HT0011-20-R-0043 HFAS PWS Attachment 2b - DHA PM 6025.13 CQM in the MHS Vol 1, General CQM.pdf

Defense Health Agency

PROCEDURES MANUAL

NUMBER 6025.13, Volume 1 August 29, 2019

Medical Affairs

SUBJECT: Clinical Quality Management in the Military Health System, Volume 1: General Clinical Quality 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 (ab), 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 1

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 (ab), 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.

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 (JPSR), 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 1, 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. Responsibilities

3. General Clinical Quality Management Glossary

4 TABLE OF CONTENTS

TABLE OF CONTENTS

ENCLOSURE 1: REFERENCES

ENCLOSURE 2: RESPONSIBILITIES

MILITARY DEPARTMENTS

DIRECTOR, DEFENSE HEALTH AGENCY

ASSISTANT DIRECTOR, HEALTHCARE ADMINISTRATION, DHA/MILITARY

DEPARTMENT DESIGNEE

DEPUTY ASSISTANT DIRECTOR MEDICAL AFFAIRS DEFENSE HEALTH

AGENCY/MILITARY

DEPARTMENT DESIGNEE

DEFENSE HEALTH AGENCY MARKET DIRECTOR/INTERMEDIATE

HEADQUARTERS

MILITARY TREATMENT FACILITY DIRECTOR/MILITARY DEPARTMENT

DESIGNEE

ENCLOSURE 3: GENERAL CLINICAL QUALITY MANAGEMENT

GENERAL OVERVIEW

KEY OPERATIONAL DEFINITIONS

GOVERNANCE

MEDICAL QUALITY ASSURANCE PROGRAM

TRANSPARENCY FOR LEARNING AND IMPROVEMENT

GLOSSARY

PART I: ABBREVIATIONS AND ACRONYMS

PART II: DEFINITIONS

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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 (MQA) and Clinical Quality Management in the Military Health System (MHS),” October 29, 2013

(f) National Defense Authorization Act for Fiscal Year 2017, Section 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) Office of the Under Secretary of Defense, Personnel and Readiness Memorandum, “Strengthening Clinical Quality Management in the Military Health System,” April 1, 2019

(p) United States Code, Title 10

(q) Office of Management and Budget, Statistical Policy Working Paper 22, December 20051

(r) The High Reliability Organization Task Force Report, “A Resource Guide for Achieving High Reliability in the Military Health System,” September 15, 20152

(s) Institute of Medicine (IOM). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, D.C: National Academy Press, 2001

(t) 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

1 This reference can be found at: https //www.hhs.gov/sites/default/files/spwp22.pdf 2 This reference is available internally through a CAC–enabled website at:

https://info.health.mil/coi/mhshro/Documents/Deliverables

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(u) Deputy Secretary of Defense Memorandum, “Implementing Congressional Direction for Reform of the Military Health System,” September 28, 2018

(v) DoD Manual 5400.07, “DoD Freedom of Information Act (FOIA) Program,” January 25, 2017

(w) Code of Federal Regulations, Title 45, Parts 160 and 164

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

(y) DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007

(z) Office of the Deputy Chief Management Officer Administrative Instruction 15, “OSD Records and Information Management Program,” May 3, 2013, as amended

(aa) Public Law 101-629, “Safe Medical Devices Act of 1990,” November 28, 1990

(ab) DoD Instruction 8580.02, “Security of Individually Identifiable Health Information in DoD Health Care Programs,” August 12, 2015

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ENCLOSURE 2

RESPONSIBILITIES

1. MILITARY DEPARTMENTS. The Military Departments will establish, direct implementation of, and ensure compliance with standards and procedures in this DHA-PM.

2. DIRECTOR, DHA. The Director, DHA will:

a. Establish, direct implementation of, and ensure compliance with standards and procedures in this DHA-PM.

b. Ensure that contracts for all MCSCs, designated providers, personal services contractors and non-personal services contractors, overseas contractors, and civilian authorized provider agreements throughout the MHS reflect the applicable guidance set forth in this DHA-PM through contract language.

c. Approve exceptions to policy contained in this manual, consistent with law and applicable DoD policy. Exceptions to policy may be requested by the Military Departments, acting through the Surgeon General or Military Department Secretariat.

(1) During the period of transition to full operational capability of the DHA under Section 1073c of Reference (p), consideration of potential exceptions to policy will take into account practical circumstances of the transition, pursuant to Reference (o).

(2) Although this manual is applicable to the entire MHS, consideration of potential exceptions will take into account practical circumstances of MHS functions and activities that are under the primary responsibility of the Military Departments. However, exceptions to policy shall maintain comparable clinical quality standards.

3. ASSISTANT DIRECTOR, HEALTHCARE ADMINISTRATION, DHA/MILITARY

DEPARTMENT DESIGNEE. The Assistant Director, Healthcare Administration, DHA/Military Department Designee will:

a. Establish, direct implementation of, and ensure compliance with standards and procedures in this DHA-PM.

b. Ensure that contracts for all MCSCs, designated providers, personal services contractors and non-personal services contractors, overseas contractors, and civilian authorized provider agreements throughout the MHS reflect the applicable guidance set forth in this DHA-PM through contract language.

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4. DEPUTY ASSISTANT DIRECTOR MEDICAL AFFAIRS (DAD MA), DHA/MILITARY

DEPARTMENT DESIGNEE. The DAD MA, DHA/Military Department Designee will:

a. Be responsible for the execution of CQM in the MHS.

b. Monitor and evaluate execution of CQM in the MHS. Align CQM reporting with associated DHA and MHS committees.

c. Prepare correspondence of waivers, requests for release of data, data sharing agreements (DSA), and registry participation requests for the Assistant Secretary of Defense for Health Affairs (ASD(HA)) or DHA Director/Military Department Designee, as appropriate.

d. Standardize CQM activities, to include the DHA DAD MA established core competencies of CQM personnel.

e. Develop implementing guidance for data use, data transparency, release of aggregated statistical data, and protection of Medical Quality Assurance Program (MQAP) data.

f. Ensure CQM review or coordination of appropriate DHA clinical issuances.

5. DHA MARKET DIRECTOR/INTERMEDIATE HEADQUARTERS. The DHA Market Director/Intermediate Headquarters will:

a. Be responsible for the execution of CQM in the DHA Market/Intermediate Headquarters organizations, as per DHA guidance.

b. Support Clinical Community clinical quality improvement (CQI) priorities, as per DHA guidance.

c. Support coordination of CQM activities with clinical service delivery operations to implement highly reliable, high value, patient-centered experiences and outcomes.

d. Ensure requests for the release of CQM aggregated statistical data are in accordance with Section 1102 of Reference (p) and Reference (q). Ensure requests are sent to DHA DAD MA (or designee).

6. MTF DIRECTOR/MILITARY DEPARTMENT DESIGNEE. The MTF Director/Military Department Designee will:

a. Be responsible for the execution of CQM in their organization.

b. Ensure the protection of Medical Quality Assurance Records (MQAR). Ensure that release violations of MQAP data are reported, as well as violations of the Health Insurance Portability and Accountability Act (HIPAA).

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c. Ensure requests for the release of CQM aggregated statistical data are in accordance with Section 1102 of Reference (p) and Reference (q). Ensure requests are sent through the respective DHA Market/Intermediate Headquarters CQM personnel prior to sending requests to DHA DAD MA (or designee).

d. Communicate concerns or barriers to compliance with policy or regulatory standards to DHA DAD MA through appropriate higher headquarters.

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ENCLOSURE 3

GENERAL CLINICAL QUALITY MANAGEMENT

1. GENERAL OVERVIEW. This overview and each of the subsequent volumes outline the CQM activities that occur to assure and improve the quality and safety of healthcare services delivered. Through competent and committed staff, a robust foundation for the provision of high-quality care and the highest levels of MHS leadership advocacy, the MHS strives to promote health, prevent harm, and provide high-quality, evidence-based care with each encounter.

a. Purpose. The purpose of CQM in the MHS is 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. The framework is guided by CQM strategy elements and supported by CQM functions and programs. Through CQM, the MHS affirms its unwavering commitment to quality healthcare for beneficiaries, joint healthcare teams, and Combatant Commands across the globe.

b. Functions. Subsequent volumes of this DHA-PM outline programs and specific procedures through which the MHS defines, measures, assures, and improves the quality of care received by the beneficiaries. These volumes provide accountability, transparency, and standardization throughout the MHS. The CQM programs include:

(1) Patient Safety (PS). MHS program to promote safety and prevent harm.

(2) Healthcare Risk Management (HRM). MHS program to mitigate risk in the clinical aspects of healthcare delivery.

(3) Credentialing and Privileging (CP). MHS program to ensure qualified and competent staff.

(4) Accreditation and Compliance (AC). MHS program to ensure compliance with standards.

(5) Clinical Measurement (CM). MHS program to objectively define, measure, assess, and report the quality of care delivered.

(6) Clinical Quality Improvement (CQI). MHS program to improve the quality of care and services delivered.

c. CQM Strategy Elements. The elements are foundational aims and principles that guide CQM in the MHS. They include:

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(1) MHS Quadruple Aim. The MHS Quadruple Aim, the MHS’s goal, represents leadership’s commitment to delivering value to all they serve. The Quadruple Aim is aligned with the MHS strategic goals. Elements of the Quadruple Aim include:

(a) Increased Readiness. Ensuring the entire military force is medically ready to deploy and the medical force is ready to deliver healthcare anytime, anywhere, in support of the full range of military operations.

(b) Better Care. Providing a care experience that is patient and family centered, compassionate, convenient, equitable, safe, and always of the highest quality.

(c) Better Health. Improving the health of a population by encouraging healthy behaviors and reducing the likelihood of illness through focused prevention and increased resilience.

(d) Lower Cost. Creating value by focusing on quality, eliminating waste, and reducing unwarranted variation. Considering the total cost of care over time, not just the cost of an individual healthcare activity.

(2) MHS High Reliability Organization (HRO) Principles. Through application of HRO principles, MHS staff affirm and express a single-minded focus on identifying potential problems and high-risk situations before they lead to a PS event that reaches the patient. The MHS aims for harm prevention and process improvement to become second nature for everyone.

HRO principles provide a common knowledge base for healthcare personnel and provide information on how all staff and leadership can demonstrate behaviors necessary for HRO maturity. Taken individually, each principle may improve elements of the healthcare delivery system; however, collectively, they form the foundation for an HRO and are critical enablers for the MHS to achieve its strategic goals of the Quadruple Aim. MHS HRO principles include (Reference (r)):

(a) First, Do No Harm (changed to “Preoccupation with Failure” per the Medical Operations Group approval March 13, 2017)

1. By eliminating harm and maximizing benefits, leaders and staff enable better care and better health, improve the efficiency of the MHS, and improve readiness to execute missions.

2. Evidenced by commitment from all members of the healthcare team at every level to first consider the risks and potential benefits of any clinical decision or action.

(b) Sensitivity to Operations

1. High-performing healthcare organizations have leaders and staff who are constantly aware of the state of systems and processes that affect patient care.

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2. Evidenced by the use of standards and standard work to mitigate errors, reduce undesired variability, and identify opportunities for improvement.

3. Leaders support the use of regular staff huddles to share information and engage in walk rounds to learn more about how they can help frontline staff improve care and eliminate harm.

(c) Deference to Expertise

1. When confronted by a new threat, HROs have mechanisms in place to identify the individuals with the greatest expertise relevant to managing the new situation and to place decision-making authority in the hands of that person or group.

2. Evidenced by seeking out, listening to, and valuing the input of those with the most knowledge and expertise on an issue, rather than relying on top-down direction to solve problems.

(d) Reluctance to Simplify

1. Staff are reluctant to simplify, avoiding simple or easy explanations for mishaps.

2. Evidenced by seeking to understand how complex, interdependent policies and processes can better support safe healthcare delivery.

3. Leaders and staff recognize that healthcare delivery is highly complex with inherent patient risks that must be explored, mitigated, and overcome.

(e) Commitment to Resilience

1. Leaders and staff recognize that, despite safeguards and a shared commitment at every level of eliminating harm, systems can still fail in unexpected ways.

2. Evidenced by ensuring all staff are trained, supported, and prepared to learn from failures to minimize the risk of recurrence.

3. Leaders incorporate appropriate redundancies or safeguards to mitigate the effects of system failures before they lead to harm.

4. Commitment to resilience enables staff to continue to deliver high-quality care even after a major mishap.

(f) Constancy of Purpose

1. Leaders evidence constancy of purpose by agreeing on a clear commitment to eliminating harm and setting organizational goals based on a shared vision of safety.

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2. Staff evidence constancy of purpose by aligning actions with the organization’s highest priority to eliminate harm.

3. Over time, with a focus on constancy of purpose to eliminate harm, there is a collective mindfulness, which fosters a culture of safety.

(g) Respect for People

1. Healthcare organizations that deliver the safest and most effective care also uniformly endorse the principle of respect for people as the foundation for improving healthcare delivery.

2. Evidenced by striving to create a just culture in which staff and patients are trusted, valued, and relied on to initiate improvement and innovations at the frontlines.

3. Every member of the healthcare team demonstrates respect for the patients and the families they serve, as well as their professional colleagues.

(h) Fostering a Culture of Safety

1. Staff in high-performing organizations rely on leadership commitment to create a culture focused on safe care, continuous learning, innovation, and improvement.

2. Evidenced by staff with openness to change, seeking knowledge and making application of process improvement tools.

3. Evidenced by proactive vigilance for any deviations from leading practices and speaking up at any opportunity to improve the safety of the care they provide or the environment in which they work.

4. Evidenced by staff members who view themselves as leaders committed to:

influencing others to strive for zero harm in the MHS; learning from feedback; engaging in effective teamwork; and anticipating the unexpected (Reference (r)).

(3) MHS Aims for Healthcare Quality. The MHS strives to adopt the six aims of healthcare put forth by the Institute of Medicine (IOM) (now known as the National Academy of Medicine). According to the IOM, quality healthcare should be safe, timely, effective, efficient, equitable, and patient-centered (STEEEP) (Reference (s)).

(a) Safe. Avoiding harm to patients from the care intended to help them. In addition to the DoD Patient Safety Program (PSP), staff safety is also an MHS priority for safe patient care.

(b) Timely. Reducing wait times and sometimes harmful delays for both those who receive and give care.

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(c) Effective. Providing services based on scientific knowledge, to all who could benefit and refraining from providing services to those not likely to benefit (e.g., avoiding underuse and misuse, respectively).

(d) Efficient. Avoiding waste of equipment, supplies, ideas, and energy.

(e) Equitable. Providing care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, socioeconomic status, or any other demographic detail.

(f) Patient-centered and provider-centered. Providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring patient values guide all clinical decisions.

d. Healthcare Resolutions and a Patient’s Right to Be Heard. In addition to many patient-centered advocacies and activities throughout the MHS, the Healthcare Resolutions Program uniquely focuses on disclosures for PS events that reach the patient, complex clinical issues requiring assistance with resolution, and peer support for involved providers. Healthcare Resolutions Specialists are neutral and must serve the needs of patients, providers and the involved organization. Healthcare Resolutions is separate and distinct from Legal, CQM (to include PS and HRM), and patient experience programs, such as Patient Advocacy or Patient Relations. Furthermore, any patient, including any uniformed Service member, who believes they have suffered personal harm due to a perceived failure to provide quality medical care, has the right to submit their concerns in writing as part of an MQAP review of the care provided.

The requirement that a patient’s concerns be written will ensure inclusion of the patient’s input throughout the MQAP review procedures; this includes, but is not limited to, those described in Volume 2 and Volume 3 of this manual. This written requirement does not include the complaint and grievance procedures handled by Healthcare Resolutions and Patient Experience staff (e.g., Patient Advocacy or Patient Relations). For further guidance on Healthcare Resolutions and a Patient’s Right to Be Heard, please see Reference (t).

2. KEY OPERATIONAL DEFINITIONS. The quality of healthcare in the MHS is defined as the degree to which healthcare services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. Knowledge of this term is essential to understanding the scope, core responsibilities, and procedures of CQM.

A full list of definitions for this manual is included in the Glossary.

3. GOVERNANCE. The DHA Director/Service Surgeon General (SG) supports the ASD(HA) by executing effective CQM in the MHS in accordance with References (d) and (u), and aligns CQM reporting with associated MHS committees for ASD(HA) oversight.

4. MEDICAL QUALITY ASSURANCE PROGRAM (MQAP). The term “Medical Quality Assurance Program (MQAP)” (per the law) means any peer review carried out before, on, or

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after November 14, 1986 by or for the DoD to assess the quality of medical care, including activities conducted by individuals, military medical or dental treatment facility committees, or other review bodies responsible for quality assurance, credentials, infection control, patient care assessment (including treatment procedures, blood, drugs, and therapeutics), medical records, health resources management review, and identification and prevention of medical or dental incidents and risks. The term “Medical Quality Assurance Record (MQAR)” means the proceedings, records, minutes, and reports that emanate from quality assurance program activities described under MQAP and are produced or compiled by the DoD as part of an MQAP. The term “peer review” means any assessment of the quality of medical care carried out by a healthcare provider, including any such assessment of professional performance, any PS program Comprehensive Systematic Analysis (CSA) or report, or any assessment carried out by a healthcare provider under the provisions of this manual. Each of the six CQM programs may potentially create an MQAR from peer review and care must be taken to protect such records, in accordance with Section 1102 of Reference (p).

a. Confidentiality of Records

(1) MQARs created by or for the DoD as part of an MQAP are confidential and privileged. MQARs may not be disclosed to any person or entity, except as provided in Section 1102 of Reference (p).

(2) In accordance with Section 1102 of Reference (p), these records are exempt from the disclosure requirements in Reference (v).

(3) Except for the subject of an MQAP action, the identity of any person receiving healthcare services from the DoD or the identity of any other person associated with the DoD for purposes of an MQAP that is disclosed in an MQAR must be redacted in accordance with Section 164.514(a) and (b) of Reference (w) before any disclosure is made outside of the DoD.

(4) Information in an MQAR may also contain protected health information (PHI) relating to a patient. The use of this PHI is authorized in accordance with References (w) and (x). PHI contained in an MQAR may also be released, pursuant to Section 4.4.d. of Reference (x), to other government agencies and outside entities that have been designated as part of the DoD MQAP. To be so designated, Reference (x) requires:

(a) A written business associate agreement (BAA) between the DoD Component and the other entity.

(b) A DSA restricting further dissemination of the information.

(5) Release of personally identifiable information (PII) and PHI to entities engaged in MQAP activities, but that have not been incorporated into part of an MQAR, is not authorized.

Nothing in this enclosure limits access to information:

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(a) In a record created and maintained outside an MQAP, including a patient’s medical records, because the information was presented during meetings of a review body and that review body is part of an MQAP.

(b) That is part of an organization’s policies or procedures because the information was considered in an MQAR.

(c) That is not part of a peer review under an MQAP.

(6) If an actual or possible compromise of PII or PHI occurs, as defined in References

(x) and (y), the event must be treated as a breach and required breach response activities must be initiated. Such requirements have been established by References (x) and (y). Among other requirements, a cyber-related breach must be reported to www.us-cert.gov within one hour of a discovery of a potential compromise and must be reported to the DHA Privacy Office within 24 hours via email at DHA.PrivacyOfficer@mail.mil, or Service Privacy Office, where appropriate (within the same timeframe).

b. Prohibition on Disclosure and Testimony

(1) No part of an MQAR may be subject to discovery or admitted into evidence in any judicial or administrative proceeding, except as provided in Section 1102 of Reference (p).

(2) A person who reviews or creates an MQAR by or for the DoD as part of an MQAP or who participates in any proceeding that reviews or creates such records may not be permitted or required to testify in any judicial or administrative proceeding with respect to such records or with respect to any finding, recommendation, evaluation, opinion, or action taken by such person or body in connection with such record, except as provided in Section 1102 of Reference (p).

(3) A person or entity having possession of or access to an MQAR or testimony may not disclose the contents of such record or testimony in any manner or for any purpose, except in accordance with Section 1102 of Reference (p).

(4) An unauthorized willful disclosure must be reported as a breach to the DHA Privacy and Civil Liberties Office as per Paragraph 4.a.(6) of this enclosure. Any person who willfully discloses an MQAR, except in accordance with Section 1102 of Reference (p), knowing that such record is an MQAR, will be subject to adverse personnel action (to include, in appropriate cases, dismissal or separation). He or she shall be fined not more than $3,000 in the case of a first offense and not more than $20,000 in the case of a subsequent offense.

(5) As provided in Paragraph (g) of Section 1102 of Reference (p), a person who participates in or provides information to a person or body that reviews or creates an MQAR shall not be civilly liable for such participation or for providing such information if the participation or provision of information was in good faith, based on prevailing professional standards at the time the MQAP activity took place.

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(6) MQARs are protected from disclosure, except as described in this enclosure. For additional guidance regarding the disclosure of an MQAR, local, DHA Market, DHA Headquarters, or other appropriate servicing healthcare legal counsel should be consulted.

Regarding the disposition of an MQAR, refer to Reference (z), which includes procedures for the management and disposition of OSD records.

(7) Subject to Paragraph (c) of Section 1102 of Reference (p), an MQAR or testimony may be disclosed for the following authorized purposes:

(a) To a federal executive agency or private organization, if the MQAR or testimony is needed by the agency or organization to perform licensing or accreditation functions related to DoD healthcare facilities or to perform monitoring, required by law, of DoD healthcare facilities.

An example of an authorized disclosure is the mandatory requirement, in accordance with Reference (aa), to report to the Food and Drug Administration (FDA) the details of fatal or serious adverse events relating to the use of a medical device.

(b) To an administrative or judicial proceeding commenced by a present or former DoD healthcare provider concerning the termination, suspension, or limitation of clinical privileges of the healthcare provider.

(c) To a governmental board or agency or a professional healthcare society or organization, if an MQAR or testimony is needed by such board, agency, society, or organization to perform licensing, credentialing, or the monitoring of professional standards with respect to any healthcare provider who is or was a member or an employee of the DoD. This includes reports to the National Practitioner Data Bank (NPDB), in accordance with this manual.

(d) To a hospital, medical center, or other institution that provides healthcare services, if an MQAR or testimony is needed by the institution to assess the professional qualifications of any healthcare provider who is or was a member or employee of the DoD and who has applied for or been granted authority or employment to provide healthcare services in or on behalf of the institution.

(e) To an officer, employee, or contractor of the DoD who has need for a record or testimony to perform official duties. Such official duties are not limited to MQAP activities and should protected health information as defined in References (w) and (x) be included, information may not be disclosed to any party without an authorization or exception.

(f) To a criminal or civil law enforcement agency or instrumentality charged under applicable law with the protection of the public health or safety, if a qualified representative of the agency or instrumentality makes a written request that the record or testimony be provided for a purpose authorized by law.

(g) To an administrative or judicial proceeding commenced by a criminal or civil law enforcement agency or instrumentality referred to in this enclosure, but only with respect to the subject of the proceeding.

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(8) This enclosure must not be construed as an authority to withhold any MQARs from a committee of Congress or any joint committee of Congress or the Comptroller General, if the record pertains to any matter within their respective jurisdictions.

5. TRANSPARENCY FOR LEARNING AND IMPROVEMENT. The MHS aims to promote transparency where disclosure of data does not conflict or is not protected by law or other guidance. Transparency promotes internal visibility of performance across the MHS by identifying leading practices over a sustained period of time; by providing important information about MHS PS, clinical quality outcomes, access, and patient experience that can help patients with their own healthcare decisions while improving the health literacy of the patient population;

and by clearly establishing the MHS as accountable to its mission and the people it serves.

a. Transparency is a core characteristic of HROs and sets the course for a culture that embraces open and honest communication.

b. The MHS adopted the National Patient Safety Foundation’s four domains of transparency in its Transparency Framework:

(1) Transparency between Clinicians and Patients;

(2) Transparency between Clinicians Themselves;

(3) Transparency between Healthcare Organizations; and

(4) Transparency between Clinicians and Healthcare Organizations with the Public.

c. Transparency with the Public

(1) This enclosure must not be misconstrued as authorizing or requiring the withholding from any person or entity aggregate statistical information regarding the results of the MQAP.

(2) The MHS will promote transparency where disclosure of data does not conflict or is not protected by law or other guidance. To ensure MHS CQM data transparency while protecting the patients and providers, all MHS personnel must take adequate precautions to protect the identity and privacy of the individual patients and providers involved.

(3) The MHS is committed to providing patient-centered and quality healthcare by providing CQM and MQAP aggregated statistical data in order to improve the services provided to all beneficiaries.

(4) The MHS will maintain readily available, transparent, and relevant CQM data, including MQAP aggregated statistical data, to provide its beneficiaries, enrollees, and providers in an understandable manner.

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(5) MHS CQM and MQAP aggregated statistical data may be released publicly outside of the DoD, consistent with the requirements for release of aggregated statistical information.

This includes response to written requests, however received, or as directed by the ASD(HA).

(a) Written requests for CQM or MQAP aggregated statistical data must be processed by the respective DHA Headquarters/Service SG CQM personnel as the primary point of contact, in close coordination with their respective legal counsel. CQM personnel support CQM and MQAP data collection, analysis, report writing, publication, and distribution. Local Privileging Authorities do not have public release authority of CQM or MQAP aggregated statistical data without prior authorization from the DHA Director or ASD(HA).

(b) Freedom of Information Act (FOIA) requests are directed to the DHA Headquarters Privacy and Civil Liberties Office or Service Privacy Office, where appropriate.

(c) Requests received by MCSC staff shall be directed in accordance with the TRICARE MCSC and reported to the MCSC Privacy Office. The MCSC’s Privacy Office staff will direct the request to the DHA Headquarters Privacy and Civil Liberties Office or Service Privacy Office, where appropriate.

(6) Requirements and Standards for Release of Aggregated Statistical Data, and for Ensuring Record Privacy

(a) In accordance with Section 1102 of Reference (p) and Reference (q), CQM and MQAP aggregated statistical data may only be released outside of the DoD if adequate precautions, including but not limited to the de-identification requirements of Reference (w) and (x), are taken to protect the identity and privacy of the individual patients and providers involved. The measures must minimize the risk that a third party could use the information, along or in combination with other reasonably available information, to identify an individual who is the subject of the information released.

(b) Although CQM and MQAP data and information from individual medical records may not be released, the data may be released publicly when stated as part of aggregated statistical data, in accordance with the requirements and standards set forth in Section 1102 of Reference (p), and this manual. Statistical measures used to ensure the sufficient aggregation of data for purposes of release must be approved by the DHA Director, or ASD(HA) in the case of Service SG authority (unless delegated to the DHA Director).

(c) Requirements for release of CQM and MQAP data, including standards for the sufficient aggregation of data, have been developed to ensure the privacy of the individual’s health and treatment records, as well as to prevent the inadvertent release of information that would allow identification of the individuals involved when the released information is combined with other publicly available data. DoD has adopted a threshold rule (Reference (q)), which helps ensure data are appropriately aggregated to protect health information prior to release. Compliance with aggregation standards alone may not be sufficient to comply with the fundamental requirement that CQM and MQAP aggregated statistical data derived from medical records may only be released outside of the DoD if adequate precautions are taken to protect the

20 ENCLOSURE 3

identity and privacy of the individual patients and providers involved per the requirements of References (w) and (x). In all cases, measures must minimize the risk that a third party could use the information alone, or in combination with, other reasonably available information, to identify an individual who is the subject of the information released.

(d) These requirements recognize that there may be instances when a third party possesses insider information or knowledge about a patient or individual provider based on a personal relationship (e.g., family member, neighbor, close friend) with that patient or individual provider and that these persons may be able to add their insider knowledge to the information released by the DoD to the public, thereby identifying that individual as a member of the demographic grouping. However, absent this insider information, the requirements outlined in this section provide protections against others being able to positively identify a member of a demographic grouping.

(e) The ASD(HA) shall establish guidance regarding other releases of individual organizational (e.g., MTF, other) CQM data. Generally, CQM aggregated statistical data may be released outside of the DoD when adequate precautions have been taken to protect the identity and privacy of the individual patients and providers involved.

(f) The MHS shall utilize a threshold rule of four, as described in Chapter II, Section D.2.b. of Reference (q), pertaining to the release of aggregated statistical data, to protect the identity and privacy of the individual patients and providers involved. With the threshold rule, a cell in a table of frequencies is defined as sensitive if the number of respondents, or non-zero observations or events, is less than four. The choice of the minimum number was made in accordance with Reference (q) in consideration of: (1) the sensitivity of the information that the MHS is considering publishing and (2) the amount of protection the MHS determines to be necessary given the degree of precision required to achieve disclosure. The threshold rule of four provides the standard "minimum" level of protection against statistical disclosure by essentially masking numbers below the threshold. By withholding data with numerical values below "4" (essentially, withholding 1's, 2's and 3’s), the DHA introduces a level of ambiguity so that reviewers of this data cannot single out specific individuals.

1. In some instances, information may be of a nature that when combined with other relevant publicly-available data may lead to the reasonable identification of the individual.

On a case-by-case basis in consultation with legal counsel, information may be withheld from release even though the data complies with the threshold rule, where a determination has been made that the identity and privacy of the individual patients and providers involved is subject to identification.

2. Limiting disclosure to a threshold rule of four is not mandatory in every instance where the information presented is sufficiently broad and lacks meaningful identifying demographic groupings. On a case-by-case basis in consultation with legal counsel, sufficiently broad information may be released, where a determination has been made that the identity and privacy of the individual patients and providers involved is not likely subject to identification.

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Such a determination must include consideration of compliance with the HIPAA Privacy Rule, to include situations where the data includes geographic subdivisions smaller than a state (e.g., MTF-specific data).

d. DSAs

(1) A DSA is required for release of patient-related information. In addition to maintaining the confidentiality of PII of MHS providers and other DoD personnel involved in an MQAP, the DoD is also required to establish safeguards to protect the privacy of beneficiaries’ PHI, in accordance with References (x), (y), and (ab). Among the required safeguards are DSAs.

DSAs must be executed by outside parties who request access to DoD beneficiary data. DSAs obligate outside parties to maintain the confidentiality of patient-related data they receive. This is not intended to require a DSA when releasing patient-related information to Congressional committees or to individuals involved in accreditation, state licensing boards, and the like.

(2) Prior to requesting access to MHS CQM or DoD beneficiary data, the requestor should obtain an approved DSA. To do so, the requestor should submit a DSA application (DSAA) to the DHA Headquarters Privacy and Civil Liberties Office. The DHA Headquarters Privacy and Civil Liberties Office will review the DSAA for compliance to determine whether the intended data use complies with all applicable requirements. If the DSAA is approved, the DHA Headquarters Privacy and Civil Liberties Office will provide a DSA for execution. Once the DSA is executed, the requestor may apply for data access to the DHA Program Office.

22 GLOSSARY

GLOSSARY

PART I. ABBREVIATIONS AND ACRONYMS

Unless otherwise noted, these abbreviations and acronyms are for the purpose of this DHA-PM

AABB AABB (formerly known as American Association of Blood Banks) AAMFT American Association of Marriage and Family Therapy AAO American Academy of Optometry ABA American Board of Audiology ABCMO American Board of Certification in Medical Optometry ABMS American Board of Medical Specialties ABO American Board of Optometry AC accreditation and compliance ACS American College of Surgeons ACGME Accreditation Council for Graduate Medical Education ACLS Advanced Cardiac Life Support ACPE Accreditation Council for Pharmacy Education AD CS Assistant Director for Combat Support ADA American Dental Association ADA American with Disabilities Act ADN Associate’s Degree in Nursing AHRQ Agency for Healthcare Research and Quality ALS Advanced Life Support AMA American Medical Association ANCC American Nurses Credentialing Center AO accrediting organization AOA American Osteopathic Association APA American Psychological Association APMA American Podiatric Medical Association APN advance practice nurse APTA American Physical Therapy Association ASD(HA) Assistant Secretary of Defense for Health Affairs ASHA American Speech-Language-Hearing Association Au.D. Doctor of Audiology

BAA business associate agreement BLS Basic Life Support BSN Bachelor of Science in Nursing

CAC Common Access Card CADE Commission on Accreditation for Dietetics Education CAI Corrective Action Implementation CAP College of American Pathologists CCE Council on Chiropractic Education CDR Commission on Dietetic Registration

23 GLOSSARY

CE continuing education CFR Code of Federal Regulations CGFNS Commission on Graduates of Foreign Nursing Schools CHBC Criminal History Background Check CIS Criminal Investigative Service CLIP Clinical Laboratory Improvement Program CM clinical measurement CMO Chief Medical Officer CMS Centers for Medicare & Medicaid Services CNM certified nurse midwife CNS certified nurse specialist COAMFTE Commission on Accreditation for Marriage and Family Therapy Education COMLEX Comprehensive Osteopathic Medical Licensing Examination COR Contracting Officer’s Representative CP credentialing and privileging CPME Council on Podiatric Medical Education CQI clinical quality improvement CQIS Clinical Quality Improvement Studies CQM clinical quality management CRNA certified registered nurse anesthetist CSA Comprehensive Systematic Analysis CUSP Comprehensive Unit-based Safety Program CVO Centralized Credentials Verification Office

DAD MA Deputy Assistant Director for Medical Affairs DEA Drug Enforcement Agency DES Disability Evaluation System DHA Defense Health Agency DHA-PI Defense Health Agency-Procedural Instruction DHA-PM Defense Health Agency-Procedures Manual DHHS Department of Health and Human Services DMAT Disaster Medical Assistance Team D.O. Doctor of Osteopathic Medicine DoD RE DoD Reportable Event DSA data sharing agreement DSAA data sharing agreement application DLA Defense Logistics Agency

EDIS Educational and Developmental Intervention Services EHR electronic health record ECFMG Educational Commission for Foreign Medical Graduates EIDS Enterprise Intelligence and Data Solutions eMSM Enhanced Multi-Service Market ER emergency room ERM enterprise risk management

24 GLOSSARY

FAAO Fellowship in the American Academy of Optometry FDA Food and Drug Administration FHPQA Force Health Protection Quality Assurance FMEA Failure Mode Effect Analysis FNLH Foreign National Local Hire FNP family nurse practitioner FOIA Freedom of Information Act FPGEC Foreign Pharmacy Graduation Examination Committee FPPE focused professional practice evaluation

GME Graduate Medical Education GS General Schedule GTT Global Trigger Tool

HAI healthcare-associated infection HAR Hazards, Alerts, and Recalls HAR-NESS Hazards, Alerts, and Recalls Notice System HEDIS® Healthcare Effectiveness Data and Information Set HIPDB Health Integrity Protection Data Bank HIPAA Health Insurance Portability and Accountability Act of 1996 HIT health information technology HPSP Health Professions Scholarship Program HRM healthcare risk management HRO high reliability organization HROM High Reliability Operating Model

ICTB Inter-facility Credentials Transfer Brief IDES Integrated Disability Evaluation System IHPP Impaired Healthcare Provider Program IMA Individual Mobilization Augmentee IO Investigating Office IOM Institute of Medicine IPC infection prevention and control IPCWG Infection Prevention and Control Working Group

JCCQAS Joint Centralized Credentials Quality Assurance System JOES Joint Outpatient Experience Survey JPSR Joint Patient Safety Reporting

LEIE List of Excluded Individuals and Entities LIP licensed independent practitioner LPN licensed practical nurse LVN licensed vocational nurse

MC Medical Corps MCSC Managed Care Support Contractor

25 GLOSSARY

M.D. Doctor of Medicine MEB medical evaluation board MEDLOG Medical Logistics Division MHS Military Health System MHSPHP Military Health System Population Health Portal MOU memorandum of understanding MPL Master Privilege List MQA medical quality assurance MQAP medical…