Attachment 7 DHA 6025.13.pdf

Defense Health Agency

PROCEDURES MANUAL

NUMBER 6025.13, Volume 3 August 29, 2019

Medical Affairs

SUBJECT: Clinical Quality Management in the Military Health System, Volume 3:

Healthcare Risk Management

References: See Enclosure 1.

1. PURPOSE. This Defense Health Agency-Procedures Manual (DHA-PM), based on the authority of References (a) and (b), and in accordance with the guidance of References (c) through (ac), establishes the Defense Health Agency’s (DHA’s) procedures to assign responsibilities and establish procedures for managing Clinical Quality Management (CQM) in the Military Health System (MHS). This DHA-PM replaces, in full, the contents of the DoD Manual 6025.13 (Reference (e)), which is targeted for cancellation. This DHA-PM, replaces, in Volume 2, the full contents, unless otherwise stated, of the following memorandums, which are targeted for cancellation: Assistant Secretary of Defense for Health Affairs Memorandum, "Policy on Reporting Joint Commission on Accreditation of Healthcare Organizations- Reviewable Sentinel Events in the Military Health System," July 13, 2004 (Reference (h));

Assistant Secretary of Defense for Health Affairs Memorandum, "Amplifying Guidance Relating to the Reporting of Sentinel Events and Personally Identifiable Information Breaches to the Office of the Assistant Secretary of Defense (Health Affairs)," February 13, 2012 (Reference (i)) [as related to the reporting of sentinel events only]; and Assistant Secretary of Defense for Health Affairs Memorandum, "Medical Quality Assurance and Clinical Quality Management in the Military Health System Sentinel Event and Root Cause Analysis Process Improvements," March 12, 2015 (Reference (j)).

2. APPLICABILITY. This DHA-PM applies to:

a. OSD, Military Departments, Office of the Chairman of the Joint Staff and the Joint Staff, Combatant Commands, Office of the Inspector General of the DoD, Defense Agencies, DoD Field Activities, and all other organizational entities within the DoD (referred to collectively in this DHA-PM as the “DoD Components”);

b. The entire MHS, including each DoD Military Medical Treatment Facility (MTF) and all other healthcare provided by the MHS;

DHA- PM 6025.13, Volume 3

c. Uniformed services personnel of the active and reserve components (including National Guard personnel in a Federal duty status), civilian, contract, volunteer, and other medical or dental healthcare providers who are assigned to and deliver healthcare; and

(1) Credentialed healthcare providers who are members of the Army National Guard or the Air National Guard, while working in a non-federal status (Reference (k) are subject to the procedures, policies, and authorities, as prescribed by their respective Army Regulation Reference (l)) and Air Force Instruction (Reference (m)), or as defined in the policies, rules, procedures, and laws of the State, territory, or District of Columbia in which they are credentialed and/or privileged;

(2) Trainees who have been granted clinical privileges outside the training program when patient safety concerns arise;

d. Managed care support contractors (MCSCs), designated providers, and overseas contractors, consistent with their respective contracts awarded by the DoD.

3. POLICY IMPLEMENTATION. It is DHA’s instruction, pursuant to authority delegated in Reference (b) and based on authorities in Reference (a) through (ac), that:

a. Establishes CQM procedures in the MHS to provide an organized structure for an integrated framework of programs to objectively define, measure, assure, and improve the quality of care received by MHS beneficiaries.

b. Strengthens MHS CQM accountability, transparency, and standardization in the MHS.

c. Affirms the MHS’s unwavering commitment to quality healthcare for our beneficiaries, joint healthcare teams, and Combatant Commands across the globe, through CQM.

4. CANCELLED DOCUMENTS. This DHA-PM replaces, in Volume 2, the full contents of DHA-Procedural Instruction (DHA-PI) 6200.01, "Comprehensive Infection Prevention and Control (IPC) Program," April 24, 2017 (Reference (n)), which is being cancelled.

5. RESPONSIBILITIES. See Enclosure 2 of Volume 1 of this DHA-PM.

6. PROCEDURES. Procedures specific to each program within the MHS CQM are addressed in Volumes 2–7 of this DHA-PM.

7. INFORMATION REQUIREMENTS. CQM uses several data capture, analysis, reporting, and decision support tools for patient safety, clinical quality assurance, and improvement to include the electronic medical record, databases such as the Joint Centralized Credentials Quality Assurance System (JCCQAS), and the Joint Patient Safety Reporting, data visualization and report tools on CarePoint (a SharePoint platform), and more.

8. RELEASABILITY. Cleared for public release. This DHA-PM is available on the Internet from the Health.mil site at: http://www.health.mil/dhapublications.

9. EFFECTIVE DATE. This DHA-PM:

a. Is effective on October 01, 2019.

b. Will expire 10 years from the date of signature if it has not been reissued or cancelled before this date, in accordance with Reference (c).

Enclosures

1. References

2. Healthcare Risk Management Overview

3. Clinical Adverse Actions, Criminal Convictions Related to Healthcare, and Other Adjudicated Actions or Decisions

4. Impaired Healthcare Provider Program

5. Potentially Compensable Events, Active Duty Disability, Active Duty Death, and Medical Tort Claims Glossary

4 TABLE OF CONTENTS

TABLE OF CONTENTS

ENCLOSURE 1: REFERENCES

ENCLOSURE 2: HEALTHCARE RISK MANAGEMENT OVERVIEW

GENERAL OVERVIEW

KEY OPERATIONAL DEFINITIONS

GOVERNANCE STRUCTURE

SCOPE AND CORE RESPONSIBILITIES

ENCLOSURE 3: CLINICAL ADVERSE ACTIONS, CRIMINAL CONVICTIONS

RELATED TO HEALTHCARE, AND OTHER ADJUDICATED ACTIONS OR

DECISIONS

GENERAL OVERVIEW

CLINICAL ADVERSE ACTIONS

CRIMINAL CONVICTIONS RELATED TO HEALTHCARE AND OTHER

ADJUDICATED ACTIONS OR DECISIONS

ENCLOSURE 4: IMPAIRED HEALTHCARE PROVIDER PROGRAM (IHPP)

GENERAL OVERVIEW

OBJECTIVES OF THE IHPP

IHPP COMMITTEE

IMPAIRED HEALTHCARE PROVIDER INDIVIDUAL RESPONSIBILITIES

MANAGEMENT OF HEALTHCARE PROVIDER IMPAIRED BY SUBSTANCE

USE/ABUSE OR MEDICAL/MENTAL HEALTH CONDITIONS

NATIONAL GUARD AND RESERVE MEMBERS

HEALTHCARE PROVIDERS WITH INFECTIOUS DISEASES

ENCLOSURE 5: POTENTIALLY COMPENSABLE EVENTS, ACTIVE DUTY

DISABILITY, ACTIVE DUTY DEATH, AND MEDICAL TORT CLAIMS

BACKGROUND

POTENTIALLY COMPENSABLE EVENTS

ACTIVE DUTY DISABILITY/DEATH REVIEW USING POTENTIALLY

COMPENSABLE EVENT REVIEW PROCEDURES

MEDICAL TORT CLAIMS

GLOSSARY

PART I: ABBREVIATIONS AND ACRONYMS

PART II: DEFINITIONS

5 ENCLOSURE 1

ENCLOSURE 1

REFERENCES

(a) DoD Directive 5136.01, “Assistant Secretary of Defense for Health Affairs (ASD(HA)),” September 30, 2013, as amended

(b) DoD Directive 5136.13, “Defense Health Agency (DHA),” September 30, 2013

(c) DHA-Procedural Instruction 5025.01, “Publication System,” August 24, 2018

(d) DoD Instruction 6025.13, “Medical Quality Assurance (MQA) and Clinical Quality

Management in the Military Health System (MHS),” February 17, 2011, as amended

(e) DoD Manual 6025.13, “Medical Quality Assurance and Clinical Quality Management in the Military Health System,” October 29, 2013

(f) National Defense Authorization Act for Fiscal Year 2017, Sections 702

(g) National Defense Authorization Act for Fiscal Year 2019, Sections 711 and 712

(h) Assistant Secretary of Defense for Health Affairs Memorandum, "Policy on Reporting Joint Commission on Accreditation of Healthcare Organizations-Reviewable Sentinel Events in the Military Health System," July 13, 2004

(i) Assistant Secretary of Defense for Health Affairs Memorandum, "Amplifying Guidance Relating to the Reporting of Sentinel Events and Personally Identifiable Information Breaches to the Office of the Assistant Secretary of Defense (Health Affairs)," February 13, 2012

(j) Assistant Secretary of Defense for Health Affairs Memorandum, "Medical Quality Assurance and Clinical Quality Management in the Military Health System Sentinel Event and Root Cause Analysis Process Improvements," March 12, 2015

(k) United States Code, Title 32, Sections 502 – 505

(l) Army Regulation 40–68, “Clinical Quality Management,” February 26, 2004, as amended

(m) Air Force Instruction 44–119, “Medical Quality Operations,” August 16, 2011

(n) DHA-Procedural Instruction 6200.01, "Comprehensive Infection Prevention and Control (IPC) Program," April 24, 2017, hereby cancelled

(o) United States Code, Title 42, Section 11101

(p) Code of Federal Regulations, Title 45, Part 60

(q) U.S. Department of Health and Human Services, Health Resources and Services Administration. NPDB Guidebook. Rockville, Maryland: U.S. Department of Health and Human Services, 2018

(r) Memorandum of Understanding between the Department of Health and Human Services and the Department of Defense of September 1987, Participation of the DoD in the national reporting system established under Part B of The Health Care Quality Improvement Act of 1986 (the Act)1

(s) Assistant Secretary of Defense for Health Affairs Letter of November 9, 1992, Participation in the National Practitioner Data Bank2

1 This reference is available internally through a CAC–enabled website at:

https://info.health.mil/hco/clinicsup/quality/SitePages/Home.aspx 2 This reference is available internally through a CAC–enabled website at:

https://info.health.mil/hco/clinicsup/quality/SitePages/Home.aspx

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(t) United States Code, Title 10

(u) Public Law 104-191, “Health Insurance Portability and Accountability Act of 1996,” August 21, 1996, as amended

(v) United States Code, Title 5, Section 552a, as amended

(w) United States Code, Title 5, Chapter 75

(x) DoD Instruction 6490.04, “Mental Health Evaluations of Members of the Military Services,” March 4, 2013

(y) United States Code, Title 29, Section 701

(z) Code of Federal Regulations, Title 29, Part 1630

(aa) Code of Federal Regulations, Title 5, Part 339

(ab) DoD Manual 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in DoD Health Care Programs,” March 13, 2019

(ac) DHA-Procedural Instruction 6025.17, "Healthcare Resolutions, Disclosure, Clinical Conflict Management and Healthcare Provider Resiliency and Support in the Military Health System (MHS)," June 18, 2019

7 ENCLOSURE 2

ENCLOSURE 2

HEALTHCARE RISK MANAGEMENT OVERVIEW

1. GENERAL OVERVIEW

a. Enterprise Risk Management (ERM). ERM provides the framework for the Healthcare Risk Management (HRM) Program to mitigate risk in the clinical aspects of healthcare delivery.

This includes achieving safe and reliable healthcare through activities to identify and manage risk holistically by considering all forms of risk across the organization. ERM integrates the concepts and programs of operational risk management, HRM, patient safety (PS), high reliability, and process improvement. It provides a process for identifying explicit risks relevant to the MHS’s mission and objectives, assessing the potential frequency and magnitude of those risks, determining a response strategy, and monitoring process improvement and sustainment.

ERM includes analyzing risk from a broader, cross-functional and enterprise-wide perspective, defining roles and responsibilities, and creating a strategy matrix to address specific risk areas.

These risks can include clinical, operational, financial, human capital, strategic, legal and regulatory, and technological risks. Risks do not exist in isolation or silos and should be viewed across the organization. A robust ERM Program incorporates the concepts of risk identification, risk assessment, risk control and risk mitigation. Risk identification includes tracking, trending, and reporting of adverse and no-harm events, trends, and other relevant risk data. Risk assessment includes the use of tools aimed at both proactive and reactive evaluation of the sources (common causes) of risks within the organization. Risk control and risk mitigation encompass activities to prevent or reduce risk, improve processes, and sustain or enhance performance. ERM creates organizational value through improved clinical outcomes, reduction of adverse and no-harm events, improved satisfaction for patients, family, and staff, and reduced financial loss to the government. Healthcare Risk Managers at all levels of the MHS manage ERM activities, in accordance with the requirements outlined in this manual, applicable federal and state laws, and accrediting organization’s (AO) standards.

b. HRM Program.

(1) The overarching goal of the HRM Program is to protect PS, mitigate risks and harm within our healthcare delivery system, and improve the reliability of MHS healthcare. The HRM Program supports risk identification and assessment, and the development of prioritized, systematic risk reduction strategies and process improvement activities to provide safe, high-quality patient care. This is a collaborative effort within the organization’s CQM team, with leadership, and with other relevant process owners throughout the organization.

(2) This volume, in all of its enclosures, addresses HRM procedures in the management of medical tort claims, active duty death, active duty disability, potentially compensable events, and the required due process for clinical adverse actions taken against privileged and non-privileged healthcare providers, in accordance with References (o), (p), (q), (r), and (s).

Hereinafter, the term “clinical adverse action” will be used to describe the due process procedures for both privileged providers and non-privileged providers. In addition, the term

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“individual” may be used to describe both the privileged and non-privileged provider. All documents generated through professional review activities are protected as Medical Quality Assurance Program (MQAP) documents, in accordance with Section 1102 of Reference (t).

These documents must not be released without proper authority.

(3) HRM Guiding Principles

(a) Advance safe, trusted, and effective healthcare

(b) Promote a fair and just culture

(c) Use risk data/trends to prioritize risks and strategic responses to those risks

(d) Manage risks effectively

(e) Use strategies to reduce financial losses to the government

(f) Encourage organization and individual accountability

(g) Optimize organizational preparedness and performance

2. KEY OPERATIONAL DEFINITIONS. Knowledge of these terms is essential to understanding the scope, core responsibilities, and procedures of the HRM Program. A full list of definitions for this manual is included in the Glossary.

a. adverse event. See definition for patient safety (PS) event.

b. adverse practice action. Restriction, reduction, or revocation of the clinical practice of a non-privileged provider as a result of a due process professional review action, based upon evidence of misconduct, impairment, incompetence, or any conduct that adversely affects, or could adversely affect, the health or welfare of a patient.

c. adverse privileging action. Denial, restriction, reduction, or revocation of clinical privileges as a result of a due process professional review action, based upon evidence of misconduct, impairment, incompetence, or any conduct that adversely affects, or could adversely affect, the health or welfare of a patient.

d. clinical adverse action. Action invoked against a healthcare provider, privileged or not, with the result that the authority to practice clinically is adversely affected. Adversely affected privilege(s)/practice are the result of a due process professional review action based on evidence of misconduct, impairment, incompetence, or any conduct that adversely affects, or could adversely affect, the health or welfare of a patient, and that leads to the inability of a provider to exercise their privilege(s)/practice with their own independent judgment. This is the collective term used in this manual that encompasses both an adverse practice action and an adverse privileging action.

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e. clinical privileges. Permission granted by the Privileging Authority to provide medical and other patient care services. Clinical privileges define the scope and limits of practice for privileged providers and are based on the capability of the healthcare facility, licensure, relevant training and experience, current competence, health status, judgment, and peer and department head recommendations.

f. clinical privileging. The granting of permission and responsibility of a healthcare provider to provide specified or delineated healthcare within the scope of the provider’s license, certification, or registration.

g. denial of clinical privilege(s). Refusal to grant requested privilege(s) to a healthcare provider at the time of initial application or renewal. Denials that result from a professional review action following appropriate due process proceedings, and relating to evidence of the provider’s misconduct, impairment, incompetence, or any conduct that adversely affects, or could adversely affect, the health or welfare of a patient are reported to the National Practitioner Data Bank (NPDB), state(s) of licensure, and other applicable certifying/regulatory agencies.

Denials that occur solely because a provider does not meet a healthcare institution’s established threshold criteria for that particular privilege, should not be reported to the NPDB - these are considered decisions based on eligibility and are not deemed to be a result of a professional review action.

h. deviation. The action of departing from an established course or accepted standard; the amount by which a single measurement differs from a fixed value such as the mean.

i. DoD Reportable Event (DoD RE). Any patient safety (PS) event resulting in death, permanent harm, or severe temporary harm, as per the AHRQ Harm Scale; or meeting The Joint Commission’s (TJC) sentinel event (SE) or the National Quality Forum’s (NQF) serious reportable event (SRE) definitions. DoD REs require a Comprehensive Systematic Analysis (CSA) and follow on Corrective Action Implementation (CAI) Plan Report. (See Volume 2 of this manual for additional information.)

j. enterprise risk management (ERM). ERM provides a comprehensive framework for making risk management decisions to promote safe and reliable healthcare and to mitigate risks across the organization. Effective ERM practices are continuous in nature and support the journey to high reliability.

k. focused professional practice evaluation (FPPE). A process whereby the organization evaluates the privilege/practice of the healthcare provider who does not have documented evidence of competently performing the requested privilege, or of demonstrated practice competency, at the organization. This process may also be used when a question arises regarding a healthcare provider’s ability to provide safe, high quality patient care. Focused professional practice evaluation is a time-limited period during which the organization evaluates and determines the healthcare provider’s professional performance.

l. healthcare provider. Any member of the uniformed services, civilian employee of the DoD, or contract employee authorized by the DoD to perform healthcare services.

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m. healthcare risk management (HRM). Includes clinical and administrative activities, processes, and policies to identify, monitor, assess, mitigate, and prevent risks to the healthcare organization, patients, and staff. By employing risk management, the healthcare organization proactively and systemically safeguards patient safety and the organization’s resources, accreditations, legal/regulatory compliance, assets, and customer confidence (integrity).

n. Joint Centralized Credentials Quality Assurance System (JCCQAS). A secure, worldwide healthcare provider credentialing, privileging, adverse actions, and risk management web-based application mandated by the Military Health System (MHS) used in the provider credentialing and privileging process. Portions of the information contained in JCCQAS are confidential, privileged and protected from disclosure in accordance with Section 1102 of Reference (t).

JCCQAS is the official file for healthcare providers credentialed and privileged within the MHS.

o. monitoring and evaluation. A well-defined, time-limited, well documented plan of focused professional practice evaluation (FPPE) to confirm a healthcare provider possesses the knowledge, skills, and ability to render safe and effective healthcare. It must include a documented plan with delineation of clear expectations and measures of success. It requires a preceptor who provides full written evaluation of the monitoring period, with regular interval feedback, to both the provider and the Credentials Committee/Function. Privileges/practice remain intact during the period of monitoring and evaluation.

p. National Practitioner Data Bank (NPDB). The NPDB is a web-based repository of reports containing information on medical malpractice payments and certain adverse actions related to healthcare practitioners, providers, and suppliers. The NPDB is managed by the Department of Health and Human Services in accordance with Reference (o).

q. near miss event. See definition for patient safety (PS) event.

r. no-harm event. See definition for patient safety (PS) event.

s. non-privileged provider. An individual who possesses a license, certification, or registration by a state, commonwealth, territory, or possession of the United States, and is only permitted to engage in the delivery of healthcare as defined in their granted scope of practice.

Examples include registered nurse (RN), licensed vocational nurse (LVN), registered dental hygienist (RDH), and medical technician.

t. ongoing professional practice evaluation (OPPE). A documented summary of ongoing data collected for the purpose of assessing a healthcare provider’s clinical competence and professional behavior. The information gathered during this process allows for identification of practice trends that may adversely affect, or could adversely affect, the health or welfare of a patient. It is the responsibility of the organization to determine the criteria used in the ongoing professional practice evaluation.

u. patient safety (PS) event. A PS event is an incident or condition that could have resulted, or did result, in harm to a patient. A PS event can be but is not necessarily the result of a

11 ENCLOSURE 2

defective system or process design, a system or process breakdown, equipment failure or malfunction, or human error. PS events include adverse events, no-harm events, near miss events, and unsafe/hazardous conditions as defined below:

(1) adverse event. PS event that resulted in harm to the patient. The event may occur by the omission or commission of medical care.

(2) no-harm event. PS event that reached the patient but did not cause harm.

(3) near miss event. PS event that did not reach the patient (also known as “close call” or “good catch”).

(4) unsafe/hazardous condition. A condition or a circumstance (other than a patient’s own disease process or condition) that increases the probability of an adverse event.

v. peer. A healthcare provider with generally similar privileges, practice, clinical specialty and level of training.

w. peer review. Any assessment of the quality of medical care carried out by a healthcare provider, including any such assessment of professional performance, any patient safety program Comprehensive Systematic Analysis (CSA) or report, or any other such assessment carried out by a healthcare provider under the provisions of this manual.

x. potentially compensable event (PCE). Any patient safety (PS) event that both a) reaches the patient (i.e., adverse event and no-harm event) and b) has a Healthcare Risk Management assessment that determines that the event is likely to present a possible financial loss to the Federal Government. All DoD Reportable Events (DoD REs) are PCEs. All events that trigger a PCE will also be referred to the Patient Safety Manager to ensure capture in the Joint Patient Safety Reporting (JPSR) system and investigation/analysis as defined in Volume 2 of this manual.

y. preceptor. A clinical peer who has been appointed in writing to evaluate a healthcare provider’s clinical practice. The preceptor is designated for consultation, clinical feedback, and general oversight of the clinical activities of the provider. A preceptor may review medical records, and conduct direct observation of a provider’s practice, however they are not required to be present for or approve the provider’s procedures or clinical decisions since the provider’s clinical privilege(s)/practice is not restricted in any manner. [Contrast with the definition for “proctor”.]

z. privileged provider. An individual who possesses appropriate credentials and is granted authorized clinical privileges to diagnose, initiate, alter, or terminate regimens of healthcare within defined scope of practice.

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aa. Privileging Authority. The Privileging Authority is a designated official who grants permission to individuals to provide specific care, treatment, or services within well-defined limits. The Privileging Authority also initiates and makes determinations on clinical adverse actions.

ab. proctor. A clinical peer who has been appointed in writing to supervise all or some of a healthcare provider’s clinical practice. The proctor is required in order for the provider to proceed in exercising designated clinical privilege(s)/practice. The proctor provides direct oversight of designated clinical activities and must co-sign all such documentation conducted by the provider. Certain procedures may require proctor approval prior to performing. All designated procedures will require some period of direct observation by the proctor. Proctors are required for providers with supervised privileges, and for those who have had a clinical adverse action taken against them with subsequent restriction in privilege(s)/practice. [Contrast with the definition for “preceptor”.]

ac. reduction of clinical privilege(s)/practice. A portion of a healthcare provider’s clinical privilege(s)/practice that is permanently removed as a result of a professional review action following appropriate due process proceedings. It may be based on evidence of misconduct, impairment, incompetence, or any conduct that adversely affects, or could adversely affect, the health or welfare of a patient. Reductions in privilege(s)/practice are reportable to the National Practitioner Data Bank (NPDB), state(s) of licensure, and other applicable certifying/regulatory agencies.

ad. reinstatement of clinical privilege(s)/practice. The return of regular clinical privilege(s)/practice as a result of a professional review action following appropriate due process proceedings that may or may not include a period of monitoring and evaluation. Reinstatement after a clinical adverse action that was previously reported to the National Practitioner Data Bank (NPDB) is documented in the Revision-to-Action Report to the NPDB. Reinstatement is also reported to state(s) of licensure, and other applicable certifying/regulatory agencies.

ae. Report Authority. The official with responsibility to report to the National Practitioner Data Bank (NPDB), state(s) of licensure, and other certifying/regulatory agencies following appropriate due process proceedings. The Report Authority is:

(1) The Director of the DHA with respect to matters arising from acts or omissions of healthcare providers privileged by a Privileging Authority under the responsibility of the DHA.

(2) The Surgeon General of the Army, Navy, or Air Force, respectively, with respect to matters arising from acts or omissions of healthcare providers privileged by a Privileging Authority under the responsibility of the Army, Navy, or Air Force, respectively.

(3) In cases in which the healthcare provider is privileged by more than one of the Report Authorities listed in subparagraphs (1) and (2), the one whose responsibility applies to the Privileging Authority most responsible for the matters under review. In cases of uncertainty, the DHA Director will designate the Report Authority. The designated Report Authority will ensure there is a comprehensive review of the entire matter.

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af. restriction of clinical privilege(s)/practice. A temporary or permanent limit placed on a portion of a healthcare provider’s clinical privilege(s)/practice that results from a professional review action following appropriate due process proceedings. It may be based on evidence of misconduct, impairment, incompetence, or any conduct that adversely affects, or could adversely affect, the health or welfare of a patient. Restricted privilege(s)/practice require supervision by a proctor. Restrictions are reportable to the National Practitioner Data Bank (NPDB), state(s) of licensure, and other applicable certifying/regulatory agencies.

ag. revocation of clinical privileges/practice. The permanent removal of all of a healthcare provider’s clinical privileges/practice as a result of a professional review action following appropriate due process proceedings. It may be based on evidence of misconduct, impairment, incompetence, or any conduct that adversely affects, or could adversely affect, the health or welfare of a patient. Revocations of privileges/practice are reportable to the National Practitioner Data Bank (NPDB), state(s) of licensure, and other applicable certifying/regulatory agencies.

ah. significantly involved provider (SIP). A SIP is one who actively delivered care (based on clinical record entries) in either primary or consultative roles during the episodes of care that gave rise to the allegation, regardless of standard of care (SOC) determination. Additional defining characteristics include providers that: have the authority to start, stop or alter a course of treatment; have the authority to recommend to start, stop, or alter a course of treatment; or have the responsibility to implement a plan of evaluation or treatment. Authority to recommend means that input was solicited and legitimate (i.e., the individual making the recommendation was acknowledged to have special expertise or other specific standing in the clinical issues).

This term is not meant to include the providers who had only peripheral, yet appropriate, patient interaction, nor those providers whose patient involvement was not reasonably related to the specific indications or allegations of sub-standard care and injury.

ai. standard of care (SOC). Healthcare judgments and actions of a healthcare provider generally accepted in the discipline or specialty involved as reasonable and appropriate.

aj. summary suspension of clinical privilege(s)/practice. The temporary removal of all or a portion of a healthcare provider’s privilege(s)/practice, taken prior to the completion of due process procedures, based on determination by the Privileging Authority for concerns regarding suspected misconduct, impairment, incompetence, or any conduct that adversely affects, or could adversely affect, the health or welfare of a patient. A summary suspension continues until due process proceedings are complete. All summary suspensions of privileged providers that last longer than 30 calendar days must be reported to the National Practitioner Data Bank (NPDB), state(s) of licensure, and other applicable certifying/regulatory agencies.

ak. trainee. Any resident, intern, or other healthcare provider in a formal healthcare training status.

al. unsafe/hazardous condition. See definition for patient safety (PS) event.

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3. GOVERNANCE STRUCTURE. The HRM Program develops, promotes, and supports a comprehensive mission that mitigates and/or prevents risk within the healthcare delivery system, applying principles and practices of a high reliability organization (HRO). The HRM Program shares risk data/trends to contribute to organizational learning and to support an integrated response to risk prevention, mitigation, and management, as appropriate. The DHA HRM Program is managed out of the CQM Branch under the Clinical Support Division within the Directorate of the Deputy Assistant Director for Medical Affairs (DAD MA). Service Surgeon General (SG) HRM Programs are respective to Service structures.

a. The DHA HRM Program Lead manages operations in collaboration with the DoD Risk Management Working Group (DoD RMWG), DoD Joint Credentials Working Group; DoD and DHA Office of General Counsel; DHA Office of Strategic Communications; the DoD Patient Safety Program (PSP); the DHA Office of the Chief Informatics Officer; and other DHA, Service and Office of the Assistant Secretary of Defense for Health Affairs (ASD(HA)) working groups and offices impacting HRM functions.

b. The DoD RMWG is co-chaired by the Deputy ASD(HA) Health Services Policy and Oversight designee, and the DHA DAD MA representative. Membership includes representatives from the DHA Clinical Support Division to include the DoD PSP, the DHA Medical Legal Office within the DHA HRM Program, the Services HRM Program representation, the DHA Office of General Counsel, and subject matter experts (SMEs), as needed. The purpose of the DoD RMWG is to develop, promote, and support a comprehensive, MHS-wide HRM Program that mitigates and/or prevents risk and loss (financial, human injury, human capital) within the healthcare delivery system. The DoD RMWG:

(1) Defines HRM for the DoD;

(2) Facilitates just culture supportive of DoD HRM;

(3) Supports principles and practices of an HRO;

(4) Establishes the HRM structure for the DoD;

(5) Approves the HRM plan for the DoD (e.g., communications, reporting plans); and

(6) Provides oversight for the DHA/Services HRM Programs, specifically:

(a) Monitors HRM Program compliance with Federal, DoD, and DHA regulations and policies;

(b) Reviews and reports DoD compliance with reporting to the National Practitioner Data Bank (NPDB) as mandated by References (o), (p) and (q), (r), and (s); and

(c) Reviews current DoD and DHA policies related to HRM to ensure they support current standards and that policies are congruent.

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4. SCOPE AND CORE RESPONSIBILITIES. DHA Headquarters/Military Departments, DHA Markets/Intermediate Headquarters, and MTF and other military leadership will interpret DoD policies and provide direction for the implementation of the HRM Program requirements within their scope of their authority, direction, and control. Each echelon of leadership will provide appropriate oversight to their Healthcare Risk Managers who will plan and manage the processes and procedures in accordance to this manual. Three roles in particular bear specific mention.

a. MTF Chief of the Medical Staff or Military Department Chief of the Medical Staff designee (descriptive term, role may also be known as Chief Medical Officer, Medical Executive Committee Chair, or other titles for similar responsibilities):

(1) Must be a privileged physician with an active appointment to the medical staff.

(2) Is the principal executive staff advisor to the Privileging Authority concerning matters of medical quality assurance and CQM, to include the scope of medical care under the respective Privileging Authority and clinical adverse actions.

(3) Is accountable for the HRM Program, to include clinical adverse action procedures.

(4) Initiates Quality Assurance Investigations (QAI) in coordination with the Healthcare Risk Manager, and in consultation with the servicing healthcare legal counsel.

(5) Chairs the Credentials Committee/Function, or ensures an appropriate alternate (physician appointed to the medical staff and in good standing).

(6) Is authorized to intervene on behalf of the Privileging Authority to immediately summarily suspend a healthcare provider’s privileges/practice if the provider’s conduct adversely affects or could adversely affect the health or welfare of a patient, employee or other individual, until the matter is investigated and resolved in accordance with this manual.

(7) Collaborates with the Healthcare Risk Manager to communicate summary suspension, and/or hearing notifications on behalf of the Privileging Authority.

(8) Ensures with the Healthcare Risk Manager that providers are informed of their due process rights.

b. Healthcare Risk Managers are responsible for providing HRM consultation and educational support to their areas of responsibility, specifically they:

(1) Manage HRM activities according to this manual and in consultation with the appropriate servicing healthcare legal counsel, and in coordination with the Chief of the Medical Staff, the Chief Nurse, and the Chair of the Credentials Committee/Function.

(2) Are a member of the local committee that performs and reviews HRM functions.

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(3) Develop, implement and report HRM activities and related topics as required not only to their local leadership but also to the DHA Headquarters/Military Departments HRM Program through their respective DHA Market/Intermediate Headquarters.

(4) Collaborate with the Chief of the Medical Staff, Chair of the Credentials Committee/Function (if it is a different person), Chief Nurse, Senior Enlisted Advisor, Chief Administrator, and PS program and other CQM program leads on HRM activities and on all other CQM activities as appropriate, to identify, analyze, trend, mitigate risk, and to recommend corrective actions for processes/procedures needing improvement.

(5) Evaluate CQM activities for real and potential risks for provision of clinical care.

(6) Direct actions to preserve, protect, secure evidence and equipment involved in PS events that reach the patient (adverse and no harm events).

(7) Facilitate clinical adverse action due process, and procedures for other HRM activities as per this manual.

(8) Forward information to respective higher headquarters in support of reports to the NPDB, state(s) of licensure, and other applicable certifying/regulatory agencies.

(9) Disseminate lessons learned, advisories, alerts and other formal communications as needed pertaining to ERM/HRM.

c. Healthcare Professional Appropriate Panel

(1) The DHA Headquarters/Military Departments healthcare professional appropriate panel is a panel of senior clinician executives on behalf of the Report Authority. The panel reviews full and complete Medical Quality Assurance Records (MQAR) for concerns with procedures and due process, and standard of care (SOC) determination variance between DoD and the external peer review (as designated by the ASD(HA)), for active duty disability, active duty death, paid medical tort claims, and for clinical adverse actions. The healthcare professional appropriate panel will include:

(a) The Chair: this is a senior quality physician, e.g., DHA Headquarters/Military Departments HRM Program Lead or CQM Functional Capability Lead or deputy. This person is responsible for ensuring a complete and appropriate composition for every healthcare professional appropriate panel, and for ensuring relevant clinical consultants (or designees) are available to provide expert review of the case.

(b) Voting Members, assigned by the Chair and issued an appointment letter from the

DAD MA:

1. Senior Physician Executive: must have Chief of the Medical Staff experience.

2. Senior Nurse Executive: must have Chief Nurse experience.

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3. Senior Enlisted Advisor: must have Senior Enlisted Advisor experience, e.g., be the Senior Enlisted Advisor for an MHS medical center or large hospital, or regional or major command, or higher.

(c) Ad Hoc Voting Members, as appropriate for SIP under review:

1. Senior Dental Executive

2. Senior Advanced Practice Registered Nurse or Physician Assistant

3. Senior Allied Health Provider

(d) Non-voting Member: appropriate servicing healthcare legal counsel

(e) One of the voting members is recommended to be a civilian if the SIP under review is a civilian.

(2) The healthcare professional appropriate panel members may neither have provided care, nor acted as Quality Assurance Investigating Officer (QAIO) or peer reviewer, in the case under review.

(3) Healthcare professional appropriate panel functions:

(a) Will consider a full and complete MQAR, to include external peer SOC reviews.

The Chair will ensure each SIP has an appropriate clinical peer reviewer provide a report to the panel upon review of the full and complete MQAR. The healthcare professional appropriate panel Chair will ensure these clinical peer reviewers are available for questions during the panel’s deliberations.

(b) Recommend final action to the Report Authority on adverse privileging/practice actions, paid medical tort claims, and active duty death and disability events. Verify and make recommendations to change the status of providers as “significantly involved” or remove provider as “not significantly involved” as appropriate.

(c) Provide in writing, signed by the panel Chair, a reporting recommendation to the Report Authority for report to the NPDB, state(s) of licensure, and other applicable certifying/regulatory agencies. Written recommendations will include review and analysis of any appeals to clinical adverse actions, or of any provider statements to the standard of care determinations made by senior peer reviewers, as appropriate to the case under review. Written recommendations in active duty death or disability events will include review of the SOC determinations for each SIP and analysis of whether that care was related to the active duty death or disability. See Enclosure 5 for further guidance.

(d) Identify clinical lessons learned and opportunities to improve healthcare management and clinical processes.

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(e) Identify clinical policy/procedure changes as appropriate based on analysis of malpractice claims, active duty cases, and adverse privileging/practice actions using relevant clinical consultants within the clinical communities and other subject matter experts.

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ENCLOSURE 3

CLINICAL ADVERSE ACTIONS, CRIMINAL CONVICTIONS RELATED TO

HEALTHCARE, AND OTHER ADJUDICATED ACTIONS OR DECISIONS

1. GENERAL OVERVIEW. Clinical adverse actions, criminal convictions related to healthcare, and other adjudicated actions or decisions are managed in accordance with Reference (o), applicable accreditation standards, and this enclosure. The MHS provides safe and effective healthcare by ensuring its healthcare providers are properly qualified, trained, and competent to perform their clinical duties. When there are concerns for suspected misconduct, impairment, incompetence, or any conduct which adversely affects, or could adversely affect, the health or welfare of a patient, or staff member, a Quality Assurance Investigation (QAI) for a clinical adverse action may be indicated with potential report to the NPDB, state(s) of licensure, or other applicable certifying/regulatory agencies. Additionally, criminal convictions of, civil judgments against, or administrative actions taken against healthcare providers, which are related to, or could adversely affect, the delivery of healthcare items or services, are subject to review for potential reporting of the healthcare provider to the NPDB, state(s) of licensure, or other applicable certifying/regulatory agencies.

2. CLINICAL ADVERSE ACTIONS

a. Purpose. The purpose of the clinical adverse action process is to protect PS, preserve the quality and safety of healthcare, protect the integrity of the MHS, protect the rights of the involved healthcare provider, ensure timely resolution of the issues, and ensure timely reporting to regulatory entities, when required.

b. Basic Principles and Guidance

(1) Clinical adverse action basic principles:

(a) Clinical adverse action procedures are Medical Quality Assurance Program (MQAP) activities. The primary goal is to assure and advance the delivery of safe, trusted, and effective healthcare items or services.

(b) The clinical adverse action process is not a disciplinary tool. Concerns for suspected misconduct, impairment, incompetence, or any conduct related to the delivery of healthcare and services that adversely affect, or could adversely affect, the health or welfare of a patient, or staff member, are the basis for a clinical adverse action. Routine and regular evaluation of clinical privileges/practice is required and provides an opportunity for continuous learning and practice improvement in addition to a means to validate clinical proficiency. Non-adverse procedures for routine and regular evaluations include ongoing professional practice evaluations (OPPE), focused professional practice evaluations (FPPE) with monitoring and evaluation, and regular training and education. A robust peer review system for privilege/practice evaluation is an important risk mitigation strategy for preventing harm, and for

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increasing the reliability of safe, high quality clinical outcomes. However, a period of FPPE with monitoring and evaluation may be indicated for concerns of substandard care, or incompetence, when there is not sufficient information to warrant immediate removal from practice through summary suspension and initiation of a QAI. (See Volume 4 in this manual for more information on OPPE, FPPE and associated monitoring and evaluation plans.)

(c) Conduct that violates local, state, or federal law, the Uniform Code of Military Justice (UCMJ) or other military regulations, or those civil judgments against a healthcare provider, when related to the delivery of healthcare items or services, may be the basis for reporting to the NPDB, state(s) of licensure, and other applicable certifying/regulatory agencies.

A separate report could be required for any clinical adverse action needing to take place concurrently or following final disposition of these circumstances. Similarly, military leadership, in consultation with appropriate servicing legal counsel, may determine a personnel administrative action against a provider is required concurrent with, during, or following clinical adverse action due process. Such “other adjudicated action or decision” may be the basis for reporting, separate from the clinical adverse action. Consultation with servicing Staff Judge Advocate or servicing healthcare legal counsel is required to ensure proper military and/or civilian procedures are followed. See “Criminal Convictions Related to Healthcare and Other Adjudicated Actions or Decisions” in Paragraph 3. of this enclosure for further guidance.

(2) Clinical adverse action guidance:

(a) Privileging Authorities or designees will consult with the appropriate servicing healthcare legal counsel when initiating the clinical adverse action and ensure notification issuances to the healthcare provider are reviewed by such legal counsel prior to release.

(b) All decisions must be warranted by the findings of fact and comply with the due process procedures in this enclosure.

(c) Severing the employment relationship with the MHS (e.g., separation, resignation, termination, or retirement), a permanent change of station (PCS), or negotiating a contractual or employment settlement in lieu of the Privileging Authority taking a clinical adverse action is not permitted.

(d) An individual may not voluntarily surrender or self-relinquish clinical privileges/practice in lieu of investigation for concerns for suspected misconduct, impairment, incompetence or any conduct that adversely affects, or could adversely affect, the health or welfare of a patient. Any voluntary surrender of clinical privileges or failure to renew clinical privileges, while under investigation, is reportable to the NPDB.

(e) Individuals who separate from or end affiliation with the MHS while in summary suspension or follow-on clinical adverse action due process procedures, have the right to request continued due process to include a hearing. The request must be submitted in writing by the individual to the Privileging Authority, or designee, within five calendar days following their knowledge of the change in affiliation status. If the individual fails to submit the request for this right, it is considered waived.

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(f) If the individual waives the right to further due process, the following actions will be taken:

1. The QAI will be completed and the report of investigation forwarded to the respective Credentials Committee/Function for review. The Credentials Committee/Function will then recommend a final action to the Privileging Authority.

2. The Privileging Authority will give written notice to the individual of their decision on clinical privileges/practice.

3. Clinical adverse action decisions are reported in accordance with this enclosure.

(g) If a Service SG is considering initiating clinical adverse action due process under their Privileging Authority, the MTF at which the provider also is privileged/practices shall assist, as needed, due to operational resource constraints. With regard to the MTF, the MTF Privileging Authority, as evidence is provided from the Service, may need to consider evaluation of the privileges/practice within the MTF for a separate clinical adverse action.

(h) When a deployed Reserve Component individual is returned to the Reserve Component unit from the theater of operations, the Reserve Component command and MTF (as appropriate) Credentials Committee/Function Chairperson will coordinate with the respective Reserve Component Service SG to conduct the clinical adverse action due process.

(i) To ensure compliance with required due process and the procedures in this manual, the healthcare provider under review will be notified in writing, delivered in person when possible; otherwise, by certified return receipt requested mail, or secure electronic system with confirmation of receipt.

c. Disposition of Clinical Adverse Action Case Files When MTFs Close. When an MTF is closed to any future delivery of healthcare items or services, clinical adverse action case files are not destroyed.