D.1 QUALITY ASSURANCE SURVEILLANCE PLAN.docx

D.1 ATTACHMENT 36C25622Q0525 QUALITY ASSURANCE SURVEILLANCE PLAN

QUALITY ASSURANCE SURVEILLANCE PLAN

For Anatomic Pathology Referral Laboratory Testing Services Specializing in Renal Biopsy RFQ Number: 36C25622Q0525 Contract Description: Renal Pathology Biopsy 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: Frank Mendoza Organization or Agency: Network Contracting Office 16 Telephone: 713-791-1414 x22769 Email: Francisco.Mendoza@va.gov

b. 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 KO, the COR shall provide documentation to the KO. 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 KO for action.

Assigned COR: Peter Basten Telephone: 713-791-1414 ext. 24392 Email: Peter.Basten@va.gov

d. Other Key Government Personnel – Benjamin Farmer, MHS< HTL (ASC) and PA Title: Supervisory Histotechnologist Telephone: 713-791-1414 ext. 27259 Email: Benjamin.Farmer@va.gov

3. CONTRACTOR REPRESENTATIVES:

The following employees of the contractor serve as the contractor’s Program Manager and Task Manager for this contract. <Communication should occur with them during QASP development. It will help if they review the draft QASP and accept the final version.>

a. Program Manager: ___________________________ Telephone: _____________________________ Email: ______________________________

b. Task Manager:____________________ Telephone:_______________________ Email:_______________________________

c. Other Contractor Personnel:

Title:______________________ Telephone:_______________________ Email:_______________________________

4. PERFORMANCE STANDARDS.

The Government performs surveillance to determine if the contractor exceeds, meets or does not meet the performance standards outlined in this QASP.

The Performance Requirements Summary Matrix, paragraph 5.2 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. 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.

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

· Patient safety incidents must be reported to Benjamin Farmer, MHS, HTL (ASC), & PA, by fax, phone call or email (information will be provided after award of contract).

b. VALIDATED USER/CUSTOMER COMPLAINTS. (Relies on the patient to identify deficiencies. Complaints are then investigated and validated.)

· Complaints about the quality of service will be reported to the COR and/or the Laboratory Manager for resolution.

c. RANDOM SAMPLING. (Designed to evaluate performance by randomly selecting and inspecting a sample of cases.)

· Random sampling of test report will be reviewed to check for timeliness of reporting of tests

· Timely Invoicing

d. CONTRACTOR PROVIDED DOCUMENTATION. (Relies on documentation provided by the contractor).

· Mandatory Training

· Privacy, Confidentiality, HIPAA

· Clinical Laboratory Improvement Amendments (CLIA)

· College of American Pathologists Approval Documentation

· Anatomic Pathologists’ unrestricted license to practice medicine in one of the states or territories of the United States of District of Columbia

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

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 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:

Indicator No

PWS

Reference

Satisfactory: Performance meets contractual requirements.

Unsatisfactory: Performance does not meet contractual requirements.

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, on a daily or weekly basis 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. Interim assessments will be completed annually. A final assessment will be completed after the last period of performance of the contract

Prepared by: Peter Basten, MHA Management & Program Analyst

Signature – Contracting Officer’s Representative

PERFORMANCE REPORT

1. CONTRACT NUMBER: _____________________________

2. Prepared by: ____________________________

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: ________________________

CONTRACT DISCREPANCY REPORT (CDR)

1. Contract Number: <insert number>

2. TO: (Contractor Task Manager or on-site representative)__________________

3. FROM: (Name of COR) ________________________

4. Date and time observed discrepancy:

5. DISCREPANCY OR PROBLEM:

<Describe in detail. Identify any attachments.>

5. 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: _________________________

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.>