Attachment 4 - QASP - Clinical Support Services.doc

ATTACHMENT 4

QUALITY ASSURANCE SURVEILLANCE PLAN

Clinical Support Services for

Human Studies Projects - WHNRC Davis, CA

TABLE OF CONTENTS

Section 1:

Introduction 1.1 Purpose

1.2 QASP Relation to the Contract

1.2.1 QASP Revisions

1.2.2 Surveillance Performance Progression

1.3 QASP Relation to the Quality Control Plan

Section 2:

Performance Description …………………………………………………… 2.1 Performance Standards and Acceptable Quality Level

2.1.1 Allowable Deviation

2.1.2 Substantially Complete 2.2 Nonperformance

2.2.1 Documentation

2.2.2 Remedial Actions

Section 3:

Contractor and Government Responsibility .………………………

3.1 Contractor Responsibility

3.2 Government Responsibility

3.2.1 Contracting Officer

3.2.2 Contracting Officer Representative

3.2.3 Customers

Section 4:

Surveillance Methods to Perform Quality Assurance .…………

4.1 Surveillance Methods

4.2 Analysis Results

4.3 Performance Requirement Summary

Section 5:

Appendixes ………………………………………………………………………...8

A Discrepancy Report

B Customer Feedback Record

C Sampling Guide/Inspection Checklist

D Quality Assurance Monitoring

E Customer Complaint Investigation

F Surveillance Activity Checklist

SECTION 1: INTRODUCTION

This Quality Assurance Surveillance Plan (QASP) is pursuant to the requirements listed in the performance work statement (PWS) entitled Performance Work Statement - Clinical Support Services. This plan sets forth the procedures and guidelines that the USDA, Western Human Nutrition Center (WHNRC) Davis, CA will use in ensuring the required performance standards or services levels are achieved by the contractor.

1.1 Purpose The purpose of the QASP is to describe the systematic methods used to measure performance and to identify the reports required and the resources to be employed. The QASP provides a means for evaluating whether the contractor is meeting the performance standards identified in the PWS. This QASP is designed to define roles and responsibilities, identify the performance objectives, define the methodologies used to monitor and evaluate the contractor’s performance, describe quality assurance reporting, and describe the analysis of quality assurance monitoring results.

1.2 QASP Relation to the Contract

1.2.1 QASP Revisions The Contracting Officer Representative (COR) may make revisions or changes to the QASP procedures and surveillance methods or increase or decrease the degree of surveillance methods at any time during the contract performance period. Changes to the Metric must be incorporated into the PWS, Performance Requirement Summary (PRS) and QASP by a bilateral modification to contract that is issued by the Contracting Officer (CO). A copy of the QASP is provided to the contractor to enable the contractor to enhance its Quality Control (QC) program to perform in accordance with its Quality Control Plan (QCP).

1.2.2 Surveillance of Performance Progression As the performance period progresses, the levels of surveillance may be altered for service areas where performance is either consistently excellent or unsatisfactory. If consistently good performance, then the amount of surveillance may be reduced. If observations reveal consistent deficiencies, increased surveillance may be implemented.

1.3 QASP Relation to the Quality Control Plan (QCP) The QCP is a required element of contract and the Contractor shall adhere to its established quality control processes and procedures in managing and performing work as described in the contract. While the QCP represents the way in which the Contractor will ensure its quality and timeliness of services, as defined in the PWS, the QASP represents the way in which the Government personnel specified in Section 3: Contractor and Government Responsibilities, Paragraph 3.2, Government Responsibilities will evaluate the contractor’s performance. The contractor’s QC program and the residual organization’s QASP should be complementary programs that ensure successful contractor performance.

SECTION 2: PERFORMANCE DESCRIPTION

Performance of the contractor will be monitored through the surveillance methods described in Section 4: Surveillance Methods to Perform Quality Assurance to assess the Contractor’s performance against PWS requirements.

2.1 Performance Standards and Acceptable Quality Levels (AQLs) For selected activities in the PWS, the PRS provides a performance standard and an AQL. A performance standard is the expected level of contractor performance. An AQL defines the level of performance that is satisfactory. Depending on the service evaluated and the evaluation method selected, performance standards and AQLs may be stated as a number of occurrences or as a percentage. Performance standards and AQLs for random sampling and 100 percent inspection are generally stated as percentages. For periodic inspections, performance standards may be stated as either percentages or as absolute numbers.

The contract requires the Contractor to perform all work as specified. Any inaccuracies or omissions in services or products are referred to as “defects” on the part of the Contractor. The Contractor shall be responsible for all identified defects and may be required to perform the work at no cost to the government. The AQLs take into account that in some instances an allowable level of deficiencies (deviations) is possible while overall performance continues to meet the government’s desired level of service.

2.1.1 Allowable Deviation The AQLs define the level or number of performance deficiencies the Contractor is permitted to reach under this contract. AQLs take into account the difference between an occasional defect and a gross number of defects. AQLs can be expressed as a percentage of or as an absolute number (e.g., three per month). There may be instances where 100 percent compliance is required, and no deviation is acceptable (e.g., where safety is involved).

2.1.2 Substantially Complete In some cases, service outputs are evaluated using subjective values (e.g., excellent, satisfactory, unsatisfactory). The criteria for acceptable performance and for defects must be defined for these service outputs. The concept of “substantially complete” should be the basis for inspections based on subjective scales. Work is considered “substantially complete” where there has been no significant departure from the terms of the contract and no omission of essential work. In addition, the Contractor has performed the work required to the best of its ability and the only variance consists of minor omissions or deficiencies.

2.2 Non-performance Non-performance occurs when the contractor’s performance does not meet the AQL for a given requirement. Requirements may contain multiple performance elements, and therefore, deficiencies may occur in one or more aspects of performance (e.g., timeliness, accuracy, completeness, etc.) or subject areas of effort.

When surveillance indicates that the contractor's service output is not in compliance with the contract requirements, the Contracting Officer’s Representative (COR) must determine whether the Contractor or the Government caused the deficiency. If the cause of the defect rests with the Government, corrective action must be taken through Government channels. If the cause of the defect is due to action or inaction by the contractor, the contractor is responsible for correction of the problem at no additional expense to the Government.

2.2.1 Documentation Documentation of work non-performed or unacceptable work is essential for tracking Contractor performance. The COR will document deficient work by compiling facts describing the inspection methods and results and to substantiate nonconformance with the contract. A sample documentation reporting form is provided in Appendix A. The documentation, with any recommendations, will be forwarded to the CO. In the case of the Contractor, the COR will decide whether to elevate the problem to the CO for corrective action.

2.2.2 Remedial Actions The Federal Acquisition Regulation allows for penalties in the event that the Contractor fails to perform the required services. Penalties are defined as those actions taken under the direction of the CO against the contractor within the general provisions of the contract for nonconformance to the PWS and PRS.

SECTION 3: CONTRACTOR AND GOVERNMENT RESPONSIBILITIES

3.1 Contractor Responsibility The Contractor is responsible for delivering products or services in accordance with the contract. Implementing its QCP, which describes the Contractor’s methods for ensuring all products and services under the contract meet established performance standards and AQLs. Maintaining, and providing for audit, quality control records and reports and all records associated with the investigation and complaint resolutions. Appointing a single quality control point-of-contact to act as a central recipient of communication from the COR or CO.

3.2 Government Responsibility 3.2.1 Contracting Officer (CO) The CO is responsible for administering and monitoring contract compliance, contract administration, and cost control and for resolving any differences between the observations documented by COR and the contractor’s performance. The CO may delegate various day-to-day contract administration duties to an Administering ACO (ACO) and/or the COR for performance management and administrative actions such as invoice approval and issuance of Contract Discrepancy Reports may be, and normally are, delegated by the CO to the COR. The CO shall approve any revisions to the QASP processes or standards.

3.2.2 Contracting Officer Representative (COR) The COR, is designated in writing, by the CO. The COR will ensure that the QA function is properly executed, plays a key role in contract administration, and performs the contract surveillance and monitoring. Some key contract administration duties include, but are not limited to, performs surveillance as required by this QASP; make recommendations to the CO for issuance of Contract Discrepancy Reports or letters of commendation and acceptance or rejection of completed work and for administrative actions based on unsatisfactory or non-performed work, and revisions or changes to the QASP; and assists the CO in identifying necessary contract modifications and preparing reports of Contractor performance and cost.

The COR may use the form(s) included in the Appendices to perform the inspection or other forms as approved by the CO. The Contractor overall guidance is also provided by FAR clause AGAR 452.246-70 Inspection and Acceptance. (FEB 1988) which can be found in the Terms and Conditions of the solicitation.

3.2.3 Customers Customers or organizations/offices that the Contractor provided support may be requested to assist the COR in conducting QA to provide information relating to the Contractor’s performance through Customer Feedback. Information gained from the Customer Feedback may be used in conjunction with other methods of observation to rate the performance of the Contractor.

SECTION 4: SURVEILLANCE METHODS TO PERFORM QUALITY ASSURANCE

4.1 Surveillance Methods The surveillance methods used in the QA process are the Government’s tools to monitor the Contractor’s products and services. The best means of determining whether the Contractor has met all contract requirements is to inspect the Contractor’s service products and analyze the results. Further, documented inspection results are an effective tool in contract administration that can confirm the successful achievement of all performance requirements or highlight areas where defects exist, and improvements are necessary.

4.1.1 100 Percent Inspection The 100 percent inspection method requires complete inspection each week of service and will be used for critical contract requirements. The Contractor's designated representative shall meet with the ACO weekly during the first three (3) months of the contract. Thereafter, meetings shall be held as often as deemed necessary by the ACO, but at least once per month. At these meetings, a mutual effort will be made to resolve any and all problems identified. The Quality Assurance Plan for the Center contains further procedures for quality assurance determination and administration. A copy of this plan shall be provided at contract award.

4.1.1.1 Performance Standards and AQLs

The performance standards and AQLs may be stated as either percentages or absolute numbers. The AQLs will be evaluated as a % of adherence. These are listed in the table in example 1 below

4.1.1.2 Evaluation Procedures

Observed defects for a service monitored by 100 percent inspection is compared to the performance standard and AQL. In an effort to minimize the performance management burden, simplified surveillance methods shall be exercised by the government to evaluate contractor performance when appropriate. Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP that shall be captured from the NAO Peer Review Form.

Analysis of Contractor's Progress

Reports: Compile data from the Peer Review CSU Provider Exit

Profile.

COR or WHRNC’s Center Director Staff

4.2 Analysis and Results When the inspections and research participant feedback customer feedback validations have been completed, the COR will perform an analysis of the Contractor’s performance. The purpose of the analysis is to ensure Government is receiving high-quality products and services from the Contractor. The COR will review the results, rate the Contractor’s compliance with the performance standards and AQLs, and characterize the Contractor’s overall performance. Analysis of all types of contract monitoring will result in one of the following outcomes:

4.2.1 Outstanding Performance Outstanding performance is the result of the Contractor substantially exceeding the performance standards with significant achievements and no significant deficiencies. The Government may reduce its level of surveillance when the COR determines that the Contractor provides sustained performance that significantly exceeds the requirements with no significant deficiencies.

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following rating elements are derived from the NAO Peer Review Form.

4.2.2 Documenting Unacceptable Performance

When unacceptable performance occurs, Key Government Personnel and the COR shall inform the CO. The CO will notify the Contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

If formal written communication is required, the CO shall prepare a cure notice, and present it to the Contractor. The contractor shall acknowledge receipt of the cure notice in writing. The cure notice will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The cure notice will also state how long after receipt the contractor has to present this corrective action plan to the CO. The Government shall review the contractor’s corrective action plan to determine acceptability.

4.3 PERFORMANCE REQUIREMENT SUMMARY

Contractor shall provide research support for Nutrition for Precision Health Project

QUALITY LEVEL

METHOD OF

SURVEILLANCE

inspection and an analysis of contractor’s progress reports

inspection and an analysis of contractor’s progress reports

Periodic inspection, 100% inspection and an analysis of contractor’s progress reports

Score of acceptable or higher required on scale

Direct observation, 100% inspection and an analysis of contractor’s progress reports.

SECTION 5: APPENDIXES

APPENDIX - A

CONTRACT NUMBER: DATE:

4. DISCREPENCY OR PROBLEM (Describe in Detail. Include PWS references. Attach Continuation Sheet if Necessary)

5. SIGNATURE OF COR

8. CONTRACTOR RESPONSE AS TO CAUSE, EFFECT, CORRECTIVE ACTION AND ACTIONS TO PREVENT RECURRENCE (Attach Continuation Sheet if necessary. Cite applicable Contractor QC program procedures or new QC procedures)

11. GOVERNMENT EVALUATION (Acceptance, partial acceptance, or rejection. Attach Coordination Sheet if necessary)

12. GOVERNMENT ACTIONS (Cure notice, show cause, other)

CLOSE OUT

COR

APPENDIX - B

CUSTOMER FEEDBACK RECORD

DATE AND TIME OF COMPLAINT CONTRACT NUMBER/ OR PROJECT:

SOURCE OF COMPLAINT ORGANIZATION

INDIVIDUAL

NATURE OF COMPLAINT

PWS REFERENCE

VALIDATION

ACTION TAKEN BY CONTRACTOR (Responsible officer)

RECEIVED AND VALIDATED BY

Determination:

Complaint Valid Complaint Invalid

APPENDIX - C

SAMPLING GUIDE/INSPECTION CHECKLIST

CONTRACT NUMBER: ___________________________________

SERVICE FUNCTION:

PWS SECTION:

or fewer defects are discovered per month. Performance is Unsatisfactory (U) when _______ or more defects are discovered per month.

Performance: Excellent (E), Satisfactory (S), Unsatisfactory (U), Not Applicable (N/A)

Overall Rating of Inspection (E, S, U or N/A)

COR/Inspector Comments:

Contractor Signature:

Date:

COR Signature:

____________________Date: _________________

APPENDIX - D

QUALITY ASSURANCE MONITORING

CONTRACT NUMBER: ______________________________________

SERVICE or STANDARD:

SURVEY PERIOD:

SURVEILLANCE METHOD (Check the applicable item):

Random Sampling 100% Inspection Periodic Inspection Customer Complaint

LEVEL OF SURVEILLANCE (Check the applicable item):

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 the applicable item):

( Meets Standards

( Does Not Meet Standards

Narrative of Performance During Survey Period:

Prepared By: _______________________________

Date: ______________

APPENDIX - E

CUSTOMER COMPLAINT INVESTIGATION

CONTRACT NUMBER: _________________________

SERVICE or STANDARD:

SURVEY PERIOD:

DATE COMPLAINT RECEIVED: ____________

SOURCE OF COMPLAINT: _________________________________________ (Name)

_______________________________________________________________ (Organization)

___________________ (Phone No.) _______________________________ (Email Address)

NATURE OF COMPLAINT: ____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

RESULTS OF COMPLAINT INVESTIGATION: ____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

DATE SERVICE PROVIDER INFORMED OF COMPLAINT: _____________

CORRECTIVE ACTION TAKEN BY SERVICE PROVIDER: _________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Received and Validated By: __________________________________________

Prepared By: _____________________________ Date: _________________

APPENDIX - F

SURVEILLANCE ACTIVITY CHECKLIST

Performance

Requirement Performance

Standard Method of

Measurement

Performance

Metrics Method of

Surveillance Date

Accomplished Compliance

(Exceed, Met, Partial Met)

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