Quality Assurance Surveillance Plan (QASP).pdf

Quality Assurance Surveillance Plan (QASP)

Contract Number: TBD

1. PURPOSE

a. 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.

b. 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.

c. 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 Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

a. 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.

Contracting Officer: Joleo Dianala

b. Contracting Officer’s Technical Representative (COTR) - The COTR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COTR shall keep a quality assurance file. The COTR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COTR: Lisa Narvaez

Other Key Government Personnel: Erin Smith, Program Manager

3. CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s program manager for this contract.

a. Program Manager – TBD

b. Other Contractor Personnel - TBD

4. PERFORMANCE STANDARDS

a. The contractor is responsible for performance of ALL terms and conditions of the contract.

CORs will provide contract progress reports quarterly to the CO reflecting performance on this plan and all other aspects of the resultant contract. The performance standards outlined in this QASP shall be used to determine the level of contractor performance in the elements defined.

b. Performance standards define desired services. The Government performs surveillance to determine the level of Contractor performance to these standards.

c. The Performance Requirements are listed below in. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the standard and assign a rating. At the end of the performance period, these ratings will be used, in part, to establish the past performance of the contractor on the contract.

QUALITY ASSURANCE SURVEILLENCE PLAN (QASP)

Measure

Paragraph in

PWS

Performance

Standard

Standard for Quality

Level

Acceptable

Quality

Level

Method of

Surveillance

Proper labeling of Specimens 22.4.1

All laboratory staff must handle specimens without labeling errors.

Contractor must handle the specimens properly during the tests processing.

100% satisfactory

Review at the

Pathology monthly QI meeting.

Indication of

Specimens

Volume

22.4.2

10-40 tests per month and depending on the specimen availability

Excellent lab. work services within the scope of practice

100% of the time.

100% satisfactory

Review at monthly QI meeting

Quality and TAT of test results 22.4.3

Excellent quality of slides staining.

Accurate diagnosis and turnaround time within

1 -3 days

Satisfactory rating of

100%

Review at monthly QI meeting

Proficiency

Testing

Data

22.4.4

The proficiency testing (PT) is necessary to verify the

The PT test will improve the quality of testing for VA patients.

100% satisfactory with accurate diagnosis

If any discrepancy of diagnosis will be discussed in accuracy and reliability of its testing.

QI monthly meeting.

Maintains licensing and

Certification

22.4.5

Licensing and registration information kept current.

All (100%) licensing for contract laboratory technicians shall be provided as they are renewed.

100% compliance

Periodic inspection

Privacy, Confidentiality and HIPPA

22.4.6

Contractor technicians and pathologists must comply with all laws, regulations, policies and procedures relating to

Privacy, Confidentiality and HIPAA

All (100%) contractor technicians and pathologists comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and

HIPAA

100%

Compliance

Periodic inspection

5. INCENTIVES

The Government shall use the scoring methods above for continuing contract performance. Incentives shall be based on exceeding, meeting, or not meeting performance standards.

6. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance. There will be quarterly meetings held with the Contractor to discuss any issues. In addition, the COR shall use the following surveillance methods in the administration of this QASP.

a. PERIODIC INSPECTION. The COR will perform periodic inspection of test results received, encounters and other standard communications, procedures and follow up to ensure both completion of the documentation and completion to the established standards.

b. CUSTOMER COMPLAINTS. The COR will review and investigate as necessary laboratory managers’ complaints, with results to be discussed with vendor as required.

7. 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.

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 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 and exceeds some to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with some 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: Performance meets contractual requirements. The contractual performance of the element or sub-element contains some minor problems for which corrective actions taken by the contractor appear 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 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 rating, 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 tools used to notify the contractor of the contractual deficiencies (e.g. Management, Quality, Safety or Environmental Deficiency Reports, or letters).

8. 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 CO. The CO will in turn review and will present to the contractor's program manager for corrective action.

c. 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.

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

9. FREQUENCY OF MEASUREMENT

a. The frequency of measurement is defined in the methods of surveillance table. The government (COR or CO) will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.

b. 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.

Signature – Contractor Program Manager

Signature - Contracting Officer’s Representative