A.01.02_6-Quality_Assurance_Surveillance_Plan_(QASP).pdf

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

1. Purpose.

This QASP is a Government developed and applied document used to provide a standard of surveillance for monitoring the HIV testing services contract and provides the approach the Government will use to conduct surveillance over the performance aspects of the effort. The intent is to ensure that the contractor performs in accordance with (IAW) performance metrics set forth in the contract documents, that the Government receives the quality of services called for in the contract, and that the Government only pays for the acceptable level of services received.

2. Scope.

The QASP is put in place to provide Government surveillance oversight of the contractor’s quality control efforts to assure they are timely, and effective, and results are performed as specified in the contract. The QASP is not a part of the resulting contract nor is it intended to duplicate the contractor’s internal quality management efforts.

3. Government Roles and Responsibilities.

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (KO). The KO is responsible for monitoring contract compliance, contract administration, and cost control and for resolving any differences between the observations documented by the Contracting Officer’s Representative (COR) and the contractor. The KO will designate a COR as the Government representative for performance management. The number of additional Government representatives serving as inspectors depends on the complexity of the services measured, as well as the contractor’s performance, and must be identified and designated by the KO.

b. Contracting Officer’s Representative. The COR is designated in writing by the KO to act as his or her authorized representative. The COR will assist the KO with the technical administration of the contract to ensure proper Government surveillance of the contractor’s performance. Any COR limitations will be identified with the designation letter. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. Any changes the contractor deems may affect contract price, terms, or conditions shall be referred to the KO for action. The COR is responsible for quality assurance (QA) monitoring and completion of forms/reports used to document the inspection and evaluation of the contractor’s work performance. Government surveillance may occur under the terms and conditions of the contract for inspection.

c. Other Key Government Personnel. Upon award, the Government may enter performance monitors, clinical quality experts, etc., who may provide input to the COR for reporting purposes.

4. Inspection Instructions.

a. The contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the contractor shall be maintained and made available to the Government during contract performance.

b. If any of the services do not conform to contract requirements, the Government may require the contractor to perform the services again in conformity with contract requirements, at no additional cost to the Government.

When the 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.

c. The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government will perform inspections and tests in a manner that will not unduly delay the work.

d. 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 terminate the contract for default.

e. If the Government performs inspections or tests on the premises of the contractor or a subcontractor, the contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties.

5. Methods of Inspection.

a. The below listed methods of surveillance may be used in the administration of this QASP. They can occur quarterly, monthly, or as needed:

1) 100% Inspection. The COR may conduct 100% inspections of the work defined in the Performance Work Statement (PWS). The COR will also review information submitted in the required reports defined in the PWS.

2) Periodic Inspection. The Government may conduct periodic inspections monthly, quarterly, or on an as-needed basis. The periodic inspection shall be conducted by the COR and/or his designees.

3) Random Inspection. The Government may conduct random monitoring by reviewing information/reports required and submitted IAW the contract. The random monitoring shall be performed by the COR.

4) Customer Feedback – The COR may provide and collect customer surveys or complaints regarding performance. A mutual effort will be made to resolve any problems/issues identified.

b. Level of surveillance may be conducted on a monthly, quarterly or as-needed basis and an analysis of the results will determine if the contractor met the standards or did not met the standards identified in the PWS/contract.

6. Performance Requirements Summary (PRS).

PWS Requirement PWS Reference Acceptable Quality Level (AQL) Primary Surveillance Method

Contractor – Furnished Written Instructions and Training Materials

Para. 4.3.2 98% of written instructions and training will be current and electronically available.

COR/Designee Random Checks

Contractor – Furnished Materials

Para. 4.3.1 – 4.6.1.

> 95% Proper stock replacement and delivery timelines met.

COR/Designee Random Checks

Contractor – Furnished Equipment

Para 4.4 – 4.4.4.4

100% of equipment repaired or replaced within 24 hours of notification.

COR/Designee Random Checks

Maintain Accreditations and Licenses

Para. 4.2.10 Ensure all requirements relevant to clinical testing accreditation requirements and licensing agencies are met at all times throughout the contract period.

COR/Designee Random Checks/Random/Periodic Inspection

Proficiency Test Panels

Para. 5.9.1 Maintain an accuracy score of at least 90% (percent) on Government provided EQA Viral Marker Proficiency Test panels at every testing location.

Periodic, HDRL Reports/ Random/Periodic Inspection

Contractors – Quality Management Program

(QMP)

Paras. 4.2.9. Maintain successful Proficiency Testing (PT) performance IAW regulatory and accreditation guidelines. In the event that the PT event was less than 100%, the contractor shall forward a Proficiency Testing Exception Summary as per CAP or equivalent as dictated by other CLIA approved accrediting organizations to

HDRL

within 10 business days post receipt of the Proficiency Test evaluation report.

Periodic, HDRL Reports/ Random/Periodic Inspection

Initial Testing. Para 5.2.3. The contractor shall perform an initial test and provide initial Negative Screening (Non-Reactive) results for all SAs within 24 hours of specimen receipt at the lab

Periodic, Monthly Report/ Random/Periodic Inspection

Prepare and Ship “Reactive” specimens.

Para 5.2.4. Initial “Reactive” specimens shall be aliquoted from original specimen tube, inventoried, frozen, packaged, and shipped frozen to HDRL by close of business on the next business day post initial receipt within the Laboratory.

Periodic, Monthly Report/Random/Periodic Inspection

Contractor Laboratory Information Management System (LIMS) and Interface

Para 5.3.7. The contractor shall report to the COR or the COR’s designee within one (1) hour any transmission failure of the VPN tunnel(s), and transmit patient data via the alternative back-up method.

By exception/ Random/Periodic Inspection

Contract Personnel Qualification

Para. 5.2.2. All testing related personnel must meet the minimum requirements commensurate with the complexity of testing performed, 100% of the time.

Quarterly Audits/ Random/Periodic Inspection

Rejection Rates Exhibit F Para B.5.b.

No more than 20% of rejected specimens that meet PWS requirements for forwarding to HDRL should be reportable using Government’s current in-house testing methods.

Monthly Reports, COR/Designee Random Checks

Management Reports Para 5.6 98% for accuracy and 95% for timeliness

COR/Designee Random Checks

7. Successful Performance:

a. Successful performance can be incentivized with favorable past performance ratings and award of follow-on opportunities.

b. Acceptable services for performance is demonstrated by an accepted and executed certified invoice and receiving report, as applicable.

c. The Acceptable Quality Level (AQL) consists of the performance standards established for the services required by the Government to meet contract requirements. The AQL will be measurable and structured to permit an assessment of the contractor’s performance.

8. Documentation of Surveillance.

a. Effective contract surveillance relies on the COR identifying and documenting discrepancies during performance of routine daily services, or through the contractor’s quality control program. The COR will report discrepancies to the contractor for timely resolution. Surveillance may consist of periodic reports, and customer feedback and timeliness of contract deliverables/reports.

b. The COR will maintain a complete QA file which will be retained by the COR for the life of the contract.

Information in the QA file will be considered when completing the annual CPARS report.

c. Documented surveillance will consist of inspections performed by the COR and/or designees. All paperwork that supports contract surveillance such as details of inspections or data gathering, conversations or meetings with the contractor, notes and comments that support inspection paperwork, to include quality assurance surveillance reports. If performance is deemed unacceptable, the COR will inform the contractor.

Disagreements or disputes will be referred to the KO for re-address.

d. All documentation resulting from surveillance will be made a part of the contract file. The COR must keep the documentation files during the surveillance period, but at the conclusion of the contract and as directed by the KO, the COR must give the files to the KO for inclusion in the official contract file.

9. Corrective Actions.

a. The contractor will be provided the opportunity to submit proposed corrective action to resolve the discrepancy. The COR will review proposed corrective action and determine whether or not it is acceptable and whether or not the discrepancy has been corrected. If the discrepancy has been resolved, the COR will notify the contractor and document the quality assurance surveillance checklist.

b. The COR will notify the KO of unacceptable performance if any services do not conform to contract requirements. The KO may require the contractor to re-perform the services to conform with contract requirements at no additional cost to the Government.

c. When unacceptable performance cannot be corrected by re-performance, the Government may require the contractor to take action necessary to ensure future performance conforms with contract requirements.

d. The Government may, by separate contract or otherwise, perform the services and charge the contractor any cost incurred that is directly related to the performance of such service, or issue:

1) Cure Notice

2) Show Cause

3) Terminate the contract for convenience of the Government

4) Terminate the contract for cause

10. Certification of Services. Certification of services is performed by the COR and/or designee via Wide Area

Work Flow (WAWF) system. At the end of each billing period, the contractor inputs invoice information into WAWF system. WAWF automatically notifies the appropriate individual via email of pending invoice. This individual accesses WAWF and verifies the accuracy of services provided by the contractor. The COR and/or his/her WAWF acceptor will certify the invoice and payment is conducted by the Defense Finance Accounting System (DFAS). If the COR and/or their WAWF acceptor encounter errors in the contractor’s invoice, they will reject the invoice, state the reason for rejection and send back to the contractor. If the contractor disagrees with them, the issue will be forwarded to the KO for resolution.