Clinical process standardization



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DEPARTMENT OF VETERANS AFFAIRS

VETERANS HEALTH ADMINISTRATION

OFFICE OF INFORMATICS AND INFORMATION GOVERNANCE

(formerly Office of Informatics and Analytics)

APPLIED INFORMATICS

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)
for
CLINICAL PROCESS STANDARDIZATION”

February 22, 2017

Project: Applied Informatics Clinical Process Standardization”
Contract/Order Number: TBD
Contract/order Description:
Services acquired under this contract will provide training needs assessments, training plans, training content, and deliver clinical training to field facility staff. The scope of this Performance Work Statement (PWS) includes tasks to assess and analyze training needs, develop a training plan, deliver training, and measure and track the performance of training execution, effectiveness, and progress achieved towards preparedness and adoption of Health Information Technology (HIT) released to the field.

Contractor’s Name: TBD
1. PURPOSE
This Quality Assurance Surveillance Plan (QASP) provides a systematic method to monitor Contractor performance. This QASP describes:


  • What will be monitored

  • How monitoring will take place

  • Who will conduct the monitoring

  • How monitoring efforts and results will be documented

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall notify the Contractor of any changes. Copies of the original QASP and revisions shall be provided to the Contractor and Government officials responsible for surveillance activities.



1.2 Performance Management Approach
The PWS sets forth “what” service or quality level is required, as opposed to “how” the Contractor should perform the work (i.e., results, not compliance). This QASP will define the performance management approach taken by the government to monitor the Contractor’s performance to ensure the expected outcomes or performance objectives communicated in the PWS are achieved. Performance management rests on developing a capability to review and analyze information generated through performance assessment. The ability to make decisions based on the analysis of performance data is the cornerstone of performance management; this analysis yields information that indicates whether expected outcomes for the project are being achieved by the Contractor.
Performance management represents a significant shift from the more traditional quality assurance (QA) concepts in several ways. Performance management focuses on assessing whether outcomes are being achieved and to what extent. This approach migrates away from scrutiny of compliance with the processes and practices used to achieve the outcome. A performance-based approach enables the Contractor to play a large role in how the work is performed, as long as the proposed processes are within the stated constraints. Required processes are those required by law (federal, state, and local) and compelling business situations, such as safety and health. A “results” focus provides the Contractor flexibility to continuously improve and innovate over the course of the contract/order as long as the critical outcomes expected are being achieved and/or the desired performance levels are being met.

1.3 Performance Management Strategy
The Contractor is responsible for the quality of all work performed. The Contractor measures that quality through the Contractor’s own quality control (QC) program. QC is work output, not workers, and therefore includes all work performed under this contract/order regardless of whether the work is performed by Contractor employees or by subcontractors. The Contractor’s QC Program (QCP) will set forth the procedures for self-inspecting the quality, timeliness, responsiveness, customer satisfaction, and other performance requirements in the PWS. The Contractor will implement a performance management system with processes to assess and report its performance to the designated government representative.
1.3.1 Performance Feedback
The Government representative(s) will monitor performance by the Contractor to determine how the Contractor is performing against communicated performance objectives. The Contractor will be responsible for making required changes in processes and practices to ensure performance is managed effectively.
2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.


a. Contracting Officer (CO) - The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract/order terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the Contractor receives impartial, fair, and equitable treatment under this contract/order. The CO is ultimately responsible for the final determination of the adequacy of the Contractor’s performance.
Assigned CO: TBD
Organization or Agency: Department of Veterans Affairs, Program Contracting Activity Central
b. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract/order and shall assure proper Government surveillance of the Contractor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.
Assigned COR: Deborah Worthey
c. Other Key Government Personnel – Project Managers, Rodney Laster and Byron Fong
3. CONTRACTOR REPRESENTATIVES


  1. Program Manager – TBD

b. Other Contractor Personnel – To be completed at award; if any (name and title)
4. PERFORMANCE STANDARDS
Performance standards define acceptable performance. The Government performs surveillance to determine if the Contractor exceeds, meets or does not meet these standards.
The Performance Metrics for Deliverables and Performance Measures are outlined in the Performance Work Statement (PWS) of the solicitation. The schedule of deliverables is in same section. The Government shall utilize the Performance Requirements Summary Table, Attachment 1, in monitoring Contractor performance and shall compare Contractor performance to the Acceptable Quality Level (AQL).
5. METHODS OF QA SURVEILLANCE
Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.
100% INSPECTION. (Evaluates all outcomes.)

  • Each month, the COR, shall review the Contractor’s performance/generated documentation and enter summary results on Attachment 2, Quality Assurance Monitoring Form.


6. ACCEPTABLE QUALITY LEVELS
Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level.
The acceptable quality levels (AQLs) are included in Attachment 1, Performance Requirements Summary Table, for Contractor performance and are structured to allow the Contractor to manage how the work is performed, while providing negative incentives for performance shortfalls. Incentive for the Contractor to meet contractual requirements is to prevent rework that would be at their own expense. Also, failure to meet contractual requirements would also reflect poorly on Past Performance Evaluations.
7. INCENTIVES
The incentive for the Contractor to meet contractual requirements is to prevent rework that would be at their own expense. Work that meets or exceeds the standards will be reflected on the annual performance review.
8. DISINCENTIVES
The Disincentive for the Contractor would be the potential negative Past Performance Evaluations generated and used for future Government requirements.
9. DOCUMENTING PERFORMANCE
a. Acceptable Performance
The Government shall document positive performance on the Quality Assurance Monitoring Form, Attachment 2. Any report may become a part of the supporting documentation for any contractual action.
b. Unacceptable performance
When unacceptable performance occurs, the COR shall inform the Contractor. This will always be in writing although when circumstances necessitate immediate verbal communication, that communication will be followed in writing. The COR shall document the discussion and place it in the COR file.
When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the Contractor's program manager.
The Contractor shall acknowledge receipt of the CDR in writing. The CDR will state how long after receipt the Contractor has to take corrective action. The CDR will also specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The Government shall review the Contractor's corrective action plan to determine acceptability.
Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.
10. FREQUENCY OF MEASUREMENT

a. Frequency of Measurement.
During contract/order performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.
b. Frequency of Performance Assessment Meetings.
The COR shall meet with the Contractor monthly to assess performance and shall provide a written assessment.
ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY
BASE AND OPTION PERIODS:


TASK

DESCRIPTION

PERFORMANCE STANDARD

ACCEPTABLE QUALITY LEVELS

METHODS OF SURVELLIANCE

INCENTIVE (POSITIVE / NEGATIVE). IMPACT ON CONTRACTOR PAYMENT.

TASK 5.1

PROJECT MANAGEMENT

100% of briefings shall be performed with accuracy, timeliness, and comprehensiveness

95%

100% Inspection

Contractor shall re-work products found to be unacceptable or not meeting the intent of the task and the re-work will be considered to be within scope of this PWS.

TASK 5.2

CLINICAL TRAINING ASSESSMENT AND GAP ANALYSIS

100% of briefings shall be performed with accuracy, timeliness, and comprehensiveness

95%

100% Inspection

Contractor shall re-work products found to be unacceptable or not meeting the intent of the task and the re-work will be considered to be within scope of this PWS.

TASK 5.3

CLINICAL TRAINING PLAN

100% of briefings shall be performed with accuracy, timeliness, and comprehensiveness

95%

100% Inspection

Contractor shall re-work products found to be unacceptable or not meeting the intent of the task and the re-work will be considered to be within scope of this PWS.

TASK 5.4

TRAINING CONTENT, MATERIALS, DELIVERY, AND SUPPORT

100% of briefings shall be performed with accuracy, timeliness, and comprehensiveness

95%

100% Inspection

Contractor shall re-work products found to be unacceptable or not meeting the intent of the task and the re-work will be considered to be within scope of this PWS.

TASK 5.5

TRAINING COORDINATION AND COMMUNICATION MANAGEMENT

100% of briefings shall be performed with accuracy, timeliness, and comprehensiveness

95%

100% Inspection

Contractor shall re-work products found to be unacceptable or not meeting the intent of the task and the re-work will be considered to be within scope of this PWS.

TASK 5.6

TRAINING EFFECTIVENESS AND PERFORMANCE MEASURES

100% of briefings shall be performed with accuracy, timeliness, and comprehensiveness

95%

100% Inspection

Contractor shall re-work products found to be unacceptable or not meeting the intent of the task and the re-work will be considered to be within scope of this PWS.

TASK 5.7

POST-TRAINING SUPPORT AND CLOSE-OUT

100% of briefings shall be performed with accuracy, timeliness, and comprehensiveness

95%

100% Inspection

Contractor shall re-work products found to be unacceptable or not meeting the intent of the task and the re-work will be considered to be within scope of this PWS.


ATTACHMENT 2: QUALITY ASSURANCE MONITORING FORM

SERVICE or STANDARD:








SURVEY PERIOD:

SURVEILLANCE METHOD (Check): Inspection in the form of approved publication/dissemination of artifacts combined with 100% inspection of monthly summaries.

LEVEL OF SURVEILLANCE (Check): As needed for specific tasks combined with monthly summaries.

PERCENTAGE OF ITEMS SAMPLED DURING SURVEY PERIOD: ______ %

ANALYSIS OF RESULTS:

Observed Service Provider Performance Measurement Rate: ______%

Service Provider’s Performance (Check):  Meets Standards

 Does Not Meet Standards



Narrative of Performance During Survey Period:









PREPARED BY: ___________________________________ DATE: _________________



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