developing for the QAPI program.  CMS states that this will be an opportunity for nursing facilities to try out these tools and provide feedback.  The tools can be downloaded off of CMS’s website.  Ultimately, it does not appear that the QAPI program will be fully operational this summer, as CMS is still in the testing and evaluation stage of the program.  However, nursing facilities must be prepared to implement a QAPI program in the very near future.  The five key elements discussed below should serve as a starting point to creating a QAPI program that will be compliant with the forthcoming federal regulations.

Quality Assurance and Performance Improvement Programs
Not later than 1 year after the date on which the regulations are promulgated, a facility must submit to the Secretary a plan for the facility to meet such standards and implement such best practices, including how to coordinate the implementation of such plan with quality assessment and assurance activities conducted under sections 1819(b)(1)(B) and 1919(b)(1)(B), as applicable.

Ultimately, facilities should begin to create QAPI programs that are consistent with the elements released by CMS in advance of the federal regulations.  Facilities should also consider downloading the prototype programs released by CMS this summer so that they are familiar with the direction CMS is taking and can prepare to be ahead of the curve.

Conclusion

Under the ACA, the regulatory environment for Skilled Nursing Facilities and Nursing Facilities has drastically changed.  These changes will likely impact facilities’ policies, operations and management practices. Therefore, it is important that facilities take the appropriate steps to be ready for upcoming changes in the law under the ACA.  In addition, facilities should currently have procedures in place consistent with the OIG’s guidance on compliance programs.  Facilities should consult with experienced health care and business counsel in order to develop compliance, ethics, quality assurance and performance improvement programs.

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