36C24720Q0166-004.docx

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Q522--Mobile MRI Service and PET/CT Atlanta VA Medical Center
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36C24720Q0166
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This document is a statement of work for a mobile magnetic resonance imaging (MRI), positron emission tomography/computed tomography (PET/CT), and related radiology services contract opportunity with the Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 7. The statement of work requires the contractor to provide a mobile MRI unit five days a week to perform various examinations at the Atlanta Veterans Affairs Medical Center and Atlanta Veterans Affairs Clinic from July 2020 through July 2025. The contractor must also provide a mobile PET-CT unit and all necessary radiopharmaceuticals to perform oncology-related studies. The contractor will be responsible for equipment, supplies, staffing, and radiopharmaceutical ordering, acquisition, and disposal. The contractor must adhere to all regulatory requirements and VA policies and procedures. Pricing is to be provided by the contractor on a unit basis for evaluation.

36C24720Q0166 Attachment 4 - QASP Mobile Imaging.docx

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S06 - 36C24720Q0166 0003.pdf PDF
S06 - 36C24720Q0166 0002.pdf PDF
Attachement 5 - 36C24720Q0166 Questions and Answers.docx DOCX document
S06 - 36C24720Q0166 0001.pdf PDF
36C24720Q0166-000.docx DOCX document
36C24720Q0166-003.pdf PDF
36C24720Q0166-002.docx DOCX document
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Radiology Service

508-19-4-2041-XXXX

QUALITY ASSURANCE SURVEILLANCE PLAN

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: TBD Organization or Agency: Atlanta VA Healthcare System

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: Sally Vaughn Organization or Agency: Atlanta VA Healthcare System

3. CONTRACTOR REPRESENTATIVES

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

Name: __Sally Vaughn___________ Phone: 404-321-6111 X 123564___ Email: Sally.Vaughn@va.gov_____

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.

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. METHOD OF QA SURVEILLANCE

A. PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed. Ten (10) randomly selected patient files will be reviewed per inspection period. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards.)

Measure
Performance

Requirement

Standard
Acceptable Quality Level
Surveillance

Method

Patient images and Documentation

All images and documentation sent for dictation in a timely manner.
Compliance with VA Rules and Regulations
95%
Periodic Inspection and Random Sampling
Quality Assurance/Quality Improvement (QA/QI) Documentation
Reviewable records of device quality assurance shall be maintained. Daily, monthly and annual QA documentation records
100% of QA/QI documents complete in accordance with ACR standards.
90%
Periodic sampling.
Patient Safety
Patient safety incidents, including medical events involving miss administrations, must be reported.
100% of incidents reported promptly (within 24 hours of discovery.)
100%
Direct Observation
Maintains licensing, registration, and certifications
Updated Licensing, registration and certifications will be provided as they are renewed.
100% Licensing and registration information kept current.
100%
Periodic Sampling and Random Sampling
Mandatory Training
Contractor completes all mandatory required training
All Training (100%) completed as required per VAMC policy
100%
Contractor to provide documented evidence

Privacy, Confidentiality and HIPAA

Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPPA and complies with all standards
Zero breaches of privacy or confidentiality
100%

Contractor to provide evidence of annual training required by VAHCS, reports violations per policy

Professionalism/ Conduct

Contractor employees maintain excellent relationships with patients and VA Medical Center staff members.
Zero complaints from VA Medical Center staff members related to the contractor’s employee interfering with patient care or the ordinary operation of the facility.
100%
COR notification of complaints

Radiology Service

6. RATINGS

Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The following ratings shall be used:

EXCEPTIONAL:
Contractor always meets the standard. 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:
Contractor almost always meets the standard, always performs over the Acceptable Quality Level. 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:
Contractor occasionally meets the standard, but more often meets the 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:
Contractor most often meets the Acceptable Quality Level, occasionally does not meet the Acceptable Quality Level and CDRs have been reported. 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:
Contractor has history of not meeting Acceptable Quality Level. Significant efforts have been made to bring Contractor into performance. 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), 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 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.

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

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.

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