Clinical Quality Management How Lawyers Must Assist

1. Clinical Quality Management How Lawyers Must Assist COL Kimberly L. Kesling Deputy, Clinical Performance Assurance Directorate September 2014

2. BRIEFING OUTLINE • Basics of Quality Management • References • Adverse privileging/practice actions • Risk Management • Patient Safety PURPOSE: To provide information the MHS Clinical Quality program and where legal assistance is critical. Pre-decisional – FOUO – Pre-decisional

3. Definitions • Quality of Care: The degree to which health care and services increase the likelihood of achieving desired health outcomes and are consistent with current professional knowledge. • Quality Management: a systematic, organized, multidisciplinary approach to the ongoing assessment, monitoring, evaluation, and modification of the processes of health care and services to enhance quality. • Quality of Service: Tied directly to the Patient experience and how they perceive that encounter.

4. Components of Quality Management • Accreditation (The Joint Commission) • Credentialing and Privileging • Adverse Privileging or Practice Actions • Risk Management • Patient Safety • Performance Improvement

5. References • AR 40-68 Clinical Quality Management, 26 Feb 2004 (RAR 22 May 2009. • DoDM 6025.13 Military Health System Clinical Quality Assurance Program, 29 October 2013. • Confidentiality of medical quality assurance records: qualified immunity for participants, Pub. L. 99-661, 10 USC §1102 (QA) • Health Insurance Portability and Accountability Act of 1996, Pub.L.104-191, Rule @ 45 CFR §§ 160.102, 160.103 (HIPAA). • The Privacy Act (5 U.S.C. 552a, as amended) (PA)

6. Credentialing and Privileging • Credentialing: The process of obtaining, assessing, and verifying the qualifications of a health care provider to render beneficiary care/service in or for a health care organization. • Privileging: The privileging authority, upon recommendation from the credentials committee (medical staff), grants to individuals the authority and responsibility for making independent decisions to diagnose, initiate, alter, or terminate a regimen of medical or dental care. • The MTF Commander is the privileging authority

7. Adverse Privileging or Practice Actions • The denial, suspension, restriction reduction or revocation of clinical privileges or practice based upon misconduct, professional impairment, or lack of competence. • Process has been standardized for Army, Navy, Air Force • Adverse privileging actions must strictly follow the regulation to ensure due process to providers • Currently the average time to complete an adverse privileging action is 700 days. Multiple delays at MTF, RMC, MEDCOM.

8. Adverse Privileging or Practice Actions • Due Process is exactly the same for Privileging actions or Practice actions. The only difference is the type of provider privileged vs non-privileged. • There must be a legal review done prior to the action leaving the Military Treatment Facility (MTF). The due process must be compared against AR 40-68 Chapter 10 for completeness. If this is done early, any errors can be corrected. • Once the case leaves the MTF, the review is only documentary. No new evidence is added. • Only The Surgeon General can report to the National Practitioner Data Bank or licensing bodies. • Unless the DoDM/AR process is followed, the reviewers are not afforded QA protection

9. Adverse Actions Bottom Line • If found legally insufficient when the case comes to MEDCOM Legal, i.e. after all the MTF and RMC input, then TSG is unable to complete the action to restrict or revoke a provider’s privileges/practice and report the provider if indicated. • TSG can only uphold the provider’s appeal and return them to practice or return to the MTF to start all over again. • Adverse actions are started due to an egregious negligent act or a negligent pattern of behavior. • REVIEW AT THE MTF IS CRITICAL, AND THE LAWYER MUST ENFORCE AR 40-68.

10. Adverse Action Process • Abeyance – not reportable • QI Investigation by disinterested party – results to credentials committee (CC) • Committee recommendation • Restore privileges • Peer Review Panel • A period of Focused Professional Practice Evaluation(FPPE) • Commander decision and notification of provider • Peer Review Panel held (like Providers) – results to CC who makes recommendations to the Commander • Commander decision and notification of the provider, including right to request a hearing

11. Adverse Action Process • Hearing held • Credentials committee usually is the Hearing Committee • MTF attorney advisor present to advise on procedures • Provider has right to attorney, examine witnesses, present witnesses (Attorney may participate) • Provider and his attorney do not stay for committee deliberations • Record of the hearing committee • Tape recording available to provider/attorney (not including the deliberations) • May use summarized minutes – but must provide significant detail of the discussions that occurred

12. Adverse Action Process • Recommendations to commander • Commander notifies provider of his right to appeal the decision • Appeal is forwarded to RMC/MEDCOM for appeals board • Appeals board meets and makes recommendation to The Surgeon General (TSG) on upholding the commanders action • TSG can accept or modify ONLY TSG HAS THE AUTHORITY TO REPORT ADVERSE PRIVILEGING/PRACTICE ACTIONS to NPDB or LICENSING BODIES. • NPDB paperwork done by MEDCOM QM after TSG decision

13. Acts of misconduct or unprofessional conduct will be reported to state licensing boards. Commission of sexual abuse, misconduct or exploitation Commission of an offense punishable by a fine of $1000 or 30 days in jail (civilian jurisdiction) UCMJ Actions – criminal offenses UCMJ nonjudicial punishment when the offense is related to the practice of medicine or which impairs the practitioner’s credibility within the health care community or within his/her professional community. Titling is at the discretion of the PMO Other Reportable Events

14. Important Tips • Adverse privileging/practice actions are investigated separately from any UCMJ/criminal actions. • Adverse privileging actions are QA protected so cannot be used in a 15-6, however the results of a 15-6 may be used in the adverse action. • If peer review information comes to light in a 15-6, it is also QA protected and not releasable. • Legend does not make it QA: content, use and origin does. • Be familiar with 10 USC §1102: NO Waivers • Do not assume anyone has a right to the information, even if they claim the info will save the Army. • Do utilize resources locally, at Region, MEDCOM to resolve questions.

15. QUALITY ASSURANCE INFORMATION WHAT IT IS: • The proceedings, records, minutes, and reports that derive from healthcare QA program activities and are produced or compiled as part of a healthcare QA program DL1.1.39 of DoD 6025.13-R and 10 USC §1102 (j)(2). • MTF does not have the authority to release this information to licensing boards or others • All releases come from MEDCOM and are redacted.

16. Adverse Actions are not Risk Management • Do not confuse the two and do not combine the two. They must be completely separate. • Risk Management has a standardized process but is not a due process proceeding. • Peer Review is a term used in both • Adverse privilege/peer review looks at an individual’s competency or actions as they relate to their privileges as a whole. • Risk Management Peer Review is done to determine standard of care in a particular case. (if this is noted to be a pattern of behavior with this provider, then this is referred to the CC for adverse action) • Patient Safety Root Cause Analysis (RCA) is looking at systems and processes and not used for either of the above.

17. Risk Management • Activities taken to • Identify • Evaluate • Reduce • Risk of injury to patients, staff, and visitors • Risk of financial loss to organization • DOD has a standardized process with established timelines

18. Reporting RequirementsAR 40-68 Chapter 13 • Potentially Compensable Events (PCEs) • Medical Malpractice Claims • Incident to service and MEB cases involving the death/injury of a soldier (related to medical care) • DoDI 6025.13 dated Feb 2011 • CCQAS is the system into which RM review of all PCEs, claims, and active duty cases MUST be entered

19. PCE Potentially Compensable Event: an adverse event that occurs in the delivery of health care and services with resulting beneficiary injury. It includes any adverse event or outcome, with or without legal fault, in which the patient experiences any unintended or unexpected negative results. APPLIES TO ACTIVE DUTY PATIENTS!!!

20. AHRQ Harm Scale – Degree of Harm Death Death at the time of the assessment Severe Permanent Harm Severe lifelong bodily or psychological injury or disfigurement that interferes significantly with the functional ability or quality of life. Prognosis from time of assessment. Permanent Harm Lifelong bodily or psychological injury or increased susceptibility to disease. Prognosis at the time of assessment. Temporary Harm Bodily or psychological injury, but likely not permanent. Prognosis at the time of assessment. Additional Treatment Injury limited to additional intervention during admission or encounter and/or increased length of stay, but no other injury. Treatment since discovery, and/or expected treatment in future as a direct result of event Emotional Distress or Inconvenience Mild and transient anxiety or pain or physical discomfort, but without the need for additional treatment other than monitoring (such as by observation; physical examination; laboratory testing, including phlebotomy; and/or imaging studies). Distress/inconvenience since discovery, and/or expected in the future as a direct result of event. No Harm Event reached patient, but no harm was evident

21. Medical Malpractice Claims • Paid claims must be reviewed at MEDCOM Special Review panel (SRP) for recommendation on reporting providers to the NPDB. Recommendation is based on standard of care determination and any extenuating circumstances. • Payment decisions are made by the US Army Claims service and are not related to MEDCOM standard of care determinations. • Death benefits (gratuity) are classified as paid claims • Not a “due process” procedure, but providers asked for their written input IAW AR 40-68 Ch. 13. • Process is supposed to be completed within 180 days of notification of payment of a claim • May require review external to DoD

22. Negligence / Standard of Care • Duty • Breach of Duty • Injury • Causation • A physician/provider is under a duty to use that degree of care and skill which is expected of a reasonablycompetent practitioner in the same class to which he belongs, acting in the same or similar circumstances.

23. Education and collaboration • Bi-monthly Risk Management teleconferences • Soon to be announced Credentials teleconferences regarding adverse privileging/practice actions. • Monthly Quality Management VTC

24. Army Patient Safety Program • Mission Establish an environment of trust, transparency, teamwork and communication to facilitate an interdisciplinary proactive approach to improving safety and preventing adverse events. • Vision An integrated, responsive and proactive Patient Safety Program that facilitates the critical concepts of a Patient Safety culture.

25. Army Patient Safety Program • Goals: • Engage leadership at all levels to foster a culture of Patient Safety • Analyze AMEDD Patient Safety cultural elements to drive program initiatives • Integrate teamwork concepts, knowledge, skills and attitudes to improve the quality of Patient Safety • Provide facilities with meaningful and useful data to identify safe practices, to mitigate potential risks and hazards and to improve clinical outcomes • Provide transparency and education on patient safety events and best practices.

26. Transparency Executive Order “…It is the purpose of this order to ensure that health care programs administered or sponsored by the Federal Governmentpromote quality and efficient delivery of health care through the use of health information technology, transparency regarding health care qualityand price, and better incentives for program beneficiaries, enrollees, and providers…” Executive Order 13410 of August 22, 2006 Promoting Quality and Efficient Health Care in Federal Government Administered or Sponsored Health Care Programs

27. Transparency EO • Has to be done within existing law and regulation • Title X Section1102 issues • “This is confidential medical quality assurance information exempt from discovery and restricted from release under 10 U.S.C. 1102. Information contained in this correspondence may be used only by authorized persons in the conduct of official business. Any unauthorized disclosure or misuse of information may result in civil penalties. ”

28. 10 U.S.C. 1102 • (a) Confidentiality of Records.— Medical quality assurance records created by or for the Department of Defense as part of a medical quality assurance program are confidential and privileged. Such records may not be disclosed to any person or entity, except as provided in subsection (c)[Authorized Disclosure and Testimony]. • (f) Exemption From Freedom of Information Act (FOIA).— Medical quality assurance records described in subsection (a) may not be made available to any person under section 552 of title 5. • (i) Regulations.— The Secretary of Defense shall prescribe regulations to implement this section. [which has been interpreted as aggregate statistical data only]

29. Transparency • Current DoD policy and regulation (60s5.13-R) requires authorization of the ASD (HA) to release “aggregate” data below the level of the Service • We can post overall Army compliance with HEDIS measures • We cannot post MTF, clinic, provider level data for public use • Plan: DoD will publish policy allowing the release of HEDIS and ORYX data below the Service level • Definitions of “aggregate” data (denominator of 3 or more) • Does not stop “internal transparency”