Attach_J.5_QASP_5-18-18.pdf

DRAFT QUALITY ASSURANCE SURVEILLANCE PLAN

FOR BIOWATCH LABORATORY STAFFING

Contract Number: TBD Contract Description: The Biowatch Laboratory support Component includes capabilities to analyze collected samples to detect the presence of select biological agents and report the results. The BioWatch Progam Office currently provides contracted laboratory staff to most BioWatch laboratories to perform the laboratory analysis under the guidance of the local Laboratory Director. BioWatch currently maintains operational laboratories in approximately 30 jurisdictions across the country. The Program must ensure each location is able to perform daily sample collection and analysis in a timely manner and be flexible enough to provide additional coverage for large special security or other high-risk events Contractor’s name: < upon award, enter contractor name > (hereafter referred to as the contractor).

1 PURPOSE.

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

• What will be monitored.

• How monitoring will take place.

• Who will conduct the monitoring.

• How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created 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.

This 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.

The following FAR clauses may apply depending on contract type:

52.246-6 Inspection of Services – Time-and-Material and Labor-Hour (May 2001)

2 GOVERNMENT ROLES AND RESPONSIBILITIES.

The following personnel shall oversee and coordinate surveillance activities.

2.1 Contracting Officer (CO)

The CO 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 CO shall also assure that the contractor receives impartial, fair and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned CO: Tisha Blue Organization or Agency: DHS OPO Telephone: 202-447-0589 Email: Tisha.Blue@hq.dhs.gov

2.2 Contracting Officer’s Representative (COR)

The COR is 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 CO, the COR shall provide documentation to the CO. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms or conditions to the CO for action.

Assigned COR: To be inserted at time of award Telephone: To be inserted at time of award Email: To be inserted at time of award

2.3 Other Key Government Personnel

N/A

3 CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s representatives for this contract

3.1 Project Manager

<upon award, enter name> Telephone: <enter number> Email: <enter address>

3.2 Technical Manager

- <upon award, enter name> Telephone: <enter number> Email: <enter address>

3.3 Other Contractor Personnel

Title: <enter title> Telephone: <enter number> Email: <enter address>

4 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, paragraph 10 in the Performance Work Statement includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

5 INCENTIVES

The Government shall use positive CPAR report as incentives. Incentives shall be based on exceeding, meeting or not meeting performance standards. Information about incentives can be found in Quality Assurance Surveillance Plan Table (see Section 7 below) of the contract.

6 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 task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR, with assistance from the CO, if needed, shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

The Performance Requiremet Summary, PWS section 10, and the Quality Assurance Surveillance Plan Table, Section 7, address the same requirements. The following methods are utilized to address the quality of the deliverables described in the PWS, secton 2 Task 2 and 3.

100% INSPECTION

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 in the Contract becomes the basis for the CO’s actions.

7 QUALITY ASSURANCE SURVEILLANCE PLAN TABLE

The PRS establishes key elements of Contractor performance that represent “mission essential” service requirements, which are identified in the table below in the “Service Output” column. The “Performance Objective” column represents the standard against which Contractor performance will be measured in relation to accomplishment of the corresponding service output. The performance objective or “standard” describes the minimum acceptable level of service by the Contractor for satisfactory performance.The “Acceptable Quality Level (AQL)” column displays the maximum allowable deviation from the performance objective, which, if exceeded, evokes the negative incentive specified in the table below.

Service Output Performance Objective Surveillance Method

Acceptable Quality Level

(AQL)

Outcome

1. Overall Laboratory Staffing Levels (PWS 2.2.2)

Laboratory staffing levels overall shall not fall below 90 percent per year

Monthly Staffing Reports and Annual Program Review

100% Reflected in

CPARS

evaluation

Acceptable Quality Level

(AQL)

Outcome

2. Local Laboratory Staffing Level (PWS 2.2.2)

The staffing level shall not fall below 75 percent in excess of one month for any BioWatch laboratory

Monthly Staffing Reports and Annual Program Review

100% Reflected in

CPARS

evaluation

3. Replacement of personnel (PWS 2.2.3)

Notification to the Contracting Officer (CO) and Contracting Officer Representative (COR) of the departure of personnel within at least 10 business days prior to the outgoing person’s departure or within 24 hours if positions are vacated without notice.

Documentation of staffing actions provided on a monthly basis

100% Reflected in

CPARS

evaluation

4. Replacement of personnel (PWS 2.2.4)

Resumes for at least 3 proposed candidates provided to local Laboratory Director for review within 12 business days of personnel notification of intent to leave positions and/or if the positions are vacated without notice

Documentation of staffing actions provided on a monthly basis

100% Reflected in

CPARS

evaluation

5. Protocol Review and Training (PWS 2.3.2.1)

Prior to arrival at operational lab, new staff must review each of the BioWatch laboratory operations protocols listed on the current version of the Master Document List and have documentation indicating they achieved an understanding of the content

Documentation of completion of training and competency in Monthly Report

100% Reflected in

CPARS

evaluation

6. New Staff Training (PWS 2.3.2.2)

Prior to arrival at an operational laboratory new staff must have, at a minimum, demonstrated competency at sample processing and PCR set-up processes

Documentation of completion of training and competency in Monthly Report

100% Potential denial of access for new staff to the operational laboratory;

Reflected in

Acceptable Quality Level

(AQL)

Outcome

7. New Staff Training (PWS 2.3.2.3)

New staff shall successfully complete Demonstration of Competency within 90 days of the initiation of training.

Documentation of completion of training and competency in Monthly Report

100% Possible removal of staff from lab for additional training;

Reflected in

8 RATINGS.

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 ratings shall be used:

9 DOCUMENTING PERFORMANCE

9.1 Acceptable Performance.

The Government shall document positive performance. A report template is attached. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other contractual actions.

9.2 Unacceptable performance.

When unacceptable performance occurs, the COR shall inform 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.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's program manager or on-site representative.

A CDR template is attached to this QASP.

The “Acceptable Quality Level (AQL)” column is based on a scale of 1-5 with the following definition:

1 – Fails to meet expectation 2 – Meets some expectations or meets expectations with modifications 3 – Meets expectations (favorable rating) 4 – Exceeds some expectations 5 - Exceeds expectations

<Documentation must be accurate and thorough. Completeness, currency, and accuracy support both satisfactory and unsatisfactory performance.>

The contractor shall acknowledge receipt of the CDR in writing. The CDR 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 CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other contractual actions deemed necessary by the CO.

10 FREQUENCY OF MEASUREMENT

10.1.1 Frequency of Measurement.

During contract/order performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.

10.1.2 Frequency of Performance Assessment Meetings.

The COR shall meet with the contractor monthly to assess performance and shall provide a written assessment.

<The COR shall sign this document.>

Contracting Officer’s Representative Date

Performance Report

1. CONTRACT NUMBER: <insert number>

2. Prepared by: (Name of COR) LCDR Michelle Hohensee

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: <Enter COR’s name>

Contracting Officer’s Representative Date

Contract Discrepancy Report (CDR)

1. Contract Number: <insert number>

2. TO: (Contractor Program Manager, Task Manager or on-site representative) <insert name>

3. FROM: (Name of COR) <insert 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 not later than < # days after receipt of this CDR. >

Prepared by: <Enter COR’s name>

Contracting Officer’s Representative Date Received by:

Contractor Program Manager, Task Manager or Date on-site representative

< 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;

anytime unacceptable performance is determined critical in nature and requires formal corrective action; and whenever an unfavorable trend is detected in contractor performance.>