Quality Assurance Surveillance Plan (QASP) - 188 MDG Medical Lab Services Blanket Purchase Agreement .pdf

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

188th Medical Group – Medical Laboratory Services

Issued: 01 APR 2024 ii

TABLE OF CONTENTS

1 INTRODUCTION

1.1 Purpose

1.2 Performance Management Approach

1.3 Performance Management Strategy

2 ROLES AND RESPONSIBILITIES

2.1 The Contracting Officer

2.2 The Contracting Officer’s Technical Representative

3 IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY LEVELS

4 METHODOLOGIES TO MONITOR PERFORMANCE

4.1 Surveillance Techniques

4.2 Customer Feedback

4.3 Acceptable Quality Levels

5 QUALITY ASSURANCE DOCUMENTATION

5.1 The Performance Management Feedback Loop

5.2 Monitoring Forms

6 ANALYSIS OF QUALITY ASSURANCE ASSESSMENT

6.1 Determining Performance

6.2 Reporting

6.3 Reviews and Resolution

ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY

ATTACHMENT 2: SAMPLE QUALITY ASSURANCE MONITORING FORM

QUALITY ASSURANCE SURVEILLANCE PLAN

(QASP)

1 INTRODUCTION

This quality assurance surveillance plan (QASP) is pursuant to the requirements listed in the PWS for

Blanket Purchase Agreement for Medical Laboratory Testing Services. This plan sets forth the procedures and guidelines the 188th Medical Group Squadron will use in ensuring the required performance standards or services levels are achieved by the contractor.

1.1 Purpose

1.1.1 The purpose of the QASP is to describe the systematic methods used to monitor performance and to identify the required documentation and the resources to be employed. The QASP provides a means for evaluating whether the contractor is meeting the performance standards/quality levels identified in the

PWS and the contractor’s quality control plan (QCP), and to ensure that the government pays only for the level of services received.

1.1.2 This QASP defines the roles and responsibilities of all members of the integrated project team

(IPT), identifies the performance objectives, defines the methodologies used to monitor and evaluate the contractor’s performance, describes quality assurance documentation requirements, and describes the analysis of quality assurance monitoring results.

1.2 Performance Management Approach

1.2.1 The PWS structures the acquisition around “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 188th Medical Group Squadron to monitor and manage 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.

1.2.2 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. The only exceptions to process reviews 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 if the critical outcomes expected are being achieved and/or the desired performance levels are being met.

1.3 Performance Management Strategy

1.3.1 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 regardless of whether the work is performed by contractor employees or by subcontractors. The contractor’s QCP will set forth the staffing and procedures for self-inspecting the quality, timeliness, responsiveness, customer satisfaction, and other performance requirements in the PWS. The contractor will develop and implement a performance management system with processes to assess and report its performance to the designated government representative. The contractor’s QCP will set forth the staffing and procedures for self-inspecting the quality, timeliness, responsiveness, customer satisfaction, and other performance requirements in the

PWS. This QASP enables the government to take advantage of the contractor’s QC program.

1.3.2 The government representative(s) will monitor performance and review performance reports furnished by the contractor to determine how the contractor is performing against communicated performance objectives. The government will make determination regarding incentives based on performance measurement metric data and notify the contractor of those decisions. The contractor will be responsible for making required changes in processes and practices to ensure performance is managed effectively.

2 ROLES AND RESPONSIBILITIES

2.1 The Contracting Officer

The contracting officer (CO) is responsible for monitoring contract compliance, contract administration, and cost control and for resolving any differences between the observations documented by the 188th

Medical Group’s contracting officer's representative (COR) and the contractor. The CO will designate one full-time Project Manager / COR as the government authority for performance management. The number of additional representatives serving as technical inspectors depends on the complexity of the services measured, as well as the contractor’s performance, and must be identified and designated by the

CO.

2.2 The Contracting Officer’s Technical Representative

The contracting officer’s technical representative (COTR) is designated in writing by the CO to act as his or her authorized representative to assist in administering a contract. COTR limitations are contained in the written appointment letter. The COTR is responsible for technical administration of the project and ensures proper government surveillance of the contractor’s performance. The COTR is not empowered to make any contractual commitments or to authorize any contractual changes on the government’s behalf.

Any changes that the contractor deems may affect contract price, terms, or conditions shall be referred to the CO for action. The COTR will have the responsibility for completing QA monitoring forms used to document the inspection and evaluation of the contractor’s work performance. Government surveillance may occur under the inspection of services clause for any service relating to the contract.

3 IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY LEVELS

The required performance standards and/or quality levels are included in the PWS and in Attachment 1, “Performance Requirements Summary.” If the contractor meets the required service or performance level, it will be paid the monthly amount agreed on in the contract.

4 METHODOLOGIES TO MONITOR PERFORMANCE

4.1 Surveillance Techniques

To minimize the performance management burden, simplified surveillance methods shall be used by the government to evaluate contractor performance when appropriate. The primary methods of surveillance are (include those that apply)

➢ Random monitoring, which shall be performed by the COTR/COR designated inspector.

➢ 100% Inspection – Each month, the COTR/COR, shall review the generated documentation and enter summary results into the Surveillance Activity Checklist.

➢ Periodic Inspection – COTR/COR typically performs the periodic inspection monthly.

4.2 Customer Feedback

The contractor is expected to establish and maintain professional communication between its employees and customers. The primary objective of this communication is customer satisfaction. Customer satisfaction is the most significant external indicator of the success and effectiveness of all services provided and can be measured through customer complaints.

Performance management drives the contractor to be customer focused through initially and internally addressing customer complaints and investigating the issues and/or problems but the customer always has the option to communicate complaints to the CO or COR as opposed to the contractor.

Customer complaints, to be considered valid, must set forth clearly and in writing the detailed nature of the complaint, must be signed, and must be forwarded to the COTR/COR. The COTR/COR will accept those customer complaints and investigate using the Quality Assurance Monitoring Form – Customer

Complaint Investigation, identified in Attachment 3.

Customer feedback may also be obtained either from the results of formal customer satisfaction surveys or from random customer complaints.

4.3 Acceptable Quality Levels

The acceptable quality levels (AQLs) included in Attachment 1, Performance Requirements Summary

Table, for contractor performance are structured to allow the contractor to manage how the work is performed while providing negative incentives for performance shortfalls. For certain critical activities such as those involving maintenance, repair, renovation, and new construction work, the desired performance level is established at 100 percent. Other levels of performance are keyed to the relative importance of the task to the overall mission performance at the 188th Wing.

5 QUALITY ASSURANCE DOCUMENTATION

5.1 The Performance Management Feedback Loop

The performance management feedback loop begins with the communication of expected outcomes.

Performance standards are expressed in the PWS and are assessed using the performance monitoring techniques shown in Attachment 1.

5.2 Monitoring Forms

The government’s QA surveillance, accomplished by the COR, will be reported using the monitoring forms in Attachments 2 and 3. The forms, when completed, will document the government’s assessment of the contractor’s performance under the contract to ensure that the required results (execution of maintenance, repair, renovation, and new construction work in accordance with the plans and specifications) are being achieved.

5.2.1 The COR will retain a copy of all completed QA surveillance forms.

6 ANALYSIS OF QUALITY ASSURANCE ASSESSMENT

6.1 Determining Performance

6.1.1 Government shall use the monitoring methods cited to determine whether the performance standards/service levels/AQLs have been met. If the contractor has not met the minimum requirements, it may be asked to develop a corrective action plan to show how and by what date it intends to bring performance up to the required levels.

6.2 Reporting

6.2.1 At the end of each month, the COR will prepare a written report for the 188th Medical Group

Squadron summarizing the overall results of the quality assurance surveillance of the contractor’s performance. This written report, which includes the contractor’s submitted monthly report and the completed quality assurance monitoring forms (Attachment 2), will become part of the QA documentation. It will enable the government to demonstrate whether the contractor is meeting the stated objectives and/or performance standards, including cost/technical/scheduling objectives.

6.3 Reviews and Resolution

6.3.1 The COR may require the contractor’s project manager, or a designated alternate, to meet with the CO, COR and other government IPT personnel as deemed necessary to discuss performance evaluation. The CO and COR will define a frequency of in-depth reviews with the contractor, including appropriate self-assessments by the contractor; however, if the need arises, the contractor will meet with the COR, as often as required or per the contractor’s request. The agenda of the reviews may include:

➢ Monthly performance assessment data and trend analysis

➢ Issues and concerns of both parties

➢ Projected outlook for upcoming months and progress against expected trends, including a corrective action plan analysis.

➢ Recommendations for improved efficiency and/or effectiveness

➢ Issues arising from the performance monitoring processes

6.3.2 The QAR must coordinate and communicate with the contractor to resolve issues and concerns regarding marginal or unacceptable performance.

6.3.3 The COR and contractor should jointly formulate tactical and long-term courses of action.

Decisions regarding changes to metrics, thresholds, or service levels should be clearly documented.

Changes to service levels, procedures, and metrics will be incorporated as a contract modification at the convenience of the CO.

ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY

PWS

Paragraph

Task Performance

Standard

Acceptable Quality Levels

(AQL)

Surveillance Method by Whom

5.1

The contractor will retrieve all test samples provided by the 188 MDG to their collection site(s)

The contractor will retrieve all test samples provided by the 188 MDG to their collection site(s)

100% 188 MDG personnel delivering specimens

5.11

The contractor will process all samples provided IAW industry standards

The contractor will process all samples provided IAW industry standards

100% Random inspection/COR

5.12

The contractor will compile the results for each patient into a lab report

The contractor will compile the results for each patient into a lab report

100% Monthly Inspection/COR

5.13

The contractor will submit reports electronically to the 188 MDG for each patient within 72 hours (could vary depending on the test)

The contractor will submit reports electronically to the 188 MDG for each patient within 72 hours (could vary depending on the test)

Immediate notification of lab results after processing

Random inspection/COR

5.14

The contractor will submit a detailed invoice monthly for requesting payment to the 188 MDG POC and the Contracting Officer within 14 business days

The contractor will submit a detailed invoice monthly for requesting payment to the 188 MDG POC and the Contracting Officer within 14 business days

Invoice is received later than 14 business days twice during the POP

Random monitoring/COR

ATTACHMENT 2: SAMPLE QUALITY ASSURANCE MONITORING FORM

SERVICE or STANDARD: Accomplishment of all work in accordance with the PWS Blanket Purchase

Agreement for Medical Laboratory Testing Services. as well as in compliance with all applicable government regulations and standard industry practices.

SURVEY PERIOD: The Period of Performance shall be 1 Base Year of 12 months and four (4) 12-month option years.

SURVEILLANCE METHOD (Check):

_ Random Sampling X 100% Inspection _ Periodic Inspection X Customer Complaint

LEVEL OF SURVEILLANCE (Check):

X Monthly _ Quarterly _ As needed

PERCENTAGE OF ITEMS SAMPLED DURING SURVEY PERIOD: 100 %

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: _________________

ATTACHMENT 3 QUALITY ASSURANCE MONITORING FORM – CUSTOMER

COMPLAINT INVESTIGATION

Customer Information

Customrer Name: PH #:

Address:

Contact Name: Title:

Invoice Number:

Lab Code:

Lab Description:

Complaint Information

Date: Complaint Taken By :

Complaint Details:

Corrective Action Taken:

Suspected Cause:

Corrective Action Person(s):

Corrective Action Follow-up:

What steps should be considered to avoid a repeat of the problem: