36C25719Q0360-003.pdf

Quality Assurance Surveillance Plan (QASP) Lithotripsy Services NTX VA

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: Marisela Galarza, Contracting Officer, NCO 17 Assigned CS: Noel Ramirez, Contract Specialist, NCO 17

Organization or Agency: Department of Veterans Affairs, NCO 17, El Paso

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(s): Eric Wikoff, Management Analyst, Surgical Service

Organization or Agency: Department of Veterans Affairs North Texas Health Care System.

3. CONTRACTOR REPRESENTATIVES

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

a. Primary Contact: ___________________________

b. Alternate: ________________________________

4. PERFORMANCE STANDARDS

The contractor is responsible for performance of ALL terms and conditions of the contract. CORs will provide contract progress reports yearly 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.

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 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: A physician and/or COR will be in direct observation of the lithotripsy technician at all times to provide ESWL services.

b. PERIODIC INSPECTION. The contractor shall make equipment service records, preventive maintenance, and corrective maintenance record(s) available to the Federal Government upon request by the COR. COR randomly request maintenance documentation at minimum, ten (10) cases a year.

c. VALIDATED USER/CUSTOMER COMPLAINTS. The standard is zero (0) cancellations by contractor. ESWL procedures are scheduled by the Dallas VA, Urology section and the COR will audit any cancelled ESWL procedures every three months, as they will have access of the scheduled procedures. Service not provided by contractor in fault by the contractor can result in non-payment and impact on CPARS rating.

d. RANDOM SAMPLING. Ten (10) randomly selected patient files will be reviewed per quarter. All reviews and reports will be conducted in compliance with VA Privacy and Information security standards.

e. Verification and/or documentation provided by Contractor. All providers must be credentialed in accordance with Department of Veteran Affairs. Radiologic Technicians credentials will be furnished upon request, random inspection and auditing.

Measures PWS Ref.

Performance Requirement

Standard Acceptable Quality Level

Surveillance Method

Met AQL/DID NOT MEET AQL-

CPAR RATING/ADD COMMENTS

1. Joint Commission Standards

2.B.8

(pg. 2 of 14)

Compliance with all industry Joint Commission

Standards

Radiologic technologist shall be onsite during all elective scheduled ESWL procedures.

100% compliance required

Periodic inspection and random sampling

2. Monthly invoices

12 (pg. 8 of 14)

Procedure completion documentation to be completed weekly and turned in-to Urology Section Chief for concurrence.

Provide Monthly

100% compliance expected

Random inspection of records

3. Mandatory 15.A.

(pg. 11 of 14)

Information All contractor personnel shall comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality, and HIPAA.

100% compliance expected

Random inspection of records

4. VA 15.C

(pg.11 of 14)

Security, All contractor personnel shall comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality, and HIPAA.

100% compliance expected

Education, Cyber Security, Training, and and HIPPA HIPPA training must be completed on an annual basis

5. OSHA

Requirement

4. (pg. 3-4 of 14)

All annual

PPD/TB

screening;

current immunizations and evidence of having been offered the HEPB vaccine for contract personnel shall always be kept current.

Required to have annually PPD/TB screening;

current immunizations and evidence of having been offered the HEPB vaccine prior to commencement of work

100% Compliance required prior to commencement of work.

Upon request, Random inspection and auditing

6. Patient Safety

11.G (pg.8 of 14)

Patient safety incidents shall be reported using Patient Safety Report (located at https://patientsafet y.csd.disa.mil/)

All of patient safety incidents are reported using Patient Safety Report within 24 hours of incident

100% Direct observation and periodic inspection

6. RATINGS

Metrics and methods are designed to determine rating for a given standard and acceptable quality level. In accordance with FAR 42.1503, Table 42-1, 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. In addition, 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. Inclusive, 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).

7. 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 – Attachment 1), and present it to 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 will 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 a part of the supporting documentation for any contractual action deemed necessary by the CO. See Sample CDR below.

c. If non-performance occurs, an equitable adjustment for nonconforming services will be done in accordance with FAR 46.407.

8. 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 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.

9. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR NAME/TITLE DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

ATTACHMENT 1: Contract Deficiency Report

VHAPM Part801.603-70 COR SOP Revision 06 Page 1 of 1 Original Date: 05/20/2011 Revision 05 Date: 03/11/2019

CONTRACT DISCREPANCY REPORT

1. CONTRACT NUMBER

Report Number: Date:

2. TO: (Contractor and Manager Name)

3. FROM: (Contracting Officer’s Representative Name)

DATES

CONTRACTOR NOTIFICATION:

CONTRACTOR RESPONSE DUE BY: RETURNED BY CONTRACTOR: ACTION COMPLETE:

4. DISCREPANCY OR PROBLEM (Describe in detail; Include reference in PWS / Directive. Attach continuation sheet if necessary.)

5. SIGNATURE OF CONTRACTING OFFICER’S REPRESENTATIVE (COR)

6. TO: (COR)

7. FROM: (Contractor)

8. CONTRACTOR RESPONSE AS TO CAUSE, CORRECTIVE ACTION, AND ACTIONS TO PREVENT RECURRENCE (Attach continuation sheet if necessary.)

9. SIGNATURE OF CONTRACTOR REPRESENTATIVE

10. DATE

11. GOVERNMENT EVALUATION OF CONTRACTOR RESPONSE/RESOLUTION PLAN (Acceptable response/plan, partial acceptance of response/plan, rejection. Attach continuation sheet if necessary)

12. GOVERNMENT ACTIONS (Payment withholding, cure notice, show cause, other.)

CLOSE OUT

NAME AND TITLE SIGNATURE DATE

CONTRACTOR

NOTIFIED

COR

CONTRACTING

OFFICER