S02 - Attch - D.2. QASP.pdf

36C26322R0024

D.2. QASP

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Pathology & Laboratory Medicine Services (P&LMS)

The contractor will be evaluated in accordance with the following:

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?

a. 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.

b. 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 through contract modification.

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.

Assigned CO: Erica Morris Organization or Agency: Department of Veterans Affairs, Network 23 Contracting Office

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. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned CORs:

Susan Dover, P&LMS Lab Manager Kimberly Hemrick, Supervisor Medical Technologist, Microbiology Diane Wilkins, COR, Chief of Staff Office Janelle Fredrick, COR, Chief of Staff Office

Organization or Agency: Department of Veterans Affairs, Nebraska Western Iowa Health Care System, Omaha Division

3. CONTRACTOR REPRESENTATIVES:

The following employee(s) of the contractor serve as the contractor’s program manager(s) for this contract:

Primary: ______________________________________

Alternate: __________________________________

4. PERFORMANCE STANDARDS: 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.

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

b. The Performance Requirements are listed below in Section 6. 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.

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. REVIEW MONTHLY REPORT: 100% surveillance via monthly report.

b. CYTOLOGY: 100% surveillance

c. INSPECTION – TIMELY INVOICES: The COR reviews the invoice through the VA Invoice Payment

Processing System (IPPS) to ensure that the invoice is timely and accurate.

d. DOCUMENTATION WHEN SLIDES ARE RECEIVED: Upon receipt of slides, VA NWIHCS Pathology &

Laboratory Medicine Service will identify when specimen slides are mislabeled.

6. SAMPLE QASP PERFORMANCE REPORT

PERFORMANCE MEASURES

Measure PWS Reference

Performance Requirement

Standard Acceptable Quality Level

Method of Surveillance Met AQL / DID NOT

MEET AQL-

CPAR RATING /

COMMENTS

Patient ID Rate

3.5.3.1

3.13.5.1

Patient ID Rate

(TJC requirement)

Patient’s name (first and last), full SSN and/or full Date of Birth (DOB) or identification number (i.e., case number).

100% Review monthly report

Reference

Performance Requirement

Standard Acceptable Quality Level

Method of Surveillance Met AQL / DID NOT

MEET AQL-

CPAR RATING /

COMMENTS

Cytology 3.5.1.2 3.5.4.1 3.13.5.2

Cytology Report Completion

Gynecological (GYN) within fourteen (14) working days; Non- GYN within five (5) working days

95% Review of Cytology Report

Timely Invoicing

3.13.5.3

5.2.2

Within 30 days of the end of each month services were provided, as described above, the vendor shall provide itemized invoicing

All itemized invoices provided within 30 days of end of prior month services delivered.

98% VA Invoice Payment Processing System (IPPS)

Autopsy 3.3.9.1

3.13.5.6

Provisional Report Provisional anatomic diagnosis must be provided to the VA within 2 working days via encrypted e-mail and secured fax.

100% Review monthly report

Autopsy 3.3.9.2

3.13.5.7

Final Report The completed post-mortem exam, with final copy of succeeding pages must be submitted to the VA within 30 working days, unless exceptions for special studies are established by the medical staff.

100% Documentation when slides are received.

10% Review

3.3.8 3.13.5.5

Global Case Review

Review 10% of all global cases monthly per accrediting agency guidelines. Prepare monthly report and deliver to the COR by the 20th day of the following month. Any discrepant results must be communicated within one (1) working day to a VA Pathologist.

100% Review all global SNOMED cases and review submitted global case report.

Tests 3.3.2

3.13.5.4

% of specimen slides mislabeled

No mislabeling 100% Documentation when slides are received

Colon and Rectum Resection

3.3.10

3.5.5

3.5.5.1

3.13.5.8

At least 12 regional lymph nodes must be removed and pathologically examined for resected colon

If fewer than 12 lymph nodes are found, re-examining the specimen for additional lymph nodes, with or

85% Review of final monthly reports

Reference

Performance Requirement

Standard Acceptable Quality Level

Method of Surveillance Met AQL / DID NOT

MEET AQL-

CPAR RATING /

COMMENTS

cancer. Any deviation from CAP Protocols must be documented in the patient’s final report.

without visual enhancement techniques, and document in the patient’s final report.

7. 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 – Acceptable Quality Level (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 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:

(Acceptable Quality Level)

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 REPORTING SYSTEM (CPARS).

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 Report (CR), 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 CR in writing. The CR 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 CR 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 CRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

9. FREQUENCY OF MEASUREMENT:

a. Frequency of Measurement: The frequency of measurement is defined in the contract or otherwise in this document. The government (COR or CO) will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.

b. Frequency of Performance Reporting: The COR shall communicate with the contractor on a quarterly and semi-annual basis. Formal written reports, as outlined in the contract, will be submitted to the Contracting Officer for review of contractor performance.

10. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

Susan Dover, Pathology/Laboratory Manager, COR DATE

Diane Wilkins, COR, Chief of Staff Office DATE

CONTRACTOR NAME/TITLE DATE

CONTRACT REPORT (CR)

1. CONTRACT NUMBER 2. REPORT NUMBER FOR THIS DISCREPANCY

3. TO: (Contracting Officer) 4. FROM: (Name of COR)

5. DATES

a. CR PREPARED:

b. RETURNED BY

CONTRACTOR:

c. ACTION COMPLETE:

6. Issue Identified (Describe in detail. Include reference to PWS Directive; attach continuation sheet if necessary.)

7. SIGNATURE of COR Date:

8. SIGNATURE of CONTRACTING OFFICER Date:

9a. TO (Contracting Officer) 9a. FROM (Contractor)

10. CONTRACTOR RESPONSE AS TO CAUSE AND ACTIONS TO PREVENT RECURRENCE.

applicable quality control program procedures or new procedures. Attach continuation sheet(s) if necessary.)

11. SIGNATURE OF CONTRACTOR REPRESENTATIVE

Date:

12. GOVERNMENT EVALUATION.

13. GOVERNMENT ACTIONS

14. CLOSE OUT

NAME TITLE SIGNATURE DATE

CONTRACTOR

NOTIFIED

COR

CONTRACTING

OFFICER