mega rule update heading for the finish line€¦ · compliance / ethics program 24|© 2019 remedi...

9/13/2010

1

© 2019 Remedi SeniorCare®1 |

Mega Rule UpdateHeading for the Finish Line

Jennifer L. Hardesty, PharmD, FASCPChief Clinical Officer

Corporate Compliance Officer

William M. Vaughan RN, BSN Vice President, Education and Clinical Affairs


DISCLOSURE / CONTACT INFO

Disclosure:Jen- Remedi SeniorCare- Board Commissioner, Maryland Board of Pharmacy

Bill- Remedi SeniorCare- Clinical Advisory Board – ISMP LTC Newsletter

Contact: [email protected]@remedirx.com


“Welcome to the ISMP Long-Term Care Advise-ERR, a medication safety newsletter designed specifically to meet the

needs of administrators, nursing directors, and nurses who transcribe medication orders, administer medications, monitor the effects of medications on residents, and/or supervise those

who carry out these important tasks.”

http://www.ismp.org/Newsletters/longtermcare/default.aspx

mailto:[email protected]

mailto:[email protected]

9/13/2010

2


MEGA RULE: NOVEMBER, 2019

• Quality Assurance / Performance Improvement

• Compliance and ethics program• Trauma Informed care


QUALITY ASSURANCE / PERFORMANCE IMPROVEMENT

• Indicators of the outcomes of care and quality of life

• Plan à state by 11/28/18, annual survey, when requested • Numerous F tags à QAPI

• Corrective actions address gaps in systems, and are evaluated for effectiveness;

• Clear expectations are set around safety, quality, rights, choice, and respect.


QUALITY ASSURANCE / PERFORMANCE IMPROVEMENT Identifying and correcting problems requires facilities to:

• • Collect data from various sources related to high risk, high volume, and problem-prone issues such as medical errors and adverse events;

• • Analyze the data collected to identify performance indicators signaling deviation from expected performance;

• • Study the issue to determine underlying causes and contributing factors;

• • Develop and implement corrective actions; and

• • Monitor data related to the issue to determine if they are sustaining corrections, or if revisions are necessary.

9/13/2010

3



• “Adverse Events”• An adverse event is defined as an

untoward, undesirable, and usually unanticipated event that causes death or serious injury, or the risk thereof, which includes near misses.



• 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.



• 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.

9/13/2010

4



• As part of their performance improvement activities, the facility must conduct distinct performance improvement projects

• 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



• 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


9/13/2010

5



• If the survey team has identified a current

issue which will be cited at S/S level of E or

above, or has identified substandard quality

of care, the surveyor conducting the

QAPI/QAA Review should consider if the

facility’s monitoring systems should also

have identified the same issue.



• Sword or Shield?• A State or the Secretary may not require

disclosure of the records of such committee [QAA] except in so far as such disclosure is related to the compliance of such committee with the requirements of this section.



• Sword or Shield?• Protection from disclosure is generally

afforded documents generated by the QAA committee, such as minutes, internal papers, or conclusions. However, if those documents contain the evidence necessary to determine compliance with QAPI/QAA regulations, the facility must allow the surveyor to review and copy them.

9/13/2010

6



• Protected from disclosure?• Consultant pharmacist's notes in the

medical records identified as “Quality Assurance Document / Confidential”

• Resident information contained exclusively on the consultant pharmacist’s laptop

• Emails to the DON• Pharmacy delivery manifests



• Sword or Shield?• Protection from disclosure is generally

afforded documents generated by the QAA committee, such as minutes, internal papers, or conclusions. However, if those documents contain the evidence necessary to determine compliance with QAPI/QAA regulations, the facility must allow the surveyor to review and copy them.



• Sword or Shield?• Incident and accident reports, wound logs,

or other reports or records used to track adverse events are not protected from disclosure. Surveyors may request these documents as part of their normal investigation of other areas of concern throughout the survey to support their findings.

9/13/2010

7



• Sword or Shield?• Surveyors must not use documentation

provided by the facility during the QAA review to identify additional concerns not previously identified by the survey team during the current survey, nor can they expand the scope or the severity of the problem based on information gleaned from this disclosure.



• Sword or Shield?• If the facility, through its QAA committee,

has identified and made a good faith attempt to correct the same issue identified by the survey team during the current survey, the facility will not be cited for QAA (it may however, still be cited with deficiencies related to actual or potential issues at other relevant tags).



9/13/2010

8


COMPLIANCE / ETHICS PROGRAM

• 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

• Mandatory annual training program on the operating organization's compliance and ethics program

• Staff, individuals providing services under a contractual arrangement, or volunteers


COMPLIANCE / ETHICS PROGRAM


TRAUMA INFORMED CARE

• The facility must ensure that residents who are trauma survivors receive culturally competent, trauma-informed care in accordance with professional standards of practice …

9/13/2010

9


POST MEGA RULE HIGH SEVERITY DEFICIENCIES

MEDICATION MANAGEMENT



9/13/2010

10


SELF ASSESSMENT QUESTIONS 1. To qualify as an adverse event under F 867, death or serious injury must occur.

False – near miss incidents quality as adverse events

2. Data collection and analysis are optional components of the quality assurance and performance improvement (QAPI) program requirements.

False – data collection and analysis is required throughout the QAPI process

3. The standards, policies, and procedures of a facility’s compliance and ethics program do not apply to the consultant pharmacist.

False – a facility’s compliance and ethics program applies to the organization's entire staff; individuals providing services under a contractual arrangement; and volunteers, consistent with the volunteers' expected roles.

4. Since the implementation of the phase 2 regulations, less than 10 actual harm cases have been cited under F 756 (Drug Regimen Review) nationwide.

True – As of 2/1/19, only 2 actual harm deficiencies cited have been cited under F 756 (Drug Regimen Review).

mega rule update heading for the finish line€¦ · compliance / ethics program 24|© 2019 remedi...

Documents