Att_3_Quality-Assurance-Surveillance-Plan_Final.pdf

NIH/OLAO/OA

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

DHHS/National Institutes of Health

Occupational Medical Service (OMS)

Quality Assurance Surveillance Plan (QASP) Contract No. [Insert No.]

Issued [Insert Date]

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 Representative

2.3 Contractor

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: OMS Contract Perfomrance Report

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 performance work statement (PWS) entitled NIH Occupational Medical Service, Section C.6.4, Quality Assurance.

This plan sets forth the procedures and guidelines NIH, Division of Occupational Health and Safety (DOHS) 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 or quality levels identified in the PWS, and to ensure that the government pays only for the level of services received consistent with the type of contract sought, namely cost-reimbursement plus fixed fee with an award term incentive.

1.1.2 This QASP defines the roles and responsibilities of certain key 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 DOHS 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.

1.3 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) and quality improvement (QI) programs. All work performed under this contract, regardless of whether the work is performed by the contractor’s employees or by subcontractors, is covered by the QC and QI plans. The contractor’s QC/QI plans 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, including improvement measures to services identified as defective. This QASP enables the government to take advantage of the contractor’s QC/QI 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 may provide the contractor with an assessment of quality of services midway through each term period. The government will make the 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 contracting officer's representative (COR) designated by the CO, and the contractor. The CO will designate one full-time COR as the government authority for performance management. The CO may designate subject matter experts such as a technical representative (TR) to assist the COR. The number of additional representatives serving as technical advisors depends on the complexity of the services measured, as well as the contractor’s performance.

2.2 The Contracting Officer’s Representative

The contracting officer’s representative (COR) is designated in writing by the CO to act as his or her authorized representative to assist in administering a contract. COR limitations are contained in the written appointment letter. The COR is responsible for technical administration of the project and ensures proper government surveillance of the contractor’s performance. The COR request that the CO approve a Technical Representative (TR) to work in the Bethesda Clinic and assist with the monitoring and reporting on the Contractor’s performance. Neither the COR nor the TR are 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 COR, working with the TR, 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.

2.3 The Contractor

The Contractor is required to perform the contract services in accordance with the PWS and the QASP.

The Contractor will provide acceptable QC/QI programs and submit Reports/Deliverables, as required, in the PWS. In addition, the Contractor will attend meetings as requested by government representatives and take part in any required risk management measures. The Contractor is responsible for developing and implementing corrective actions aimed to remedy identified defects in services rendered.

2.3.1

The Contractor’s key personnel (see PWS, C.8.2) shall serve as the Contractor’s principal on-site representative(s) and effector for fulfilling the Contractor’s roles and responsibilities under this contract.

3 IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY LEVELS

The required performance standards or quality levels are included in the PWS and summarized in the OMS Contract Performance Report. The Report’s interim (quarterly) and final annual ratings are shared with the Contractor upon completion of each rating (see Section 6, below). The Contractor is expected to achieve quarterly and annual ratings of “satisfactory,” i.e., meet the required performance standards.

For each 12-month assessment, an additional year may be added to the end of the life of the contract if the Contractor’s performance for the contract year consistently exceeds the expected level of performance (i.e., superior) outlined in OMS Contract Performance Report as determined by the CO. If the Contractor fails to meet or exceed the expected level of performance in a subsequent contract year, the previously awarded term incentive(s) may be voided by the CO (see 6.3.3 and 6.3.5).

METHODOLOGIES TO MONITOR PERFORMANCE

3.1 Surveillance Techniques

In order to ensure that OMS services are of the high quality expected by OMS customers, the COR or TR shall observe, monitor or inspect the Contractor’s performance. This QASP is designed to provide flexibility in rating the Contractor’s performance and encourage collaboration. The COR or TR will choose from the following surveillance methods those that are best suited to individual measures and performance history to evaluate the contractor:

Direct observation – COR or TR observe the Contractors’ performance without direct interference with services being provided.

Random monitoring – COR or TR evaluate a representative sample of frequently provided Contractor services.

Periodic Inspection – COR or TR evaluate tasks subject to this planned sampling at least on a quarterly basis. Periodicity may become more frequent, or augmented by random sampling, e.g., based on performance record in individual or all performance measures, at the COR’s discretion.

100% Inspection – COR or TR evaluate all services in certain categories, typically those related to rare, high-impact events.

Customer input – The Contractor shall solicit feedback from OMS patients and EAP clients with surveys and reports results to the COR or TR at least on a quarterly basis (see 4.2). Unsolicited customer feedback shall supplement the COR’s planned and random monitoring of services and may affect their frequency.

3.2 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. Customers include those who are eligible for OMS clinical services (patients/clients, workers with work-related medical needs) and administrative services (those supported by OMS, e.g., with interdependent procedures, reports, presentations, or representation).

Performance management drives the contractor to be customer-focused through initially and internally addressing customer complaints and investigating the issues or problems, but the customer always has the option to communicate complaints to the CO, COR, or TR, 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 TR. The TR or his or her designee within OMS will accept those customer complaints and investigate using the Quality Assurance Monitoring Form – Customer Complaint Investigation, identified in Attachment 2.

Customer feedback may also be obtained either from the results of formal customer satisfaction surveys in accordance with Section C.5 in the PWS, or from random customer complaints.

3.3 Acceptable Quality Levels

The acceptable (satisfactory) quality levels included in the OMS Contract Performance Report are structured to allow the contractor to manage how the work is performed while providing an award term incentive at the end of each 12-month period for superior ratings (exceeding satisfactory) in the majority of required services and no downward trend in any performance measures, and negative incentives (as determined by the CO) for performance shortfalls. For certain critical activities such as those involving patient or client care, regulatory compliance, mandatory reporting and training, and data security, 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 DOHS.

4 QUALITY ASSURANCE DOCUMENTATION

4.1 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 surveillance methods shown in the OMS Contract Performance Report.

4.2 Monitoring Forms

The government’s QA surveillance, accomplished by the COR with the assistance of the TR, will be reported by assessing quarterly ratings for each measure in the OMS Contract Performance Report. The report, when completed, will document the government’s aggregate assessment of the contractor’s performance under the contract to ensure that the required results of satisfactory ratings for individual Program Management and Performance measures are routinely evaluated, reported and communicated to key stakeholders. These aggregate ratings are composed of individual measures’ assessments and singular occurrences (such as customer complaints, capture of specific service deficiencies). The TR is responsible for documenting singular occurrences by creating a record using the Sample Quality Assurance Monitoring Form (Attachment 2).

4.2.1 The COR and TR will retain a copy of all completed QA surveillance forms. The government will share completed QA surveillance with the contractor as part of routine performance reviews.

5 ANALYSIS OF QUALITY ASSURANCE ASSESSMENT

5.1 Determining Performance

5.1.1 Government shall use the monitoring methods cited to determine whether the performance standards or service levels have been met with a satisfactory rating on a quarterly basis. 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. The government may choose to increase formal performance assessments if warranted by level of service observed.

5.2 Reporting

5.2.1 Twenty-eight days after the end of each quarter, the TR and COR rate the overall results of the quality assurance surveillance of the Contractor’s performance. This written report, which includes the contractor’s submitted quarterly reports, other deliverables at specified intervals, the completed OMS Contract Performance Report and Sample Quality Assurance Monitoring Forms from the most recent quarter 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.

5.3 Reviews and Resolution

5.3.1 The CO may require the Contract Program Manager (CPM) to meet with the COR and TR and other government IPT personnel as deemed necessary to discuss performance evaluation. The CO in consultation with the COR and TR 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 CO, COR, or TR as often as required or per the Contractor’s request. The agenda of the reviews may include:

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, and

Issues arising from the performance monitoring processes.

6.3.2 The CO 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.

Substantial changes to service levels, procedures, and metrics will be incorporated as a contract modification by the CO in consultation with the COR or TR.

5.3.3 Annual ratings other than “satisfactory” (i.e., “superior” or “unsatisfactory”), overall trends of quarterly ratings, and deficiencies in critical performance measures may affect the award of additional term(s) in 12-month increments at the end of the life of the contract (one base year and four optional years). The CO will notify the Contractor within one month of the end of a contract year of the rating determined for that year and its effect on award terms to be added (for “superior” rating) or subtracted (for “unsatisfactory ratings).

6.3.3.1. For each 12-month term of the base year and any of the four optional extension years rated “superior,” the CO may award an additional term of twelve months at the end of the contract (base period and four option years). The maximum number of award terms is one per contract year (maximum five award years). To earn an award term, ratings for the year-long period under consideration:

Must have at least four “superior” year-end ratings in the Program Management Measures

(column A, OMS Contract Performance Report) and three “superior” year-end ratings in the Performance Measures.

Should show no trends of declining or inconsistent service for individual performance measures.

Must not have any quarterly critical service deficiencies (“unsatisfactory” rating in Performance

Measures 1-4).

Must not have any “unsatisfactory” annual ratings in any Measure.

To be considered for award term(s) at the end of the five contractual years, the last contract year cannot be “unsatisfactory” or have serious or pervasive deficiencies in critical performance measures during that last year (i.e., no negatively trending ratings).

6.3.3.2 The CO may revoke previously awarded term incentive year(s), if the Contractor fails to provide acceptable service as defined in the OMS Contract Performance Report, including an “unsatisfactory” overall rating for a given term (contract or award).

5.3.4 The CO must coordinate and communicate with the contractor to resolve issues and concerns regarding marginal or unacceptable performance upon receipt of quarterly and annual ratings. The Contractor and TR will communicate with each other to resolve significant concerns as they arise. The Government and the Contractor should commit to working collaboratively and transparently to address service deficiencies. The Government expects that the Contractor will inform the TR of service deficiencies in a timely fashion (commensurate with the defective service’s criticality), and that the Contractor will engage with OMS management to anticipate and solve problems on continual basis in an effort to avert ratings of “unsatisfactory.”

6.3.5 The Contractor may not appeal the summary assessment of their performance for any given year or related CO judgements such as the voiding of a previously awarded term incentive.

ATTACHMENT 1:

INSERT Spreadsheet entitled OMS Contract Performance Report here -

ATTACHMENT 2: SAMPLE QUALITY ASSURANCE MONITORING FORM

SERVICE 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: _________________

5.3.4 The CO must coordinate and communicate with the contractor to resolve issues and concerns regarding marginal or unacceptable performance upon receipt of quarterly and annual ratings. The Contractor and TR will communicate with each other to reso...