QASP.pdf

QUALITY ASSURANCE SURVEILLANCE

PLAN (QASP)

ECMO TRANSPORT

The Department of Veterans Affairs Sierra Pacific Network (VISN 21)

1. Objective: The contract requirement is to provide all equipment, parts, transportation necessary to provide ground ECMO ambulance services, staff and equipment at the San Francisco Veterans Affairs (VA) Medical Center (SFVAMC), in accordance with the attached Performance Work Statement (PWS). Contractor's service will provide all labor, materials, tools, equipment, parts, transportation, etc. required to fulfill the requirements of the PWS. This QASP has been developed to evaluate contractor actions while implementing the Performance-based PWS. It is designed to provide an effective surveillance method of monitoring contractor performance for each item listed objective on the Service Summary (SS) in the PWS. The QASP provides a systematic method to evaluate the services and products the contractor is required to furnish. This QASP is based on the premise that the contractor, and not the government, is responsible for management and quality control actions to meet the terms of the contract. The role of the government quality assurance personnel is to ensure contract standards are achieved.

In this contract, the quality control program is the driver for service quality. The contractor is required to develop a comprehensive program of inspections and monitoring actions. The first major step to ensuring a “self-correcting” contract is to ensure that the quality control program, approved at the beginning of the contract, provides measures needed to lead the contractor to success. Once the quality control program is approved, careful application of the process and standards presented in the remainder of this document will ensure a robust quality assurance program.

2. Government Roles and Responsibilities. The goals and responsibilities of the government are outlined below.

2.1. Contracting Officer (CO) Responsibilities:

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.

2.2. COR Responsibilities:

1. Ensures supplies or services rendered by Contractor meet contract requirements.

2. Notifies the CO and the Contractor of any performance deficiencies in writing or by e-mail.

3. Assists with contract/order closeout.

4. Ensures discrepancy reports are accurate and reported properly.

5. Identifies areas that warrant a change in assessment method, frequency, or performance threshold and provides suggestions about the surveillance plan to the CO.

6. Maintains accurate documentation of Contractor assessment activities as required by the surveillance plan and reports the results of Contractor assessment activities to the CO.

7. Works with the Contractor and the CO to resolve issues.

8. Maintains a file* in accordance with (IAW) the Surveillance Plan and requests CO disposition at the completion of the contract or termination of COR appointment (if applicable).

9. Submits all requests for corrective action to the CO.

10. Inspects and accepts Contractor services at the completion of each contract payment period, usually monthly. The COR will certify services actually received, unless the CO retains the authority for acceptance.

*File should include a copy of the contract/order and all modifications (unless readily available electronically); a copy of COR designation memorandum (if applicable);

correspondence between you and the Contractor; copies of correspondence to or from CO;

minutes of all meetings; copies of all invoices submitted and paid; and all other documentation of actions taken by COR.

4. Performance Assessment.

The required performance objectives can be found in the Service Summary in the PWS. The contractor service requirements are summarized into performance objectives that relate directly to the mission essential items. The performance threshold describes the minimum acceptable levels of service for each requirement. The contractor shall be aware that the absence of any contract requirement from the service summary does not detract from its enforceability nor limit the rights or remedies of the Government under any other provision of the contract.

Method of Surveillance:

Performance Objective PWS Para Acceptable Quality

Levels Surveillance Method

SS-1. Service: Provide 24-hour certified paramedic personnel and ambulances services required for patient transport in support of Veteran beneficiaries.

2 100% Periodic Inspection And Customer Complaint COR shall monitor vendor personnel and transport performance of patient transport services.

SS-2. Ambulance Response: Response time to Urgent calls within 1-hour response time.

Response time to Standard calls within 2 hours response time.

2 No more than 1 late response in a contract period of performance.

Quarterly inspection by the COR of a random sampling of run reports.

SS-4. Certification Requirements: Current BLS, ACLS and NREMT Paramedic certification on file for contract personnel

4 100%, all employees must satisfy this requirement

100% Annual Inspection COR shall inspect to ensure vender compliance.

SS-5. Health Requirements: Physical examinations and required immunizations current and on file for contract personnel.

6 100%, all employees must satisfy this requirement

100% Annual Inspection COR shall inspect to ensure vender compliance.

SS-6. Quality Control Plan: Contractor shall maintain quality program to ensure requirements to meet established standards.

13 90% COR shall perform periodic inspection to ensure vendor compliance.

SS-7. Conversion: Contractor must be able to convert patients from VA ECMO, IABP, mechanical ventilator and external LVAD support system to their transport versions, at bedside at the patient.

2 100% Periodic surveillance of contractor and interview OR team for conversion process.

SS.8. Surveillance: The VA reserves the right to inspect the contractor’s equipment and vehicles or require documentation of compliance with contract specifications and

3 100%

State laws, rules, regulations, and guidelines governing medical transport vehicles (ambulances).

4.1. Procedures.

The government COR will periodically perform inspections to ensure Contractor compliance with the appropriate paragraphs of the PWS and will record the results of inspections, noting the date and time. If inspection indicates a performance threshold is not met, the COR will notify the Contractor and the contracting officer of the deficiency for correction. The Contractor shall be given a reasonable time after notification to correct the unacceptable performance if such correction is possible. The length of time allowed to correct the problem will depend upon the requirement and the deficiency, and the Contractor will be notified by the CO of the time allowed for correction when the deficiency is reported to the Contractor. The COR will not consider the services complete until all deficiencies have been rectified. Deficiencies not corrected or estimated dates of completion that are not acceptable to the COR will be forwarded to the CO for action.

Performance of the contracted services will occur on site at a government facility at the

SFVAMC.

The COR will certify services actually received under this contract in accordance with its terms and conditions, unless the CO retains authority for acceptance. Format is at the discretion of the

COR.

Upon notification from the contractor that the defect has been corrected, the COR will re-inspect the area/task associated with the customer complaint or Correction Action Report that was issued by the Government. The COR will verify the root cause and corrective/preventative actions submitted by the contractor are effective and prevent reoccurrence.

4.1.1. Corrective Action Report (CAR) A CAR shall be used by the COR to document contract requirement findings and subsequent corrective actions to be taken. A computer-generated CAR may be used, provided the information on the CAR remains the same. See attached CAR and instructions for filling out.

4.1.2. Definitions of Major Findings & Minor Findings.

Major Findings. Major findings are contract non-conformances which are considered critical or major. IAW FAR 46.101, a major non-conformance means a non-conformance, other than critical, that is likely to result in failure or reduce the usability of the services for their intended purpose. A critical non conformance means a non-conformance that is likely to result in a hazardous or unsafe condition for individuals using, maintaining, or depending upon the services; or is likely to prevent performance of a vital agency mission. If at any time COR identifies a condition as having a significant adverse effect on the quality of the activity, such as those stated below, the COR shall document their findings and notify the Contracting Officer immediately in writing (email is acceptable).

A. Contractor failure to meet a Performance Threshold.

B. Failure to provide adequate corrective action to preclude reoccurrence of Government identified findings.

C. Failure to provide corrective action to deficiencies identified by the contractor within a prescribed suspense period.

D. Any failure to adhere to security and/or safety regulations that results in a security or safety incident.

4.1.3. Minor Finding. IAW FAR 46.101, a minor non conformance means a non-conformance that is not likely to materially reduce the usability of the services for their intended purpose, or is a departure from established standards having little bearing on the effective use or operation of the services. When the COR identifies a minor finding, the COR shall document the findings, but is not required to notify the Contracting Officer. However, if the same minor finding is repeatedly identified, it may be an indication that a major finding is occurring, or has occurred, because the Contractor has not taken proper steps to prevent recurrence. In this case, the COR shall notify the Contracting Officer in writing (email is acceptable).

4.2. Methods of Surveillance. 1) Customer Complaint/Observation; 2) 100% Inspection; 3) Periodic Inspection of process or output; or 4) Random Inspection.

4.2.1. Customer Complaint/Observation.

The requiring organization will furnish written instructions and/or customer training to each organization receiving the contractor's services. Any customer observing unacceptable services, either incomplete or not performed, for any of the above performance objectives should immediately contact the COR. The COR must evaluate the complaints on a case-by-case basis.

If any Government action or lack of action caused unacceptable performance, the complaint is not valid. The COR will document the invalid complaint and keep for their records. If the complaint is not a result of any Government action, the procedures in paragraph 4.1 will be followed.

4.2.2. 100% Inspection. All deliverables (reports etc.) will be inspected 100% for errors and omissions.

4.2.3. Periodic Inspection. This type of surveillance is based upon selecting samples for evaluation on other than 100% inspection on a statistically random basis.

4.2.4. Random Inspection. A statistically based method that assumes a receipt of acceptable performance if a given percentage or number of scheduled assessments are found to be acceptable.

4.3. Standard. The Contractor must correct each discrepancy through re-performance.

Recurring discrepancies during the reporting period which bring the performance threshold below the acceptable level will be recorded and reported to the CO for appropriate action.

Additionally if the same discrepancy (ies) occurs repeatedly throughout different reporting periods, this will reflect upon the Contractor's performance. The COR will annotate the unacceptable performance and notify the CO in order to address the problem areas with the Contractor. In those instances where re-performance is not possible, the CO may deduct payment IAW the inspection of services clause.

4.4. Surveillance of Non-Service Summary Items.

The Government reserves the right to inspect and test services required by the contract, to the extent practicable, at all times and places, during the term of the contract IAW the contract inspection clause.

4.5. Remedies for Non-Conformance. If inspections indicate unacceptable performance, the COR will notify the Contractor of the deficiencies for correction. The Contractor shall be given an appropriate time frame (depending on the discrepancy identified) after notification to correct the unacceptable performance. If deficiencies are not corrected within the required time frame, the COR should notify the CO for action. If the Contractor disagrees with the noted discrepancy and an agreement cannot be reached, the CO shall be notified for a final decision.

4.6. Positive and Negative Incentives. IAW the results of the COR surveillance documentation, areas warranting a change in assessment method, frequency, or performance threshold will be changed in either a positive or negative manner throughout the life of the contract, if warranted.

5. Performance Management.

5.1. Market Research. Market research will be used as a tool throughout the life of the contract to remain current with the most efficient and effective assessment methods and techniques of the commercial marketplace.

5.2. Disputes. Attempts will be made to resolve all disputes arising under this plan using the Alternate Dispute Resolution (ADR) as outlined in FAR 33.214. The objective is mutually agreeable resolutions that are relatively inexpensive and expeditious. If no resolution can be made under ADR, the CO shall be notified for a final decision.

5.4. INITIAL PERFORMANCE REVIEW. The initial evaluation of contractor performance will take place within 30 days after the contractor assumes full performance responsibilities (i.e.

after completion of transition/mobilization) to ensure the contractor has successfully started performance, completed transition, is fully operational, and is within the estimated cost, schedule, and performance parameters of the contract. The COR may waive the initial evaluation for contractors that have continued performance under a successor contract award (i.e. prior incumbent) or for contractors which have otherwise demonstrated full compliance with contract start-up.

5.4.1. INITIAL PERFORMANCE REVIEW CRITERIA. The COR will report the results of the initial performance review to the CO. The report will include an assessment of schedule, management, technical, and staffing. Negative variations in schedule, staffing, and/or performance will be reported with an assessment of the root causes and corrective action plan.

5.4.1.1. SCHEDULE. The assessment will include a discussion of the contractor’s adherence to the required delivery schedule, milestones, administrative requirements and should address the contractor’s efforts during the assessment period that contributes to or affect the schedule variance, as applicable.

5.4.1.2. MANAGEMENT/PERFORMANCE. The assessment will include a discussion of the integration and coordination of all activity needed to execute the contract, specifically the timeliness, completeness and quality of problem identification, corrective action plans, proposal submittals, the contractor’s history of reasonable and cooperative behavior (to include timely identification of issues in controversy), customer satisfaction, timely award and management of subcontracts including progress on small business subcontracting goals.

5.4.1.3. TECHNICAL. The assessment will include a discussion of the contractor’s conformance to contract requirements, specifications and standards of good workmanship (i.e.

commonly accepted technical, professional, environmental, or safety and health standards), as applicable.

5.1.1.4. STAFFING. The assessment will include a discussion of contractor’s performance in selecting, retaining, supporting, and replacing, when necessary, key personnel, as applicable.

5.4.1.5. SPECIAL INTEREST ITEMS. Special interest items are to be included in the initial performance report when significant modifications to the contract have been made since contract award.

5.4.2. ASSESSMENT VALUES.

5.4.2.1. GREEN—No issues.

5.4.2.2. YELLOW—Issue(s) but contractor has an adequate mitigation or corrective action plan in place.

5.4.2.3. RED—Issue(s) with inadequate or no contractor’s mitigation or corrective action plan.

Any “RED” assessment will include the government proposed actions with respect to the failing contractor.

6. Revisions to this Surveillance Plan. Revisions are the joint responsibility of the CO and COR. This document can be changed at any time.

REVISION QASP CHANGE ACTIVITY DATE

Original Surveillance Plan for Ambulance Service 20 Feb 15

Corrective Action

Report (CAR) Templa