A07-Attachment_11_Quality_Assurance_Surveillance_Plan_Base_IDIQ.docx

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Walter Reed Army Institute of Research (WRAIR) - Bioresearch Support to the Lugar Center, The Republic of Georgia
Solicitation number
W81XWH-16-R-0019
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Attachment 11 Quality Assurance Surveillance Plan Base IDIQ

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QASP

1.0 Quality Assurance Surveillance Plan (QASP)

1.1 Purpose: This Quality Assurance Surveillance Plan (QASP) defines the performance standards and performance measures of deliverables indicated in the Contract. The QASP also describes the procedures that WRAIR will use to monitor the contractor’s contract performance. It is important to note WRAIR’s primary concern is with the products and services provided by the contractor. Therefore, the QASP focuses on examining the products and services provided by the contractor. It is intended that the QASP be a tool to guide the Contracting Officer (KO) and the Contracting Officer’s Representative (COR) in assessing contractor performance.

1.2 QASP Relation to the Quality Control Plan (QCP): The QCP is a required element of the contractor’s technical proposal in response to the solicitation. While the QCP represents the way in which the contractor will ensure its quality and timeliness of services, as defined in the PWS, the QASP represents the way in which WRAIR will evaluate the contractor’s performance. The contractor’s QCP and the QASP should be complementary programs that ensure successful contract performance.

1.3 Revisions to the QASP: The QASP is a tool for use in Government administration of the PWS and remains subject to revision at any time by the Government throughout the contract performance period. Revisions to this surveillance plan are the responsibility of the COR. Changes may be made unilaterally and need not be announced to the contractor; the Government will provide informational copies to the contractor. The contractor will assume responsibility for all tasks and deliverables in the PWS under this award. All operational procedures and quality control measures will be tested and implemented. As the performance period progresses, the levels of surveillance may be altered for service areas in cases where performance is either consistently excellent or consistently unsatisfactory. If observations reveal consistently good performance, then the amount of surveillance may be reduced. If observations reveal consistent deficiencies, increased surveillance may be implemented.

1.4 Performance Standard: A performance standard is a level of performance the contractor must meet for each performance measure for each deliverable defined in the Contract. WRAIR is contracting to have all work performed as specified. Any inaccuracies or omissions in services or products are referred to as “defects” on the part of the contractor. The contractor shall be held responsible for all identified defects, and WRAIR may require the work to be re-performed. Performance standards take into account that in some instances an allowable level of deficiencies (deviations) is possible while overall performance continues to meet WRAIR desired level of service. Often deficiencies result from misunderstandings or inadequate communication between contractor, COR and customers. In general, these detected deviations can be quickly corrected and resolved by contractor through communication with COR and customer.

1.4.1 Allowable Deviation: The allowable deviation is the level or number of performance deficiencies the contractor is permitted to reach under this contract. Allowable deviations take into account the difference between an occasional defect and a gross number of defects. Allowable deviations can be expressed as a percentage of or as an absolute number (e.g., three per month).

1.4.2Non-performance: Non-performance occurs when the contractor’s performance does not meet the prescribed performance standard for a given requirement. Requirements may contain multiple performance elements, and therefore, deficiencies may occur in one or more aspects of performance (e.g., timeliness, accuracy, completeness, comprehensiveness, etc.) or subject areas of effort. When inspection and review indicates that the contractor's service output is not in compliance with the Contract requirements, the COR must determine whether the contractor or the Government caused the deficiency. If the cause of the defect rests with the Government, corrective action must be taken through Government channels. If the cause of the defect is due to action or inaction by the contractor, the contractor is responsible for correction of the problem at no additional expense to the Government.

1.5 Documentation: Thorough documentation of unperformed or poorly performed work is essential for tracking contractor performance throughout the period of performance. The COR will document deficient work by compiling facts describing the inspection methods and results. The COR will develop documentation to substantiate nonconformance with the Contract. The COR will make the KO aware of underperformance or poor performance.

1.6 Remedial Actions: Service contracts allow for penalties in the event that the contractor fails to perform the required services. Penalties are defined as those actions taken under the direction of the KO against the contractor within the general provisions of the Contract for nonconformance. In accordance with FAR 52.246-4: Inspection of Services-Fixed-Price, the Government may require the contractor to re-perform any services that do not conform to contract requirements. If the defects cannot be corrected by re-performance, the KO may either require the contractor to take the necessary action to ensure that future performance conforms to the requirements, or the KO may reduce the Contract price to reflect the reduced value of the services performed. At an extreme decision point, penalties may include a decision not to exercise contract options. The KO will determine the penalty for nonconformance based upon his or her judgment and the severity of the nonconformance.

1.7 Roles and Responsibilities: The purpose of Quality Assurance (QA) is to ensure that the customers are satisfied with the products and services received from the contractor and to ensure that the contractor is meeting its obligation to WRAIR. The roles and responsibilities of the stakeholders involved in QA are described below:

1.7.1 Contractor Responsibility: The contractor is responsible for delivering products or services in accordance with the Contract. The contractor is responsible for implementing a QCP, which is included as part of its technical proposal. The QCP describes the contractor’s methods for ensuring all products and services provided under this Contract meet established deliverables and performance standards. The contractor is responsible for producing, maintaining, and providing for audit, quality control records and reports and all records associated with the investigation. The contractor shall appoint a single quality control point-of-contact to act as a central recipient of communication from the Government.

1.7.2 Government Responsibility: The COR is responsible for oversight of QA for this requirement.

1.7.3 Contracting Officer: The KO has the authority to administer the WRAIR Contract. The KO may delegate many of the day-to-day contract administration duties to the COR. However, certain contractual actions such as negotiation and issuance of contract modifications, resolution of contractor claims and disputes, issuance of cure notices, issuance of show-cause letters, termination of the Contract, and Contract close-out functions are retained by the KO. Administrative actions such as invoice approval and issuance of contractor Deficiency Reports (CDR) may be, and normally shall be, delegated by the KO to the COR. All communication regarding questions or issues related to QA and inspection will be directed to the KO or the COR. The KO shall approve any revision to the QASP processes or standards.

1.7.4 Designated Government Representative: The COR shall be appointed upon award of this contract and shall serve as the first line manager of this contract. The COR represents the KO and is therefore the contractor's initial point-of-contact with the Government. If modifications to the Contract, or at the task/subtask level, are necessary, the COR will assist the cognizant KO in preparing and negotiating the modifications. If there are problems with contractor performance, the COR will inform the contractor of the problems and recommend to the KO that adverse contractual actions are appropriate (e.g., CDR, issuance of a cure notice or task/subtask closure) if the contractor fails to correct the problem. Also, the COR must refer differences of contract interpretation to the KO.

1.7.4.1 The COR will perform the actual contract surveillance and report to KO. Some of the key QA contract administration duties of COR include, but are not limited to, the following:

1.7.4.1.1 Complete surveillance as required by this QASP and the specific task/subtask, and make recommendations to the KO.

1.7.4.1.2 Make recommendations to the KO for the acceptance or rejection of completed work and for administrative actions based on unsatisfactory work or non-performed work.

1.7.4.1.3 Identify necessary changes to the contract, prepare WRAIR cost and/or staffing requirements estimates, conduct QA/contractor meetings, approve submittals of effort and/or reports, and maintain work files.

1.7.4.1.4 Promptly furnish the KO with any requests for changes, deviations, or waivers to the contract, with justifications/rationale.

2.0 Quality Assurance Methods:

2.1 The methods used in the QA process are the Government’s tools to monitor the contractor’s products and services. The means of determining whether the contractor has met all contract requirements will be by three approaches: COR review and approval and customer review. Reviews either confirm the contractor’s successful achievement of all performance requirements or highlight areas where defects exist and improvements are necessary. In cases of poor performance, WRAIR may increase the level of review and focus on known problem areas. In either case, the reasons for the change in review will be documented. In all cases, the applicable requirements shall be included in each task/subtask at issuance.

2.2 COR review and approval: COR review and approval provides a systematic way of looking at service outputs and forming conclusions about the contractor's level of performance in accordance with a planned schedule of deliverables.

2.3.2.2 Satisfactory Performance: When the contractor’s performance is satisfactory, performance meets the specified standard and the number of defects does not exceed the allowable deviation. Although the contractor’s performance may be deemed satisfactory, the COR may determine that an increased level of surveillance be used for individual products or services that show defect rates approaching the minimum performance standards. The contractor will be notified by the COR when performance is marginal or not in compliance with stated standards, SOPs, Industry or accreditation organization compliance, or approaching an unacceptable level in any area.

2.3.2.3 Unsatisfactory Performance: When the performance standard for any service has not been met, the contractor’s performance is unsatisfactory, and is, therefore, unacceptable. The following responses are available to the COR regarding that task/subtask:

2.3.2.3.1 The KO and/or COR meet with the contractor to discuss discrepancies, trends, and intended corrective measures;

2.3.2.3.2 The level of surveillance is increased until the contractor demonstrates acceptable performance over a period of time.

2.3.2.3.3 The KO issues a Contract Deficiency Report for each service that does not meet WRAIR’s performance standard;

2.3.2.3.4 Should deficiencies be significant and affect multiple tasks/subtasks, KO action such as a ‘Cure’ notice may be appropriate.

3.0 Performance Requirements Table: The following performance requirements will be used to measure the performance of the Service Provider. WRAIR Designated Government Representatives (COR) will monitor contractor performance as stipulated in the Contract under the performance based task assignments. By monitoring the Contractor, the COR will determine whether the performance levels set forth in the order have been attained. The following table outlines contractor responsibilities for performance metrics, performance standards, and surveillance methods:

No.
Standard language/Specific PWS Req
Requirement
Inspection Method
Performed by Who
Acceptable Quality Level
1
4.3
Organizational Conflict of Interest will be documented and disclosed and mitigation plans outlined by the contractor will be implemented and monitored.
Random Sampling
COR
100% compliance
2
5.1
Necessary personnel are recruited in a timely manner when required.
100% inspection
COR
personnel are hired within 30 days of requirement 90% of the time.
3
5.1
Necessary equipment is procured in a timely manner when required.
100% inspection
COR
Equipment will arrive at Lugar center within 30 days 90% of the time
4
5.2
Contractor shall manage personnel in accordance with approved staffing plan.
Random Sampling
COR
No more than 3 discrepancies noted annually
5
5.3
Contractor shall manage operations in accordance with apporved operational support plan.
Random Sampling
COR
No more than 3 discrepancies noted annually
6
5.4.1
Contractor will manage Incoming transition in accordance with approved Transition Plan.
100% inspection
COR
All personnel will be onboarded to the contract as planned.
7
5.4.1
Contractor will manage Incoming transition in accordance with approved Transition Plan.
Random Sampling
COR
The government will document no more than 3 problematic issues overlooked in the incoming transition plan
8
5.4.2
Contractor will finalize comprehensive out-going transition plan.
Random Sampling
COR
The government will document no more than 2 problematic issues overlooked in the outgoing transition plan
9
5.4.2
Outgoing transition documents are provided to COR prior to contract end.
100% inspection
COR
Identified documents as well as contractor revised SOPs will be provided to the COR prior to contract end.
10
5.5
Contingency Operations Plan is comprehensive and feasible.
Random Sampling
COR
The contractor shall test COOP annually and report less than 2 significant findings.
11
5.6
Contractor shall continue to perform in accordance with the COOP in an actual emergency.
Random Sampling
COR
In the event of an actual emergency, the contractor shall be fully operational within 12 hours of activation of plan.
12
5.7
Use of foreign nationals
100% inspection
COR
Contractor shall recruit on the local economy 95% of the time.
13
6.1
Human Resources: Recruit, hire, manage and terminate Personnel 1) Be responsive to USAMRD-G personnel needs and requirements as outlined in the PWS; 2) Manage routine issues of pay and accurate calculation of hours worked; 3) Effectively and efficiently recruit and fill open positions or newly created positions; 4) Work with USAMRU-G management to handle sub-standard employee performance; 5) Manage process of annual evaluations; and 6) Efficiently terminate employees when required
Demand Inspection
COR
Contractor will provide these functions 95% of the time.
14
6.1
Contractor shall provide oversight of operations and personnel.
Random Sampling
COR
Contractor shall provide all required operational support to employees performing work under this task order. No more than 10% of the time will Gov't staff have to specifically request contractor provided operational support.
15
6.2
Contractor shall provide adequate programmatic support to personnel.
Random Sampling
COR
Contractor shall provide all required programmatic support to employees performing work under this task order. No more than 10% of the time will Gov't staff have to specifically request contractor provided programmatic support.
16
6.3
Contractor shall plan and request travel in a timely manner.
Random Sampling
COR
Travel requests will be submitted and complete 90% of the time.
17
6.4
Contractor shall provide translation services when needed.
Random Sampling
COR
Translation services will be provided on first request 99% of the time.
18
6.4
Contractor shall provide accurate translation services.
Random Sampling
COR
Products provided as a result of translation services will be 100% accurate upon review.
19
6.5
Contractor shall conduct Human Resources in accordance with the Human resources Support Plan.
Random Sampling
COR
Support will be in accordance with this plan 90% of the time.
20
6.5.1
Contractor shall maintain and operate in accordance with their training program.
Random Sampling
COR
Support will be in accordance with this plan 90% of the time.
21
6.6
Contractor shall maintain and operate in accordance with their logistics support plan.
Random Sampling
COR
Support will be in accordance with this plan 90% of the time.
22
6.6.3
(1) Ensure shipment of biologics as required are shipped to all applicable country standards and policies (2.) Ensure safe transport and shipment of biologics
100% inspection
COR
No deviations are allowed
23
6.6.4
The Contractor shall maintain the facilities/buildings and all associated Real Property Installed Equipment (RPIE) .
random inspection
COR
Facility maintenance will be accomplished 90% of the time.
24
6.7
Contractor shall maintain and operate in accordance with their IT Support Plan.
random inspection
COR
Support will be in accordance with this plan 90% of the time.
25
6.7.1
Ensure prompt response and resolution to IT network and user technical problems.
Demand Inspection
COR
Help desk tickets shall be resolved within 5 business days 90% of the time.
26
6.7.2
Contractor shall ensure network is functional for daily routine use
100% inspection
COR
Network up time shall be no less than 98% annually.
27
6.7.3
Contractor shall maintain configuration management on all systems.
Demand Inspection
COR
Systems will be maintained within documented configurations 95% of the time.
28
6.7.4
Contractor shall prepare and respond when IT disasters strike.
100% inspection
COR
Contractor will provide successful mitigation for disaster 99% of the time.
29
6.7.5
Contractor shall manage SLAs.
Demand Inspection
COR
No more than 3 discrepancies noted annually
30
6.7.7
Ensure network security tasks are performance per DOD guidelines
Demand Inspection
COR
Network security and performance will be in accordance with DoD guidelines 99% of the time.
31
6.8
Contractor shall maintain and operate in accordance with the Occupational Health and Safety Plan.
random inspection
COR
No deviations are allowed
32
6.8.7
Contractor shall ensure no out of pocket costs for employees requiring emergency medical treatment for work place injury.
100% inspection
COR
No deviations are allowed
33
6.9
Ensure all research conducted is in accordance with WRAIR Human Subjects Protection Board, WRAIR IRB, and host-country IRBs as applicable
Demand Inspection
COR
No deviations are allowed
34
6.10
Contractor shall conduct clinical research support in accordance with specific tasks outlined in each awarded task order.
Demand Inspection
COR
Support will be in accordance with the PWS 90% of the time.
35
6.10
Contractor shall conduct clinical research support with safety as a primary objective.
100% inspection
COR
Contractor shall cause no adverse safety events in the laboratory.
36
6.10
Contractor shall document all research support activities in accordance with policies, guidelines, and SOPs.
Demand Inspection
COR
Support will be in accordance with established guidelines 90% of the time.
37
6.10.5
Contractor will not conduct any research or surveillance activities that do not have approved Human Subjects protocols and business agreements when required.
100% inspection
COR
No deviations are allowed
38
7.1
Contractor shall provide correct guidance and advise regarding IND, BLA/PLA submissions.
Demand Inspection
COR
95% of information given by contractor will be correct.
39
7.1.1
Contractor will establish, document, and monitor Human Use compliance. Any compliance issues will be documented in writing to the COR within 1 day of discovery.
Demand Inspection
COR
99% of activities will be documented
40
7.1.1
Contractor will provide training to other lab staff regarding human use compliance
Random Sampling
COR
Not more than 2 defects included in training materials
41
9.1
Travel: (1) support travel needs of employees as defined by USAMRU-G mission (2) ensure compliance with all applicable policies and regulations
Random sampling
COR
Travel requirements will be met 95% of the time
42
9.1
Contractor will provide COR with actual costs for approved expenditures.
Random sampling
COR
No deviations are allowed
43
9.2
Contractor will submit invoices monthly.
100% inspection
COR
99% of invoices will be submitted monthly.
44
9.2
Contractor will provide adequate substantiating documentation with each monthly invoice.
100% inspection
COR
99% of invoices will include substantiating documentation.
45
10.1
Contract manager will be available during specified duty hours.
Demand Inspection
COR
Contract manager reachable 95% of the time during specified hours.
46
10.1
Participation agreements are signed in advance of work performing.
100% inspection
COR
No deviations are allowed
47
10.2
Monthly task status report is accurate and timely.
100% inspection
COR
Monthly report is delivered on time 90% of the time and has less than 3 errors detected by the government.
48
10.3
Subcontracting: subcontract personnel or services as required by mission 1) subcontractors demonstrate ability to meet cost, schedule and performance metrics desired by USAMRU-G; 2) subcontractors follow all applicable regulations or policies governing the particular scope of work
Demand Inspection
COR
No deviations are allowed
49
10.4
Contractor maintains and operates in accordance with approved Quality Control Plan.
random inspection
COR
Support will be in accordance with this plan 90% of the time.
50
10.5
Contractor will be available and prepared for meetings with the government.
Demand Inspection
COR
No deviations are allowed
51
10.6
Contractor shall enter data in CMR by 15 October each year.
100% inspection
COR
99% of data will be entered by 15 October each year.
52
11.3
Contractor shall ensure all employees meet documented AT and OPSEC requirements.
Demand Inspection
COR
No deviations are allowed
53
11.3
Contractor shall not hire employees for work requiring a CAC if the individual does not qualify to obtain a CAC.
100% inspection
COR
No deviations are allowed
54
11.4
Key personnel shall be maintained in accordance with the awarded contract.
100% inspection
COR
Key personnel shall be managed in accordance with the contract 99% of the time
55
11.4
New key personnel proposed shall be acceptable to the government.
100% inspection
COR
Proposed personnel shall meet the government's requirement 99% of the time.
56
11.5
PII and PHI will be maintained in accordance with Government requirements
Random Sampling
COR
No deviations are allowed
57
11.6
Contractor will not conduct any human subjects research or surveillance activities that do not have approved Human Subjects determinations.
Demand Inspection
COR
No deviations are allowed
58
11.7
Contractor will not conduct any animal research or surveillance activities that do not have approved IACUC protocols.
Demand Inspection
COR
No deviations are allowed
59
12.1.2
Contractor maintains inventory and status of issued GFE/GFI.
Demand Inspection
COR
Inventory is available within 1 business day of government request 90% of the time.
60
12.1.2
Contractor does not acquire property without proper authorization.
Demand Inspection
COR
No deviations are allowed
61
12.1.3
Facility access items (keys, badges, codes, etc.) shall be returned to the government within 1 day of employee departure or at end of contract performance.
100% inspection
COR
No deviations are allowed
62
15.1
Contract employees will identify themselves as contractors in all correspondence both written and verbal.
Demand Inspection
COR
No deviations are allowed
63
15.3
Contract employees will not use military rank during performance of activities on this award.
Demand Inspection
COR
No deviations are allowed
64
15.4
The contractor shall ensure appropriate relationships are maintained during performance of this contract. Discrepancies will be reported to the COR and KO.
Demand Inspection
COR
No deviations are allowed
65
16.1
Contractors shall ensure employees conduct support services in accordance with all applicable regulatory guidance. All training will be completed as required.
Demand Inspection
COR
No deviations are allowed
66
16.1.2
No Government data will be compromised in any way during performance of this contract.
Demand Inspection
COR
No deviations are allowed
67
16.1.2a
No information will be disseminated, disclosed or published without appropriate government review and approval.
Demand Inspection
COR
No deviations are allowed
68
16.1.2b
Intellectual property will be protected and disclosed in a timely manner during performance of this contract.
Demand Inspection
COR
IP generated will be disclosed to the government before the end of the contract option period.
69
17.1
Current compliance documents are listed in PWS. Should these be superseded, contractor will identify new compliance requirements to the COR and comply with new requirements.
Demand Inspection
COR
99% of the time the contractor will adapt to new compliance standards when discovered. 100% of the time contractor will report discrepancies or outdated compliance documents.
70
18
Current regulatory documents are listed in PWS. Should these be superseded, contractor will identify new compliance requirements to the COR and comply with new requirements.
Demand Inspection
COR
99% of the time the contractor will adapt to new regulatory standards when discovered. 100% of the time contractor will report discrepancies or outdated regulatory documents.
71
general
Contractor’s written work shall be written at a professional level, including grammar and spelling conforming to common American-English style guides (e.g., The Chicago Manual of Style) and dictionaries.
Random Sampling
COR
It is expected that written products have no more than 2 grammatical errors and no more than 1 spelling error per 5 pages
72
general
Contractor shall maintain personal accountability. Contractor employees shall notify a designated point of contact upon arrival and departure, including lunch breaks and work during non-standard times or days. Contractor shall reply with all due promptness to accountability requests from department leadership during any emergency or event which may impact operations or safety.
Daily spot checks
COR
Contractor shall not fail to provide accountability information more than 1 day per month.
73
general
Contractor shall maintain positive customer service relationships with all US Government personnel at all times.
Inspection as prompted by observation.
COR
No more than 10% of supported staff report a negative interaction with contractor employees at any one time.

4.0 AT/OPSEC Performance Standard.

4.1. For contracts that require OPSEC Training. Per AR 530-1, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

4.2. For contractors requiring CAC. Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

4.3. Army Training Certification Tracking System (ATCTS) registration for contractor employees who require access to Government information systems. All contractor employees with access to a Government info system must be registered in the ATCTS at commencement of services and must successfully complete the DoD Information Assurance Awareness prior to access to the information system and annually thereafter.

4.4. For IA/IT training. All contractor employees and associated subcontractor employees must complete the DoD IA awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD and Army training requirements in DoDD 8570.01, DoD 8570.01-M, and AR 25-2 within six months of appointment to IA/IT functions.

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