Attachment_8_QASP(Draft).docx

Quality Assurance Surveillance Plan for Biomedical Equipment Technician (BMET), Administative, and National Maintenance Program Support Services

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.

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.

Assigned KO: Laura N. Charles Organization or Agency: US Army Medical Research Acquisition Activity Telephone: Phone: 301-619-8392 Email: laura.n.charles2.civ@mail.mil

b. Contracting Officer’s Representative (COR) – The COR is located at the U.S. Army Medical Materiel Agency (USAMMA) Office at 693 Neiman Street, Fort Detrick, MD 21702-5009. The COR will be responsible for technical administration of this contract, and shall assure proper Government surveillance of the contractor’s performance with the assistance of two (2) Contracting Officer’s Technical Representatives (COTRs). 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 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 KO for action.

Primary COR: Mr. Stephen Drumsta Telephone: 301-619-4335 Email: stephen.t.drumsta.civ@mail.mil

Alternate COR: Ms. Susan Wilders Telephone: 301-619-4359 Email: susan.a.wilders.civ@mail.mil

3. CONTRACTOR REPRESENTATIVES:

The following employee of the contractor will serve as the contractor’s Program Manager for this contract.

Program Manager: TBD Title: TBD Telephone: TBD Email: TBD

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.

Table 1. Performance Requirements

3.1. BMET Support Services

Random Observation and Inspection by the Depot Chief, Shop Supervisor, or QA team.

The contractor shall complete maintenance actions. Maintenance actions include but are not limited to, technical inspections, repair, calibrations, verification, and complete refurbishment of medical equipment.

AQL: Quarterly – Maintenance actions shall be completed within 12% or less above the standard.

Random Observation and Inspection as well as review of monthly and quarterly reports by the Depot Chief and/or Shop Supervisor

3.2. M3D Administrative Support Services

Random Observation and Inspection by the Depot Chief, Shop Supervisor, or QA team.

Random Observation and Inspection by the Depot Chief, Shop Supervisor, or Inventory Manager.

3.3. Support of National Maintenance Program (NMP)

AQL: Data gathered shall be 100% accurate, up to date, and shall not contain errors.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

AQL: Data gathered and resultant recommendations should be 100% accurate, up to date, and contain no errors.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

AQL: Data gathered shall be 100% accurate, up to date, and contain no errors.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

The contractor shall develop and integrate policies, programs, and procedures that provide sustained maintenance support of Army medical equipment.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

Provide raw data to requestor/supervisor in response to routine requests within 2 working days and perform analysis (as required) within 5 working days.

Provide raw data to requestor/supervisor in response to moderate requests within 5 working days and perform analysis (as required) within 7 working days.

Provide raw data to requestor/supervisor in response to complex requests within 7 working days and perform analysis (as required) within 10 working days.

AQL: Data gathered should be 100% accurate, up to date, and contain no errors.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

The contractor shall track cost effectiveness and efficiency of medical maintenance repair programs.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

Provide raw data to requestor/supervisor in response to routine requests within 2 working days and perform analysis (as required) within 5 working days.

Provide raw data to requestor/supervisor in response to moderate requests within 5 working days and perform analysis (as required) within 7 working days.

Provide raw data to requestor/supervisor in response to complex requests within 7 working days and perform analysis (as required) within 10 working days.

AQL: Data gathered shall be 100% accurate, up to date and contain no errors.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

The contractor shall support Army medical maintenance quality and training programs.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

b) STD: When selected to conduct MAIT visit, conduct investigation prior to MAIT visit, conduct the MAIT visit within the allocated time frame (available time will be different depending on type of unit(s) visited), complete the after action report (AAR) within 5 working days of returning from the MAIT visit, and provide recommendations for improvement as part of the AAR.

AQL: Data gathered shall be 100% accurate, up to date, and shall not contain errors.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

The contractor shall monitor capability and capacity of maintenance activities within Major Command (MACOM).

Provide raw data to requestor/supervisor in response to routine requests within 2 working days and perform analysis (as required) within 5 working days.

Provide raw data to requestor/supervisor in response to moderate requests within 5 working days and perform analysis (as required) within 7 working days.

Provide raw data to requestor/supervisor in response to complex requests within 7 working days and perform analysis (as required) within 10 working days.

AQL: Data gathered shall be 100% accurate, up to date and contain no errors.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

Establish an approver account with PD TMDE; review and validate that TMDE SP request packets are accurate and complete, following up with customers for clarification as required; perform NMP TMDE coordinator post procurement actions in accordance with ISO work instructions. Attend scheduled and unscheduled TMDE meetings and conferences and provide subject matter expertise for the acquisition, sustainment and disposal of medical TMDE SP.

AQL: Data gathered shall be 100% accurate, up to date, and contain no errors.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

AQL: Data gathered and subsequent analysis should be 100% accurate, relevant, up to date, and contain no errors.

Observation and 100% Inspection by the NMP Chief and/or Deputy.

5. METHODS OF QA SURVEILLANCE.

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

· Feedback from Oversight Board

· Feedback from Government Users

· Feedback from Property Book Officers

· Direct Observation

· 100% Inspection

· Review of Quarterly Reports (various)

· Review of Monthly Reports (various)

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 shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

· DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

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

· PERIODIC INSPECTION. Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled as required.

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

· Performance reporting.

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 and the Inspection of Supplies clause in the Contract becomes the basis for the KO’s actions.

6. 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:

Example 1:

7. DOCUMENTING PERFORMANCE.

a. 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 actions.

b. 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 task manager or on-site representative. A CDR template is attached to this QASP.

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 actions deemed necessary by the KO.

8. FREQUENCY OF MEASUREMENT.

a. Frequency of Measurement.

During contract/order performance, the COR shall take periodic measurements, quarterly as specified in the AQL column of the Performance Standards Summary Matrix, and shall analyze whether the negotiated frequency of measurement is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings.

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

PERFORMANCE REPORT

1. Contract Number: TBD

2. Prepared by: COR Name Entered At Time of Award

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

CONTRACT DISCREPANCY REPORT (CDR)

1. Contract Number: TBD

2. To: (Contractor Task Manager or on-site representative) Philippe Deschamps

3. From: TBD

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: COR

Received by:

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.