Attachment_2_-_QASP.doc

Quality Assurance Surveillance Plan

Navy Expeditionary Medical Support Command

Integrated Logistics and Warehouse Program

A. PURPOSE. This Quality Assurance Surveillance Plan (QASP) has been developed by the Government pursuant to the requirements of solicitation, Request for Proposal Number N62645-13-R-0035, Deployable Medical Systems and Material Management as required by Navy Expeditionary Medical Support Command (NEMSCOM), Williamsburg, VA. This plan sets forth the procedures and guidelines that will be used in evaluating the performance of the Contractor to ensure that the Government receives the quality of services called for in the contract documents and the Government only pays for the acceptable level of services received. The plan:

1. Provides a basis for evaluating the Contractor’s quality control program, contract performance, and helps to ensure that service levels reach and maintain the required levels throughout the contract term.

2. Provides a proactive way to avoid unacceptable or deficient performance, and provides verifiable input to be used as a basis for completing Contractor Performance Assessment Reporting System (CPARS) reports.

3. Define the roles and responsibilities of participating Government Officials, describes the evaluation methods, quality assurance monitoring forms for documenting and evaluating the Contractor’s performance, and the process of performance documentation.

4. Describes specific surveillance activities to be conducted.

Nothing in the plan shall be construed to limit the Government’s authority to conduct surveillance activities in accordance with Federal Acquisition Regulation (FAR) clause 52.246-4.

B. ROLES AND RESPONSIBILITIES OF GOVERNMENT OFFICIALS. The following Government Officials will participate in assessing the quality of the Contractor’s performance. Their roles and responsibilities are described as follows:

1. Contracting Officer – The Contracting Officer is a person duly appointed with the authority, as specified by a warrant, to enter into, administer, or terminate contracts and make related determinations and findings on behalf of the Government. The Contracting Officer ensures performance of all necessary actions for effective contracting, ensures compliance with the terms of the contract and safeguards the interest of the United States in the contractual relationship. It is the Contracting Officer that assures the Contractor receives impartial, fair, and equitable treatment under the contract. The Contracting Officer is ultimately responsible for the final determination of the adequacy of the Contractor’s performance.

2. Contracting Officer’s Representative (COR) – The COR is an individual designated in writing by the Contracting Officer to act as his or her authorized representative to assist in the administration of the contract requirements and ensures proper Government surveillance of the Contractor’s performance. The COR is the liaison between the government and the Contractor and is the Contractor’s primary point of contact (POC). The COR will be informed, updated, and briefed of all substantial communications/meetings with the Contractor. The COR is the KO’s authority and responsibilities are contained in the written letter of appointment. The COR is not empowered to make any contractual commitments or authorize any contractual changes on behalf of the Government. However, the COR is authorized to grant no-cost extensions to task orders if agreed upon by the KO and NEMSCOM staff, as long as the extension has no effect on the contract price, terms, or conditions. Any changes that NEMSCOM and the Contractor deem may affect contract price, terms, or conditions shall be referred to the Contracting Officer for action.

3. NEMSCOM Quality Assurance Evaluators (QAE) - NEMSCOM QAE are NEMSCOM staff responsible for assisting the COR in the monitoring, assessing, recording, and reporting on the technical performance of the Contractor on a day-to-day basis. A NEMSCOM QAE does not have the authority to make any contractual commitment or authorize any contractual change on behalf of the Government. Any changes that the Contractor deems may affect contract price, terms, or conditions shall be referred to the Contracting Officer for action. NEMSCOM QAE has responsibility for performing quality assurance over the Contractor’s quality control program and performs Government inspections when required by the contract or when determined necessary by the Government.

4. NEMSCOM Government Property Administrator – The NEMSCOM Government Property Administrator is a specialized QAE appointed in writing by the Contracting Officer who is responsible for assisting the COR and monitoring the Contractor’s quality control and work performance related to Government-furnished property (GFP). NEMSCOM Government Property Administrator authority and responsibilities are contained in the written letter of appointment. The NEMSCOM Government Property Administrator does not have the authority to make any contractual commitment or authorize any contractual change on behalf of the Government. Any changes that the Contractor deems may affect contract price, terms, or conditions shall be referred to the Contracting Officer for action. NEMSCOM Government Property Administrator will have primary responsibility for evaluating the Contractor quality control procedures and documents and perform Government inspections as required by the contract or deemed necessary by the Government concerning GFP management and control.

5. NEMSCOM Transportation Officer (TO) – The NEMSCOM TO is a specialized QAE who is responsible for assisting the COR in monitoring, assessing, recording, and reporting on the performance of the Contractors transportation service functions. The TO does not have the authority to make any contractual commitment or authorize any contractual change on behalf of the Government. Any changes that the Contractor deems may affect contract price, terms, or conditions shall be referred to the Contracting Officer for action. The TO will have primary responsibility for evaluating the Contractor quality control procedures and documents and perform Government inspections as required by the contract or deemed necessary by the Government concerning transportation management and control.

6. NEMSCOM CESE/CEEI Manager – The NEMSCOM CESE/CEEI Manager is a specialized QAE who is responsible for assisting the COR in monitoring, assessing, recording, and reporting on the performance of the Contractors CESE/CEEI and Container management services. The CESE/CEEI Manager does not have the authority to make any contractual commitment or authorize any contractual change on behalf of the Government. Any changes that the Contractor deems may affect contract price, terms, or conditions shall be referred to the Contracting Officer for action. The CESE/CEEI Manager will have primary responsibility for evaluating the Contractor quality control procedures and documents and perform Government inspections as required by the contract or deemed necessary by the Government concerning CESE/CEEI and Container management and control.

C. PERFORMANCE STANDARDS:

1. Quality Level: By monitoring the Contractor, the COR with assistants from NEMSCOM’s QAE Staff will determine whether the performance levels set forth in the contract have been attained utilizing evaluation methods and discrepancy reporting as further defined in this document. Quality standards (i.e. performance standards) for all tasks are specified in the Performance Work Statement (PWS) and the QASP.

2. Frequency: During the performance of this contract, NEMSCOM personnel will take periodic measurements (i.e. conduct surveillance) as further defined in this document.

3. Management Responsiveness: The COR with assistance from NEMSCOM’s QAE Staff will determine whether the Contractor has managed the contract effectively and efficiently utilizing the quality standards as set forth in the PWS and QASP. The COR will confirm whether the Contractor has satisfactorily met all reporting requirements including subcontracting reports when applicable.

D. EVALUATION METHODS: NEMSCOM will conduct performance evaluations to determine if contractual requirements set forth have been met. The following techniques shall be used to perform surveillance.

1. Random Sampling – Verification based on sampling of submitted material or documents by the Contractor. Samples will be based on a pre-determined Acceptable Quality Level (AQL) that is subject to change if it is determined that additional monitoring is needed for areas showing continuing trends of not meeting performance standards.

2. 100% Inspection – There may be instances in which the government determines the need to conduct 100% validation of work or products being provided by the Contractor (i.e. inspection of life saving biomedical equipment) to determine if acceptable performance levels are being attained.

3. Database Validation – Comparison analysis of the physical inventory to data posted to DMLSS modules, HIMS, TC-AIMS, or any other required information system utilized for meeting the contractual requirements.

4. Audits – Surveillance of Contractor processes and quality control procedures.

E. DISCREPANCY REPORTING: The Contractor shall be notified of discrepancies identified during surveillance activities in writing via the COR. The Contractor shall take timely action to correct deficiencies and shall conduct causative research and actions to prevent future discrepancies from occurring. The Contractor is required to correct the discrepancy, re-inspect the product and resubmit for QAE verification. Contractor staff shall not remove QAE reject tags attached to material. In cases where discrepancies cannot be reworked, the Contractor shall develop and submit to the originator via the COR a corrective action plan to prevent future discrepancies. The following documents will be utilized to note discrepancies:

1. Discrepancy Notice (DN): A document issued by QAE or the COR to document discrepancies noted during quality inspections/audits. A DN shall be prepared in a specific, clear and concise manner that identifies the error and may have attached supporting documentation (i.e. DMLSS packing slips, transaction history, etc.).

2. The Contractor shall be given up to 3 business days to respond and 10 business days for closure of the DN.

3. Contractor responses shall be verified to ensure that documented corrective and/or preventative action has been taken and were effective. Follow up shall be completed by the Government within 5 business days of response receipt. The COR shall notify the Contractor if responses to DN’s are acceptable. If a response is not acceptable further action to achieve an acceptable response will be taken and in major cases of disagreement will be submitted to the Contracting Officer for a final decision and/or course of action.

F. SURVEILLANCE PROCESSES TO ENSURE CONTRACTOR PERFORMANCE:

1. NEMSCOM QAE staff shall develop and implement the use of Quality Assurance Checklists to assist in the performance of surveillance inspections for the below Tasks within the PWS. Performance standards shall be further defined within the below table. Note that the following information is not inclusive of audits conducted by the COR or QAE staff on required documents, processes, or plans (i.e. Property Control Plan, Quality Control Plan, Phase in/Out plan, Safety Plan, janitorial services, etc.) as outlined by the PWS or compliance with Contractor submitted plans and timeframes that they are required to be submitted to NEMSCOM. Discrepancies in these areas shall be identified and resolved via the COR.

TASK I (Warehouse Management Services):

1. The effectiveness and efficiency of Contractor management of the overall Warehouse Management Services portion of the PWS shall be broken down into Contractor performance within 6 specific areas of warehouse operations. These areas shall have surveillance conducted on them to determine contractor compliance. These areas along with performance standards, frequency of inspections, and areas of inspection are provided as follows:

2. Receipt and Stowage Processes: Government QAE staff shall conduct weekly surveillance to provide monthly reporting of Contractor compliance with receipt and stowage process as defined in the PWS paragraphs 3.3.1.3 through 3.3.1.5.2. Government QAE will validate a minimum of 95% Contractor compliance within this area. Government QAE shall inspect the following receipt and stowage functions:

a. Tailgate date established

b. Receipt timeframes met

c. Database updates posted to DMLSS (to include serial #, Lot #, Expiration Dates, etc. as appropriate)

d. Stowage location on receipt document matches with location in DMLSS/HIMS

e. If required QDR/SDR completed and submitted

f. If required UID/ECN labels attached

g. If required receipt inspection for equipment conducted

h. Copy of receipt document with stowed material

i. Hazmat material identified and properly stowed

j. Pilferable, refrigerated, or controlled substances identified and securely/properly stowed

k. Material in open storage properly secured

3. Inventory Processes: Government QAE staff shall conduct surveillance to provide quarterly reporting of Contractor compliance with inventory processes as defined in the PWS paragraphs 3.3.1.6 through 3.3.1.6.3. Government QAE shall conduct samples of Contractor conducted inventories as required in PWS paragraph 3.3.1.6.1. The Government Property Administrator shall ensure that all required inventories are submitted within the time intervals of the PWS, CDRLS are provided, DD Form 200’s are done as required, and that causative research is conducted as required. Inventory accuracy standards are set forth in paragraph 3.3.1.6.1 for each specific inventory area. Government QAE shall inspect each specific inventory area for the following items to obtain the overall health and Contractor compliance of the inventory program:

a. Physical Quantity of material matches Quantity in DMLSS/HIMS

b. Physical location(s) of material matches location(s) in DMLSS/HIMS

c. ECN/serial number/USN Number on physical material matches ECN/serial number/USN Number in DMLSS/HIMS

d. Lot number and expiration date on physical material matches lot number and expiration date in DMLSS

4. Re-Warehousing Processes: Government QAE staff shall conduct surveillance of government directed re-warehousing requirements upon submission of completion of the re-warehousing efforts by the Contractor. Government QAE staff shall report compliance within this area as defined in the PWS paragraph 3.3.1.7. Government QAE will validate a minimum of 95% Contractor compliance within this area. Government QAE shall inspect the following re-warehousing functions:

a. Re-warehoused physical location(s) matches DMLSS/HIMS location(s)

b. Re-warehoused physical qty matches DMLSS/HIMS quantity

5. Redistribution/disposal of excess/NRFI material: Government QAE staff shall conduct surveillance of the redistribution or disposal of excess and/or NRFI material upon submission of this material by the Contractor. Government QAE staff shall report compliance within this area as defined in the PWS paragraphs 3.3.1.8 through 3.3.1.8.7. Government QAE staff will validate a minimum of 95% Contractor compliance within this area. Government QAE shall inspect the following redistribution/disposal functions:

a. Correct material and quantity identified by the government as excess or unserviceable pulled for transfer/disposal by the Contractor

b. Proper disposal method determined by the Contractor

c. All documentation (i.e. DD 1348-1A, DD 1149, various transportation documentation, etc.) properly filled out and maintained

d. Material transferred/disposed of properly taken out of DMLSS/HIMS

e. POL and Hazmat removed from CEE material as required

f. Transfer documents for CEE material provided on time

g. Recalled material properly identified, pulled, and transferred/disposed of

h. Qualified drivers used to transport material

6. Shelf Life Management Processes: Government QAE staff shall conduct surveillance and report status of shelf life management processes on a monthly basis. Government QAE staff will validate a minimum of 98% Contractor compliance within this area as defined in the PWS paragraphs 3.3.1.9 through 3.3.1.9.2. The COR will ensure that the Contractor submits a shelf life plan within the timeframes as specified in paragraph 3.3.1.9.1. Government QAE shall inspect the following shelf life management functions:

a. Physical material, quantities, and locations match data posted to the DMLSS system

b. Lot number and expiration date on physical material matches lot number and expiration date in DMLSS

c. Contractor can show documentation that they have identified to the government expired or about to expire material as per the PWS prior to QAE inspection

7. Transportation Management Processes: Government QAE staff shall conduct surveillance and report status of the transportation management processes on a monthly basis. Government QAE staff will validate a minimum of 98% Contractor compliance within this area as defined in the PWS paragraphs 3.3.1.10 through 3.3.1.10.11. Government QAE staff shall inspect the following transportation management functions:

a. Contractor transportation personnel trained as required by PWS

b. Proper transportation mode at best value determined

c. Contractor utilizes and properly posts information to TC-AIMS, MDSS-II, and EDI as required

d. Proper marking and documentation of material being transported

e. Weight and cube data obtained for each shipment

f. Transportation files maintained per PWS

g. Demurrage and detention charges avoided

TASK II (Maintenance Services):

1. The effectiveness and efficiency of Contractor management of the overall Maintenance Services portion of the PWS shall be broken down into Contractor performance within 3 specific areas of maintenance operations. These areas shall have surveillance conducted on them to determine contractor compliance. These areas along with performance standards, frequency of inspections, and areas of inspection are provided as follows:

2. GFE Maintenance: Government QAE staff shall conduct surveillance and report status of the GFE Maintenance processes on a monthly basis. Government QAE staff will validate a minimum of 98% Contractor compliance within this area as defined in the PWS paragraphs 3.3.2.1 through 3.3.2.1.3. Government QAE staff shall inspect the following GFE maintenance functions:

a. Submission of a monthly GFE preventative maintenance and calibration plan accomplished

b. Documentation is available showing notification by the Contractor to the Government of equipment calibration getting ready to expire 1 month in advance of expiration

c. Maintenance properly performed

d. DMLSS or other database system(s) updated and accurate

3. Biomedical Equipment Maintenance: Government QAE staff shall conduct surveillance and report status of the Biomedical Equipment Maintenance processes on a monthly basis. Government QAE staff will validate a minimum of 98% Contractor compliance within this area as defined in the PWS paragraphs 3.3.2.2 through 3.3.2.9. Government QAE staff shall inspect the following biomedical equipment maintenance functions:

a. Submission of a monthly biomedical equipment preventative maintenance and calibration plan accomplished

b. Maintenance/repair of equipment properly performed

c. Maintenance/repairs completed in the timeframes given in the PWS

d. DMLSS or other database system(s) updated and accurate

e. Accessory consumables not being used to test equipment

f. Technical library established and accurate

g. If required method 30/40/50 packaging completed properly

4. CEE Maintenance: Government QAE staff shall conduct surveillance and report status of the CEE Equipment Maintenance processes on a monthly basis. Government QAE staff will validate a minimum of 98% Contractor compliance within this area as defined in the PWS paragraphs 3.3.2.10 through 3.3.2.14.6. Government QAE staff shall inspect the following CEE equipment maintenance functions:

a. Only properly trained/qualified personnel operate or perform maintenance/repair of CEE equipment

b. Bench stock listing provided to NEMSCOM IAW PWS

c. ERO forms utilized, submitted, and are accurate

d. Maintenance/repairs are properly performed

e. Maintenance/repairs are completed on time per the PWS

f. DMLSS/HIMS or other database system(s) are updated and accurate

g. Container handling is properly performed

h. Container CSC certification performed properly

i. CEEI pre-packaging inspection performed properly

j. Packing and Pilferage control properly completed for ABFC Tool Kits

k. ABFC Took Kits inventories, inspection and testing completed properly and on time

l. Receipt inspection properly completed for CESE equipment

m. CESE equipment properly preserved IAW PWS

n. Transfer of CESE to and from outside maintenance activities properly performed

o. CESE properly prepared for deployment

p. CESE cleaned per the PWS

TASK III (Download of DEPMEDS):

1. Government QAE staff shall conduct surveillance and report status of the Download of a DEPMED upon execution of a Task Order to perform this service. Surveillance will continue until completion of the service and closeout submission by the Contractor. Government QAE staff will validate a minimum of 98% Contractor compliance within this area as defined in the PWS paragraphs 3.3.3 through 3.3.3.1.12. Government QAE staff shall inspect the following download functions:

a. Download Document and tailgate date established for downloaded material

b. Physical material and quantity downloaded matches on Download Document and DMLSS/HIMS

c. Physical location of downloaded material matched DMLSS/HIMS

d. Material stowed on time per PWS

e. Downloaded material cleaned properly

f. Required labels removed per PWS

g. Required labels attached to material per PWS

h. Material requiring maintenance submitted to respective maintenance shops

i. Damaged, deteriorated, obsolete, or incomplete material identified, segregated and posted properly

j. Download completed on time

TASK IV (DEPMED Build):

1. Government QAE staff shall conduct surveillance and report status of the Build of a DEPMED upon execution of a Task Order to perform this service. Surveillance will continue until completion of the service and closeout submission by the Contractor. Government QAE staff will validate a minimum of 98% Contractor compliance within this area as defined in the PWS paragraphs 3.3.4 through 3.3.4.2.6. Government QAE staff shall inspect the following build functions:

a. Material and associated quantity and location packed matches posted data within DMLSS/HIMS

b. Packing slips generated and accurate

c. Packing to minimize weight and cube accomplished

d. Cleaning and preservation of material completed properly

e. Surgical Trays and various kits validated and packaged properly

f. Marking and labeling of material, intermediate containers and aircraft pallets/containers accomplished properly

g. If required stuffing of air craft pallets/containers properly completed

h. Build completed on time

TASK V (Painting and preservation of containers and shelters):

1. Government QAE staff shall conduct surveillance and report status of the painting and preservation of containers and shelters upon execution of a Task Order to perform this service. Surveillance will continue until completion of the service and closeout submission by the Contractor. Government QAE staff will validate a minimum of 98% Contractor compliance within this area as defined in the PWS paragraphs 3.3.5 through 3.3.5.9. Government QAE staff shall inspect the following build functions:

a. Contractor proposals prepared properly

b. Surface preparation completed properly

c. Protective coating (primer, top coat, understructure coating) applied properly

d. Data plates re-attached properly

G. QASP SUMMARY MATRIX: The following matrix provides the summary of the performance standards, minimum performance standard achievement rate, and price reduction formulas.

1. If minimum performance standards are not met as measured by Government QAE staff then the following procedures may be taken. Additionally, one or more of the listed procedures may be taken in each instance that a minimum performance standard is not met.

a. Adverse Performance Evaluation: The quality of the contractor’s performance will be noted in past performance assessments.

b. Issuance of Contract Discrepancy Report (CDR) (per Contract Administration Plan (CAP))

c. No Cost Re-Performance (FAR 52.246-4, Inspection of Services – Fixed-Price)

d. Corrective Action Plan (FAR 52.246-4, Inspection of Services – Fixed-Price)

e. Reduction of Task Order Price: Reduction for late performance (FAR 52.211-11, Liquidated Damages –Supplies, Services or Research and Development) or reduction for deficient performance in place of re-performance (FAR 52.246-4, Inspection of Services – Fixed-Price)

f. Termination of Task Order or Contract for Default (FAR 52.249-8, Default – Fixed- Price Supply & Service) Warehouse Management Services:

Maintenance Services:

Remaining Services: