36C26318R0485-004.pdf

Quality Assurance Surveillance Plan (QASP) Computer Assisted Surgery Specialist providing Stealth® Navigation & O-Arm® Services

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

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.

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: Daniel Vagts, Contracting Officer Phone: 612-244-2186 Email: Daniel.Vagts@va.gov

Organization or Agency: VA 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 COR: Lynda Dent, Administrative Officer/COR, SSC PSL Phone: 612-467-2384

Organization or Agency: Minneapolis VA Health Care System Email: Lynda.Dent@va.gov

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.

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

mailto:Daniel.Vagts@va.gov mailto:Lynda.Dent@va.gov

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. DIRECT OBSERVATION. For this service 100% direct observation will not be performed by the COR. Direct observation will be performed by the Surgeon or Surgery Supervisor and reported to the COR on a quarterly basis.

b. PERIODIC INSPECTION. For this service, quarterly periodic inspection will be completed by the Service Chief or designee and reported to the COR. Physical presence is checked on a monthly basis by the COR checking with the using service to see if provider is present in the medical center when scheduled and providing services as required by the contract.

c. VALIDATED USER/CUSTOMER COMPLAINTS. All complaints about contract provider’s performance will be immediately reviewed and referred to the contracting officer for action if necessary.

d. RANDOM SAMPLING. Discussion with VA staff involved in services provided who are familiar with the provider’s work will be randomly polled quarterly or as needed by the COR.

e. VERIFICATION and/or DOCUMENTATION PROVIDED BY CONTRACTOR: The COR will verify license, certification, and training of provider a minimum of annually.

6. QASP PERFORMANCE REPORT DATE:

Measures PWS

Reference

Performance

Requirement

Standard Acceptable

Quality

Level

Surveillance

Method

Met AQL/Did Not Meet ACL

CPAR Rating/Add Comments

1 –Contractor’s Key

Personnel

1 thru 1.9; 7;

15 and 16

Must be present at VA and providing required services as specified in the contract requirements

Qualified personnel are on-site, on time and in location as needed to properly perform tasks as specified in the

PWS

100% Random audit & observation by

Service Chief and

COR, Time &

Attendance Logs, Quality Assurance

Reports

2 - Mandatory

Training and

Education

8.1; 8.2. Contract personnel completes all mandatory VA education & training requirements

Contractor must complete all required VAtraining per VAMC policy

100% VA TMS training reports will be verified semi-annually by the COR

3 – Standard of Care and Patient Safety

1.1; 1.5; 1.8 Contractor provider’s standard of care is of highest quality to ensure patient safety

No complaints as to standard and quality of patient care

100%

COR will track reports from Surgery

Service; O.R. Staff;

and Patient Family

Center

4 - Invoicing 20 Within 30 days of the end of each month services were provided, contractor will provide itemized invoice

All invoices are itemized and accurate

100% Inspection and review by COR monthly

7. CPAR 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/pdfs/CPARS-Guidance.pdf p. A2-1):

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).

https://www.cpars.gov/pdfs/CPARS-Guidance.pdf

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 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 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 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. See sample of CR on following page.

9. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:___________________________________________ _____________

COR Name/Title: Lynda Dent, AO Surgery/Specialty Care-PSL DATE

SIGNED:______________________________ ______________

CONTRACTOR NAME/TITLE DATE

CONTRACT REPORT

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, 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

CONTRACTOR

NOTIFIED

COR

CONTRACTING

OFFICER