B02 Attachment 2 - QASP Animal Husbandry Svcs.docx
DOCX document 44 KB Posted
- Attached to
- Veterinary Services Federal contract opportunity
- Solicitation number
- HT942525R0031
- Issued by
- Defense Health Agency
About this file
This is a Quality Assurance Surveillance Plan (QASP) for animal husbandry services at Walter Reed Army Institute of Research/Naval Medical Research Center (WRAIR/NMRC) Veterinary Services Program. The QASP outlines how the government will monitor contractor performance in providing comprehensive animal husbandry, management, administrative, surgery, pathology, and veterinary services.
The plan details 30 performance requirements including 24/7 full-time services, animal care program maintenance, laboratory animal handling, facility cleaning/sanitation, health surveillance, equipment maintenance, transportation, necropsy support, histopathology, diagnostic imaging, emergency services, and supply management. Key performance thresholds include 100% compliance with animal care SOPs, maintaining AAALAC accreditation, 24/7 emergency response capability, and zero security violations. The contractor must meet federal, state and local regulations including OSHA, Animal Welfare Act, and Guide for the Care and Use of Laboratory Animals standards. The Defense Health Agency contracting officer and COR will oversee contractor performance through various inspection methods including in-person observation, customer feedback, and review of contractor quality control metrics.
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Text version
QUALITY ASSURANCE AND SURVEILLANCE PLAN
Animal Husbandry Services for Walter Reed Army Institute of Research/Naval Medical Research Center (WRAIR/NMRC), Veterinary Services Program (VSP)
Contract Number: TBD <enter upon award>
Contract Description: The objective of this contract is to provide non-personal, comprehensive services for animal husbandry, management, administrative, surgery, pathology, and veterinary services for VSP, WRAIR/NMRC. All services shall be provided in accordance with (IAW) all federal, state, and local regulations including Occupational Safety and Health Administration (OSHA), Animal Welfare Act, Guide for the Care and Use of Laboratory Animals (8th ed), and US Army/Defense Health Agency (DHA) / WRAIR / NMRC guidelines, policies, and procedures. Services shall be provided to continuously operate and maintain the WRAIR/NMRC VSP facilities and animals to the outstanding levels required by the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC).
Contractor’s name: TBD <enter upon award> (hereafter referred to as the contractor)
Contents
| PURPOSE | 1 |
| GOVERNMENT ROLES AND RESPONSIBILITIES | 1 |
| CONTRACTOR REPRESENTATIVES | 2 |
| PERFORMANCE REQUIREMENTS SUMMARY MATRIX | 3 |
| PERFORMANCE REPORT | 5 |
| CONTRACT DISCREPENCY REPORT (CDR) | 6 |
1. PURPOSE
This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:
· What will be monitored
· How monitoring will take place
· Who will conduct the monitoring; and
· How monitoring efforts and results will be documented
This QASP does not detail how the contractor accomplishes the 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. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.
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. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.
The following FAR clauses may apply depending on contract type:
52.246-4 Inspection of Services – Fixed-Price,
2. GOVERNMENT ROLES AND RESPONSIBILITIES
The following personnel shall oversee and coordinate surveillance activities.
Contracting Officer (KO) - The KO 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 KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.
Assigned KO: Jennifer C. Jackson Organization or Agency: USAMRAA Telephone: 301-619-2054 Email: jennifer.c.jackson18.civ@health.mil
Contract Specialist (KS) - The CS acts as an acquisition consultant and serves as liaison between the contract office and Walter Reed Army Institute of Research (WRAIR).
Assigned KS: John (Jack) Fitzsimmons Telephone: 301-619-8435 Email: john.l.fitzsimmons8.civ@health.mil
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 keep a “QASP and Performance” file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.
TBD
Resources and Operations Department WRAIR, Veterinary Services Program
301-319-XXX
TBD
Other Key Government Personnel – N/A
2. CONTRACTOR REPRESENTATIVES
The following employees of the contractor serve as the contractor’s Program Manager and Task Manager for this contract. <Communication should occur with them during QASP development. It will help if they review the draft QASP and accept the final version. You may delete the stated roles or change the naming convention if applicable>
Contractor POC:
Phone:
Cell:
Email:
4. PERFORMANCE REQUIREMENTS SUMMARY MATRIX
PERFORMANCE REQUIREMENTS SUMMARY MATRIX
| PERFORMANCE OBJECTIVE |
| STANDARD |
| PERFORMANCE THRESHOLD ACCEPTABLE QUALITY LEVELS (AQLs) |
| METHOD OF SURVEILLANCE |
PRS#1
Full Time Services
(Para 5.2.1.1)
The contractor shall provide full Time Services, 7 Days a Week. Fail safe procedure in place and working for replacement staff.
No loss of performance quality due to personnel absences.
100% Inspection: Contractor matrices from the Quality Control Plan will be used in addition to census reviews for manning. The contractors Fail Safe procedures for manning will be monitored on a daily basis to ensure sufficient staffing at all times to not degrade service. Adequate personnel will be present to complete all core duties IAW applicable SOPs.
Method: In Person
Frequency: As needed
PRS#2
Animal Program Support
(Para 5.2.1.1)
The contractor shall maintain the animal care program. Follow all animal care SOPs and mandatory regulations.
| Provide personnel at all times to fulfill required services 99% of the time per 12 months. |
| Periodic Inspection and Customer Complaint: Scheduled and un- scheduled inspections will be made of all areas |
covering veterinary services.
Method: In Person
Frequency: As needed
PRS#3
Receipt of Laboratory Animals
(Para 5.2.2.2)
The contractor shall follow applicable animal receiving SOPs.
| Meets: 100% of the time |
| 100% Inspection: Contractor matrices from the Quality Control Plan will be used in addition to Animal records and caging requirement reviews. All animals are 100% reviewed upon arrival by the Government |
or designated
Method: In Person
Frequency: As needed
PRS#4
Feeding And Watering of Animals
(Para 5.2.2.3)
The contractor shall ensure all animals are fed and watered as specified by SOP and protocol
100% compliance with food and water directions.
Periodic Inspection and Customer Complaint: Scheduled and un- scheduled inspections will be made of all areas covering Animal care.
The use of validated customer comment notices and the Contractors matrices under the QC Plan will also be used. SOP guidance will be used as a Checklist
Method: In Person
Frequency: As needed
PRS#5
Handling And Restraint of Laboratory Animals
(Para 5.2.2.4)
| The Contractor shall not cause injury when handling or restraining animals due to negligence. |
| 100% of the time |
| Periodic Inspection and Customer Complaint: Contractor employees will be observed as they process animals. |
Customer complaint forms may also be used if the investigator so decides. Once validated by the COR these reports will be used by contractor management to correct performance.
Method: In Person
Frequency: As needed
PRS#6
Cleaning, Sanitation, and Sterilizing of Animal Caging Equipment and Facilities
(Para 5.2.2.5)
The Contractor shall follow applicable SOPs. Clean to the degree specified for the item or area. Run no washer or autoclave below required temperature or conduct 100% rewash/re-sterilize.
| Note sanitation failure and respond accordingly 100% of the time. |
| Periodic Inspection and Customer Complaint: Scheduled and un- scheduled inspections will be made of all areas covering Animal care. |
The use of validated customer comment notices and the Contractor’s matrices under the QC Plan will also be used. SOP guidance will be used as a checklist for compliance
Method: In Person
Frequency: As needed
PRS#7
Animal Health Surveillance and Environmental Monitoring
(Para 5.2.2.6)
| The Contractor shall perform operator/user maintenance and lubricate moving parts as required by operator’s manuals or QC Plan. |
| 95% of the time. No equipment malfunction or failure due to contractor neglect or failure to notify appropriate maintenance staff. |
| Periodic Inspection: Insight by the COR on a daily to weekly schedule will document equipment repair status. Contractor QC reports will be used to track trends and increased or decreased performance. Equipment analysis and status reports along with personal observations |
shall document progress.
Method: In Person
Frequency: As needed
PRS#8
General Animal Equipment Maintenance
(Para 5.2.2.7)
| The Contractor shall perform operator/user maintenance and lubricate moving parts as required by operator’s manuals or QC Plan. |
| No repeat customer complaints concerning providing technical services |
| Customer Complaint: All investigators and Government personnel will be trained in the use of the customer comment procedure and will provide data documenting both outstanding and poor performance by the |
contract employees.
When validated the information will provide trends and training data.
Method: In Person
Frequency: As needed
PRS#9
Transportation
(Para 5.2.2.9)
| The Contractor shall provide transportation services MON.-FRI. of live animals, lab specimens, food supplies, equipment, cages and miscellaneous data, reports and materials. |
| 100% of the time. All records and reports complete and on time. 50 out of 52 weeks without follow- up. |
| 100% Inspection and Customer Complaint: Daily vehicle reports will be reviewed to ensure compliance and required attendance. Validated Customer complaint forms will also be reviewed to ensure performance is at the necessary standard of care, timeliness and operation. Operator and Maintenance records will also be analyzed for |
quality and compliance.
Method: In Person
Frequency: As needed
PRS#10
Necropsy Support
(Para 5.2.4)
The contractor shall perform necropsies of laboratory animals and/or assist veterinary pathologists during performance of necropsy procedure
| No repeat customer complaints concerning provided necropsy services |
| Customer Complaint: All investigators and Government personnel will be trained in the use of the customer comment procedure and will provide data documenting both outstanding and poor performance by the contract employees. |
When validated the information will provide trends and training data.
Method: In Person
Frequency: As needed
PRS#11
Histo-pathology Support
(Para 5.2.4.2)
| The Contractor shall perform histology and immunohistochemistry procedures |
| No repeat customer complaints concerning provided histopathology services |
| Customer Complaint: All investigators and Government personnel will be trained in the use of the customer comment procedure and will provide data documenting |
both outstanding and poor performance by the contract employees. When validated the information will provide trends and training data.
Method: In Person
Frequency: As needed
PRS#12
Diagnostic Pathology Imaging and Clinical Pathology Support
(Para 5.2.4.3)
| The Contractor shall provide technical support to perform diagnostic pathology imaging and clinical pathology procedures |
| No repeat customer complaints concerning provided diagnostic pathology imaging and clinical pathology services |
| Customer Complaint: All investigators and Government personnel will be trained in the use of the customer comment procedure and will provide data documenting both outstanding and poor performance by the contract employees. |
When validated the information will provide trends and training data.
Method: In Person
Frequency: As needed
PRS#13
Report Generation/ Preparation
(Para 5.2.6.2.1)
| The contractor shall perform all reporting as required by the contract terms and the QC Plan. |
| No failure to report for a second time and no more than 1 late report per month |
| Periodic Inspection: QC Plan data will be used as a checklist to confirm all required reports are on time and accurate. The COR or report recipient |
will document the review
Method: COR Report
Frequency: As needed
PRS#14
Emergency Services (Para 5.2.5)
| The Contractor shall be on-call 24 hours per day, 7 days a week. |
| 100% response to emergency calls from the COR during and after core hours |
100% Inspection: Contractor matrices from the Quality Control Plan will be used in addition to COR records as to when personnel were notified and actions taken. All emergencies will be declared by the COR or Division Director.
Method: In Person
Frequency: As needed
PRS#15
Training of Personnel
(Para 5.2.3.5, 5.2.6.2.2)
The Contractor shall perform and document all required employee training. Safety 90% of the time. Document training through QC plan. Follow the plan 100% of the time 100% Inspection: Contractor training records and matrices from the Quality Control Plan will be used in addition to observation of performance by employees. Daily, weekly, and monthly review of online files expected.
PRS#16
General Cleaning and Sanitation in Vivarium Areas
(Para 5.2.2.5)
The contractor shall provide all management, and labor necessary to ensure that animal space and custodial services are performed in the Bldg. 503 and 511 vivarium areas
| Follow industry standards and all applicable SOPs |
| 100% Inspection: Monthly analysis of Contractor matrices from the Quality Control Plan will be used in addition to Government Safety Reports, Bio/Hazard Training files, and review of documentation internal to the sites will ensure full compliance. |
Method: In Person
Frequency: As needed
PRS#17
Provide Daily Use Supplies
(Para 5.2.2.8)
| The Contractor shall purchase feed, bedding, vivarium-use personal protective equipment (PPE), feed enrichment and daily use cleaning supplies to support the animal research mission |
| 100% of the time. Follow Government- provided list of items for purchase. |
Maintain inventory levels to prevent excess or running out of contractor- purchased supplies.
Periodic Inspection: Review of purchasing/receiving documents and inventory levels.
Method: In Person
Frequency: As needed
PRS#18
Provide Administrative Information
(Para 5.2.6.2)
| The contractor shall provide requested information in less than 1 week. |
| 80 % of the time. In two weeks 98% of the time |
| Periodic Inspection: Information Requests will be documented when provided to the contractor each time. This record |
will provide verification of response.
Method: In Person
Frequency: As needed
PRS#19
Mishap and Injury Incident Reports
(Para 1.19.1)
The contractor shall notify COR and Safety Office immediately. Submit mishap report in accordance with WRAIR/NMRC Safety guidance.
| 100% of the time |
| 100% Inspection: Contractor matrices from the Quality Control Plan will be used in addition to submitted copies of Mishap reports. |
PRS#20
Security Compliance
(Para 1.11.2)
The Contractor shall have a WRAIR/NMRC security photo ID within 1 week of start date. The Contractor shall not open a secure area for others. The contractor shall comply with WRAIR/NMRC Security requirements.
| Comply with all Security directives 100% of the time. No security violations |
| 100% Inspection: Contractor matrices from the Quality Control Plan will be used in addition to review of all Security reports from WRAIR Security Office constitutes 100% coverage. |
Method: In Person
Frequency: As needed
PRS#21
Contractor Quality Control and Quality Assurance
(Para 1.5.1)
1) Quality Control Plan and metrics shall be completed and current
2) Corrective actions shall be on time and sufficient.
3) Sufficient revision of actions
1) 100% of the time.
2) 90 % of the time.
3) 100% of the time.
100% Inspection: Contractor matrices from the Quality Control Plan will be used. This function will be a joint effort between the Project Manager, and the Section Supervisors.
Method: In Person
Frequency: As needed
PRS#22
Logistics Support (Receipt Stocking Inventory and Maintenance)
(Para 5.2.2.8)
a. Order all requirements so as to not have an out of stock or overstock condition. Rotate feed and supplies using FIFO. Comply with SOP feed age requirement and storage requirement.
b. Do not run out of a food product for animals on protocol or in the activity more than once a year.
a. 100% of time.
b. No repeat failures within a calendar year.
100% Inspection: Weekly inventories will be performed and orders placed as necessary to ensure adequate stock levels. Government-purchased supply orders will be placed as needed to ensure supplies are on hand to meet facility needs.
Method: In Person
Frequency: As needed
PRS#23
Maintain AAALACi Accreditation
(Para
| Loss of as a result of Contractor’s failures is a reason for Termination for Default and assessment of re- procurement costs. |
| 100% |
accreditation maintained Periodic Inspection and Customer Complaint: Scheduled and un- scheduled inspections will be made of all areas. The use of validated customer comment notices and the Contractor’s matrices under the QC Plan will also be used.
Method: In Person
Frequency: As needed
PRS#24
SOP Compliance and Revisions
(Para 5.2.6.3.1)
| The contractor shall comply with SOPs and assist with rewrite if/when required. Request exceptions to SOP guidance from COR. |
| 100% |
compliance.
Periodic Inspection and Customer Complaint: Scheduled and un- scheduled inspections will be made of all areas covering Animal care.
The use of validated customer comment notices and the Contractors matrices under the QC Plan will also be used. Review all SOPs for current practice during last month of the first year and each subsequent option year.
Submit re-writes to COR within 2 weeks after procedures change.
Method: In Person
Frequency: As needed
PRS#25
Qualified Personnel
(Para 1.10.1)
a. Contractor shall propose for work under this contract only qualified personnel.
b. All replacements will be fully trained to the required contract level within two weeks of reporting to work.
c. Key personnel will be approved by COR.
a. 100% of the time.
b. 2 failures per award period. Replace any untrained employee at once.
C. 100% of time
100% Inspection: Contractor matrices from the Quality Control Plan will be used in addition to OS training records and required formal documentation in the OS areas. All issued safety reports from internal and external reviews will also be included in the inspection process
Frequency: As needed
PRS#26
Management and Employee Availability
(Para 1.10.1)
The contractor shall have fully qualified key personnel supervisor on duty whenever employees are working.
| 100% of the time. |
| 100% Inspection: Reviews of Contractor matrices from the Quality Control Plan will be used in addition to face to face conferences with Top Management. The COR or Alternates will observe Management on the job every day as one or more of these positions are required to be on the site any time employees are |
working.
Method: In Person
Frequency: As needed
PRS#27
Security Clearance Requirements
(Para 1.7.4)
| The contractor shall obtain NAIC for all personnel. Obtain other checks as may be required. |
| 100% |
NCIC/Background and Credit check prior to work.
Background and NAC papers timely and correct 99% of the time 100% Inspection: Contractor matrices from the Quality Control Plan will be used in addition to all NAC documentation and Background checks flowing through the COR from WRAIR Security will provide total review.
PRS#28
Medical Examinations
(Para 1.10.5)
| The contractor shall ensure compliance and training with OHS Directives and SOPs. No employees shall be on the job without full medical requirement compliance. |
| 100% |
compliance with SOPs, Policy Letters, and Regulations.
100% Inspection: Contractor matrices from the Quality Control Plan will be used in addition to a partial review of start-up medical records along with contractor certification. These data will ensure full compliance. Same procedure will be used for annual renewals.
PRS#29
Installation Access
(Para 1.7.3)
| The Contractor shall follow installation access procedures. |
| < 1 incident per month |
| Sum of all incidents in which contractor personnel did not follow |
installation access procedures
Direct observation by COR and installation security.
PRS #30
SCR
(Para 5.3)
| The Contractor shall completely fill in all the information in the format using the following web address www.sam.gov The contractor shall provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period shall be the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. If contract period of performance ends prior to September 30, the contractor has 30 days from end date of the contract to complete the SCR requirement. |
| Zero deviation from Standard |
| 100% Inspection |
PERFORMANCE REPORT
Contract Number: <insert number>
Prepared by: (Name of COR) <insert name>
Date and time of observation: <insert date>
Observation:
<Examples of items to include in a report are:
· Method of surveillance.
· How frequently you conducted surveillance.
· Surveillance results (Exceeds, Meets, Does Not Meet).
· Number of observations.>
Prepared by: <Enter COR’s name>
COR’s Signature
Date
CONTRACT DISCREPANCY REPORT (CDR)
< The COR may initiate a CDR at any time, including whenever the number of monthly recorded defects for a performance standard exceeds the allowable number of defects; anytime unacceptable performance is determined critical in nature and requires formal corrective action; and whenever an unfavorable trend is detected in contractor performance.>
Contract Number: <insert number>
Contractor Project Manager: <insert name>
From: <insert name of COR>
Date and time observed discrepancy:
Contract Discrepancy:
<Describe in detail. Identify any attachments.>
Corrective action plan:
A written corrective action plan < is / is not > required.
< If a written corrective action plan is required include the following. > The contractor shall provide the COR with the Corrective Action Plan not later than < # days after receipt of this CDR. >
Prepared by: <Enter COR’s name>
COR’s Signature
Date
Received by: <Enter contractor project manager’s name>
Contractor Project Manager’s Signature
Date
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