S02 - Attachment D.1 - Quality Assurance Surveillance Plan QASP.pdf

Quality Assurance Surveillance Plan (QASP)

The contractor shall 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 shall be monitored?

• How shall monitoring take place?

• Who shall conduct the monitoring?

• How shall monitoring efforts and results 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 VA’s responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a “living document” and the VA may review and revise it on a regular basis. However, the VA shall coordinate changes with the contractor through contract modification. Copies of the original QASP and revisions shall be provided to the contractor and VA officials implementing surveillance activities.

2. VA 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: Jayne L. Messer

Organization or Agency: Department of Veterans Affairs Network Contracting Office 8 (NCO 8)

b. Contracting Officer’s Representative (COR) – The COR is responsible for technical administration of the contract and shall assure proper VA 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 VA’s behalf.

Assigned COR: Susan Elrod

Organization or Agency: Malcom Randall VAMC

Attachment D.1 - Quality Assurance Surveillance Plan QASP

RFQ# 36C24826Q1057

3D Imaging and Case Planning Services Malcom Randall VAMC, NF/SG VA Healthcare System

3. PERFORMANCE STANDARDS

The contractor is responsible for performance of ALL terms and conditions of the contract. CORs shall 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. Performance standards define desired services. The VA performs surveillance to determine the level of contractor performance to these standards.

The Performance Requirements are listed below in Section 6. The VA 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 shall be used, in part, to establish the past performance of the contractor on the contract.

4. 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. 100% surveillance: Vascular Service members will ensure that accuracy, quality and timeliness are not compromised. This will be performed upon receipt and review of each 3D images. Performance evaluation will be reviewed by the COR semi-annually, more so if necessary.

b. PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed. Inspections will be scheduled and reported quarterly per COR Delegation or as needed a minimum of ten (10) samples will be selected randomly and reviewed for accuracy, quality and timeliness of submission. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards.

c. VALIDATED USER/CUSTOMER COMPLAINTS. Documented and verbal complaints will be evaluated as indicated

d. RANDOM SAMPLING. A minimum of ten (10) samples will be selected randomly and reviewed for accuracy, quality and timeliness of submission. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards

e. Verification and/or documentation provided by Contractor: Documentation study deliverables, and reports will be provided quarterly, as scheduled and upon requests.

5. SAMPLE QASP PERFORMANCE REPORT DATE:

Measures PWS

Reference

Performance

Requirement

Standard Acceptable Quality Level

Surveillance

Method

Met AQL/DID NOT

MEET AQL-

CPARS RATING/ADD

COMMENTS

Documentation (A)

4.8.5 Upload all necessary digital

images and create multiplanar reformatting and 3D reconstruction

Documentation completed within established/required time frames

99% Compliance

Direct Observation and review of submitted reports/data

Documentation (B)

4.8.6 Confirms CT scan data is

valid

Documentation completed upon acquisition of digital images

99% Compliance

Direct Observation and review of submitted reports/data

Patient Safety (A)

4.8.7 Efficient turnaround of digital

images and 3D reconstructions.

No delay in patient surgery planning and scheduling

99% Compliance

Direct Observation

Patient Safety (B)

4.8.8 Availability of electronic data

files containing 3D reconstruction for urgent cases. Usually within 24-48 hours

Case planning not delayed due to unavailability of images

99% Compliance

Direct Observation & Semi-annual Performance Evaluation

Privacy, Confidentiality and HIPAA

4.8.9 Contractor is aware of all

laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and complies with all standards Zero breaches of privacy or confidentiality

All (100%) contractor’s support staff comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and

HIPAA

99% compliance

Periodic Inspection:

Contractor shall provide evidence of annual training required by the facility, reports violations per VA Handbook 6500.6.

6. CPARS RATINGS ASSIGNED TO QASP ITEMS:

Metrics and methods are designed to determine rating for a given standard and acceptable quality level.

The following ratings shall be used (Reference: CPARS User Manual:

https://www.cpars.gov/cparsweb/assets/documents/CPARS_User_Manual.pdf.

EXCEPTIONAL: Performance meets contractual requirements and exceeds many to the VA’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 VA. 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 VA’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 VA. 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 VA. 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 VA. However, a singular problem could be of such serious magnitude that it alone constitutes an unsatisfactory rating. An Unsatisfactory rating should be supported by https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.cpars.gov%2Fcparsweb%2Fassets%2Fdocuments%2FCPARS_User_Manual.pdf&data=05%7C02%7C%7C1299a8a1556647c9c9b208dd897915ec%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638817875334440754%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=6A9MQEEm9YUvO1cWqDUn1sC8wYUJvuCVqG%2F2AhW8s1E%3D&reserved=0 referencing the management tools used to notify the contractor of the contractual deficiencies (e.g., Management, Quality, Safety or Environmental Deficiency Reports, or letters).

7. DOCUMENTING PERFORMANCE

a. The VA 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 shall 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 determine formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to CO. The CO shall in turn review and shall present to the contractor's program manager for corrective action.

The contractor shall acknowledge receipt of the CDR in writing. The CDR shall 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 shall also state how long after receipt the contractor has to present this corrective action plan to the CO. The VA shall review the contractor's corrective action plan to determine acceptability. The CO shall also ensure 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 a part of the supporting documentation for any contractual action deemed necessary by the CO. See Sample on following page.

8. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR NAME/TITLE DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

CONTRACT DISCREPANCY REPORT

1. CONTRACT NUMBER 2. REPORT NUMBER FOR THIS

DISCREPANCY

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

5. DATES

a. CDR PREPARED b. RETURNED BY

CONTRACTOR:

c. ACTION COMPLETE

6. DISCREPANCY OR PROBLEM (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, CORRECTIVE ACTION AND ACTIONS

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

11. SIGNATURE OF CONTRACTOR REPRESENTATIVE Date:

12. GOVERNMENT EVALUATION. (Acceptance, partial acceptance, reflection. Attach continuation sheet(s) if necessary.)

13. GOVERNMENT ACTIONS (Acceptance, partial acceptance, reflection. Attach continuation sheet(s) if necessary.)

14. CLOSE OUT

NAME TITLE SIGNATURE DATE

a. CONTRACTOR

NOTIFIED

b. COR c.

CONTRACTING

OFFICER