Attachment 2 QASP and CDR.docx
DOCX document 42 KB Posted
- Attached to
- Q301--Referral Lab Services - VISN 15
- Solicitation number
- 36C25521R0004
About this file
This document contains a Quality Assurance Surveillance Plan (QASP) for laboratory testing services. The QASP outlines performance standards and monitoring procedures to ensure a contractor meets contractual obligations to provide accurate testing for clinical and anatomical pathology specimens. Key details include methods for surveillance such as random sampling and customer feedback to validate test result accuracy and licensing compliance. The QASP also defines a process for issuing Contract Deficiency Reports if performance is non-compliant and requires corrective action from the contractor. Performance will be assessed quarterly using a rating system to populate a QASP Matrix report.
The related federal contract opportunity notice indicates the Department of Veterans Affairs intends to issue a Request for Proposal for Referral Laboratory Services for VISN 15. Interested parties should register on beta.sam.gov to receive the solicitation, which is expected to publish in December 2020. The requirement is for pre-analytic processing, analysis, and result interpretation of clinical and anatomical pathology specimens. The NAICS code is 621511 for medical laboratories up to $35 million in size.
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Contract Deficiency Report
ATTACHMENT 1:
QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)
1. PURPOSE
This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the contract. The QASP does not detail how the Contractor accomplishes the work or monitors the quality of its 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. Copies of the original QASP and revisions shall be provided to the Contractor and Government officials implementing surveillance activities.
1.1 INTENT
The intent of this plan is to hold the Contractor accountable for the terms and conditions of their base contract and to encourage the contractor to take appropriate steps to control and improve quality. The Contractor is responsible to develop an efficient methodology to ensure they meet and/or exceed the required thresholds of service as outlined in this acquisition. The Government intends to perform surveillance on this contract in accordance with (IAW) this Quality Assurance Surveillance Plan (QASP), but reserves the right to monitor the contract in any manner necessary, at any times necessary, and at all places necessary to ensure that the rendered services conform to contract requirements. The Government reserves the right to perform quality assurance at the subcontract level and perform quality assurance at the contractor's place of business, if applicable. Non-conforming services discovered with subcontractors will be addressed with the prime contractor for resolution.
1.2 SCOPE
The Contractor, and not the Government, is responsible for management and quality control actions to meet the terms of the contract. The role of Government Quality Assurance is to ensure contract standards are achieved. The QASP provides guidelines and methods for the Government’s oversight of the Contractor’s quality control efforts to assure timely, effective services are provided in accordance with the contract. The QASP provides a framework that enables the Government to monitor the contractor's performance and notify the contractor of deficiencies observed during surveillance and initiate appropriate action to effect correction.
2. GOVERNMENT ROLES AND RESPONSIBILITIEs The following personnel shall oversee and coordinate surveillance activities in accordance with the QASP.
a. Contracting Officer (CO) – The CO is a person duly appointed with the authority to enter into, administer and terminate contracts on behalf of the Government. The CO is the only person who can legally commit the Government and only the CO, as the Government’s agent, can modify the contract &/or task order. 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 the final authority for determining the adequacy of the Contractor’s performance. The CO has retained the responsibility of a COR for this contract. A COR will be appointed for each resultant task order.
Assigned CO: Ashley Osborn Organization or Agency: Network Contracting Office (NCO) 15, Department of Veterans Affairs
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 maintain 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. Any changes that the Contractor deems may affect contract price, terms or conditions shall be referred to the CO for action.
c. Assigned COR shall be delegated and communicated upon award.
3. CONTRACTOR REPRESENTATIVES
The following employees of the contractor serve as the contractor’s program manager for this contract.
a. Program Manager -
b. Other Contractor Personnel -
4. METHODS OF SURVEILLANCE
Include but are not limited to:
a. 100% Inspection - Reserved for the highest risk areas where consequence of failure is high (i.e. life or limb are threatened) or there is likelihood of mission failure.
b. Random Sampling - When a service is performed relatively frequently and a statistically valid sample can be selected for audit. The most appropriate method for frequently recurring tasks.
c. Periodic Sampling - Planned sampling of a service at specific predetermined dates and times. May be appropriate for tasks that occur infrequently.
d. Customer Feedback – Not necessarily a valid method of surveillance but a good indicator for areas surveillance should be conducted or intensified.
5. QUARTERLY SURVEILLANCE SCHEDULE
Since the COR duties will be retained at the Contracting Officer level, a monthly surveillance will be done to support the statutory and regulatory requirements for the base contract as well as any other critical contractual requirements determined to be higher risk requiring oversight. The surveillance outlined in the quarterly schedule will be as detailed and in-depth as necessary to provide the Government with the objective quality evidence required to support acceptance of the services at the base contract level provided by the Contractor. The schedule is “FOR OFFICIAL USE ONLY” and is not releasable to anyone other than authorized Government personnel.
Documentation of Inspections. All inspections/observations will be documented and will include what was inspected, to what standard and the results. Successful or exceptional performance will be documented as well as deficiencies in Contractor performance. Documentation will be maintained for future reference, audit and proof of inspection and past performance documentation. The QASP Quarterly Report shall be used to report a summary of inspection results each quarter of the contracts period of performance.
6. NON-CONFORMING PERFORMANCE
The CO will provide notification to the Contractor each time a contractual noncompliance is observed and require the Contractor to immediately correct the problem. All valid non-conformances observed by the Government will be documented! The CO will record the contract requirement, the specific deficiency to the requirement, and record the date and time it was discovered. Deficiencies that cannot be immediately corrected will be reported via a Contract Deficiency Report for further action.
Contract Deficiency Reports. The Contract Deficiency Report (CDR) will state the Contract Requirement, the specific contract reference and the specific violation (s) to the requirement. The CO will forward copies of CDR to the Contractor and request corrective action to the specific non-conformance, identification of the root cause and corrective action for the root cause with a required suspense date. The Contractor will return a copy of the completed and signed document along with their Corrective Action Plan (CAP) to the CO for review, approval and inclusion in the contract/order file. The CO will conduct a review of the CAP and re-inspect the items that were found deficient to ensure the CAP included adequate root cause analysis, corrective action for the root cause and that it was accomplished in the timeframe agreed upon. The CO will not consider the CDR closed until all deficiencies have been corrected and all agreed upon actions of the CAP have been completed. Contractor’s failure to follow through and complete corrective actions will cause the CO to take for further action. The CO shall follow-up after the Contractor has completed the corrective action to ensure that the Contractor’s corrective action was sufficient to preclude recurrence.
7. PERFORMANCE STANDARDS
All deliverables shall meet the following QASP performance standards to the acceptable quality level. The Government shall perform surveillance to determine if the Contractor meets or does not meet these standards.
8. CPAR Ratings Assigned to QASP Items:
| 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. A singular event could be of such magnitude that it alone constitutes an Exceptional rating. 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. 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. 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).
Metrics and methods are designed to determine rating for a given standard and acceptable quality level.
| 9. | 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.
10. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP
| ___________________________________ | __________________ |
| Signature – Contractor Program Manager | Date |
| __________________________________ | __________________ | |
| Signature – Contracting Officer’s Representative | Date |
QASP Matrix /Quarterly Report Format
Quarterly Report is due no later than the 15th of the beginning of each new quarter
"FOR Official USE ONLY"
1) Task Order #:
2) Contractor:
3) COR:
4) Surveillance Period:
Contracting Officer’s Representative Comments: Provide an overall summary of the rating period.
Your statements may include observations that Contractor met (or exceeded) all contractual requirements during the reporting period. If there was a specific issue…identify it! If the Contractor went over and above the acceptable quality levels listed or provided extraordinary service, document it!
| SOW Task |
| Deliverable |
| Acceptable Quality Level |
| Method of Surveillance |
| Observation |
| 1.6 Maintains Licensing and Accreditation |
| The Contractor shall comply with all applicable OSHA, Federal and State Law, the Joint Commission, and regulations as required for performing the type of services required. |
| All CAP and CLIA licenses (100%) are current for facilities within the contractors testing system. |
No deviations accepted.
Random inspection of licenses.
| 4.1.2 Test Result Accuracy |
| Contractor shall provide accurate testing. |
| All samples (100%) should be reported accurately. |
<0.02% of all patient results received per 7.3.3 Notification by Contractor to ordering activity of modified test report.
| 4.3 Transportation of Samples |
| Contractor shall provide routine scheduled specimen pickup at times mutually agreed upon by the ordering activity. |
| All samples (100%) should be picked up for transport to the Contractor’s site. |
<3 missed courier pickups per Quarter per 7.3.2 Notification by ordering activity to Contractor of missed courier pickup.
| 4.3.3 Sample Processing |
| Contractor shall ensure integrity of samples during transport. |
| All samples (100%) shipped to the Contractor should arrive at the Contractor site and be assayed. |
<3 lost specimens per Quarter per 7.3.1 Review of incomplete test list with shipping manifest.
| 4.5.3 Turnaround Time |
| Contractor shall provide routine results to the ordering activity in accordance with the testing specifications defined with the Contractor’s Test Schedule, maximum turnaround time. |
| 100% of results should be released with published turnaround. |
Less than 6 delays from published turnaround times per month.
Review of 20 random tests compared to published turnaround times provided by the vendor. Ordering activities will compare information to published TAT’s and time provided on final report.
Other noted comments related to performance
__________________________ COR’s signature
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
VHAPM Part801.603-70 COR SOP Revision 06 Page 1 of 1 Original Date: 05/20/2011 Revision 05 Date: 03/11/2019
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