HT0011-20-R-0043 HFAS PWS Attachment 2h - DHA PM 6025.13 CQM in the MHS, Vol 7, CQI.pdf

Defense Health Agency

PROCEDURES MANUAL

NUMBER 6025.13, Volume 7 August 29, 2019

Medical Affairs

SUBJECT: Clinical Quality Management in the Military Health System, Volume 7: Clinical Quality Improvement

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 (u), 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 7

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 (u), 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 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. Clinical Quality Improvement Glossary

4 TABLE OF CONTENTS

TABLE OF CONTENTS

ENCLOSURE 1: REFERENCES

ENCLOSURE 2: CLINICAL QUALITY IMPROVEMENT

GENERAL OVERVIEW

KEY OPERATIONAL DEFINITIONS

GOVERNANCE

SCOPE AND CORE RESPONSIBILITIES

PROCEDURES

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,” 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, 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) DoD Instruction 6200.05, “Force Health Protection Quality Assurance (FHPQA) Program,” June 16, 2016, as amended

(p) DHA-Procedural Instruction 6200.05, “Force Health Protection Quality Assurance (FHPQA) Program,” May 2, 2018

(q) Quality Improvement, U.S. Department of Health and Human Services Health Resources and Services Administration, April 20111

(r) Centers for Medicare & Medicaid Services (CMS) Quality Initiatives, CMS’ Center for Clinical Standards & Quality, April 19, 20182

1 This reference can be found at:

https://www.hrsa.gov/sites/default/files/quality/toolbox/508pdfs/qualityimprovement.pdf 2 This reference can be found at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment- Instruments/QualityInitiativesGenInfo/index.html

6 ENCLOSURE 1

(s) U.S. Department of Veterans Affairs (VA) Quality of Care, VA Health Care, March 29, 20163

(t) QI Essentials Toolkit: Failure Modes and Effects Analysis (FMEA) Tool, Institute for Healthcare Improvement, 20174

(u) United States Code, Title 10 Section 1102

3 This reference can be found at: https://www.va.gov/QUALITYOFCARE/index.asp 4 This reference can be found at:

http://www.ihi.org/resources/Pages/Tools/FailureModesandEffectsAnalysisTool.aspx

7 ENCLOSURE 2

ENCLOSURE 2

CLINICAL QUALITY IMPROVEMENT

1. GENERAL OVERVIEW. The MHS Clinical Quality Improvement (CQI) Program focuses on improving the quality of care and services delivered regardless of the environment (direct care, purchased care, and operational environments). A key component of CQI is a dedicated clinical quality performance measurement system to evaluate quality-of-care outcomes, compare outcomes with national or evidence-based standards, and prioritize and act on opportunities for improvement. For DoD readiness mission healthcare issues, the Force Health Protection Quality Assurance Program provides another aspect of clinical quality performance measurement and is conducted in accordance with References (o) and (p). CQI is operationalized through the MHS High Reliability Operating Model (HROM). The MHS HROM enables frontline staff to drive MHS-wide performance improvements for an integrated system of readiness and health;

empower MHS-level Clinical Communities to create conditions for high reliability at the point of care (processes, standards, and metrics); and hold the MHS accountable to MHS standards and optimal clinical outcomes. The Clinical Communities are a formalized mechanism to defer to expertise for: improving patient outcomes, eliminating preventable harm and waste, improving performance and innovation, maximizing value, developing MHS process standards, reducing unnecessary variability, and embedding learning and safety culture across all care sites.

a. Purpose. Provide guidelines for the CQI activities of the MTFs. Prescribe the procedures for CQI management and reporting.

b. Functions. This enclosure outlines procedures related to CQI tools, methodologies, leading practice submission, external entity data sharing, external entity collaboration, Clinical Communities, data repository management, and collection and dissemination of leading practices.

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

a. clinical quality improvement (CQI). CQI consists of systematic and continuous actions that lead to measurable improvement in healthcare services and the health status of targeted patient groups. Focuses on the application of several widely accepted process improvement methodologies to improve clinical performance and desired outcomes (Reference (q)).

b. 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.

c. lean. A process of continuous cycle improvement to maximize value by improving efficiencies and decreasing waste.

8 ENCLOSURE 2

d. performance improvement. Continuous study and improvement of processes with the intent to achieve better services or outcomes, and prevent or decrease the likelihood of problems, by identifying areas of opportunity and testing new approaches to fix underlying causes of persistent/systemic problems or barriers to improvement.

e. plan-do-check-act/plan-do-study-act (PDCA/PDSA). A management method for the control and continuous improvement of processes and products. This four-step model includes assessing the current process; enacting the plan; evaluating and comparing data to expected outcomes; and developing corrective actions based on outcomes.

f. proactive risk assessment (PRA). Process used to identify, rate, and prioritize risks and/or hazards. Based on a risk assessment, policies, procedures and controls may be put into place to manage the risk as appropriate to the organization, with the intent of reducing risk to the lowest possible level. A form of PRA is Failure Mode Effect Analysis (FMEA): a systematic, proactive method for evaluating a process to identify where and how it might fail, to assess the relative impact of different failures, and to identify the parts of the process that are most in need of change.

g. rapid process improvement or just do it. A fast and effective approach to improve a process that usually takes a week or less to complete by the members of the process or value stream.

h. Six Sigma. The focus is a data-driven approach and methodology for eliminating defects and reducing variability. The goal is to achieve measurable and quantifiable returns by developing processes to achieve stable and predictable results and identifying procedures that can be defined, measured, analyzed, improved upon, and controlled. A commitment from the entire organization, especially high-level management, is essential to achieve sustainment in quality management.

3. GOVERNANCE STRUCTURE. The DHA CQI Program is managed out of the CQM Branch, in the Clinical Support Division, under the DHA, Deputy Assistant Director for Medical Affairs (DAD MA). CQI Program activities align with the MHS Quadruple Aim and strategic guidance from DHA leadership.

4. SCOPE AND CORE RESPONSIBILITIES

a. Scope

(1) Provide guidelines for CQI initiatives across the MHS.

(2) Prescribe procedures for the management and reporting of CQI activities.

b. Core Responsibilities

9 ENCLOSURE 2

(1) DHA Headquarters/Military Department Designee

(a) Monitor CQI activities of respective units/MTFs.

(b) Ensure CQI projects are captured in the DHA-approved project repository.

(c) Support MHS Clinical Communities in identification of leading practices.

(d) Establish processes to share CQI leading practices across the MHS.

(e) Ensure support for CQM education and training activities appropriate for targeted MHS personnel audiences, and support advancing the development of CQM professionals.

(2) DHA Markets/Intermediate Headquarters

(a) Monitor MTF CQI Programs and support analysis to identify patterns, trends, and opportunities for improvement locally and system-wide.

(b) Forward leading practices and/or identified opportunities for system-wide CQI to MHS Clinical Communities or DHA CQI Program as appropriate. (Clinical Communities focus on prioritized patient-centered conditions. Outside of those prioritized conditions and care pathway development, DHA CQI Program can help coordinate strategically aligned leading clinical practices and/or identified CQI opportunities for system-wide improvement.)

(c) Upload MTF CQI project products to the DHA-approved project repository (https://carepoint.health.mil/sites/SPIDR/SitePages/Home.aspx).

(3) Clinical Communities

(a) Provide clinical leadership and guidance on respective Clinical Community activities.

(b) Evaluate key clinical processes and care pathways (when developed) for patient-centered CQI priorities, leading practices, and evidence-based care standardization.

(c) Provide input for clinical quality strategy development, and organizational performance improvement (e.g., through the Quadruple Aim Performance Plan), as per high reliability organization (HRO) guiding principles.

(d) Support knowledge sharing and care pathway implementation, garnering feedback from identified stakeholders (especially patients), for iterative scale and spread of CQI initiatives across the MHS.

(e) Other responsibilities as identified/endorsed by the DAD MA

(4) MTF/Military Department Clinical Activities

10 ENCLOSURE 2

(a) Ensure MTF/Military Department healthcare staff are educated and trained, as directed by higher headquarters, on their role in support of CQI and application of HRO guiding principles.

(b) Identify CQI projects, in annual performance plans, and ensure alignment to DHA strategic guidance and forward to appropriate DHA Market/Intermediate Headquarters.

(c) Employ improvement science methodologies in CQI Program activities.

(d) Support MHS Clinical Community care pathway development and implementation as directed by higher headquarters. Support other CQI initiatives as appropriate.

(e) Provide feedback on clinical issues/concerns, and identify leading practices for potential MHS-wide spread through DHA Markets/Intermediate Headquarters and/or Clinical Communities.

5. PROCEDURES

a. CQI. Evidence-based clinical practices, national healthcare standards, advancements in PS, and patient-reported outcomes all provide input for CQI initiatives. The MHS is committed to continuous improvement of the care it delivers.

b. Guidelines for CQI

(1) A critical component of CQI is a dedicated system to confirm quality-of-care outcomes; compare outcomes with national or evidence-based standards; prioritize opportunities for improvement; and scientifically design, implement, and sustain improvements.

(2) The CQI Program activities focus on demonstrable improvement in the quality of healthcare provided, and the health status of populations served.

(a) The CQI program establishes a planned, systematic approach to enable frontline staff to drive system-wide performance improvement in readiness and health. Coordination with federal partners provides opportunities for the MHS to participate in national efforts to improve care while leveraging their expertise for data-driven CQI in the MHS (Reference (r) and (s)).

(b) The use of the scientific method to build robust performance capabilities across the DHA enhances the development of sustained change.

(c) Clinical Community involvement in CQI is essential.

1. The Clinical Community construct is designed to define, prioritize, and implement initiatives to enable frontline staff to drive MHS-wide performance improvement for an integrated system of readiness and health.

11 ENCLOSURE 2

2. CQI will be guided by organizational and Clinical Community priorities.

3. Performance on clinical measurements compared to benchmarking and evidence-based practice standards will be used to identify priorities for improvement.

(d) CQI factors for project success:

1. Determine the goal and aims in the initial project development phase. Record goals and refer to them regularly to maintain the focus of the group and to meet project milestones.

2. Involve frontline staff in the improvement project. The frontline staff have in-depth knowledge on how a process does or needs to work to reach the desired outcomes. The frontline staff will be intimately involved in implementing the new or redesigned process.

3. Determine if a single, consistent process exists or if multiple processes are used to complete the work included in the performance improvement project. Study existing processes to gain the thorough knowledge of current performance.

4. Plan for data collection. Data will be needed throughout the improvement project to determine if the change made was just a change or an improvement. Data collected on project performance both pre- and post-improvement helps determine the success of the project.

5. Implement strategies to maintain process changes that resulted in improved performance. Update policies, procedures, structures, orientation, annual training, team huddle information, and senior leadership reviews to consistently and repetitively reinforce the desired performance.

(e) Management and reporting of CQI activities:

1. All MTF CQI project plans to be submitted to the DHA-approved project repository website will be reviewed and endorsed by the MTF’s Director/Commander prior to submission to higher headquarters.

2. MTF CQI Program leads will:

a. Coordinate with relevant Clinical Communities to prevent duplicative efforts in ongoing Clinical Community initiatives.

b. Review the DHA-approved project repository website (https://carepoint.health.mil/sites/SPIDR/SitePages/Home.aspx) prior to beginning new initiatives.

c. Submit completed CQI products through the DHA Market/Intermediate Headquarters to the respective Clinical Community for review and identification of leading practices and/or variance in care pathway implementation.

12 ENCLOSURE 2

(f) Clinical Communities will review MTF CQI products to identify leading practices for potential dissemination.

(g) Consideration should be given to performance gap and desired improvement before selecting the method and tool most appropriate. Recommended tools include:

1. Rapid Process Improvement or Just Do It. A fast and effective approach to improve a process that usually takes a week or less completed by the members of the process or value stream.

2. PRA. Process used to identify, rate, and prioritize risks and/or hazards. Based on a risk assessment, policies, procedures and controls may be put into place to manage the risk as appropriate to the organization, with the intent of reducing risk to the lowest possible level. A form of PRA is Failure Mode Effect Analysis (FMEA): a systematic, proactive method for evaluating a process to identify where and how it might fail, to assess the relative impact of the identified points of failure, and to identify the parts of the process most in need of change (Reference (t)).

3. Plan-Do-Check-Act/Plan-Do-Study-Act. A management method for the control and continuous improvement of processes and products. This four-step model includes assessing the current process, enacting the plan, evaluating and comparing data to expected outcomes, and developing corrective actions based on outcomes.

4. Clinical Measurement Drivers. The driver diagram is a visual display of a team’s theory of what “drives,” or contributes to, the achievement of a project aim. This clear picture of a team’s shared view is a useful tool for communicating to a range of stakeholders where a team is testing and working. A driver diagram shows the relationship between the overall aim of the project, the primary drivers (sometimes called “key drivers”) that contribute directly to achieving the aim, the secondary drivers that are components of the primary drivers, and specific change ideas to test for each secondary driver.

5. Targeted Solution Tools®. Voluntary performance improvement recommendations sponsored by The Joint Commission for Transforming Healthcare.

a. Users are guided through a process improvement methodology to measure baseline performance, identify root causes, and provide direction to customized solutions.

b. MTF staff enter data directly into the system and use results to support performance improvement activities.

c. Targeted Solution Tools® is approved by the ASD(HA) for use in the

MHS.

c. Clinical Quality Improvement Studies (CQIS). DHA commissions CQIS to validate and improve processes and outcomes of the care delivered to beneficiaries. These studies are recommended and prioritized through CQM’s infrastructure.

13 ENCLOSURE 2

(1) The studies are for CQI and are not research studies.

(2) The studies will be conducted through the CQIS work group with the support of external organizations and include national comparative data, as available.

(3) Participation in CQIS in which data is submitted to or exchanged with an external entity requires approval by the DHA Director.

(4) All CQIS require completion of the appropriate business associate agreement (BAA) and data sharing agreement (DSA) and must comply with Reference (u).

(5) Management and use of study data will be consistent with the requirements in Volume 1 of this manual.

(6) DHA CQM staff will upload and manage CQIS on the DHA-approved project repository.

(7) The DHA CQIS work group provides recommendations to DHA CQM leadership based on study results for integration, where appropriate, into clinical quality strategic priorities and plans.

(8) The DHA CQI Program communicates study results and recommendations to appropriate stakeholders and seeks clinical SME input for future study topics.

(9) The DHA CQI Program, with DHA CQM leadership review/endorsement, provides a report at least annually to the DAD MA on CQIS, results, and recommendations, with projections for future study topics.

d. Storage/Housing Process Improvement Projects. CQI projects will be submitted to the DHA-approved project repository which will serve as a centralized collection of all process improvement projects occurring across the MHS. All elements to support the CQI program will be housed in this robust and agile system designed to meet both current and future demands in order to sustain and continue growth of quality improvement within the MHS.

e. Sharing Leading Practice: Knowledge Sharing and Feedback Loop

(1) The DHA CQI Program supports knowledge sharing for DHA CQM activities through management of a CQM knowledge architecture, primarily using DHA LaunchPad.

CQM knowledge management will support higher DHA leadership guidance for knowledge management.

(2) CQM knowledge management will support CQI activities through at least the sharing of leading practices, providing readily available education and guidance documents for each of the six programs, and promoting advancement of improvement science skills and HRO guiding principles in appropriately targeted MHS audiences, and career development of MHS CQM professionals.

14 ENCLOSURE 2

(3) DHA Markets/Intermediate Headquarters will provide feedback (most easily through email to content owners posted on the sites) on issues, concerns, and opportunities for knowledge development.

15 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

16 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

17 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

18 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 quality assurance program MQAR medical quality assurance record MQSA Mammography Quality Standards Act MSM medical staff manager MSP medical staff professional MSW Master of Social Work MTF military medical treatment facility

NBDHE National Board Dental Hygiene Examination NCC National Certification Corporation NCQA National Committee of Quality Assurance NCCPA National Commission on Certification of Physician Assistants NDAA National Defense Authorization Act NGO non-governmental organization NHSN National Healthcare Safety Network NOTO Number of Times Occurred NPDB National Practitioner Data Bank NPI National Provider Identifier NPIC National Perinatal Information Center NQF National Quality Forum NSQIP® National Surgical Quality Improvement Program

OCONUS outside the continental United States ODE off-duty employment OHU operational healthcare unit OPM Office of Personnel Management OPPE ongoing professional practice evaluation OSD Office of the Secretary of Defense

PA physician assistant PA-C Physician Assistant-Certified PAF Provider Activity File PALS Pediatric Advanced Life Support PCE potentially compensable event PCMH Patient Centered Medical Home PCS permanent change of station PDCA Plan-Do-Check-Act PDSA Plan-Do-Study-Act

19 GLOSSARY

PEB physical evaluation board PEBLO Physical Evaluation Board Liaison Officer PECOS Provider Enrollment, Chain and Ownership System PG Postgraduate Pharm.D. Doctor of Pharmacy Ph.D. Doctor of Philosophy PHI protected health information PHM Population Health Management PII personally identifiable information PIV Personal Identity Verification Card P/MHNP psychiatric/mental health nurse practitioner POAM Plans of Action and Milestones POC point of contact PNCB Pediatric Nursing Certification Board PNP pediatric nurse practitioner PQDR Product Quality Deficiency Report PQI Prevention Quality Indicator PRA proactive risk assessment PS patient safety PSC personal services contract PSI Patient Safety Indicator PSIC Patient Safety Improvement Collaborative PSLC Patient Safety Learning Center PSM patient safety manager PSP Patient Safety Program PSPC Patient Safety Professional Course PSQAC Patient Safety Quality Academic Collaborative PSR patient safety report PSV primary source verification Psy.D. Doctor of Psychology

QA quality assurance QAI Quality Assurance Investigation QAIO Quality Assurance Investigating Officer

RAG Risk Assessment Grade RCA root cause analysis RDH registered dental hygienist RD registered dietitian RDN registered dietician nutritionist RMWG Risk Management Working Group RN registered nurse

SAFE Sexual Assault Forensic Exam SAMFE Sexual Assault Medical Forensic Examiner SANE-A® Sexual Assault Nurse Examiner – Adult/Adolescent

20 GLOSSARY

SDD Solution Delivery Division SE sentinel event SE MOS Sentinel Event Measures of Success SERCA Safety Event Root Cause Analysis SERE survival, evasion, resistance and escape SG Surgeon General SHEA Society for Healthcare Epidemiology of America SIP significantly involved provider SMDR senior medical department representative SME subject matter expert SOC standard of care SRE serious reportable event STEEEP safe, timely, effective, efficient, equitable, patient–centered

T-TPQ TeamSTEPPS™ Teamwork Perceptions Questionnaire TAA training affiliation agreement TDY temporary duty TeamSTEPPS™ Team Strategies and Tools to Enhance Performance and Patient Safety TJC The Joint Commission TRISS TRICARE Inpatient Satisfaction Survey

U.S.C. United States Code UCMJ Uniform Code of Military Justice UMO Undersea Medical Officer USMLE United States Medical Licensing Exam USN United States Navy USTRANSCOM United States Transportation Command USU Uniformed Services University of the Health Sciences

VA Department of Veterans Affairs VADM Vice Admiral VMC virtual medical center VTC video teleconferencing

WHNP women’s health nurse practitioner

PART II. DEFINITIONS

Unless otherwise noted, these terms and their definitions are for the purpose of this DHA-PM.

accreditation. Process of review that allows healthcare organizations to demonstrate their ability to meet regulatory requirements and standards established by a recognized accrediting organization (AO).

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

21 GLOSSARY

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, or incompetence, or any conduct that adversely affects, or could adversely affect, the health or welfare of a patient.

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, or incompetence, or any conduct that adversely affects, or could adversely affect, the health or welfare of a patient.

Agency for Healthcare Research and Quality (AHRQ) Harm Scale. The AHRQ Harm Scale can be found in the AHRQ Common Formats – Hospital Version 2.0, and includes the following assignment categories:

No-Harm: Event reached the patient, but no harm was evident.

Mild Harm: Bodily or psychological injury resulting in minimal symptoms or loss of function, or injury limited to additional treatment, monitoring, and/or increased length of stay.

Moderate Harm: Bodily or psychological injury adversely affecting functional ability or quality of life, but not at the level of severe harm.

Severe Harm: Bodily or psychological injury (including pain or disfigurement) that interferes substantially with functional ability or quality of life.

Death

The harm scale defined by AHRQ Common Formats – Hospital Version 2.0, further delineates harm as:

Temporary Harm. Expected to revert to approximately normal (i.e., patient’s baseline)

Permanent Harm. Not expected to revert to approximately normal (i.e., patient’s baseline) approved postgraduate training. Postgraduate training program accredited by the Accreditation Council for Graduate Medical Education (ACGME), the American Osteopathic Association (AOA), or other similar entities regulating healthcare provider training programs.

auditing. A process used by health professionals to assess, evaluate, and improve care in a systematic way; used by clinical governance to safeguard high quality of clinical care for patients.

22 GLOSSARY

certification. A process by which a nationally recognized organization confirms that an individual healthcare organization has met certain predetermined standards or procedures required for certification.

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, or 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.

clinical data evaluation. Analysis of collected, compiled, and organized data pertaining to important aspects of care. Data are compared with predetermined, clinically valid criteria;

variations from criteria are determined to be justified or unjustified; and problems or opportunities to improve care are identified.

clinical measurement (CM). CM uses tools to help evaluate and track the quality of healthcare services provided to beneficiaries in the Military Health System (MHS). Analyzing CM data and acting on identified trends for improvement helps ensure the MHS delivers safe, timely, effective, efficient, equitable, and patient-centered care.

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.

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.

clinical quality improvement (CQI). CQI consists of systematic and continuous actions that lead to measurable improvement in healthcare services and the health status of targeted patient groups. Focuses on the application of several widely accepted process improvement methodologies to improve clinical performance and desired outcomes.

clinical quality management (CQM). The integrated processes, both clinical and administrative, that provide the framework to objectively define, measure, assure, and improve the quality and safety of care received by beneficiaries. The CQM functional capability includes the following programs: Patient Safety, Healthcare Risk Management, Credentialing and Privileging, Accreditation and Compliance, Clinical Measurement, and Clinical Quality Improvement.

competency assessment. Assessment of a healthcare provider’s knowledge, skills, and ability to deliver high quality, safe patient care. The Military Health System (MHS) assesses providers

23 GLOSSARY

using standards from the Accreditation Council for Graduate Medical Education (ACGME) and the American Board of Medical Specialties (ABMS), recognizing six areas of “General Competencies” including: patient care, medical/clinical knowledge, practice-based learning and improvement, interpersonal and communication skills, professionalism, and system-based practice. These may serve as the basis for healthcare provider care evaluation and privileging decisions.

compliance. The ongoing process of meeting the legal, ethical, and professional standards applicable to a particular healthcare organization or provider.

Comprehensive Systematic Analysis (CSA). CSA is a thorough, credible, and acceptable analysis following a patient safety (PS) event that seeks to identify system vulnerabilities so that they can be eliminated or mitigated in a sustainable manner to prevent reoccurrence. A root cause analysis (RCA) is one type of CSA. CSAs can also be conducted for performance improvement purposes for those events that have the potential to be catastrophic. The following guidelines support the identification of causal factors in CSAs:

Clearly show cause and effect relationships.

Use specifics and accurate descriptions of events.

Human errors must have a preceding cause.

Violations in procedure must have a proceeding cause.

Failure to act is only causal when there is a pre-existing duty to act.

continuing education. Education beyond initial academic or professional preparation approved by an appropriate certifying professional organization that is relevant to the type of care or service delivered in an organization.

Corrective Action Implementation (CAI) Plan Report. The CAI Plan Report describes the effectiveness of the corrective action after implementation. The CAI Plan Report should include identified solutions, corrective actions implemented, and measures of effectiveness and sustainment to show that a corrective action has been implemented and is reducing or eliminating the risk of reoccurrence in a lasting way.

credentialing. The process of obtaining, verifying, and assessing the qualifications of both privileged and non-privileged providers to provide safe patient care services. This assessment serves as the basis for decisions regarding delineation of clinical privileges, as well as appointments and reappointments to the medical staff. The required information should include qualification data such as relevant education, training, and experience; current licensure; and specialty certification (if applicable) as well as performance data, such as current competency, and the ability to perform the selected privileges. This data is collected, verified, and assessed initially and on an ongoing basis.

24 GLOSSARY

credentials. The documents that constitute evidence of appropriate education, training, licensure, experience, and expertise of a healthcare provider.

credentials file. A file containing pertinent information regarding an individual privileged provider to include credentialing and privileging documents, permanent performance data, medical practice reviews, continuing health education documentation, and information related to permanent adverse privileging actions.

credentials review. The credentials inspection and verification process conducted for healthcare providers before selection for military service, employment, and procurement. The credentials review process is also conducted for healthcare providers before medical staff appointment and granting of clinical privileges and is repeated at the time of reappointment and renewal of privileges.

current competence. The state of having adequate ability and up-to-date knowledge to perform the functions of a healthcare provider in a particular discipline, as measured by meeting these criteria:

The provider has actively pursued the practice of their discipline within the past two years by having encountered a sufficient number of clinical cases to represent a broad spectrum of the privileges requested and that the individual has satisfactorily practiced the discipline as determined by the results of ongoing professional practice evaluation (OPPE).

The provider possesses documented evidence of appropriate continued medical education to maintain the currency of skills and knowledge.

data monitoring. The systematic and ongoing collection, compilation, and organization of data pertaining to indicators for the quality and appropriateness of important aspects of care in order that problems or opportunities to improve care can be identified.

denial of clinical privilege(s). Refusal to grant requested privileges 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, or 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.

denominator. The part of a fraction that is below the line and that functions as the divisor of the numerator; the population at risk in the calculation of a rate or ratio.

department/clinical unit. The department, unit, or area utilized for patient care (e.g., pharmacy, surgical area, emergency department, procedural area, nursing unit).

25 GLOSSARY

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.

direct care system. Healthcare facilities and medical support organizations managed by the DoD through the Defense Health Agency (DHA) or Service Surgeons General in accordance with applicable federal laws and regulations.

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.

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.

event reporting. The DoD Patient Safety Program (PSP) captures the full range of patient safety (PS) events listed in Volume 2 and all such events must be reported into the Joint Patient Safety Reporting (JPSR) system to be used as opportunities to prevent harm. Any PS event that reaches the patient (i.e., adverse events and no-harm events) must be reported to the appropriate Healthcare Risk Management (HRM) Program for assessment. DoD Reportable Events (DoD REs) also have reporting, notification, and analysis requirements beyond JPSR.

focused review. A review that concentrates on a perceived problem area that involves a specific standard, procedure, policy or any other limited scope healthcare delivery matter.

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.

harm. Any physical or psychological injury or damage to the health of a person, including both temporary and permanent injury.

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

healthcare risk management (HRM). Includes clinical and administrative activities, processes, and policies to identify, monitor, assess, mitigate, and prevent risks to the healthcare

26 GLOSSARY

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).

intentional unsafe act. Any alleged or suspected act or omission of a healthcare provider, staff member, contractor, trainee, or volunteer pertaining to a patient that involves a criminal act, a purposefully unsafe act, patient abuse, or an event caused or affected by drug or alcohol abuse.

Intentional unsafe acts are matters for law enforcement, disciplinary system, or administrative investigation.

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 Title 10, United States Code.