Attachment_2_-_QASP_Cardiothoracic_Perfusionist_Services_2_Feb_15.pdf

Quality Assurance Surveillance Plan (QASP) Cardiothoracic Perfusionist Services

David Grant Medical Center Travis AFB, CA

2 Feb 2015

1. Introduction.

This Quality Assurance Surveillance Plan (QASP) was developed for the Medical Treatment Facility, , David Grant Medical Center, Travis AFB, CA, in accordance with Federal Acquisition Regulation (FAR)

37.604 and FAR 46.4, for work performed under the contract resulting from this solicitation. This QASP sets forth the procedures and guidelines to be used by the government to ensure that the contractor achieves the required performance standards as specified in the Performance Work Statement (PWS).

The PWS contains a Service Summary (SS) that summarizes performance objectives (service required) and performance thresholds (specific standard) contained within the body of the PWS. The SS does not identify every service required, but only those services considered most important for mission accomplishment. This QASP is based on the premise that the contractor, and not the government, is responsible for management and quality control (QC) actions to meet the terms of the contract. The SS recognizes that the contractor is not a perfect manager and that unforeseen and uncontrollable problems do occur. Good management and use of an adequate QC plan will allow the contractor to meet or exceed the performance standards specified in the PWS.

2. Roles and Responsibilities.

The government monitors contractor performance on a continuing basis through the services of a surveillance team. The surveillance team consists of the following members: contracting officer (CO), functional commander (FC), and contracting officer’s representatives (CORs).

2.1. Contract Administrator (CA)/Contracting Officer (CO). The CO has overall responsibility for contract administration and is the primary focal point for formal government-contractor interface. The CO is responsible for monitoring contract compliance and resolving disagreements regarding interpretation of contract terms and conditions. The two primary functions of the CO with regard to surveillance are to authorize changes to the contract and to approve payment. Payment is authorized based on documented objective evidence provided by the COR that contractor performance meets the performance standards specified. The CO is also responsible for approving the QASP.

2.2. Functional Commander (FC). The FC has overall responsibility for quality assurance functions and for the surveillance personnel under his or her cognizance. The FC is responsible for the development and implementation of this surveillance plan, selecting the surveillance methods to be used to assess, document, and report contractor compliance with the contract requirements.

2.3. Contracting Officer Representative (COR). The COR provides functional surveillance for contract performance. The COR monitors and evaluates compliance with contract requirements, documents performance, and reports surveillance results to the FC and CO. The COR initiates requests for the contractor’s corrective actions, and evaluates the actions for effectiveness. The COR must be objective, fair, and consistent in evaluating the contractor’s performance. CORs shal l be trained, nominated and appointed in accordance with AFFARS MP5301.602-2(d).

2.4. Funtional Requirements Evaluator Designees (FREDs). David Grant Medical Center is required to appoint FREDs for this requirement. FRED will serve as the technical expoert in the functional area that they quality assure. The FRED will carry out inspection and surveillance duties and report these inspections to the COR who will document performance and provide monthly surveillance results to the FC and CO.

3. Methods of Surveillance.

3.1. Third Party Audits. Third Party Audits will be conducted by federal, state, and local agencies (i.e. DGMC Public Health, Food Service Accountant, OSHA, Environmental Management etc.).

3.2. Periodic Surveillance.

This type of surveillance consists of the evaluation of samples selected on other than a 100-percent or statistically random basis. The results of periodic surveillance inspections may be used as the basis for actions against the contractor. In such cases FAR 52.212-4(a), Contract Terms and Conditions – Commercial Items, Inspection/Acceptance, becomes the basis for the CO’s actions. Periodic surveillance will be used more frequently at the beginning of the contract, and is expected to decrease as standards are consistently met, but may increase if performance falls below standard.

3.3. Customer Complaints.

The COR may use customer complaints to document discrepancies in contractor performance. The CO may use validated customer complaints as the basis for actions against the contractor, and in such cases, FAR 52.212-4(a), Contract Terms and Conditions – Commercial Items, Inspection/Acceptance, becomes the basis for the CO’s actions.

3.4. Non-SS Items.

For required tasks not shown on the SS (para 2, PWS), including all other tasks in the PWS and reference documents, the government still retains the right to inspect any item included in the contract in accordance with FAR 52.212-4(a) – Contract Terms and Conditions – Commercial Items, Inspection/ Acceptance. Inspection of these services will be performed in the same general manner as periodic surveillance mentioned above. The results of these inspections are documented and, if necessary, are provided to the CO for action. Should a discrepancy be observed, the CO will handle each documented discrepancy on a case-by-case basis.

4. Documentation. All surveillance activities must be documented to provide the required audit trail to justify government acceptance and payment. The documented audit trail of the surveillance activities is required by FAR 46.104(c), Contract Administration Office Responsibilities, which states, “Maintain, as part of the performance records of the contract, suitable records reflecting, (1) The nature of government contract quality assurance actions, including, when appropriate, the number of observations made and the number and type of defects; and (2) Decisions regarding the acceptability of the products, the processes, and the requirements, as well as action to correct defects.” All documentation resulting from surveillance is made a permanent part of the contract file. The COR must keep the documentation files during the term of the contract and at the conclusion of the contract, transfer the files through the FC to the CO for inclusion in the official contract file. It is the responsibility of the FC to establish and maintain this information in a Surveillance Folder as described below.

4.1. Acceptable Performance (Excellent, Very Good, or Satisfactory Performance Rating) The COR shall document the contractor’s performance using the surveillance monitoring methods in paragraph 5.1.1. of this plan. Performance ratings must describe the specific reason(s) for the ratings. The monthly COR report shall in the surveillance documentation. report may become a part of the supporting documentation for any contractual action.

4.2. Unacceptable performance (Marginal or Unsatisfactory Performance Rating)

If a COR determines that contractor performance is unacceptable, the specific reason for the unacceptable performance shall be recorded on the COR’s surveillance documentation.

Unsatisfactory performance must be addressed early on through the CO in order to give the contractor an opportunity to resolve any on-going issues, and re-perform unacceptable performance, if possible.

Contractor feedback information is imperative and will be a significant basis for the contractor’s annual CPAR evaluation.

4.3. Remedies for Unacceptable Performance.

In accordance with FAR 52.212-4(a), Contract Terms and Conditions – Commercial Items, Inspection/Acceptance, if any of the services do not conform to contract requirements; the CO may require the contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. This includes but is not limited to contractor termination of contractor personnel and recruitment of substitute personnel that are equally qualified within established timeframes.

When defects in services cannot be corrected by re-performance, the government may:

• Require the contractor to take necessary action to ensure that future performance conforms to contract requirements; and

• Reduce the contract price to reflect the reduced value of the services performed;

• If the contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the government may; by contract or otherwise, perform the services and charge to the contractor any cost incurred by the government that is directly related to the performance of such service; or decrement invoices related to performance; or terminate the contract.

4.4. Contracting Officer Notification.

4.4.1. Major Finding. If at any time the 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 findings and notify the contracting officer immediately in writing. Email is acceptable.

4.4.1.1. Contractor failure to meet a Performance Threshold/Standard.

4.4.1.2. Failure to provide adequate corrective action to preclude reoccurrence of government identified findings.

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

4.4.1.4. Any failure to adhere to security regulations that results in a security incident.

4.4.2. Minor Finding. A departure from established standards having little bearing on the service provided. When the COR identifies a minor finding, he or she shall document the findings, but is not required to notify the CO. 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 CO in writing.

5. Forms and other standardized documentation. The following forms and form letters may be used to provide standardized documentation (objective quality evidence). Air Force and Department of Defense forms are available on line at http://afpubs.hq.af.mil/electronicforms. AF Form 714, Customer Complaint Record, DD Form 2772, Contract Discrepancy Report, and the local COR Surveillance Report for this contract.

6. COR Monthly Surveillance Reports. Prepared by the COR and provided to the FC to support acceptance of service. The sample format of the monthly report is provided at Attachment 1. The reporting period shall be from the first to the last day of the month. The COR monthly status report will be provided to the CO no later than the tenth (10) workday of the following month.

7. Quality Assurance Surveillance Summary:

Performance Objective PWS Paragraph Reference

Performance Threshold

1. Fills positions and vacancies within prescribed standards

Para 2.6. 100% of personnel are present for duty within 45 days of contract start.

2. Provide qualified staff that possesses the skills, knowledge and abilities to independently perform the services required by this contract.

Para 2.1 – 2.5 100% of personnel will be qualified at the beginning performance on this contract.

3. All schedules will always be met.

Para 1.1 and 2.1.2, f. 100% of all schedules, surgeries, and call schedules will be met.

4. Complies with Government Security requirements

Contract Security Requirements dated 6 Mar 14

100% of personnel will comply with Unit Security Manager deadlines and instructions as required.

8. Performance Management.

This section identifies the use of performance measurement information to effect positive change in organizational culture, systems, and processes, by helping to set agreed upon performance goals, allocating and prioritizing resources, informing managers to either confirm or change current policy or program directions to meet those goals, and sharing results of performance in pursuing those goals.

8.1. Market Research: On-going market research is conducted to ensure the contract requirements remain current with commercial standards, practices and industry performance evaluation methods.

8.2. Surveillance Files: An inspection file must be developed and maintained by the primary COR. This folder is typically contained in hard copy, but may be maintained in a computer database provided there is adequate back up of the data to preclude accidental loss. The surveillance folder must contain the following sections, but may contain any other sections or information that the COR finds useful.

(1) Section 1: Quality Assurance Surveillance Plan.

(2) Section 2: Contractor’s Quality Control Plan (QCP) (if required).

http://afpubs.hq.af.mil/electronicforms

(3) Section 3: Surveillance Documents – The type of information that may be included are details of inspections or data gathering, conversations or meetings with the contractor, notes and comments that may be of value at some later date.

(4) Section 4: Contract – The portions of the contract that apply to the functional area(s) of the surveillance folder, e.g., PWS paragraphs, directive documents, references, pertinent terms defined by the contract, etc.

(5) Section 5: Appointment Letters/Certificates of Training – COR appointment letters and training certificates and Letter of Designation.

(6) Section 6: Records – A section used for filing all documentation associated with contract quality assurance, e.g., correspondence, CO inputs, and customer complaints.

9. Performance Feedback. Documentation is required to record, evaluate, and report contractor’s performance. On a monthly basis, the COR will complete an evaluation of contractor performance and forward it to the CO that includes the following assessment elements.

Performance Element Description

Quality of Service

Assess the contractor’s conformance to contract requirements, specifications, and standards of good workmanship (e.g., commonly accepted technical, professional, environmental, or safety health standards).

Schedule

Assess the timeliness of the contractor against the completion of the contract, task orders, milestones, delivery schedule, administrative requirements (e.g., efforts that contribute to or effect the schedule variance).

Business Relationships Assess if the contractor is oriented toward the customer’s needs. Is interaction between the contractor and government satisfactory or does it need improvement?

Management of Key Personnel

Assess if the contractor supports key personnel so they were able to work effectively and efficiently. If key personnel did not perform well, what action was taken by the contractor to correct this?

Performance Rating

Criteria

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.

Very Good Performance meets contractual requirements and exceeds some to the government benefit. The contractual performance element or sub-element being assessed was accomplished with some minor problems for which corrective actions taken by the contractor were highly effective.

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.

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.

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.

10. Contract Performance Review.

10.1. Initial Contract Performance Review. The initial evaluation of contractor performance is a joint determination by the MFT that 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 purpose of the review is to determine if the contractor successfully completed transition, is fully operational, and is within other performance parameters required by the contract. The COR will conduct the initial 30-day post award review utilizing the monthly COR report form and submit the report to the CO. The CO will determine if the contractor has or has not successfully completed transition, is fully operational, and is within other performance parameters required by the contract. In the event that the review indicates negative performance, the COR will identify the specific categories of non-compliance (i.e., negative variation in cost, schedule, and/or other significant performance metrics, etc.), and provide an explanation of the causes for the variance. The review shall take place within 30 days after the contractor assumes full performance responsibility (performance start date). The review shall be filed in the official contract file, Section E.

10.2. Annual Performance Review. All services acquisitions with a value in excess of $100,000 will be reviewed annually. This review is to be conducted no later than 30 days prior to issuing the notification of the government’s intent to fund the follow-on year. The annual review will be documented in the CO’s determination to exercise the option. Any negative variations in cost, schedule and/or other significant performance measures required by the contract will be reported to the Services Designated Official (SDO).