1. Quality Assessment and Assurance in a QAPI World by Karen L
Quality Assessment and Assurance in a QAPI World by Karen L. Goldsmith, J.D. & Robin A. Bleier, RN, LHRM, CLC
AHFSA © August 2017

2. Program Purpose
Quality Assessment and Assurance (QAA) in a Quality Assurance Performance Improvement (QAPI) World was developed to discuss and support the process that recognizes and highlights the differences between QAA and QAPI. While each process shares the ultimate goal of quality requirements being fulfilled, their methods utilize differences and similarities.

3. Objectives

4. Objectives State and define quality related terms.
Discuss the requirements for the QAPI plan v. program.
Understanding of the legal ramifications of a provider disclosing protected information.
List the elements of an effective comprehensive QAPI plan v. program.
Discuss and define ‘Good Faith Attempts’.
Discuss the elements of an effective methodology for correcting problems through the QAPI process.

5. Definitions Adverse Event:
Untoward, undesirable, and usually unanticipated event that causes death or serious injury, including near misses.

6. Steps to Ensure
The facility must have steps to ensure QAA Committee takes necessary steps to identify (root cause analysis) and correct issues related to adverse incidents.

7. Office Inspector General
OIG report found “preventable adverse incidents were generally caused by:
Appropriate treatment provided in a substandard way (56%)”.
Lack of proper monitoring of resident progress (37%)
Not providing necessary treatment (45%).
Inadequate assessment or care planning (22%).

8. Historically Problem Prone:
Care and services areas that historically had repeated problems such as call bell response, staff turnover.

9. QA v. PI
QA v. PI
Coordinated application of two mutually- reinforcing aspects of a quality management system:
Quality Assurance
Performance Improvement

10. Four Keys to Approach Approach must be: Systemic Interdisciplinary
Comprehensive
Data-driven

11. QAPI with Purpose Purpose:
To maintain and improve quality and safety in nursing homes involving residents, families and caregivers in practical and creative problem solving.

12. Specific Standard Setting
Quality Assurance sets the specific standards including quality, service and outcomes. This is to:
To assure that care meets those standards,
Must be anticipatory and reflective,
Includes methods of identifying risk, and
Assist. in determining root cause.

13. Performance Improvement
Continuous study and improvement processes critical to improve services and outcomes,
Prevent or decrease likelihood of issues,
Identifying opportunities for improvement,
Identifying barriers to improvement, and
Supports the enhancement of quality.

14. QAPI Plan is due one year after promulgation which would be November 28, 2017.

15. QAPI Plan v. Program

16. Plan
The Plan:
Contains the process to guide the nursing home to ensure good care.
Explains how the facility will conduct QAPI and QAA Committee, and
Due this year and every year thereafter or upon request.

17. Plan to Include Contain specific and detailed information,
Include responsibilities and activities,
Include how it will identify quality deficiencies,
Include how care and services meet quality standards, and
Identify opportunities for improvement in addition to problems.

18. Disclosed Protected Info
Concern of Providers is that there will be a diminution in their ability to protect documents prepared as part of the QAPI Program.

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

20. Privacy Provision
This privacy provision has been in place under the existing requirements and has been defined by several state courts as a right belonging to the provider to protect information prepared by its Quality Assurance Committee.

21. Certain Medical Records
Providers cannot protect documents such as the content of medical records that are required by another provision to be maintained and open to inspection by surveyors.

22. Privilege
QA privilege protects self-review activities sometimes this is difficult to determine.

23. Legal Protection Advice
To further ensure protection we tell our clients:
Carefully label documents as products by or on behalf of the QA committee,
Limit circulation of the documents, and
Limit discussion of the documents.

24. Interpretation
Whether a particular document is protected is often subject to interpretation.
For example, many states require incident reports under the state law to be filed with the licensure agency – these MAY not be privileged but in some cases there may also be a state law protecting them.

25. Consultants Documents
Documents belonging to consultants may be protected if requested by QA Committee. For example, documents prepared at the direction of the facility’s attorney which are not otherwise available to surveyors should be protected. Another example could be the details of root cause analysis may also be protected.

26. QA Member Information
Information a member of the QA Committee brings to the Committee may be protected particularly if it is analytical.
Analysis by the Human Resources Department is protected.
What about s and texts?

27. IG Defined Some documents specifically identified as safe in IG’s:
minutes
internal papers
conclusions

28. Not Protected
The IG’s state that “incident and accident reports, wound logs and other reports or records used to track adverse events are not protected…”

29. In the role of Counsel
As legal counsel, I contend that if the facility maintains adequate documentation to show it is in compliance with QAPI or QA some of these records may be protected particularly if prepared under the direction of an attorney or specifically done on behalf of the QA Committee.

30. Satisfactory Evidence
The key is that “the facility must provide satisfactory evidence that it has…identified its own high risk, high volume and problem- prone quality deficiencies and [is] making a good faith effort to correct them.

31. Facility is Encouraged…
The same reasons that these types of documents are protected in the hospital setting are the reason for protecting them in the nursing home – facilities should be encouraged to conduct a full impartial analysis in order to improve care and avoid issues in the future.

32. And…
Secondly, most of the information necessary for the survey team to determine issues is available outside the protected documents – the protected documents include analysis and revelations that may or may not be accurate and a free and open opportunity for discourse should not be discouraged.

33. Additional Protection
Also may be protected under the Federal Patient Safety and Quality Improvement Act of 2005 – if prepared in conjunction with AHRQ or PSO.
Protects documents which are Patient Safety Work Product.

34. Uniform Recognition Desire
We hope that there will be a uniform recognition of surveyors as to what documents are protected and what substantiates compliance so that the intent of the quality committee requirements is met while surveyors can do their job.

35. Will Not be Used for Sanctions
“Good faith attempts by the Committee to identify and correct quality deficiencies will not be used as a basis for sanctions” (l) implemented in Phase 1.

36. Balance
There is a fine balance between what the surveyors need and the practical utilization of information to train staff and move rapidly up the quality chain

37. Five Elements Design and Scope Governance and Leadership
Feedback, Data Systems and Monitoring
Performance Improvement Projects (PIPs)
Systematic Analysis and Systematic Action

38. Design and Scope

39. Design and Scope
Our QAPI is integrated into all care and services with a focus on:
Clinical Care
Quality of Life
Resident Choice
Balance between safety and choice
Evidenced Based Best Practices

40. 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 QAPI program should address all systems of care and management practices, and should always include clinical care, quality of life, and resident choice.

41. Governance and Leadership

42. Governance and Leadership
The governing body should foster a culture where QAPI is a priority by ensuring policies are developed to sustain QAPI despite changes in personnel and turnover. The governing body and or administration of the nursing home develops a culture that involves leadership seeking input from facility staff, residents, and their families and or representatives.

43. Assurances
The governing body assures adequate resources exist to conduct QAPI efforts. 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.

44. Governance and Leadership
Their responsibilities include setting expectations around:
safety,
quality,
Individual rights (residents/staff/others),
choices, and
respect.

45. Feedback, Data Systems and Monitoring

46. Feedback, Data Systems, and Monitoring
QAPI plan uses a systematic process to deliver, monitor, and evaluate care and services using multiple sources to draw upon data. This may be completed by:
Input from residents/Families
Input from Employees/Physicians/Contractors
Outside agencies such as Department of Health (DOH), Emergency Management (EM), in Florida the Agency for Health Care Administration (AHCA), etc.
Use of effective communication and feedback.

47. Feedback, Data Systems, and Monitoring
QAPI also includes tracking, investigating, and monitoring Adverse Events that must be investigated every time they occur, and action plans implemented to prevent recurrences.

48. Performance Improvement Projects (PIPs)

49. PIPs
The Performance Improvement Projects (PIPs) are directed to improve care and services and will do so by:
Selection of PIPs based on facility thresholds and interest focus.
PIP will be worked prior to then reported on during monthly Risk Management Quality Assurance scheduled and or Ad-hoc meetings.

50. PIPs
A PIP 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. The facility conducts PIPs to examine and improve care or services in areas that the facility defies as needing attention. Areas that need attention will vary depending on the type of facility and the unique scope of services they provide. This is often created with root cause analysis (RCA).

51. Root Cause Analysis - Ishikawa

52. What are the 4 P’s The 4 P’s include: Policy and Procedure Place
People
Paper (communication)

53. What are the 5 W’s Understanding the 5 W’s: who, what, where,
when, and
why (or why not)
(Note: as in the Federal reporting process)

54. Systematic Analysis and Systematic Action

55. 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 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.

56. Systematic Analysis and Systemic Action
Facilities are encouraged to develop policies and procedures and demonstrate proficiency in the use of root cause analysis (RCA). 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.

57. ‘Good Faith Attempts’

58. Good Faith Attempts
Good faith attempts include the provider self identification of a need, problem, or concern that they develop into a PIP or other quality improvement activity. Often they include the provider creating a ‘four point plan’ that incorporates aspects of a plan of correction.
This typically includes:
Specific corrective actions,
Method to assess and analysis scope,
Review of and revision as indicated of systematic process, and
Quality assurance component to avoid re-occurrence when that is reasonable to anticipate such could occur.

59. F 868 QAA Committee The QAA Committee must have: Director of Nursing,
Medical Director or designee
Three other members of staff one of which is Administrator, owner, board member or someone in a leadership role and another would be Infection Preventionist.
The QAA Committee must meet quarterly or as necessary.

60. QAA Committee
The QAA Committee may be larger and it should be noted that some states have additional requirements.
The QAA reports to the Governing Body which the IGs implies may be a single person:
The…committee reports to the facility’s governing body, or designated person(s) acting as a governing body…

61. In Closing…
There are many important differences between QAA and Quality Assurance Performance Improvement. Both are valuable and when worked together help create a synergistic process to support the overall functioning and operation of any organization. Protection of certain documents is a right of the providers and a benefit to enhance a non-punitive approach to quality improvement allowing the residents and staff the maximum benefit.

62. Thank you for having us at your program, May we answer any questions at this time?

63. Thank you for your participation
For information please contact us:
Karen L. Goldsmith,
JD of Goldsmith & Grout P.A at or call
Robin A. Bleier, RN, LHRM, CLC
President of RB Health Partners, Inc. at or call