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I

Chapter 7

TRICARE Operations Manuai6010.56-M, February 1, 2008 Utilization And Quality Management

Section 4

Clinical Quality Management Program (CQMP)

The Managed Care Support Contractors (MCSCs), Designated Providers (DPs), and the overseas contractor (from this point forward to be referred to as the contractor) shall operate a CQMP which results in demonstrable quality improvement in the quality of health care provided beneficiaries, and in the process and services delivered by the contractor. The CQMP is defined as the integrated processes, both clinical and administrative, that provide the framework for the contractor to objectively define and measure the quality of care received by beneficiaries. This CQMP shall demonstrate how the contractor's goals and objectives, leadership, structure, and operational components are designed to achieve the efficient and effective provision of timely access to high quality health care. As part of the CQMP, the contractor shall develop a CQMP Plan with goals and objectives followed by a CQMP Annual Report (AR) describing the results of the quality activities performed during each program year.

1.0 CQMP PLAN

1.1 The contractor shall develop a written CQMP plan which is defined as a detailed description of the purpose, methods, proposed goals and objectives designed to meet the intent of the program. The contractor shall fully describe in a written CQMP Plan the structural and functional components of the program as described in Exhibit B, Contract Data Requirements List (CDRL), DD Form 1423, P040.

1.2 The appropriate TRICARE Regional Office (TRO) shall review the plan and make recommendations for revision if necessary within 45 calendar days or provide written acceptance through the Contracting Officer (CO). In the absence of clinical quality management staff in the Designated Provider Program Office (DPPO) and TRICARE Overseas Program Office (TOPO), the Clinical Quality Division in the Office of the Chief Medical Officer (OCMO) will review the plans submitted by the DP programs and overseas contractor and provide recommendations for revision or written acceptance within 45 days. The contractor shall provide a revised plan addressing the recommendations within 15 business days to the TRO/DPPO/TOPO.

2.0 CLINICAL QUALITY MANAGEMENT PROGRAM ANNUAL REPORT (CQMP AR)

See Exhibit B, CDRL, DD Form 1423, A01 0, for the structure and content of the CQMP AR. The TROs, TOPO, and DPPO will provide relevant comments to the contractors based on review of the annual CQMP report. The report will be reviewed in conjunction with the annual plan for the particular period of performance. Recommendations for revision or acceptance of the annual report shall be provided in a written format to the contractor within 45 calendar days of receipt of the annual program report.

1 C-57, September 19,2011

Attachment J-10 TOM Change 7, Section 4

TQMC HT9402-15-R-0005, Section J, Attachment J-10 1 of 6

TRICARE Operations Manual6010.56-M, February 1, 2008 Chapter 7, Section 4

Clinical Quality Management Program {CQMP)

3.0 COMMON TERMS AND DEFINITIONS

3.1 Quality Improvement Initiative (QII)

The purpose of a Qll is to improve processes internal to the organization and may include improvements in clinical administrative processes, program related issues or new methods in accomplishing outcomes of the program such as cycle time, effectiveness, efficiency, reporting tools, related processes between departments affecting desired outcomes, etc. Common tools for improvements in processes may include various methods that include core elements such as baseline data, interventions/actions, re-measurement, monitoring and follow-up. Process improvements shall be appropriately documented to demonstrate purpose of improvement, baseline measure{s), actions/interventions, re-measurement(s) and outcomes.

3.2 Quality Improvement Projects (QIP)

A QIP is a set of related activities designed to achieve measurable improvement in processes and outcomes of care. Improvements are achieved through interventions that target health care providers, practitioners, plans, and/or beneficiaries. QIPs may address administrative processes, beneficiary health, error reduction or safety improvement, beneficiary functional status, beneficiary or provider satisfaction, program related issues or to serve as a valid proxy for high-volume or high risk issues. They may result after being identified from a Clinical Quality Study {CQS) as an opportunity for improvement. QIPs should be structured with appropriate elements such as clearly defined sample sizes and inclusions/exclusion criteria. They shall be appropriately operationalized, meaning appropriate scientific methodology and rigor should be applied such as using written research questions and statistically significant analysis as applicable. Lastly, QIPs shall be appropriately documented by including the common elements of a QIP:

Common elements of a QIP:

Description and purpose of topic

• Description of the population

• Rationale for selection of the QIP baseline data

Description of data collection

• Goals and time frames

• Action plan/interventions

• Periodic re-measurements and outcomes

3.3 Clinical Quality Study

An assessment conducted of a patient care problem for the purpose of improving patient care through peer analysis, intervention, resolution of the problem, and follow-up. A CQS should be appropriately operationalized, meaning appropriate scientific methodology and rigor should be applied such as using written research questions and statistical significant analysis as applicable.

Typically these do not require evidence-based interventions, multiple measurement cycles, or sophisticated statistical analysis.

• Common elements of CQS:

Description of CQS and purpose of topic Rationale for the selection of the CQS Define the study question

2 C -57, September 19, 2011

TQMC HT9402-15-R-0005, Section J, Attachment J-10 2 of 6

TRICARE Operations Manuai6010.56-M, February 1, 2008

Clinical Quality Management Program (CQMP)

• Description of methodology used

• Select the indicators/measures

Description of data collection Description of the population and sampling techniques (if applicable) Report of findings to include a definition of the study, description of data collection, statement of hypothesis, analytic methods and population employed, data analysis and interpretation Plan for follow-up of the CQS to include interventions and measurements as applicable

3.4 Potential Quality Issue (PQI)

A clinical or system variance warranting further review and investigation for determination of the presence of an actual Quality Issue (QI).

3.5 Quality Issue (QI)

A verified deviation from acceptable standards of practice or standards of care as a result of some process, individual, or institutional component of the health care system.

4.0 CQMP STRUCTURAL AND FUNCTIONAL REQUIREMENTS

1 4.1 The contractor shall allow their respective TRO/TRICARE Area Office (TAO), TOPO, and DPPO clinical staff active participation in their CQMP and non-voting membership in their region level Quality Management Committees. The contractor shall develop and implement written policies and procedures to identify POls, steps to resolve identified problems, suggest interventions to resolve problems, and provide ongoing monitoring of all components of the contractor's operations and the care and treatment ofTRICARE beneficiaries.

4.2 Using the most current National Quality Forum (NQF) Serious Reportable Events (SREs) and Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicators, the contractor shall identify, track, trend, and report interventions to resolve the POls and Qls. Additionally, the

1 contractor shall report potential SREs to the TRO/TAO or DPPO within two business days from when the contractor becomes aware of the event. The report shall include the beneficiary's name, last four digits of sponsor's Social Security Number (SSN), beneficiary date of birth, enrollment status, brief summary of the event, location of the event, and any contractor actions taken to date. The contractor shall report, by a secure means, closure of the reported SRE within two business days to include closure date and summary of actions taken (for MCSCs, see CDRL R020).

5.0 PATIENT SAFETY OR QIIDENTIFICATION

The contractor shall apply medical judgment, evidence based medicine, best medical practice and follow the TRICARE criteria as set forth in paragraphs 4.0 and 4.1 for the identification, evaluation and reporting of all POls and confirmed Qls. The contractor shall assess every medical record reviewed for any purpose and any care managed/observed/monitored on an ongoing basis for POls.

3 C-57, September 19, 2011

TQMC HT9402-15-R-0005, Section J, Attachment J-10 3 of 6

Clinical Quality Management Program (CQMP)

5.1 Quality Intervention

The contractor shall implement appropriate quality interventions using evidence based medicine/guidelines and best medical practices to reduce the number of Qls and improve patient safety. When the contractor confirms a Ql, the determination shall include assignment of an appropriate severity level and/or sentinel event, and describe the actions taken to resolve the quality problem. For Quality Intervention Reporting, see CDRL M040.

5.2 Definitions

• PQI- A clinical or system variance warranting further review and investigation for determination of the presence of an Actual Ql.

No Ql- Following investigation there is NO Ql finding.

Ql- A verified deviation from acceptable standard of practice or standard of care as a result of some process, individual, or institutional component of the health care system.

• Severity Levell - Ql is present with minimal potential for significant adverse effects on the patient.

Severity Level2- Ql is present with the potential for significant adverse effects on the patient.

Severity Level 3- Ql is present with significant adverse effects on the patient.

• Severity Level4- Ql with the most severe adverse effect and warrants exhaustive review.

Sentinel Event- A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. (Joint Commission definition of Sentinel Event.)

5.3 PQI Jurisdiction

The contractor with geographic jurisdiction has the ability to have meaningful "quality interventions," and has the best opportunity to demonstrate improved quality by providers within its jurisdiction. Thus, consistent with the TRICARE Operations Manual (TOM) requirements, cross region PQI issues are handled as follows: The contractor who receives and/or identifies potential quality issue shall conduct an initial clinical assessment based upon the information on hand and if a potential quality issue exists, forward the case and all supporting information to the contractor with the geographic jurisdiction for the case review, investigation, and intervention(s).

4 C-57, September 19,2011

TQMC HT9402-15-R-0005, Section J, Attachment J-10 4 of 6

Clinical Quality Management Program (CQMP)

6.0 AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ) PATIENT SAFETY

INDICATORS

Annually, the contractor shall utilize the current patient safety indicator software, provider level, available from the AHRQ to evaluate the safety of care delivered in the network. The software is designed for use with administrative data sets and will not require manual chart abstraction. The contractor shall run the appropriate data for all of the patient safety indicators and use the analysis of the results to identify POls and patient safety issues for individual providers, groups or facilities .

Analysis will also be used to provide focus for specific patient safety interventions and/or study activity that will be implemented at the direction of the contractor.

-END-

5 C -57, September 19, 2011

TQMC HT9402-15-R-0005, Section J, Attachment J-10 5 of 6

TQMC HT9402-15-R-0005, Section J, Attachment J-10 6 of 6

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