Attachment 4 Quality Assurance Surveillance Plan.pdf

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Home Oxygen Services Veterans Integrated Service Network (VISN) 23

ISSUED: 2/3/2021

TABLE OF CONTENTS

1 INTRODUCTION

1.1 Purpose

1.2 Scope

1.3 Performance Management Approach

1.4 Performance Management Strategy

2 ROLES AND RESPONSIBILITIES

2.1 Contracting Officer (CO)

2.2 Contracting Officer’s Representative (COR)

2.3 Contractor Representatives

3 IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY LEVELS

3.1 Quality Assurance Surveillance Plan Changes

4 METHODOLOGIES TO MONITOR PERFORMANCE

4.1 Management Reviews and Reporting

4.2 Surveillance Methodology

4.3 Periodic Inspection

4.4 Random Sampling

4.5 100% Inspection

4.6 Customer Input

4.7 Acceptable Quality Levels

4.8 Communication

5 QUALITY ASSURANCE SURVEILLANCE AND DOCUMENTATION

5.1 Surveillance Process

5.2 Performance Monitoring and Scheduling

5.3 Government Property Administration

5.4 Surveillance Documentation

5.5 Resolving Performance Issues

6 Contractor Performance Assessment Reporting System

ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

1 INTRODUCTION

This Quality Assurance Surveillance Plan (QASP) sets forth procedures and guidelines that the U.S. Department of Veterans Affairs (VA) will use to monitor performance of the Contractor under this contract. A copy of this plan will be furnished to the contractor so that the contractor shall be aware of the methods that the Government will employ in monitoring performance on this project and address any concerns that the contractor may have prior to initiating work.

This QASP is pursuant to the requirements listed in the performance work statement (PWS) entitled “Home Oxygen Services.” This plan sets forth the procedures and guidelines VISN 23 Contracting Officer Representative (COR) and COR designees will use in ensuring the required performance standards or services levels are achieved by the contractor.

This QASP is a Government developed and applied document used to make sure that systematic quality assurance methods are used in the administration of the performance requirements standards included in this contract (and in subsequent purchase card orders issued). The intent is to ensure that the Contractor performs in accordance with performance metrics set forth in the contract documents, that the Government receives the quality of services called for in the contract, and that the Government only pays for the acceptable level of services received.

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.

The QASP is intended to accomplish the following:

• Define the roles and responsibilities of participating Government officials and outside experts;

• Define how contractor’s performance will be measured;

• Define what will be assessed and how it will be assessed;

• Describe the assessment process;

• Define the standards of performance; and

• Describe the rating procedure;

1.2 Scope

Services include delivery, set‐up, initial education, and preventative maintenance inspections as specified by the manufacturer, to include all disposable supplies as listed.

VISN 23 currently serves an estimated 5,000 oxygen‐using VA beneficiaries. The contract shall be for the actual requirements of the VA as ordered by the VA during the life of the contract. The Contracting Officer Representative (COR) and/or COR designees will provide the contractor with notification to initiate individual beneficiary service requirements, including the beneficiary’s oxygen prescription, equipment, supplies and services to be provided including date and place of delivery. The contractor shall confirm receipt of the request within two working hours of notification; the COR and/or COR designees shall also provide notification if VA owned equipment is provided; the COR and/or COR designees will also provide notification of VA initiated discontinuance of service. The notification may be made orally but will be confirmed in writing within three working days. The written documents shall include the authorizing official’s signature.

Veterans with a prescription for an oxygen concentrator shall be provided with an appropriate backup system consisting of a compressed gas source and regulator with stand and/or wheeled cart, humidifiers, fire safe valves, cannulas/mask for use during the event of a power failure or mechanical problem and necessitating the use of the backup cylinder. The cost for the above‐mentioned backup system shall be borne by the Contractor. The cost of replacement of equipment damaged, lost or misplaced not through beneficiary’s negligence shall be borne by the Contractor. Documentation is required if the VA beneficiary declines the oxygen back‐up system.

1.3 Performance Management Approach

1.3.1 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 VISN 23 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.

1.3.2 Performance management represents a significant shift from the more traditional 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.

1.4 Performance Management Strategy

1.4.1 The contractor is responsible for the quality of all work performed. The contractor measures that quality through the contractor’s own 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 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.

1.4.2 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 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

The activities detailed in this plan will be supported and performed by a group of individuals, many with differing levels of responsibilities, but all maintaining a level of consistency in terms of the surveillance strategy, approach, and activities in general. The specific entities and their associated responsibilities/input to the surveillance activities on the Contract are described in the following paragraphs.

2.1 Contracting Officer (CO)

The CO is responsible for monitoring contract compliance, contract administration, and cost control and for resolving any differences between the observations documented by the COR/COR designees 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 Contracting Officer’s Representative (COR)

The 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 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 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.

2.3 Contractor Representatives

The Contractor Program Manager (PM) and Points of Contact (POCs) shall be responsible for administering the Contractor’s QC program for this contract. Contractor shall clearly identify individual to serve as PM and individuals to serve as POCs. The PM has the overall responsibility for continually keeping the Government informed of work status and any potential issues that may affect quality of performance.

3 IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY LEVELS

The required performance standards and/or quality levels are included in the PWS.

3.1 Quality Assurance Surveillance Plan Changes

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 determination regarding disincentives 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.

The QASP is a living document and, as such, may be changed as needed. The QASP is part of the contract and may be changed by the Government via bilateral modification. The CO must approve changes. The COR will submit recommended changes to the CO for approval.

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 CO. Any changes that the Contractor deems may affect contract, price, terms, or conditions shall be referred to the COR through to the Contracting Officer for action.

4 METHODOLOGIES TO MONITOR PERFORMANCE

The COR and/or COR designees will perform evaluation using as many of the various methods applicable and outlined in the Performance Requirement Summary (PRS) table included in the

QASP.

4.1 Management Reviews and Reporting

At the end of each assessment period, the COR will prepare a written report for the CO summarizing the overall results of the quality assurance surveillance of the contractor’s performance. This written report, which includes the contractor’s submitted monthly report will become part of the QA documentation. It will enable the government to demonstrate whether the contractor is meeting the stated performance standards, including cost/ technical/scheduling objectives. Examples of management review and reporting activities that may be used in conducting surveillance include:

a. Formal, process, and progress reviews

b. Review of contract deliverables and documentation

c. Documentation of problems, issues, and concerns

d. Data collection reporting

4.2 Surveillance Methodology

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:

Surveillance Method Description

Periodic Inspection Evaluates tasks selected on other than 100% or random basis. It may be appropriate for tasks that occur infrequently and where 100% inspection is neither required nor practicable. A predetermined plan for inspecting part of the work uses subjective judgment and analysis of agency.

Random Sampling Most appropriate for recurring tasks. Services are sampled to determine whether the level of performance is acceptable. Works best when the number of instances of the services being performed in large and a statistically valid sample can be obtained.

100% Inspection Most appropriate for infrequent tasks or task with stringent performance requirements. Performance is inspected/ evaluated at each occurrence. The most expensive and should not be used in most cases.

Customer Input Can be used in conjunction with other surveillance methods customer input can be used as substantiating evidence.

Customer surveys and feedback may be a primary surveillance method and customer satisfaction an appropriate performance standard. Customer Input should be documented, preferably on a standard form.

4.3 Periodic Inspection

Evaluates tasks selected using a methodology other than a 100% or random inspection. It may be appropriate for tasks that occur infrequently and where 100% inspection is neither required nor practical. An example of periodic surveillance is weekly inspections when the QAM chooses the location and time in other than a statistically random manner. Inspections may be scheduled monthly or unscheduled, as required.

4.4 Random Sampling

This method is done to determine whether the contractor’s performance of a particular task for a given period of time meets the performance requirement based on randomly selected samples of the task. This method is the most appropriate for frequently recurring tasks.

4.5 100% Inspection

Evaluates all outcomes. This method is an inspection where specific characteristics of every performance are examined and tested to determine conformance with requirements. This surveillance method is preferred for tasks that occur infrequently, as well as for tasks that cannot be randomly inspected.

4.6 Customer Input

The contractor is expected to establish and maintain professional communication between its employees and customers (both VISN 23 and the Veteran beneficiaries). 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 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.

Customer input may also be obtained either from the results of formal customer satisfaction surveys or from random customer complaints.

This method is an independent evaluation of an activity or process to assess compliance with the terms of the contract. Customer Input may be necessary for certain types of tasks that do not lend themselves to random sampling of 100% inspection. Customer Input may be obtained from the results of formal customer satisfaction surveys or from random customer complaints.

It may provide the basis for an incentive payment to the contractor, but it cannot be used on the basis of deduction from payment since it is not a statistically valid method of surveillance.

The CO may use validated customer complaints as the basis for actions (other than payment deductions) against the contractor.

4.7 Acceptable Quality Levels

The acceptable quality levels (AQLs) are included in Performance Requirements Summary Table. 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 initial setups/education, preventative maintenance/Respiratory Therapist visits, emergency services, the desired performance level is established at 98%. Other levels of performance are keyed to the relative importance of the task to the overall mission performance at VISN 23.

4.8 Communication

Communications is a general surveillance activity. Communications is a two‐way process and includes both written and oral communication. Examples of written communications activities that may be used in conducting surveillance include:

a. Exchanges from the Contractor to the Government of plans, procedures, quality records, reports, etc., and/or provision of read‐only access to repositories which retain these items.

b. Exchanges from the Government to the Contractor of letters, reports, review results, etc.

c. Ad hoc information submitted by the COR to the CO related to the Contractor’s electronic mail.

Examples of oral communications activities that may be used in conducting surveillance include:

a. Informal telephone calls, teleconferences.

b. Informal verbal inquiries, discussions, engineering consultations.

c. Working group meetings, technical/status briefings, progress reviews, technical information meetings, and formal and informal reviews.

d. Informal discussions.

5 QUALITY ASSURANCE SURVEILLANCE AND DOCUMENTATION

5.1 Surveillance Process

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 withholding of payment, at the CO or COR’s discretion, until the problem is rectified.

5.2 Performance Monitoring and Scheduling

5.2.1 The COR may require the contractor’s PM, or a designated alternate, to meet with the

COR and other government personnel as deemed necessary to discuss 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 and COR designees as often as required or per the contractor’s request. The agenda of the reviews may include:

Monthly performance assessment data

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

5.2.2 The COR must coordinate and communicate with the contractor to resolve issues and concerns regarding marginal or unacceptable performance.

5.2.3 The COR and contractor should jointly formulate 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 CO.

5.3 Government Property Administration

The COR will carry out the following functions.

a. Validate that all accountable Government Property (AGP) is being properly utilized and maintained as applicable.

b. Conduct periodic inspection of equipment and its location, compared to the data on the property records as applicable.

c. Validate that all existing and new equipment is properly tagged as applicable.

d. Validate that Government property is made available in accordance with the terms of the contract as applicable.

e. Validate that the Contractor is maintaining records for all offsite Government‐

Furnished Property (GFP) as applicable.

5.4 Surveillance Documentation

The government’s QA surveillance, accomplished by the COR and/or COR designees, will be reported based on the the Quality Assurance Surveillance Plan Performance Summary. The surveillance, when completed, will document the government’s assessment of the contractor’s performance under the contract to ensure that the required results in accordance with Performance Summary are being achieved.

5.5 Resolving Performance Issues

It is not unprecedented that the VA and the contractor may discover performance issues or deficiencies through the surveillance process. The COR will provide a list of any unresolved deficiencies to the contractor's representative to afford him/her the opportunity to show where the problem is already in the process of being worked. If evidence is shown where the contractor’s quality program has already documented the deficiency and timely corrective action is resolving the problem, the COR will follow up with the contractor’s quality assurance personnel to ensure the deficiencies are remedied in a timely manner, in accordance with the

PWS.

All deficiencies associated with performance requirements listed on the Performance Requirements Summary, whether remedied by the contractor or not, will be included in the COR Surveillance Report regardless of who identified the deficiency.

The Contractor, and COR will meet to discuss contract performance. The COR will provide a copy of the meeting minutes to all attendees within 5 workdays of the meeting. Should the need arise for an emergency meeting because of unexpected performance issues, these meetings can be called by either the COR or the contractor’s representative.

The COR will retain a copy of all completed QA surveillance forms and documentation.

6 Contractor Performance Assessment Reporting System

The Contractor’s performance shall be documented and measured through the annual past performance evaluation through the Contractor Performance Assessment Reporting System (CPARS). Performance will be evaluated in the areas of:

Cost Control

• Utilization of Small Business (as applicable)

• Schedule

• Quality of Service

• Management

The following rating elements will be used to evaluate each area:

RATING DEFINITION

Exceptional Performance meets all contractual requirements and exceeds many to the Government’s benefit. The contractual performance of the element or sub‐ element being assessed was accomplished with few minor problems for which corrective actions taken by the Contractor were highly effective.

Very Good Performance meets contractual requirements and exceeds some to the Government’s benefit. The contractual performance of the element or sub‐ element being assessed was accomplished with some minor problems for which corrective actions taken by the Contractor were effective.

Satisfactory Performance meets contractual requirements. The contractual performance of the element or sub‐element contains some minor problems for which corrective actions taken by the Contractor appear or were satisfactory.

Marginal Performance does not meet some contractual requirements. The contractual performance of the element or sub‐element being assessed reflects a serious problem for which the Contractor has not yet identified corrective actions or the Contractor’s proposed actions appear only marginally effective or were not fully implemented.

Unsatisfactory Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The contractual performance of the element or sub‐element contains a serious problem(s) for which the Contractor’s corrective actions appear or were ineffective.

ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY

Performance Requirement/ PWS Reference

Performance Standard

Acceptable Quality Level (AQL)

Monitoring Method Incentive/Disincentive

Initial Set‐Ups and Education

PWS

“Scope of Work”, Number

Contractor shall perform initial home oxygen setups on the same day for requests within 24 hours of request

98% of actions on time

Periodic Inspection/Random Sampling

Failure to meet AQL subject to being included in CPARS performance evaluation.

Emergency Home Oxygen Services

PWS “Scope of Work”, Numbers 6a and 6b

Contractor shall provide emergency home oxygen services within two hours notification by

VA

100% of actions on time

100% Inspection Failure to meet AQL subject to being included in CPARS performance evaluation.

Disaster Effects on Performance

PWS “Scope of Work”, Number 6c

Contractor shall immediately notify COR of disaster natural or manmade that may affect services under this contract

100% of actions on time

100% Inspection Failure to meet AQL subject to being included in CPARS performance evaluation.

Alteration to VA Beneficiary Home for Set‐ Up

PWS “Scope of Work”, Number

Contractor shall notify COR by phone at time of initial set‐ up if any alteration to VA beneficiary’s home is necessary

98% of actions on time

Random Sampling/Customer Input

Failure to meet AQL subject to being included in CPARS performance evaluation.

Performance Requirement/ PWS Reference

Performance Standard

Acceptable Quality Level (AQL)

Monitoring Method Incentive/Disincentive

Oxygen Removal Issues

PWS “Scope of Work”, 13a

Contractor shall provide written report to COR within three business days if presence of oxygen presents issues requiring oxygen removal

98% of actions timely

Periodic Inspection/Random Sampling

Failure to meet AQL subject to being included in CPARS performance evaluation.

Non‐ Compliance with Safety Guidelines

PWS “Scope of Work”, 13b

Contractor shall provide written communication to COR within three business days if beneficiary non‐ compliant with safety guidelines

98% of actions timely

Periodic Inspection/Random Sampling

Failure to meet AQL subject to being included in CPARS performance evaluation.

Quarterly Reports

PWS “Scope of Work”, 8

Contractor shall provide written quarterly report to

COR

100% of actions timely

100% inspection Failure to meet AQL subject to being included in CPARS performance evaluation.

Home Visits to Beneficiary

PWS, “Scope of Work”, 27 and

Contractor shall visit beneficiary at home to re‐assess equipment compliance and educational/training needs

98% of actions timely

Customer Input/Random Sampling

Failure to meet AQL subject to being included in CPARS performance evaluation.

Documentation of Accreditation

Contractor shall submit documentation of accreditation annually to COR

100% of actions timely

100% inspection Failure to meet AQL subject to being included in CPARS performance

Invoice Auditing

PWS, “Invoicing Submissions”

COR or COR designee will review home oxygen monthly invoices for accuracy of billing

100% of actions timely

100% inspection Failure to meet AQL subject to being included in CPARS performance