QASP -Medical Laboratory Tests-BPA.pdf

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Medical Lab Services 5-year Blanket Purchase Agreement (BPA)

For

156th Wing at Muniz Air Base, Carolina, Puerto Rico

Issued February 21, 2025

(Ver May 2018)

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: QUALITY ASSURANCE MONITORING FORM

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1 INTRODUCTION

This QASP is pursuant to the requirements listed in the performance work statement (PWS) entitled PFAS Multi-installation Assessment. This plan sets forth the procedures and guidelines the PFAS Test and report submission 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 conducting Service Contract conduct PFAS sampling, analysis evaluation and submission of samples result report 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 as long as 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

(Ver. May 2018) 2 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 Contracting Officer Representative/Contracting Officer Technical Representative (COR/COTR) will monitor performance and review performance reports furnished 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 ROLES AND RESPONSIBILITIES

2.1 The Contracting Officer

The Contracting Officer (KO) is responsible for monitoring contract compliance, contract administration, cost control and for resolving any differences between the observations documented by the COR/COTR and the contractor. The KO will designate one full-time COR/COTR 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 KO.

2.2 The COR/COTR

The COR/COTR is designated in writing by the KO to act as his or her authorized representative to assist in administering a contract. COR/COTR limitations are contained in the written appointment letter. The COR/COTR is responsible for technical administration of the project and ensures proper government surveillance of the contractor’s performance. The COR/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 KO for action. The COR/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. Failure to meet the required service or performance level will result in a deduction from the monthly amount.

4 METHODOLOGIES TO MONITOR PERFORMANCE

4.1 Surveillance Techniques

In an effort 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:

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

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

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Periodic Inspection – COR/COTR typically performs the periodic inspection on a monthly basis.

4.2 Customer Feedback

4.2.1 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.

4.2.2 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 COR/COTR as opposed to the contractor.

4.2.3 Customer complaints, to be considered valid, must set forth clearly and in writing. The detailed nature of the complaint must be stated, document signed and forwarded to the COR/COTR. Upon receipt of a complaint, the COR/COTR will investigate and document the findings on the monitoring form, Attachment 2 and in the COR file.

4.2.4 Customer feedback may also be obtained from the results of formal customer satisfaction surveys or 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 samples collection and result evaluation and final report submission, 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.

5 QUALITY ASSURANCE DOCUMENTATION 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, Performance Requirements Summary.

5.2 Monitoring Forms

The government’s QA surveillance, accomplished by the COR/COTR, will be reported using the monitoring form in Attachment 2. The form, when completed, will document the government’s assessment of the contractor’s performance under the contract to ensure that the required quality levels are being achieved.

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

6 ANALYSIS OF QUALITY ASSURANCE ASSESSMENT

6.1 Determining Performance

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6.1.1 The 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. Failure to meet the AQL may result in a deduction from the monthly payment.

6.2 Reporting

6.2.1 At the end of each month, the COR will prepare a written report for the KO summarizing the overall results of the quality assurance surveillance of the contractor’s performance. This written report, which includes the contractor’s submitted draft and final report and the completed quality assurance monitoring form (Attachment 2), will become part of the QA documentation and COR/COTR file. 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/COTR may require the contractor’s project manager, or a designated alternate, to meet with the KO, COR/COTR and other government IPT personnel as deemed necessary to discuss performance evaluation. The COR/COTR 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/COTR 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 COR/COTR must coordinate and communicate with the contractor to resolve issues and concerns regarding marginal or unacceptable performance.

6.3.3 The COR/COTR 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 KO.

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ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY (PRS)

Task Performance Standard Acceptable Quality

Levels (AQL) Surveillance Method By

(5.1) Accuracy of Results

The precision and reliability of the laboratory tests performed, as reflected in the detailed reports.

- Error tolerance:

No more than 2 error per 1,000 tests.

- Accuracy threshold: no less than 98%.

- Accuracy audits will be conducted every three months.

- Corrective action trigger will be 1% in any given month.

Periodic Inspection by MSgt Eduardo

Rivera

(5.2) Timeliness

The promptness with which laboratory tests are completed and results are sent electronically to the designated personnel.

- Laboratory results should be completed and sent electronically to designated personnel no later than 7 calendar days

Periodic Inspection by MSgt Eduardo

Rivera

(5.3) Customer Satisfaction

Feedback from the medical personnel regarding the clarity, thoroughness, and utility of the laboratory results.

- Feedback from medical personnel regarding clarity and thoroughness of results.

Customer Complaint

(5.4) Compliance with Standards

Adherence to all relevant regulations, including CLIA, CAP, OSHA, and other Air Force applicable standards.

- Adherence to Air Force regulations and with CLIA, CAP, and OSHA.

Management Information

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ATTACHMENT 2: QUALITY ASSURANCE MONITORING FORM

PERFORMANCE OBJECTIVE or STANDARD:

SURVEY PERIOD:

SURVEILLANCE METHOD (Check):

Random Sampling 100% Inspection Periodic Inspection Customer Complaint

LEVEL OF SURVEILLANCE (Check):

Monthly Quarterly As needed

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: