HT0011-20-R-0043 HFAS PWS Attachment 2c - DHA PM 6025.13 CQM in the MHS Vol 2, Patient Safety.pdf

Defense Health Agency

PROCEDURES MANUAL

NUMBER 6025.13, Volume 2 August 29, 2019

Medical Affairs

SUBJECT: Clinical Quality Management in the Military Health System, Volume 2: Patient Safety

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 (ad), 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 2

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 (ad), 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

DHA- PM 6025.13, Volume 2 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. Patient Safety

3. Infection Prevention Control Glossary

DHA-PM 6025.13, Volume 2

4 TABLE OF CONTENTS

TABLE OF CONTENTS

ENCLOSURE 1: REFERENCES

ENCLOSURE 2: PATIENT SAFETY

GENERAL OVERVIEW

KEY OPERATIONAL DEFINITIONS

GOVERNANCE STRUCTURE

SCOPE AND CORE RESPONSIBILITIES

PROCEDURES

APPENDIX

DOD REPORTABLE EVENT DEFINITIONS MATRIX

ENCLOSURE 3: INFECTION PREVENTION AND CONTROL

GENERAL OVERVIEW

GOVERNANCE STRUCTURE

SCOPE AND CORE RESPONSIBILITIES

MANAGEMENT OF INFECTION PREVENTION AND CONTROL EVENTS

GLOSSARY

PART I: ABBREVIATIONS AND ACRONYMS

PART II: DEFINITIONS

5 ENCLOSURE 1

ENCLOSURE 1

REFERENCES

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

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

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

(d) DoD Instruction 6025.13, “Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health System (MHS),” February 17, 2011, as amended

(e) DoD Manual 6025.13, “Medical Quality Assurance (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) National Defense Authorization Act for Fiscal Year 2001, Sections 742 and 654

(p) National Quality Forum, “NQF Patient Safety Terms and Definitions, Safety Definitions,” February 18, 20101

(q) Agency for Healthcare Research and Quality’s Patient Safety Organization Program, “Common Formats for Event Reporting – Hospital Version 2.0,” May 20172

(r) The Joint Commission, “Sentinel Event Policy,” June 29, 20173

(s) National Patient Safety Foundation, “RCA2: Improving Root Cause Analyses and Actions to Prevent Harm,” 20154

1 Available on the Internet at https://www.qualityforum.org/Topics/Safety_Definitions.aspx 2 Available on the Internet at https://www.pso.ahrq.gov/common/scope 3 Available on the Internet at https://www.jointcommission.org/sentinel_event.aspx 4 Available on the Internet at http://www.ihi.org/resources/Pages/Tools/RCA2-Improving-Root-Cause-Analyses-and-Actions-to-Prevent-Harm.aspx

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(t) DoD Instruction 6000.11, “Patient Movement,” June 22, 2018

(u) DoD Instruction 6430.02, “Defense Medical Logistics Program,” August 23, 2017

(v) “DHA MEDLOG Division HAR Guidance,” October 31, 20171

(w) Defense Logistics Agency, “DLA Troop Support, Medical Supply Chain-DMMonline”2

(x) United States Code, Title 10, Section 1102

(y) Agency for Healthcare Research and Quality, “TeamSTEPPS™ Teamwork Perceptions Questionnaire (T-TPQ),” March 20143

(z) The Joint Commission, “Root Cause Analysis in Health Care: Tools and Techniques, 6th Edition,” October 2017

(aa) DoD Patient Safety Learning Center, “Military Health System Leadership Engagement Toolkit,” December 20174

(ab) Agency for Healthcare Research and Quality’s Patient Safety Network, “Patient Safety Primer: Culture of Safety,” January 20195

(ac) Agency for Healthcare Research and Quality, “Comprehensive Unit-based Safety Program (CUSP) Unit Level Cultural Assessments,” March 20186

(ad) The High Reliability Organization Task Force Report. A Resource Guide for Achieving High Reliability in the MHS,” September 15, 20157

1 Please contact DHA MEDLOG Chief of Quality and Safety Optimization at (301) 619-9851 for this document.

2 Available on the Internet at https://www.medical.dla.mil/Portal/Customer/ProductQualityDeficiency.aspx 3 Available on the Internet at https://www.ahrq.gov/teamstepps/instructor/printver/index.html 4 Available on the Internet at https://info.health.mil/hco/clinicsup/patientsafety/PSLCHome/SitePages/leadership.aspx 5 Available on the Internet at https://psnet.ahrq.gov/primers/primer/5/safety-culture 6 Available on the Internet at https://www.ahrq.gov/professionals/education/curriculum-tools/cusptoolkit/index.html 7 Available on the Internet at https://info.health.mil/coi/mhshro/Documents/Deliverables

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ENCLOSURE 2

PATIENT SAFETY

1. GENERAL OVERVIEW. This enclosure outlines procedures for the implementation and sustainment of the DoD Patient Safety Program (PSP) within the MHS.

a. Purpose. The DoD PSP is a comprehensive program providing products, services, and educational and training resources to promote safety and prevent harm, as mandated in accordance with Reference (o). The DoD PSP contributes to the MHS’s focus to achieve the Quadruple Aim, aligned with DoD, MHS, and DHA strategic objectives, centered on Readiness—Ready Medical Force and Medically Ready Force—across all environments.

Supporting the objective is the goal to achieve zero preventable harm and provide patient-centered, evidence-based care to improve patient outcomes. The DoD PSP provides products, services, and support to enable frontline healthcare personnel to eliminate harm and promote a culture of safety.

b. Functions. The primary functions of the DoD PSP are to promote a strong culture of safety to eliminate preventable patient harm by engaging, educating, and equipping patient care teams to institutionalize evidence-based, safe practices.

(1) Manage Patient Safety (PS) Events. Eliminate harm through identification, investigation, and mitigation of PS events.

(2) Support a Learning Organization. Strengthen systems through the implementation of robust mitigations and providing education and training to all staff to promote concepts of high reliability in healthcare.

(3) Foster a Culture of Safety. Foster a culture in which mistakes are acknowledged and lead to sustainable, positive change; respectful and inclusive behaviors are instinctive and serve as behavioral norms for the organization; and the physical and psychological safety of patients and the workforce are both highly valued and ardently protected.

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

a. Patient Safety (PS) Event. A PS event is an incident or condition that could have resulted, or did result, in harm to a patient. A PS event can be but is not necessarily the result of a defective system or process design, a system or process breakdown, equipment failure or malfunction, or human error. PS events include adverse events, no-harm events, near miss events, and unsafe/hazardous conditions as defined below:

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

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

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

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

b. Event Reporting. The DoD Patient Safety Program (PSP) captures the full range of patient safety (PS) events listed in Paragraph 2.a. 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. (See Paragraph 2.c.(1) for potentially compensable event (PCE) definition.) DoD Reportable Events (DoD REs) also have reporting, notification, and analysis requirements beyond JPSR. (See Paragraph 2.e.

for DoD RE definition.)

c. Other Event Types

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

(2) 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.

d. Harm and Assigning Harm to Adverse Events

(1) The assignment of a harm category allows a better understanding of the nature of harm when an adverse event occurs and facilitates trending and analysis for learning.

(2) Harm is any physical or psychological injury or damage to the health of a person, including both temporary and permanent injury. (Reference (p)).

(3) The MHS has adopted the Agency for Healthcare Research and Quality’s (AHRQ) Harm Scale to assign harm to PS events recorded in each of the JPSR system, the Global Trigger

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Tool (GTT), and JCCQAS. The AHRQ Harm Scale can be found in the AHRQ Common Formats – Hospital Version 2.0 (Reference (q)), and includes the following assignment categories:

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

(b) 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.

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

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

(e) Death.

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

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

(b) Permanent Harm. Not expected to revert to approximately normal (i.e., patient’s baseline).

(5) It is important to note that harm scales can vary. To promote high reliability and MHS-wide learning, the MHS seeks to align and standardize its use of harm scales across all its electronic data systems, as well as to maintain the most prudent current version.

(6) Different tasks require different tools. In the context of events known as DoD REs, it is important to be cognizant of The Joint Commission’s (TJC) classification of harm. (See Paragraph 2.e.(3) for further guidance.)

(7) While all PS events that both reach the patient (i.e., adverse events and no-harm events) and don’t reach the patient (i.e., near miss events and unsafe/hazardous conditions) must be reported in JPSR, DoD REs have additional reporting and notification requirements. (See Paragraph 2.e. for further guidance.)

e. DoD Reportable Events (DoD REs)

(1) A DoD RE is 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

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(TJC) sentinel event (SE) (Reference (r)) or the National Quality Forum’s (NQF) serious reportable event (SRE) (Reference (p)) definitions. DoD REs require a Comprehensive Systematic Analysis (CSA) and follow on Corrective Action Implementation (CAI) Plan Report.

(2) DoD REs are events not primarily related to the natural course of the patient’s illness or underlying condition and could include events identified by the Office of the Assistant Secretary of Defense for Health Affairs (ASD(HA)) or DHA leadership in alignment with MHS strategic initiatives.

(3) As stated in Paragraph 2.e.(1), DoD REs include TJC’s SE (Reference (r)) and the NQF’s SRE (Reference (p)) definitions. It is important to note TJC’s SE definition includes severe temporary harm: critical, potentially life-threatening harm lasting for a limited time with no permanent residual but requires transfer to a higher level of care/monitoring for a prolonged period of time, transfer to a higher level of care for a life-threatening condition, or additional major surgery, procedure, or treatment to resolve the condition. Recognize that TJC categorizes some event types as SEs regardless of the magnitude of the outcome and must be reported as DoD REs.

(4) All DoD REs require mandatory reporting to ASD(HA)/DHA leadership through the DoD PSP. See Appendix for a list of DoD REs. Note that this list may change based upon organizational focus.

(5) All DoD REs are PCEs and require referral and collaboration with HRM.

f. 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 (Reference (s)).

The following guidelines support the identification of casual factors in CSAs:

(1) Clearly show cause and effect relationships.

(2) Use specifics and accurate descriptions of events.

(3) Human errors must have a preceding cause.

(4) Violations in procedure must have a proceeding cause.

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

g. 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.

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h. 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.

3. GOVERNANCE STRUCTURE. The DoD PSP is managed out of the CQM Branch in the Clinical Support Division under the Deputy Assistant Director for Medical Affairs (DAD MA) within the DHA. The Chief of the DoD PSP manages program operations in collaboration with the Patient Safety Improvement Collaborative (PSIC) and Infection Prevention and Control Working Group (IPCWG).

a. The PSIC is chaired by the Chief of the DoD PSP and may include representatives from the Services, DHA Markets, the TRICARE Health Plan, and United States Transportation Command (USTRANSCOM). The purpose of the PSIC is to develop, promote, and support a comprehensively aligned DoD PSP.

b. The IPCWG is administratively aligned under the DoD PSP. In addition to providing direction and guidance, it monitors and evaluates compliance and clinical quality improvement of MHS infection prevention and control activities.

4. SCOPE AND CORE RESPONSIBILITIES

a. The DoD PSP is a comprehensive program to eliminate patient harm and promote a PS culture across the MHS continuum of care and various healthcare settings. This is accomplished through a collaborative, multidisciplinary, and systems-based approach emphasizing data-driven, continual improvement. The DoD PSP includes Infection Prevention and Control (IPC), and shares educational and training information through the Patient Safety Learning Center (PSLC).

b. The DoD PSP will be implemented in every MTF as a dedicated program to reduce harm due to medical errors and improve PS that is focused on prevention by improving medical systems and processes to mitigate preventable errors. The administration of the PSP at the MTF must be through an MTF PS or MTF CQM program. The MTF PSP, with its emphasis on process and system design, must be an integral part of the risk reduction and performance improvement efforts of the MTF, and must function as an integral part of the CQM of the MTF.

c. Within CQM, the DoD PSP collaborates with the Healthcare Risk Management (HRM), Credentialing and Privileging (CP), Accreditation and Compliance (AC), Clinical Measurement (CM), and Clinical Quality Improvement (CQI) programs to improve care for beneficiaries. The PSP collaborates with the MHS Clinical Communities and other divisions and offices within the DHA by providing PS and process improvement data and analysis, lessons learned, and updates regarding nationally recognized PS and quality organizations. The DoD PSP also collaborates

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with the Deputy Assistant Director for Healthcare Operations/TRICARE Health Plan Division, the Military Departments, and other federal and non-federal agencies to ensure alignment with the MHS strategic goals and values of the Quadruple Aim, to include:

(1) USTRANSCOM. The DoD PSP collaborates with the DoD Patient Movement Program in support of PS and quality of care for the movement of patients across the MHS continuum and enterprise healthcare settings. The operational patient movement safety program executes Reference (t), and USTRANSCOM standard operating procedures. The regulating TRANSCOM Patient Movement Requirements Center is available as a resource for patient preparation concerns (Reference (t)).

(2) DHA Assistant Director for Combat Support (AD CS)/Medical Logistics Division (MEDLOG). The DoD PSP collaborates with the Logistics community participating in the Hazards, Alerts, and Recalls Notice System (HAR-NESS) to ensure medical product, tissue, and device safety (Reference (u), Reference (v), and Reference (w)).

(3) Uniformed Services University (USU). The Patient Safety Quality Academic Collaborative (PSQAC) at USU is responsible for the development, execution, and ongoing supervision of rigorous scientific research and integration into medical education and graduate-level activities in direct support of the DoD PSP and other CQM objectives.

(4) U.S. Department of Veterans Affairs (VA). The DoD PSP collaborates with the VA National Center for Patient Safety to share trending safety information, alerts, and advisories, and develop action plans and other tools and systems designed to reduce patient harm due to medical errors and enhance PS.

d. Core Responsibilities

(1) DHA Headquarters PSP (DoD PSP) will:

(a) Provide direction and guidance, and monitor and evaluate compliance, and CQI of DoD PSP activities.

(b) Address potential PS concerns and inform senior leadership.

(c) Maintain centralized reporting structures, tools, and processes, to include reporting to the Office of the ASD(HA).

(d) Manage event investigation process.

(e) Measure PS to improve patient outcomes.

(f) Utilize data to guide and drive change.

(g) Build PS workforce capabilities.

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(h) Equip teams for safe care practices.

(i) Support MHS-wide improvements.

(j) Serve as PS advisors and consultants for the MHS.

(k) Serve as enabling expertise for Clinical Communities and work groups.

(l) Provide PS consultation on Health Information Technology (HIT)-related safety events.

(m) Support, facilitate, and enhance continuous performance improvement in IPC.

(n) Design, develop, and disseminate PS resources.

(2) DHA Market/Intermediate Headquarters PSPs, in support of MTFs/subordinate organizations, will:

(a) Participate fully in the DoD PSP including initiatives to promote the objectives of the program.

(b) Monitor for appropriate/inappropriate use of information in accordance with Reference (x).

(c) Provide interpretation of this manual, and implementation guidance to the field.

(d) Make recommendations for improvement efforts for safe care practices.

(e) Serve as a resource by providing consultation on all PS matters and training opportunities.

(f) Receive, review, monitor, and manage performance for reporting requirements to the DoD PSP of JPSR, DoD RE Notifications, CSA and CAI Plan Reports, PRAs, and Annual PS Plans.

(g) Consolidate reports and submit regularly to centralized DoD PSP repositories.

(h) Provide consultation on performance management for all deliverables.

(i) Abstract, analyze, and trend data to identify system issues, and provide feedback on system issues identified and recommendations for changes.

(j) Regularly meet with the PS community for informed dissemination of PS-related information.

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(k) Communicate findings to the field through data visualization tools and publications on a routine basis.

(3) MTF Director/Military Department Designee will:

(a) Establish and implement a PSP consistent with this manual.

(b) Designate an individual as the Patient Safety Manager (PSM) to implement this program who meets DHA competency requirements and is an integral part of the executive administrative team. There is no limitation on titles used for the PS professional; examples of terms include: PSM, patient safety specialist, patient safety coordinator, patient safety analyst, and patient safety officer. Where resources permit, the PSM and Healthcare Risk Manager should not be the same person to preclude organizational conflicts of interest.

(c) Report, investigate, and forward all DoD REs to the DoD PSP through respective DHA Market/Intermediate Headquarters.

(4) PSM will:

(a) Develop, implement, and assess the organization’s PS plan by collaborating with leadership and staff to ensure PS initiatives effectively address identified risks within the organization. This includes devising strategies to enlist medical staff, employee, and patient/family input into the PS plan annually approved by leadership.

(b) Support a culture of safety fostering trust, transparency, teamwork, and communication through reporting PS events; focusing on process improvement rather than individual blame and encouraging a systems approach to improve healthcare processes.

(c) Coordinate and collaborate with the executive leadership, the HRM Program, IPC, and others as necessary.

(d) Serve as the organizational liaison for PS to the DHA Market/Intermediate Headquarters. Ensure compliance with required PS events, DoD REs, and events reportable to accrediting organizations (AOs). This includes ensuring appropriate investigations; CSAs, including development and implementation of corrective action plans; CAI Plan Reports; and PRAs.

(e) Take necessary action as a result of any PS event to ensure staff and patients are safe.

(f) Provide key members of local executive leadership of the facts and recommendations of the result of the investigation of DoD REs and PS events, and provide updates through closure of the investigation of each event.

(g) Serve as a consultant and advisor to the local executive leadership on PS issues and concerns.

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(h) Prepare trend analysis reports of local PS outcomes.

(i) Facilitate the utilization of JPSR and other PS data in performance improvement initiatives.

(j) Prepare and present briefings on PS and outcomes improvement to all levels of organizational personnel.

(k) Support integrating team-based practices into daily work, to include training, implementation, and evaluation of Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS™) (Reference (y)), which may be supplemented by other tools that advance reliable, safe care.

(l) Facilitate development of PS/CQI projects to continuously improve healthcare delivery and outcomes for beneficiaries.

(m) Conduct an annual assessment of the adequacy of organization-wide PS activities, policies, and procedures to ensure program effectiveness and compliance.

(n) Provide expertise, training, and guidance to staff members in the areas of PS principles, PRA, DoD RE reporting, CSA using RCA methodology (Reference (s)), and data analysis review.

(o) Monitor and ensure compliance with National Patient Safety Goals and all applicable regulatory patient safety standards.

5. PROCEDURES

a. Managing PS Events. By using data, knowledge management tools, and established resources, the DoD PSP can develop actionable improvement steps that support the goal of achieving zero preventable harm. PS event reports are collected through various methods to include: 1) anonymous, self-reported PS events through JPSR, and 2) harm surveillance data using the GTT methodology, and 3) administrative data related to patient harms collected through other programs. In addition, various tools are utilized to extract risk factors contributing to errors and to develop strategies to mitigate the risks. These tools include: 1) CSA reports, 2) CAI Plan Reports, 3) PRAs, and 4) other focused efforts directed toward specific types of events.

Collection of data allows for the identification, investigation, analyses, reporting, and learning from PS events and is instrumental in ensuring the sustainment of a safe patient environment.

This information, along with culture survey results, is used for establishing strategies to address process failures and mitigate risks in the system.

(1) Identification, Documentation, and Management of PS Events

(a) MHS Event Reporting System (currently JPSR). JPSR is the DoD electronic system used to capture data for all types of PS events in MTFs and other applicable healthcare

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environments, as well as PS events identified in other quality data programs to promote a comprehensive and accurate view of PS events across the MHS. The PSM is responsible for JPSR data management, the review of facts associated with the PS event, and for ensuring an appropriate evaluation is performed as required per this manual. JPSR usage is the only authorized method for the reporting of adverse events, no-harm events, near miss events, and unsafe/hazardous conditions. Individual MTF/organizational developed applications are not authorized.

1. All PS events (adverse events, no-harm events, near miss events, or unsafe/hazardous conditions) must be reported to JPSR as soon as practicable.

2. Immediate action must be taken to make sure all affected, or potentially affected patients and staff are protected from additional injury and to minimize the effects of the event.

(b) JPSR consists of three major processes and forms: PS event reporting form, investigation and analysis form, and aggregation and reports design/development.

1. All Common Access Card (CAC) authenticated users can access and are expected to report PS events in JPSR. JPSR allows the reporter to self-identify or report anonymously. The staff member who identified the event will complete the electronic PS event reporting form. This form must be completed and submitted in one sitting due to system requirements associated with the anonymous reporting capability.

2. The investigation and analysis form will be completed by the PSM or assigned staff. This form allows the PSM to assess the event, assign a handler and investigators if needed, and complete an analysis of the PS event.

3. The roles of handler and investigator and the development of aggregation and trending reports are controlled by role-based security authorized by the PSM.

4. JPSR allows a reporter to report multiple occurrences of the identical PS event using the information from one JPSR event report (e.g., medication error where the same medication was administered three times before error identification). The Number of Times Occurred (NOTO) field in JPSR supports this capability.

a. The NOTO field must not be used to report multiple events reaching multiple patients.

b. An individual JPSR report must be prepared for each occurrence of the event.

c. To use the NOTO functionality, the reporter of the multiple occurrences of the identical PS event fills out the report and indicates the number of occurrences observed in the

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NOTO field. Then, during the PS investigation of the event the PSM must use the copy functionality for each occurrence so that the magnitude (number) of the event is accurately captured in JPSR.

d. Likewise, if the NOTO field is used to report multiple occurrences of the identical PS event involving the same patient, the PSM must use the copy functionality for each occurrence so the magnitude (number) of the event is accurately captured in JPSR.

(2) Review and Classification of a PS Event (Adverse Event, No-Harm Event, Near Miss Event, or Unsafe/Hazardous Condition)

(a) Documentation. JPSR is the electronic system used to capture data for all types of PS events which occur in the DoD (where practicable), as well as safety events tracked and trended in other programs such as those in designated national data bases.

1. The specific type of event will determine the additional documentation that is required and the responsible point of contact (POC) for follow-up action. For example, the initial event may require action and/or documentation by PS, HRM, CP or be referred to criminal investigation services. A combination may be required.

2. A DHA approved alternative hard copy documentation method may be used only if JPSR is not available for documenting the PS event. (See the PSLC Portal for the JPSR Offline Report Form:

https://info.health.mil/hco/clinicsup/patientsafety/PSLCHome/SitePages/Home.aspx.) This written document provides concise, factual, objective, and complete details about the event. The hard copy documentation method will not be included in patient medical or dental records; it will not be duplicated or maintained at the department or service level. The alternate hard copy document shall be marked with the 10 U.S.C. 1102 Medical Quality Assurance Program (MQAP) information marker. (See Paragraph 5.c.(5) for further guidance.)

3. If the JPSR Offline Report Form is used, the data collected will be entered into JPSR within 72 hours; thereafter, the hard copy may be destroyed, or it may be uploaded to JPSR as a PDF document and the original destroyed.

4. JPSR events must not be printed and held within user files.

(b) PS Event Review. Submission into the JPSR serves as the initial report of an event that requires investigation, detailed documentation, tracking, and trending.

1. Immediate action must be taken to make sure patients are protected from additional injury, or potential for injury, and to minimize the effects of the event.

2. The PSM routes PS event reports to the Chief of the Medical Staff and other appropriate individuals within the organization for further action. The PSM notifies the Healthcare Risk Manager for assessment of all PS events that reach the patient (adverse events and no-harm events). PS event reports include review of associated facts, evaluation as required

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by this manual, and assignment of harm based upon the DHA approved harm scale and the Probability/Severity Matrix for all PS events. Information on the event should be finalized in at least 80 percent of patient safety reports (PSRs) within 30 calendar days of the event report date.

3. All PS events require assessment and action. The PSM will actively and regularly review all events reported within JPSR to identify risks or potential problem areas for focus. The ultimate goal of reporting is to prevent harm.

4. If the event meets DoD RE criteria, a CSA is required.

5. For adverse events that do not meet DoD RE criteria, further action may be considered according to their Risk Assessment Grade (RAG) as determined by the Probability/Severity matrix in JPSR. The Probability/Severity Matrix is a useful way to assign priority to events based upon their risk (Reference (s)). The Probability/Severity Matrix must be used for all PS events. CSAs are strongly encouraged, along with implementation of a corrective action plan, for events with a RAG scored as high.

6. PSMs are encouraged, but not required, to conduct CSAs on other adverse, no-harm, and near miss events. PSMs are required to conduct CSAs as directed by leadership.

7. All CSAs are to be submitted in the DHA approved format to DHA Market/Intermediate Headquarters personnel for review and organizational learning.

8. An aggregate review and analysis may be performed quarterly for more common non-DoD RE event types that do not result in a RAG scored as high. The outcome should drive further action, if warranted. Aggregate review products should be shared with the DHA Market/Intermediate Headquarters and the DoD PSP for MHS-wide learning.

9. Similarly, for PS events that do not reach the patient (near miss events or unsafe/hazardous conditions), the decision may be to track, trend and complete an aggregate review and analysis. The outcome should drive further action, if warranted.

10. If the event involves physical safety issues, hazardous environment of care conditions or staff, the event response will be coordinated with the Senior Administrator and the Facility Manager for a multidisciplinary response.

11. Closure of PSRs will be monitored with the goal of 80 percent for closure within 30 calendar days of the PS event reported date. PSRs more than 30 calendar days old will be monitored weekly by the PSM.

12. Timely closure of PSRs will be tracked by the PSM and DHA Market/Intermediate Headquarters personnel.

(c) Adverse Drug Reactions. PS events caused by an adverse drug reaction will be reported using JPSR. These events require investigation by pharmacy personnel to determine if the event should be reported to the Food and Drug Administration (FDA). Adverse drug

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reactions that are determined to be significant by the local Pharmacy and Therapeutic Committee will be reported to the FDA. Adverse drug reactions will be centrally monitored to generate complete statistical data necessary to make effective recommendations.

(d) PCE. A PCE is any PS event that both a) reaches the patient (i.e., adverse event and no-harm event), and b) has a Healthcare Risk Management assessment that determines that the event is likely to present a possible financial loss to the Federal Government (to include but not limited to a medical tort claim, an active duty disability payment, or an active duty death payment). All DoD Reportable Events (DoD REs) are PCEs. All events that trigger a PCE will also be referred to the PSM to ensure capture in JPSR and investigation/analysis as defined in this volume, to include PCEs that do not meet the definition of a DoD RE. PCEs referred to PS must include identification as to whether or not the PCE is also a DoD RE, and the harm scale category and type of event (using the taxonomy established in Reference (q)). PS event investigations and their products are protected in accordance with Reference (x) are not utilized for administrative or punitive purposes. While information cannot be shared between ongoing HRM and PS investigations, following completion of both investigations, system and process findings will be shared for organizational learning.

(e) Intentional Unsafe Acts. If, in the course of the activities of the DoD PSP, information about intentional unsafe acts is revealed, the original report shall be referred to the appropriate command authority and MTF Director. The investigation and consideration of intentional unsafe acts are under the authority, direction, and control of the command authority for purposes of personnel standards and conduct, while the investigation and consideration of the intentional unsafe act for purposes of assessing the impact on healthcare is under the authority, direction, and control of the MTF Director (Commander where appropriate). The PSM will proceed with a review of facility systems and processes implicated in the actual or potential intentional unsafe act but defers to the separate investigation consideration with respect to any matter of culpability of any person involved in the act. The PSM will notify the Healthcare Risk Manager of any concern for intentional unsafe acts by a healthcare provider, for possible reporting requirements. (See Volume 3 of this manual for further guidance.)

(f) Information Concerning Clinical Competence. If professional competency is questioned or the PS event is identified as a PCE, the team leader will forward the PS event to HRM for the PCE review. (See Volume 3 of this manual for further guidance.) If, during the course of a CSA, the competence of an individual involved in the PS event is in question, the team will also determine if the healthcare system provided every opportunity for the individual to succeed. It is crucial to identify process or system obstacles that may have affected a patient outcome.

(g) Criminal Investigative Service (CIS) and Command Investigations. Allegations involving professional misconduct may also arise during the investigation of a PS event.

Allegations of professional misconduct will become the subject of a CIS or command criminal investigation. The PS investigation should not conflict or interfere with these investigations; this may result in the PS investigation being delayed pending the completion of the CIS or command criminal investigation. The Privileging Authority, or Investigating Office (IO), should

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coordinate through the servicing healthcare legal counsel with the assigned CIS agent or command IO to determine when the criminal investigation is completed, and the PS investigation can resume.

(h) Peer Support Program. Leaders recognize that conscientious healthcare workers who are involved in DoD REs are themselves victims and require support. To that end, the Healthcare Resolutions Program, as described in Volume 1 of this manual, shall be made available to the staff involved along with any additional help and resources as needed.

(i) Disclosure. All factual medical data related to a PS event that reaches the patient (i.e., adverse event or no-harm event) will be entered in the patient’s electronic medical or dental record. The entry should describe in detail exactly what occurred, any evidence of injury and the immediate action(s) initiated in response to the event. In addition, all the facts surrounding the adverse event or no-harm event must be fully disclosed to the patient/family member without attribution of blame or fault and must be at a time and in a language and terms that are readily understood by the patient and family. The annotation in the medical/dental record will neither conclude that an adverse event or no harm event occurred (use those specific terms), nor will it indicate that a PSR (which is protected in accordance with Reference (x)) was completed.

b. Management of DoD REs

(1) Knowledge gained from reporting and managing DoD REs helps in learning from those events and improve safety across the MHS through knowledge sharing.

(2) A DoD RE is any 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) (Reference (r)) or the National Quality Forum’s (NQF) serious reportable event (SRE) (Reference (p)) definitions. DoD REs require a Comprehensive Systematic Analysis (CSA) and follow on Corrective Action Implementation (CAI) Plan Report.

(3) All DoD REs require mandatory reporting to ASD(HA)/DHA leadership through the DoD PSP. See Appendix for a list of DoD REs. Note that this list may change based upon organizational focus.

(4) As stated in Paragraph 2.e.(1), DoD REs include TJC’s SE (Reference (r)) and the NQF’s SRE (Reference (p)) definitions. It is important to note TJC’s SE definition includes severe temporary harm: critical, potentially life-threatening harm lasting for a limited time with no permanent residual but requires transfer to a higher level of care/monitoring for a prolonged period of time, transfer to a higher level of care for a life-threatening condition, or additional major surgery, procedure, or treatment to resolve the condition. Recognize that TJC categorizes some event types as SEs regardless of outcome and must be reported as DoD REs.

(5) All DoD REs are PCEs and require referral and collaboration with HRM.

c. CSA

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(1) Overview. For PS events, a CSA is used to identify the root cause(s), causal and contributing factors that underlie variation in process or system performance including the occurrence or possible occurrence of a DoD RE. The CSA process provides a way to identify breakdowns in processes and systems that contributed to the event and how to prevent future events. The intention of the investigation is to find out what happened, why it happened, and determine what changes need to be made to improve performance.

(a) The product of a CSA is a corrective action plan to implement and sustain corrective measures to prevent or eliminate future harm. The corrective action plan should include the following elements (References (s) and (z)):

1. Corrective actions to eliminate or control system hazards or vulnerabilities related to causal and contributing factors

2. Identify who is responsible for implementation

3. Identify wherever possible at least one strong or intermediate strength corrective action

4. Timeline for completion

5. Strategies for evaluating the measurable effectiveness of actions and sustaining change

(b) As part of the CSA, the corrective action plan should be developed in anticipation of measuring improvement/sustainment in the required 4-month CAI Plan Report.

Effectiveness/sustainment measures are quantifiable metrics, typically with a numerator and a denominator that identify whether a planned corrective action was effective at controlling or eliminating system vulnerabilities and that its effectiveness was sustained over time. Sentinel Event Measures of Success (SE MOS) are identical to the measures expected in corrective action plans and CAI Plan Reports and may be used in a CAI Plan Report whenever SE MOS are required for AO reporting. If the AO does not require SE MOS, a report identifying the status of all identified corrective actions, including an evaluation of effectiveness and sustainment, is still due to DoD PSP within the reporting period. This assessment forms the basis for further actions taken with improvement efforts.

(c) All DoD REs will have a thorough and structured CSA conducted to ensure quality healthcare is consistently delivered across the MHS for all its beneficiaries. RCA is one type of CSA (Reference (s)).

(d) The focus of these investigations is on breakdowns in systems and processes, not individual performance. The process should seek underlying system vulnerabilities that were manifest in personnel-related performance issues. This is done in a non-punitive interdisciplinary environment (Reference (s)).

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(2) Required Performance of a CSA. CSAs will be completed on all DoD REs.

Additionally, CSAs are encouraged for any adverse event that does not meet DoD RE criteria, but results in a RAG of high, based upon the Severity/Probability Matrix in JPSR. CSAs may also be appropriate for adverse events of lesser severity, no-harm and near miss events, or when there is a potential for a future catastrophic event. Where policy guidance does not exist, the decision to complete a CSA will be at the discretion of the MTF Director/Commander with guidance from their DHA Market/Intermediate Headquarters. All CSAs must be submitted to the DoD PSP for organizational learning.

(3) Actions

(a) DHA Market/Intermediate Headquarters will:

1. Create and send notification using the DHA approved standardized DoD RE form. (See the Patient Safety Learning Center (PSLC) Portal for the DoD RE Form:

https://info.health.mil/hco/clinicsup/patientsafety/PSLCHome/SitePages/Home.aspx.) The DHA Market/Intermediate Headquarters will…