QASP Biomedical Waste Removal.pdf

ATTACHMENT 2

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

For

Biomedical Waste Disposal

1. PURPOSE:

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated non-personal services contract. This QASP explains the following:

a. What will be monitored?

b. How monitoring will take place?

c. Who will conduct the monitoring?

d. How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is treated with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government's responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

The QASP is a "living document" and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

a. QASP RELATION TO THE SOLICITATION:

QASPs shall be developed and appear in every solicitation, as well as the resultant service contract. The Government will retain the right to change the surveillance methods and Quality Assurance (QA) procedures, or to increase or decrease the degree of surveillance efforts at any time necessary to assure contract compliance.

b. REVISIONS TO THE QASP:

The QASP is a tool for use in Government administration of the Performance Work Statement/Statement of Work (PWS/SOW) and remains subject to revision at any time by the Government throughout the contract performance period. Revisions to this surveillance plan are the responsibility of the Contracting Officer's Representative (COR). Changes to the QASP shall be made bilaterally.

The contractor will assume responsibility for all tasks and deliverables in the PWS under this award. As the performance period progresses, the levels of surveillance may be altered for service areas in cases where performance is either consistently excellent or consistently unsatisfactory. If observations reveal consistently good performance, then the amount of surveillance may be reduced. If observations reveal consistent deficiencies, increased surveillance may be implemented.

2. GOVERNMENT ROLES AND RESPONSIBILITIES:

The following personnel shall oversee and coordinate surveillance activities:

a. Contracting Officer (KO) - The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor's performance.

b. Contracting Officer's Representative (COR) - The COR will be located at the United States Medical Materiel Agency (USAMMA), Fort Detrick, MD. The COR will be responsible for technical administration of the contract, and shall assure proper Government surveillance of the contractor's performance. The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. A COR is not empowered to make any contractual commitments or to authorize and contractual changes on the Government's behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

Assigned COR: Louis Marchitelli Organization: US Army Research Institute of Medicine Telephone: 508-206-2334 E-mail: Louis.J.Marchitelli.civ@mail.mil

3. CONTRACTOR ROLES AND RESPONSIBILITIES:

The contractor is responsible for delivering services in accordance with the contract. The contractor shall appoint a single off-site point-of-contact to act as a central recipient of communication from the Government.

4. CONTRACT QUALITY REQUIREMENTS:

a. Contract quality requirements are the technical requirements in the contract relating to the quality of the service and those contract clauses prescribing inspection and other quality controls incumbent on the contractor, to assure that the service conforms to the contractual requirements.

Government contract quality assurance shall be performed at such times and places as may be necessary to determine that the services conform to the contract requirements. Failure to meet or exceed the contract quality requirements is defined as a "nonconformance" on the part of the contractor. The contractor shall be held responsible for any identified nonconformance, and the government may require the work to be re-performed.

b. The Government's contract quality assurance is defined as follows:

i. "Acceptance" means the act of an authorized representative of the Government by which the Government, for itself or as agent of another, assumes ownership of existing identified supplies tendered or approves specific services rendered as partial or complete performance of the contract.

ii. "Conditional acceptance" means acceptance of supplies or services that do not conform to contract quality requirements, or are otherwise incomplete, that the contractor is required to correct or otherwise complete by a specified date.

iii. "Minor nonconformance" means a nonconformance that is not likely to materially reduce the usability of the supplies or services for their intended purpose, or is a departure from established standards having little bearing on the effective use or operation of the supplies or services.

iv. "Major nonconformance" means a nonconformance, other than critical, that is likely to result in failure of the supplies or services, or to materially reduce the usability of the supplies or services for their intended purpose.

v. "Critical nonconformance" means a nonconformance that is likely to result in hazardous or unsafe conditions for individuals using, maintaining, or depending upon the supplies or services; or is likely to prevent performance of a vital agency mission.

c. Documentation:

i. Thorough documentation of unperformed or nonconformance is essential for tracking contractor performance throughout the period of performance. The COR will document deficient work by compiling facts describing the inspection methods and results. The COR will develop documentation to substantiate nonconformance with the Contract and shall forward the documentation by means of a Contract Discrepancy Report (CDR).

ii. Remedial Action by the Contracting Officer:

A. Shall notify the contractor in writing of the nonconforming service;

B. Shall request that the contractor perform the service, at no cost to the Government; and

C. May accept consideration if offered. For guidance on solicitation of a refund, see Defense Federal Acquisition Regulation Supplement (DFARS) Subpart 252.71. In accordance with Federal Acquisition Regulation (FAR) Clause 52.246-4 - "Inspection of Services-Fixed-Price", the Government may require the contractor to re-perform any services that do not conform to contract requirements. If the defects cannot be corrected by re-performance, the KO may either require the contractor to take the necessary action to ensure that future performance conforms to the requirements, or the KO may reduce the Contract price to reflect the reduced value of the services performed. At an extreme decision point, penalties may include a decision not to exercise contract options. The KO will determine the penalty for nonconformance based upon his or her judgment and the severity of the nonconformance.

5. METHODS OF QUALITY ASSURANCE SURVEILLANCE:

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

Regardless of the surveillance method, the COR shall always contact the contractor's point of contact to inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor's performance in meeting the contract's quality requirements.

a. DIRECT OBSERVATION: Can be performed periodically or through 100% surveillance

b. MANAGEMENT INFORMATION SYSTEMS: Evaluates outputs through the use of management information reports. Best used for general surveillance and may need to be supplemented by periodic inspections.

c. PERIODIC INSPECTION: Uses a comprehensive evaluation of selected outputs.

Inspections may be scheduled as required.

i. Analysis of contractor's progress reports. (i.e. Evaluate cost, schedule, etc.)

ii. Performance reporting.

iii. Customer Feedback.

Surveillance results may be used as the basis for actions (to include payment deductions) against the contractor. In such cases, the Inspection of Services clause (52.246-4) in the Contract becomes the basis for the KO's actions.

6. FREQUENCY OF MEASUREMENT: The Government shall monitor the contractor’s performance under this contract. The Government’s Quality Assurance Surveillance Plan follows:

a. Observation of vendor development personnel during developmental tasks noting knowledge and competence with which the tasks are performed.

b. Review of technical reports to insure proper reporting of the contractor’s time and listing of all developmental parts (to include part number, nomenclature, and price) necessary to complete development.

c. Insure the technical report indicates the measures taken to continue development in support of the current or next milestone.

d. Demonstration of an operational check to ensure that the system meets thresholds and strives to meet objectives.

e. Successful performance shall be when development tasks are completed, the prototype is operational within developer’s standards, and all technical reports and invoices have been received by the

COR.

7. PERFORMANCE STANDARDS.

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The Performance Requirements Summary matrix, shown in Table 1 below and continued within the Performance Work Statement (PWS) for this contract in paragraph 3.0, includes performance standards.

The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Table 1. Performance Standards for Biomedical Waste Disposal

Louis J Marchitelli Date Contracting Officer's Representative

Performance Requirement

Performance Standard

Acceptable Quality Level

Method of Surveillance

Frequency

PWS para 2.2.1.1 Removes Regulated Medical Waste/Sharps

In accordance with Federal, State and Local regulations.

No more than one customer complaint per quarterly report.

Surveillance by the

COR.

Quarterly

5/27/21

MARCHITELLI.LO

UIS.JAY.10239454

Digitally signed by

MARCHITELLI.LOUIS.JAY.1023

945416 Date: 2021.05.27 15:10:24 -04'00'

Performance Report

1. CONTRACT NUMBER: W81XWH-15-X-XXXX

2. Prepared by: < COR's Name >

3. Date and time of observation:

4. Observation:

<Examples of items to include in a report are:

-- method of surveillance -- how frequently you conducted surveillance -- surveillance results -- number of observations>

Prepared by: < COR's Name >

Signature - Contracting Officer's Representative Date

Contract Discrepancy Report (CDR)

1. Contract Number: W81XWH-15-X-XXXX

2. To: < Contractor or Contractor Representative >

3. From: < COR's Name >

4. Date and time observed discrepancy:

5. DISCREPANCY OR PROBLEM:

< Describe in detail. Identify any attachments >

6. Corrective action plan:

A written corrective action plan < is / is not > required.

< If a written corrective action plan is required include the following. > The written Corrective Action Plan will be provided to the undersigned no later than < # days after receipt of this CDR.

Prepared by: < COR's Name >

Signature - Contracting Officer's Representative Date

Received by:

Signature - Contractor Representative Date

< The COR may initiate a CDR at any time, including whenever the number of monthly recorded defects for a performance standard exceeds the allowable number of defects; any time unacceptable performance is determined critical in nature and requires formal corrective action; and whenever an unfavorable trend is detected in contractor performance. >