ATTACHMENT B - Quality Assurance Surveillance Plan.docx

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Indian Health Service Navajo Area Indian Health Service Gallup Indian Medical Center Non-Personal Pharmacist Services PWS No. GIMC-23-01 Issued: May 25, 2026

Table of Contents

· 1.0 Introduction

· 1.1 Purpose

· 1.2 Performance Management Approach

· 1.3 Performance Management Strategy

· 2.0 Roles and Responsibilities

· 2.1 The Contracting Officer (CO)

· 2.2 The Contracting Officer's Representative (COR)

· 3.0 Identification of Required Performance Standards and Quality Levels

· 4.0 Methodologies to Monitor Performance

· 4.1 Surveillance Techniques

· 4.2 Customer Feedback

· 4.3 Acceptable Quality Levels

· 5.0 Quality Assurance Documentation

· 5.1 The Performance Management Feedback Loop

· 5.2 Monitoring Forms

· 6.0 Analysis of Quality Assurance Assessment

· 6.1 Determining Performance

· 6.2 Reporting

· 6.3 Reviews and Resolution

· Attachment 1: Performance Requirements Summary (PRS)

· Attachment 2: Quality Assurance Monitoring Form

1.0 Introduction

This Quality Assurance Surveillance Plan (QASP) is pursuant to the requirements established in the Performance Work Statement (PWS) entitled Non-Personal Pharmacist Services, PWS No. GIMC-23-01, for the Gallup Indian Medical Center (GIMC) and Tohatchi Health Center (THC), Navajo Area Indian Health Service (NAIHS). This plan sets forth the procedures and guidelines the Government will use to ensure the Contractor meets the required performance standards and service levels identified in the PWS.

1.1 Purpose

The purpose of this QASP is to describe the systematic methods used to monitor Contractor performance, identify required documentation, and define the resources employed in surveillance activities. The QASP provides the Government with a means to evaluate whether the Contractor is meeting the performance standards and acceptable quality levels (AQLs) identified in the PWS and the Contractor's Quality Control Plan (QCP), and to ensure the Government pays only for the level of services actually received.

This QASP defines the roles and responsibilities of all members of the integrated project team (IPT), identifies performance objectives, defines the methodologies used to monitor and evaluate Contractor performance, describes quality assurance documentation requirements, and describes the analysis of quality assurance monitoring results.

1.2 Performance Management Approach

The PWS structures this acquisition around what service or quality level is required, rather than how the Contractor performs the work — that is, results rather than compliance. This QASP defines the performance management approach the Government will use to monitor the Contractor's performance and ensure the expected outcomes 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 indicating whether expected outcomes are being achieved by the Contractor.

Performance management focuses on assessing whether outcomes are being achieved and to what extent, rather than scrutinizing compliance with the processes and practices used to achieve those outcomes. A performance-based approach enables the Contractor to determine how the work is performed, provided proposed processes remain within stated constraints. The only exceptions to process reviews are those required by law and compelling business situations such as patient safety and infection control. A results-focused approach provides the Contractor flexibility to continuously improve and innovate over the course of the contract, provided critical outcomes are being achieved and desired performance levels are being met.

1.3 Performance Management Strategy

The Contractor is responsible for the quality of all work performed under this contract. The Contractor measures that quality through its Quality Control Plan (QCP). Quality control encompasses all work performed under this contract regardless of whether the work is performed by Contractor employees or subcontractors. The Contractor's QCP sets forth the staffing and procedures for self-inspecting the quality of its staffing management performance — including fill rates, credential compliance, pre-placement verification, roster timeliness, and vacancy response — as well as the timeliness, responsiveness, customer satisfaction, and clinical performance requirements identified 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. This QASP enables the Government to take advantage of the Contractor's QC program.

The COR 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 determinations regarding incentives and deductions based on performance measurement data and will notify the Contractor of those decisions. The Contractor is responsible for making required changes in processes and practices to ensure performance is managed effectively.

2.0 Roles and Responsibilities

2.1 The Contracting Officer (CO)

The CO is responsible for monitoring contract compliance, contract administration, and cost control, and for resolving any differences between observations documented by the COR and the Contractor. The CO will designate a COR as the Government's authorized representative for performance management. The CO retains sole authority to make contractual commitments, authorize changes to contract terms or conditions, issue cure notices, and take remedial action including deductions and termination.

2.2 The Contracting Officer's Representative (COR)

The COR is designated in writing by the CO to act as the CO's authorized representative in assisting with contract administration. COR limitations are contained in the written designation letter. The COR is responsible for the technical administration of the contract and for ensuring proper Government surveillance of the Contractor's performance. The COR is not empowered to make contractual commitments or authorize contractual changes on the Government's behalf. Any changes the Contractor believes may affect contract price, terms, or conditions shall be referred to the CO for action.

The COR is responsible for:

1. Conducting surveillance of Contractor performance using the methods identified in Section 4.0;

2. Completing Quality Assurance Monitoring Forms (Attachment 2) to document inspections and evaluations of Contractor performance;

3. Reviewing coverage rosters, vacancy notifications, fill rate reports, QCP submissions, and individual pharmacist pre-placement verification records for completeness and timeliness;

4. Documenting and investigating valid customer complaints;

5. Preparing monthly performance reports for submission to the CO; and

6. Recommending remedial action to the CO when the Contractor fails to meet required performance standards or AQLs.

3.0 Identification of Required Performance Standards and Quality Levels The required performance standards and AQLs are established in the PWS, Section 9.0, Performance Requirements Summary, which is incorporated into this QASP as Attachment 1. If the Contractor meets the required service or performance level, it will be paid the contract price for services rendered. Failure to meet the required service or performance level will result in a deduction from payment in accordance with FAR 52.212-4(b), as documented by the CO following COR recommendation.

4.0 Methodologies to Monitor Performance

4.1 Surveillance Techniques

The Government will use the following surveillance methods to evaluate Contractor performance. Methods will be applied as appropriate to each performance requirement identified in Attachment 1.

1. Random Sampling — The COR will conduct unannounced reviews of a statistically representative sample of patient records, counseling documentation, prescription files, and other performance artifacts to assess compliance with PWS requirements.

2. 100% Inspection — For critical performance requirements — including credential compliance, pre-placement verification, coverage roster submission, unplanned vacancy notification, personnel closeout, HIM record completion, and QCP submission — the COR will review each occurrence. No sampling rate below 100% is acceptable for these requirements.

3. Periodic Inspection — The COR will conduct scheduled reviews of pharmacy inventory records, emergency drug cart logs, training completion records, and quality assurance committee participation records at intervals no less than monthly.

4. Customer Complaint Review — The COR will review, investigate, and document all customer complaints received. Valid complaints will be incorporated into the monthly performance report.

5. Document and Record Review — The COR will review coverage rosters, fill rate reports, vacancy notification logs, replacement confirmation records, ramp-up status reports, QCP submissions, personnel closeout checklists, and individual pharmacist pre-placement verification records — including licensure, certifications, medical staff credentialing status, and HSPD-12 clearance — against the deadlines and standards established in the PWS.

4.2 Customer Feedback

The Contractor is expected to establish and maintain professional communication between its personnel and patients, clinical staff, and facility management at both GIMC and THC. Customer satisfaction is a significant external indicator of the effectiveness of services provided.

Customer complaints, to be considered valid, shall be submitted in writing, shall clearly describe the nature of the complaint in detail, shall be signed by the complainant, and shall be forwarded to the COR. Complaints received by the CO will be forwarded to the COR for investigation and documentation. The COR will accept and investigate all valid customer complaints. Customer feedback may also be obtained through formal customer satisfaction surveys conducted by the Government.

4.3 Acceptable Quality Levels

The AQLs in Attachment 1 are structured to allow the Contractor to manage how the work is performed while providing clear negative incentives for performance shortfalls. For critical activities — including credential compliance, individual pharmacist pre-placement verification, patient safety, HSPD-12 clearance, medical staff credentialing, HIM record completion, personnel closeout, coverage roster submission, and unplanned vacancy response — the required performance level is 100%. Other performance levels are keyed to the relative importance of each task to the overall mission of GIMC and THC.

5.0 Quality Assurance Documentation

5.1 The Performance Management Feedback Loop

The performance management feedback loop begins with the communication of expected outcomes in the PWS. Performance standards are assessed using the monitoring techniques identified in Attachment 1. Monitoring results are documented on the forms in Attachment 2, analyzed monthly, reported to the CO, and communicated to the Contractor. The Contractor responds through its QCP and, where required, through a corrective action plan. The loop continues through the life of the contract.

5.2 Monitoring Forms

Government surveillance, conducted by the COR, will be documented using the Quality Assurance Monitoring Form in Attachment 2. Completed forms document the Government's assessment of Contractor performance to ensure required results and AQLs are being achieved.

The COR will retain a copy of all completed Quality Assurance Monitoring Forms. Completed forms will be included in the monthly performance report submitted to the CO and will become part of the permanent contract administration file.

6.0 Analysis of Quality Assurance Assessment

6.1 Determining Performance

The Government will use the monitoring methods cited in Section 4.0 to determine whether the Contractor has met the performance standards and AQLs identified in Attachment 1. If the Contractor has not met the minimum requirements for a given performance standard, the COR will document the deficiency and may require the Contractor to develop a corrective action plan describing how and by what date the Contractor intends to bring performance to the required level.

Failure to meet an AQL may result in a deduction from payment, in accordance with FAR 52.212-4(b), based on the remedies identified in Attachment 1. Deductions will be initiated by the CO upon COR recommendation and supporting documentation.

6.2 Reporting

At the end of each month, the COR will prepare a written performance report for the CO summarizing the overall results of quality assurance surveillance. This report will include:

1. A summary of surveillance activities conducted during the month and the methods used;

2. Completed Quality Assurance Monitoring Forms for each surveilled performance standard;

3. The Contractor's submitted monthly fill rate report and coverage roster reconciliation;

4. A summary of the pre-placement verification status of all pharmacists listed on the current coverage roster, including any pending, denied, or withdrawn credentialing or clearance actions;

5. A summary of personnel closeout actions completed during the month, including confirmation of PIV card surrender, HIM clearance, IT deactivation, timesheet submission, and COR sign-off for each departing pharmacist;

6. A summary of any incomplete medical record or HIM deficiencies identified during the month, including the Contractor's corrective actions and resolution status;

7. A summary of any customer complaints received, investigated, and resolved;

8. A summary of any credential compliance events, vacancy notifications, and replacement response times;

9. An assessment of whether each AQL was met, partially met, or not met; and

10. Any recommended remedial actions, deductions, or corrective action plan requirements for CO consideration.

6.3 Reviews and Resolution

The CO or COR may require the Contractor's designated point of contact to meet with Government IPT personnel as deemed necessary to discuss performance evaluations. The CO will define the frequency of formal in-depth reviews with the Contractor; however, if the need arises, the Contractor will meet with the COR as often as required or upon the Contractor's request.

The agenda for performance reviews may include:

1. Monthly performance assessment data and trend analysis;

2. Issues and concerns of both parties;

3. Projected outlook for upcoming months and progress against expected trends, including corrective action plan status;

4. Recommendations for improved efficiency or effectiveness; and

5. Issues arising from the performance monitoring process.

The COR will coordinate and communicate with the Contractor to resolve issues and concerns regarding marginal or unacceptable performance. The CO and Contractor should jointly formulate tactical and long-term courses of action where appropriate. Decisions regarding changes to metrics, thresholds, or service levels shall be clearly documented. Changes to service levels, procedures, or metrics will be incorporated by contract modification executed by the CO.

Attachment 1: Performance Requirements Summary (PRS) The Performance Requirements Summary is incorporated from PWS No. GIMC-23-01, Section 9.0, and is reproduced here for reference.

Attachment 2: Quality Assurance Monitoring Form

SERVICE OR STANDARD:

PWS REFERENCE:

SURVEY PERIOD:

SURVEILLANCE METHOD (check one):

☐ Random Sampling ☐ 100% Inspection ☐ Periodic Inspection ☐ Customer Complaint ☐ Document and Record Review LEVEL OF SURVEILLANCE (check one):

☐ Monthly ☐ Quarterly ☐ As Needed

PERCENTAGE OF ITEMS SAMPLED DURING SURVEY PERIOD: _______ %

ANALYSIS OF RESULTS:

Observed Contractor Performance Measurement Rate: _______ % Contractor's Performance (check one):

☐ Meets Standard ☐ Does Not Meet Standard Narrative of Performance During Survey Period:

Recommended Action (if standard not met):

☐ No action required ☐ Verbal notice to Contractor ☐ Written notice to Contractor ☐ Corrective action plan required ☐ Recommend deduction to CO ☐ Recommend cure notice to CO

PREPARED BY (COR): _________________________________ DATE: _______________

REVIEWED BY (CO): _________________________________ DATE: _______________