Quality Assurance Surveillance Plan.pdf

Quality Assurance Surveillance Plan

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 accomplished the work. Rather, a 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

Governments responsibility to be objective, fair, and consistent in evaluating performance. 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. Copies of the original QASP and revisions shall be provided to the contractor and the Government Officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities:

▪ 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 received impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor performance.

▪ Contracting Officer Representative (COR) – The COR is responsible for the technical administration of the contract and shall assure proper Government surveillance of the contractors’ performance. The COR shall keep a quality assurance file. The COR is not empowered to make contractual commitments or to authorize any contractual changes on the Governments behalf.

Assigned COR: Jodi Liao, Chief Technologist, VAPIHCS Laboratory Service

3. PERFORMANCE STANDARDS

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

Measure

PWS

Ref.

Performance

Requirement Standard

Acceptable

Quality Level

Method of

Surveillance

To ensure proper specimen handling

& test information during the life of contract

6.1.7

6.1.8

6.1.9

6.1.10

6.1.11

6.1.12

6.1.13

6.1.14

6.1.15

6.1.16

6.1.17

6.1.18

All laboratory staff must handle & perform lab testing for accurate test results and reporting

Contractor must handle specimens properly during pick-up, transport, testing

& reporting phases

100%

Satisfactory

Quarterly COR review of services

Timely sample pick-up & transport

6.2.2

6.2.3

6.3.2

6.3.3

6.5.2

6.5.3

6.6.3

Must provide courier pick up and laboratory testing for all samples referred from VAPIHCS main facility during the

Contractor must pick-up samples daily

Monday thru Friday or as needed between hours specified in

PWS for each location.

95%

Satisfactory

Quarterly COR review of services

6.8.1 period specified in the contract.

Communication of any delays in sample pick-up

6.2.2

6.2.3

6.3.2

6.3.3

6.5.2

6.5.3

6.6.3

Contractor shall provide notification to

VAPIHCS lab ASAP in the event of any delay in courier pick-up time

Contractor must notify VAPIHCS lab via telephone call in event of any delays

95%

Satisfactory

Quarterly COR review of services

Protection of health information

6.1.3

6.1.4

6.1.5

Contractor shall abide by all HIPPA requirements to safeguard and protect health information.

Any breeches shall be reported by the

Contractor to the

VAPIHCS laboratory.

Zero breeches in privacy or confidentiality.

100%

Satisfactory

Any breech in disclosure of protected health information will be immediately addressed

Test result reporting

6.1.7

6.1.9

6.1.10

6.1.11

6.1.12

Test results shall be reported within the prescribed turn-around-time as specified by the

Contractor in their test information.

Must meet or exceed contractor established turn-around-times for testing and result receipt.

95%

Satisfactory

Quarterly COR review of services

Invoicing

Submitted via VA

OB10 invoicing system within 30-days of the end of each month services were provided. Contractor shall provide itemized invoice.

All invoices are itemized and accurate

100%

Satisfactory

Monthly invoice validation by

COR

4. RATINGS

Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The following ratings shall be used:

EXCEPTIONAL

Performance meets contractual requirements (AQL) 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.

NOTE: To justify an Exceptional rating, you should identify multiple significant events in each category and state how it was a benefit to the GOVERNMENT. However, a singular event could be of such magnitude that it alone constitutes an Exceptional rating. Also, there should have been NO significant weaknesses identified.

VERY GOOD

Performance meets contractual requirements (AQL) and exceeds some 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 effective.

NOTE: To justify a Very Good rating, you should identify a significant event in each category and state how it was a benefit to the

GOVERNMENT. Also, there should have been NO significant weaknesses identified.

SATISFACTORY

(Acceptable Quality Level)

Performance meets contractual requirements. The contractual performance of the element or sub-element being assessed contains some minor problems for which corrective actions taken by the contractor appear to be or were satisfactory.

NOTE: To justify a Satisfactory rating, there should have been only minor problems, or major problems the contractor recovered from without impact to the contract. Also, there should have been NO significant weaknesses identified.

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. The contractor’s proposed actions appear only marginally effective or were not fully implemented.

NOTE: To justify a Marginal performance, you should identify a significant event in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. A

Marginal rating should be supported by referencing the management tool that notified the contractor of the contractual deficiency (e.g.

Management, Quality, Safety or Environmental Deficiency Report or letter).

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 being assessed contains serious problem(s) for which the contractor’s corrective actions appear or were ineffective.

NOTE: To justify an Unsatisfactory performance, you should identify multiple significant events in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT.

However, a singular problem could be of such serious magnitude that it alone constitutes an unsatisfactory rating. An Unsatisfactory rating should be supported by referencing the management tool that notified the contractor of the contractual deficiency (e.g. Management, Quality, Safety or Environmental Deficiency Report or letter).

5. DOCUMENTING PERFORMANCE

a. The Government shall document positive and/or negative performance. Any report may become a part of the supporting documentation for any contractual action and preparing annual past performance using

CONTRACTOR PERFORMANCE ASSESSMENT REPORT (CPAR).

b. If contractor performance does not meet the Acceptable Quality Level, the CO shall inform the contractor.

This will normally be in writing unless circumstances necessitate verbal communication. In any case, the CO shall document the discussion and place it in the contract file. When the COR and the CO determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the CO. The CO will in turn review and will present to the contractor’s program manager for corrective action.

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 CO. The Government shall review the contractor’s corrective action plan to determine acceptability. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance and the acceptability of the Contractor’s corrective action plan.

Any CDRs may become part of the supporting documentation for any contractual action deemed necessary by the CO.

6. FREQUENCY OF MEASUREMENT

a. The frequency of measurement is defined in the contract or otherwise in this document. The Government

(COR or CO) will periodically analyze whether the frequency of surveillance is appropriate for the work being performed.

b. Frequency of Performance Reporting: The COR shall communicate with the Contractor and will provide written reports to the Contracting Officer quarterly (or as outlined in the contract or COR delegation) to review Contractor performance.

7. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR Name/Title Date

SIGNED:

CONTRACTOR Name/Title Date