P01 Regulated Medical Waste QASP.pdf

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 Regulated Medical Waste Disposal Services. This plan sets forth the procedures and guidelines VISN4 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 identify required documentation and 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 ensure 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 VISN4 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, if 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 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 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 also 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 determinations 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 (CO)

The CO is responsible for monitoring contract compliance, contract administration, and cost control, and resolving any differences between observations documented by the VISN4 Contracting Officers Representative (COR), Facility Points of Contact (FPOC), and the contractor.

The CO will designate one full‐time 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 COR

The COR is designated in writing by the CO to act as their 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 is not empowered to make any contractual commitments or authorize any contractual changes on the government’s behalf.

Any changes the contractor deems may affect contract price, terms, or conditions must be referred to the CO for action. The COR 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 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

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:

Scheduled Reviews – meeting with contractor to review contract management

Random Samples ‐ which shall be performed by the COR designated inspector

Periodic Inspection – the COR typically performs the periodic inspection

Complaints – grievances sent to the COR by FPOCs

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 COR. The COR will accept those customer complaints and investigate.

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 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 the primary and vital elements, 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 95%

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 assessed using the performance monitoring techniques shown in Attachment 1.

5.2 Monitoring Forms

The government’s QA surveillance, accomplished by the COR and FPOCs, will be reported using the monitoring form in Attachment 2. The forms, when completed, will document the government’s assessment of the contractor’s performance under the contract to ensure the required results 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 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, using the deduction percentages shown in Attachment 1. Deducted payment amounts will be given to the contractor if corrective action plan is successful and AQL is reached within the performance period.

6.2 Reporting

6.2.1 At the end of each month, FPOCs may prepare a written report for the COR summarizing the overall results of the quality assurance surveillance of the contractor’s performance.

This 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 designated alternate to meet with the FPOCs and other government IPT personnel as deemed necessary to discuss the performance evaluation. The 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

6.3.2 The COR 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 procuring CO (PCO) or

ACO.

ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY

Required Services (Tasks)

Performance Standards

Acceptable Quality Levels

Methods of

Surveillance

Incentive (Positive and/or Negative)

(Impact on Contractor Payments)

4.4, 4.5, 4.6, 4.7, 4.9, 4.11

Provide comprehensive contract admin and management.

95% Scheduled reviews, random samples, facility POC complaints

Positive past performance rating

5.2.2 RMW disposal to

include scheduled pick‐up, transportation, sterilization, disposal, and reporting with 3 service options for facilities.

100% Scheduled reviews, inspection random samples, facility POC complaints

Positive past performance rating, deduction from monthly payments*

1st issue – 0%

2nd issue – 10%

3rd issue – 25%

4th issue – 100%

5.2.3 RMW container

and bracket availability and installation at all locations to include sharps containers

95% Scheduled reviews, inspection random samples, facility POC complaints

Positive past performance rating

5.2.4, 7.2, 7.3, 7.4, 7.5

Detailed and accurate reports to include:

Pickup Manifest

Certificate of Destruction

Spill Report Monthly Waste Stream Report

95% Scheduled reviews, inspection random samples, facility POC complaints

Positive past performance rating

5.3 Quarterly VISN‐

wide training.

98% Inspection, facility POC complaints

Positive past performance rating

6.2, 6.3 Possession of required permits and insurances.

100% 100% Inspection

Positive past performance rating

6.5 Vehicles meet all

requirements for transport of RMW

98% Scheduled reviews, inspection random samples, facility POC complaints

Positive past performance rating

6.8 Contractor

sufficiently phases‐ in at all VISN4 locations to ensure no gap in service occurs.

95% Scheduled reviews, inspection random samples, facility POC complaints

Positive past performance rating

*= deducted monthly payment incentive will only be pursued in the event that contractor issues (missed pickups, biohazard contamination, missed reports, lack of sharps service) results in VA becoming noncompliant with regulations.

ATTACHMENT 2: 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: _________________