36C25519Q0519-000.docx

FedBizOpps Sources Sought Notice

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ADDITIONAL INFORMATION

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* = Required Field FedBizOpps Sources Sought Notice Rev. March 2010 H VISN 15 - PECs & CSPs Certification and Training 66048 36C25519Q0519 06-13-2019 N 621511 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 Daniel.Thomas6@va.gov

VISN 15

Daniel.Thomas6@va.gov Daniel.Thomas6@va.gov Daniel.Thomas6@va.gov Daniel.Thomas6@va.gov PECs and CSPs Certification and Training This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter into negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort.

The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract on the basis of this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice.

The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below.

Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, fax, and email (e) DUNS number (f) Cage Code (g) Tax ID Number (h) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business and (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below.

The VA Heartland Network 15, Contracting Office located at 3450 South 4th Street, Leavenworth, KS, 66048-5055 is seeking a potential qualified contractor to provide services for VISN 15, IV Room Certification & Training. The VA Medical Center are:

1. Kansas City VA Medical Center

4801 Linwood Blvd.

Kansas City, MO 64128

Jackson County

2. Harry S. Truman Memorial Veterans' Hospital

800 Hospital Drive

Columbia, MO 65201-5272

Boone County

3. Colmery-O'Neal VA Medical Center

220 SW Gage Blvd

Topeka, KS 66622

Shawnee County

4. Dwight D. Eisenhower VA Medical Center

4101 4th Street Trafficway

Leavenworth, KS 66048

Leavenworth County

5. Robert J. Dole VA Medical Center

5500 E Kellogg Ave

Wichita, KS 67218

Sedgwick County

6. VA St. Louis Health Care System

Jefferson Barracks Division

1 Jefferson Barracks Dr.

St. Louis, MO 63125

7. VA St. Louis Health Care System

John Cochran Division

915 North Grand Blvd.

Clayton County

8. John J. Pershing VA Medical Center

1500 North Westwood Blvd

Poplar Bluff, MO 63901

Butler County

9. Marion VA Medical Center

2401 West Main St.

Marion, IL 62959

Williamson County

The North American Industry Classification System Code (NAICS Code) is 621511 Medical Laboratories, size standard $32.5 Million. Based on this information, please indicate whether your company would be a Large or Small Business and have a socio-economic designation as a small business, VOSB or SDVOSB.

Important information: The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Currently a total set-aside for Service Disabled Veteran Owned Small Business firms is anticipated based on the Veterans Administration requirement with Public Law 109-461, Section 8127 Veterans Benefit Act.

However, if response by Service Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open will be considered. Any response to this source selection from interested parties must be received by June 13, 2019 at 12:00 P.M. CST.

Attention: Daniel Thomas, Contracting Specialist. Email: Daniel.Thomas6@va.gov

PART I – GENERAL INFORMATION

a. Introduction: This requirement is for testing and certification of all the VA Heartland Health Care Network (VISN 15) facility’s primary engineering controls (PECs) and sterile clean rooms used for preparation of Compounded Sterile Preparations (CSPs). PECs include biological safety cabinets (BSCs), laminar airflow workstation (LAFW) hoods, compounding aseptic containment isolators (CACI), compounding aseptic isolators (CAI) and Isolators. Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter <797>, or current guidelines. This requirement also includes personnel training, evaluation and requalification to compound CSPs in accordance with USP <797> or current guidelines.

b. Background: VISN 15 is pursuing VISN-wide contract for standardizing testing criteria appropriate for all PECs used pursuant to current USP Chapter <797> and Chapter <800> standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals to establish consistent PEC certification procedures using the Certification Guide for Sterile Compounding Facilities CAG-003-2006. Although USP <797> states that certification procedures “such as” those outlined CAG-003-2006 shall be performed, Veterans Affairs (VA) will be requiring that CAG-003-2006 be used in lieu of any other “such as” procedures that may exist. Depending on the period of performance and option year(s), testing procedures shall be maintained in compliance with all current applicable USP standards.

The USP establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of CSPs. The Joint Commission (TJC) Accreditation Manual for Home Care, effective January 13, 2018, established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities under the Draft Guidance on “Insanitary Conditions at Compounding Facilities” which was published in August 2016.

VISN 15 facilities are in the midst of upgrades of existing compounding spaces and new construction of compounding spaces to continuously meet USP 797 and 800 standards. As such, VISN 15 requires vendor to adjust quantity of services to meet the changing needs of the facilities, as upgrades and construction are completed. Adjustments are included in the IGCE to reflect planned work and changing needs in the contract year they are expected.

Certification procedures defined in CETA CAG-003-2006 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

VISN 15 is also pursuing contracting for qualifying and requalifying personnel who perform sterile compounding to include initial training and qualification of personnel, recertification of personnel, observing hand hygiene and garbing procedures, conducting gloved fingertip and thumb sampling, and media fill testing of personnel at frequencies outlined in current USP <797> (and USP 800 after December 1, 2019). Draft revisions to USP 797 will increase frequency of personnel testing from once yearly to twice yearly if approved, and vendor needs to be able to meet that increased demand for services if those changes are approved.

PART II: SPECIAL WORK REQUIREMENTS

a. PEC Testing and Certification: The contractor shall test and certify each PEC according to USP <797> (and <800> after December 1, 2019) using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-003-2006 and CAG-002-2006). All PECs must:

1. be certified to meet ISO Class 5 or better

2. maintain unidirectional airflow

3. be supplied by HEPA filtered air

The list of tests, depending on CETA and manufacturer guidance for the type of PEC, includes, but is not limited to:

1. Viable and non-viable particle counts

2. Airflow testing

3. HEPA filter leak test

4. Induction leak/back-streaming test

5. Cabinet leak test

6. In-flow velocity test to include exhaust airflow volume rate

7. Surface sampling

Airflow Smoke pattern test under dynamic operating conditions (contractor will provide video documentation of each test to facility POCs).

b. Laminar Flow Hoods (Laminar Airflow Workbench (LAWF), Integrated Vertical Laminar Flow Zone (IVLFW), and Class II Biological Safety Cabinet (BSC)) must be tested and certified according to CETA CAG-003-2006 guidelines and to manufacturer’s specifications. Horizontal laminar flow cabinets shall be certified according to The Institute of Environmental Sciences (IEST) RP-CC-002 Testing Laminar Air Flow Devices and Induction Leak/Back-streaming Test and IEST-RP-CC034 HEPA Filter Leak Test.

Certifications for Class II Biological Safety Cabinets (BSCs) must be accomplished in accordance with the most current National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Class II (laminar flow) Biosafety Cabinetry. The contractor shall use a National Institute of Standards and Technology (NIST) traceable or comparable calibrated piece of equipment (calibrated within past 12 months) to perform all testing and provide copies of the calibration tests to the POCs upon request.

The contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and back-streaming test. Any failures shall be reported directly to the identified site point of contact(s) (POC see A.3.2.6) as soon as practicable. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified POC as soon as practicable.

c. Restricted access barrier system (Compounding Aseptic Isolator (CAI), Compounding Aseptic Containment Isolator (CACI), and Isolators (i.e. PECs with a controlled workspace, transfer devices, access devices, and a decontamination system) must be certified according to CETA CAG-002-2006 and CAG-003-2006 guidelines and to manufacturer’s specifications. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified point(s) of contact (POC) as soon as practicable.

d. Hazardous Compounding PECs Hazardous compounding PEC certification is required for:

1. Negative Pressure Hoods

2. Isolators

3. PECs where robotic enclosure is used inside of the PEC

The contractor shall test and certify each hazardous PEC to the manufacturer’s specifications. Tests shall include: face velocity test, airflow smoke pattern test and low flow alarm test. In the event that the hazardous PEC has an air flow monitor or controller, the contractor shall confirm the unit is calibrated and operating within +/-10% of actual velocity. If it is not calibrated appropriately the contractor shall calibrate the AFM or AFC. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to calculate the face velocity. The contractor shall report each individual face velocity reading and the average of those readings, a pass/fail grade for the airflow smoke pattern test and a pass/fail grade for the low flow alarm test. Any failures shall be reported directly to the COR(s) as soon as practicable.

For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

1. Company name, address and phone number

2. Unit make, model and serial number

3. Report number reflecting the room certification

4. Location (room number)

5. Certification date

6. Recertification date

7. Sash height (only for fume hoods)

8. Technician signature

e. All CSP Facilities must be tested and certified in accordance to ISO 14644-1 Classifications of Air Cleanliness, CETA CAG-03-2006 and CETA CAG-009-00 specifications. The contractor will provide comprehensive cleanroom testing and certification services with frequency required by most current USP <797> standards (and USP <800> after December 1, 2019). Test equipment used for certification will be clean, in good working order and calibrated on a calibration frequency not to exceed 12 months or more frequently if recommended by the manufacturer. Calibration certificates should be provided upon request by the facility POC for all calibrated test equipment. USP Compliance Testing for Cleanrooms and Controlled Environment certification will include but is not limited to the following:

1. Non-Viable Particle Counting under dynamic operating conditions

2. Viable / Microbial Air Testing

3. Viable / Microbial Surface Testing

4. Airflow Volume Measurements

5. Air Velocity Profile

6. Room Air Exchange Rates

7. Room Pressure Measurement

8. In-Place Leak Testing of HEPA Filters

9. Temperature, Relative Humidity Measurements

10. Lighting Measurement

11. Sound Level Measurement

12. Smoke test

13. Electrical leakage and ground circuit resistance and polarity tests

14. Pass-through chamber air quality

f. Viable and Non-viable Particle Counts For the PECs, viable and non-viable particle counts samples will be collected. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP <797> (and <800> after December 1, 2019).

g. Air Changes per Hour The contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor shall calculate air changes per hour (ACPH) for each buffer and ante room and include their findings in the report. In the event that a room does not meet USP<797> (or USP <800> after December 1, 2019) requirements for ACPH the identified site POC(s) shall be informed immediately.

h. Pressure Requirements The contractor shall include in their report differential pressure readings from each buffer/ante room to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP<797> (or USP <800> when applicable). The contractor shall report all pressures to an accuracy of 0.0001” water column (4 decimal places). Pressure differentials will be reflected on a report showing the sketch of the room(s).

i. Viable Environmental Sampling

1. The contractor shall perform viable environmental (air) sampling every 3 months for fungi and bacteria using high volume impaction samplers to conduct the sampling.

2. In addition, quarterly viable environmental surface sampling of classified areas will be performed. When conducted, surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected.

3. The interior of the PEC and the equipment contained in it

4. Staging or work area(s) near the PEC

5. Frequently touched surfaces

6. Pass-through chamber(s)

7. Air sampling: A sufficient volume of air (1000 liters) shall be tested at each location in order to maximize sensitivity. Samples of less than 1000 liters will not be acceptable.

8. Surface Sampling: The contractor shall perform surface samples for bacteria using Tryptic Soy Agar (TSA) contact plates and Malt Extract Agar (MEA) or Sab DEX contact plates for sampling of fungi. Surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected.

j. Environmental Wipe Sampling for Hazardous Drug Residue The contractor will perform environmental wipe sampling for hazardous drug surface residue semi-annually (e.g. every 6 months), or more frequently as needed to verify containment, for those facilities who opt in to this testing. The kits used to complete wipe sampling must be verified prior to use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs.

The drugs required for testing include:

1. Cyclophosphamide

2. Ifosfamide

3. Methotrexate

4. Fluorouracil

5. Platinum-containing drugs

6. Additional Drugs

i. Additional drugs may be requested based upon identified need per site.

ii. Upon identified need, the applicable site will work directly with the contractor where additional cost will be clarified and agreed upon by both parties prior to testing.

A total of 6 surface samples will be completed per certification. Surface sampling will include the following areas:

1. Interior of PEC and equipment contained in it.

2. Pass-through chambers

3. Surfaces in staging or work areas near PEC

4. Areas adjacent to PECs (e.g. floors directly under C-PEC, staging, and dispensing area)

5. Areas immediately outside the hazardous drug buffer room or C-SCA

6. Patient administration areas

k. Nonviable Particle Testing The contractor shall perform environmental nonviable particle testing semiannually (e.g. every 6 months). The contractor shall derive the minimum number of sampling locations using Annex A in the ISO 14644-1.2 standard. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following:

1. ISO Class 5: not more than 3520 particles 0.5 µm and larger size per cubic meter of air for any area primary engineering control (BSC or LAFW).

2. ISO Class 7: not more than 352,000 particles 0.5 µm and larger size per cubic meter of air for any buffer area or hazardous compounding ante room.

3. ISO Class 8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any non-hazardous compounding ante room.

Report Requirements: All of the following information should be included in the report for clean room certification. Pass/Fail notifications should be included on a per-test basis where applicable.

Reports to include at a minimum:

1. Environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates as well as the species grown.

2. The identification of highly pathogenic microorganisms will be highlighted in the report.

3. Action level for ISO area tested

4. Executive summary or summary of findings.

5. Room number and/or location

6. Room type (e.g. oncology prep room)

7. Type of PEC certified

8. Serial number of the PEC certified

9. Date and time samples collected and particle counts tested

10. Technician collecting the samples

11. Date of next required certification

12. Standards used to test room

13. Comments indicating when dynamic operating conditions were used

14. Notes

15. Room sketch (location of supply/exhaust diffusers, equipment, room dimensions)

16. Sketch identifying location of each sample obtained

17. Total room area and volume

18. Room humidity and temp

19. Room air changes per hour

20. Pressure differentials

21. Nonviable particle counts (cfu’s), action level for target ISO level

22. Viable particle count analysis

23. Sketch of viable particle test location in room

24. Viable sample results (cfu’s), action level

25. Certificates of analysis of media used

26. Comments indicating when dynamic operating conditions were used

l. Report Distribution The contractor will immediately notify identified points of contact with any results indicating failure. A formalized written report including all required aspects specified in this Statement of Work will be provided in a timely manner with receipt by identified points of contact no more than 14 days from certification evaluation.

All completed reports will be provided via email to TBD. In addition, facility specific reports will be provided to the following points of contact:

Contractor will be notified by facility of any updates to identified points of contact list on an as needed basis.

m. Testing Frequency:

1. Certification procedures defined in CETA CAG-003-2006 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

2. Environmental sampling (air and surface) will be completed quarterly (every 3 months), or more frequently if required to assess corrective actions associated with prior negative results. More frequent testing may be required should USP standards change during the performance period or option year(s).

3. Room HEPA filter testing will be completed at least once yearly, or more frequently, if required, to assess corrective actions associated with prior positive results. More frequent testing may be required should USP standards change during the performance period or option year(s).

4. Environmental wipe sampling for hazardous drug residue will be performed every 6 months, or more frequently if required to verify containment for those facilities who opt to perform this testing as part of their hazardous drug sterile compounding quality assurance activities.

n. Personnel Training Contractor will provide a written training program that describes the required training, frequency of training, and process for evaluation of personnel. Training plan shall include:

1. Hand hygiene

2. Garbing

3. Cleaning and disinfection

4. Calculations, measuring, and mixing

5. Aseptic technique

6. Achieving and/or maintain sterility and apyrogenicity

7. Use of equipment involved in compounding

8. Documentation of the compounding process

9. Principles of high-efficiency particulate air (HEPA)-filtered unidirectional airflow within the ISO Class 5 area

10. Use of primary engineering controls (for both non-hazardous and hazardous compounding)

11. Principles of movement of materials and personnel within the compounding area

It is strongly preferred that vendor provides option for obtaining Accreditation Council for Pharmacy Education (ACPE) continuing education (CE) credits for pharmacists and pharmacy technicians completing yearly competency training.

o. Personnel Competency Assessment Contractor shall provide a written description of training and assessment procedures, consistent with USP <797> (and USP <800> after December 1, 2019), to include general competency training, written testing, hand hygiene and garbing observations, gloved fingertip and thumb sampling, and media fill testing.

1. Contractor shall administer a written test covering the required training elements outlined in A.3.5.7, with a pre-established threshold for pass/fail test scores. Competency testing will coincide with frequency outlined in current USP <797> standards (and USP <800> after December 1, 2019).

2. Contractor shall visually observe compounding personnel while performing hand hygiene and garbing procedures initially, with frequency outlined in current USP <797> standards (and USP <800> after December 1, 2019) for each successfully trained employee.

3. Contractor shall obtain gloved fingertip and thumb samples three separate times after performing a separate and complete hand hygiene and full garbing procedure initially for new personnel.

4. Contractor shall obtain gloved fingertip and thumb sampling after completing the media-fill test, for those personnel who successfully completed initial competency evaluations with frequency outlined in current USP <797> standards (and USP <800> after December 1, 2019).

5. Contractor shall obtain media fill test with frequency outlined in current USP <797> standards (and USP <800> after December 1, 2019) for those personnel who successfully completed initial competency and evaluations.

6. Contractor shall incubate gloved fingertip and thumb samples and media fill tests in controlled temperature environments in accordance with USP <797> guidance (and <800> after December 1, 2019), and report results and action levels to the facility POC as soon as results are available.

7. The contractor will designate at least 2 separate days for each facility to re-qualify successfully trained personnel, to maintain current re-qualification of all staff. If gloved fingertip and thumb samples and/or media fill tests are failed by an employee, contractor will provide re-testing of those employees within 30 days of the date the failed test was performed. Facility will contact contractor upon learning of need for new employee training and contractor will perform training of new employees within a mutually agreed upon time frame.

8. Training and competency assessment frequency will be adjusted, as needed, in compliance with USP standards.

p. Reporting Requirements: Each employee’s written test will be provided to the facility point of contact for competency documentation. A summary of each employee’s training and qualification assessment shall be included in a report to document personnel training.

1. Employee name

2. Date of testing

3. Testing procedures for hazardous and/or non-hazardous compounding

4. Date of next required qualification assessment(s)

5. Written test results noting score and PASS/FAIL result

6. Observed hand hygiene and garbing procedures with PASS/FAIL result

7. Gloved fingertip and thumb samples results including action levels, cfu per hand, and PASS/FAIL result

8. Media fill testing results with PASS/FAIL result

It is also preferred that contractor provide a sterile compounding subject matter expertise development program that provides advanced, comprehensive training on all aspects of USP designed for those who would oversee and maintain responsibility for ongoing compliance of sterile compounding programs. This training would be made available to both facility and VISN pharmacy staff designated to oversee and maintain sterile compounding programs.

(Continue to next page)

q. Required Services Per Facility:

Summary of quantities needed by Facility

Changes to facility PEC will be communicated in a timely manner to contractor and facility costs will be adjusted accordingly based on these changes. Contractor to provide unit based costs for services to allow for adjustments in equipment.

PART III: SPECIAL CONSIDERATIONS

a. Contractor Furnished Materials:

1. All materials and tools to complete the work identified.

2. Contractor to ensure all staff that perform on-site testing arrive wearing non-shedding clothing.

3. All equipment will be stored and transported by the contractor in a manner that maintains cleanliness of equipment and introduces minimal microorganisms into the clean environments being tested. All equipment will be wiped/cleaned prior to taking into clean testing environments.

b. Government Furnished Materials and Services:

1. The Government will provide all necessary personnel protective equipment (PPE) required for contractors on site.

2. The Government will provide oversight and verification of contractor personnel completion of donning of PPE and hand hygiene prior to testing/sampling.

3. The Government will, on rare occasion, provide office or meeting space to discuss test results, projects, or plans.

4. May also provide desk phone service as needed.

c. Qualifications/References: VISN 15 is seeking a qualified contractor that meets the following specifications:

1. Provide three references showing the completion of at least 3 jobs of similar size and scope at other hospital facilities with at least one of those facilities being a VA Medical Center. Reference information is to include: Hospital/Medical Center name, POC name, email address and phone number.

2. All certifications must be signed by an NSF 49 certified technician. A copy of NSF 49 certifications must be attached to the bid documentation for any technicians that will be performing work at the facility.

3. All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification. A copy of the certification must be attached to the bid documentation for the supervisor or project manager of the team that will be performing work at the facility.

4. Provide AIHA accredited laboratory certification for all USP<797> viable sampling analysis. Certification must be attached with bid documentation.

5. Provide copy of clean room certification report for evaluation.

6. If required, contractor (employees performing services at the facility) will attain VA clearance (i.e. attend VA training, identification card, etc.)

d. Security Requirements: There are no security requirements required for this work, as samples are retrieved by the vendor and a test report is received in return.

e. Additional Considerations The contractor (or Representative) shall contact the facility identified COR(s) to schedule work and prior to the beginning of work. Scheduling of work will be at the direction of facility identified POC(s) to ensure services are incorporated into current facility certification cycles.

Local facility COR(s) will provide the contractor with additional facility specific procedures which include: check in and check out procedures; contractor badging requirements; parking procedures; and any additional facility specific procedures. The contractor will be expected to adhere to those procedures. If a contractor is willing to perform services after 4:00pm (CST) this service must be included within the bid pricing as no extra charge. The ability to perform work after hours is not required; however, preferences will be given to contractors that offer flexible work hours.

f. Invoicing Payment will be made monthly in arrears, invoices will be prepared by the Contractor, and submitted through Tungsten Network (formerly known as OB10) http://www.tungstennetwork.com/us/en/. A properly prepared invoice shall contain:

1. Invoice Number and Date

2. Contractor’s Name and Address

3. Accurate Purchase Order Number

4. Supply or Service provided

5. Period Supply or Service Provided

6. Total Amount Due (Continue to next page)

PART III: GENERAL ADMINISTRATION

a. Contract Officer Representative (COR)

(1) Various TBD@va.gov to coordinate this service. The contractor will contact the COR to schedule the work to be completed; upon arrival, the contractor will contact the COR. The COR will escort the contractor to the appropriate area and monitor the work being done. Upon completion of the work, the COR will escort the contractor out of the area.

b. Place of Performance

c. Period of Performance

(1) See Block 3 of SF1449 plus 4 option years.

d. Contract Administration Data

(1) All contract administration functions will be retained by the Department of Veterans Affairs. The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

e. Non-Personal Services

(1) This is a non-personal services contract. Personnel rendering services under this contract are not subject either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. The Government shall not exercise any supervision or control over the contract service providers performing services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

f. Hours of Operations

(1) Business hours: Monday through Friday, 8:00 a.m. - 4:30 p.m.

(2) Off-duty hours: Friday through Monday, 4:30 pm—8:00am; Monday through Thursday, 4:30 pm—8:00am.

(3) National Holidays: The 10 holidays observed by the Federal Government are:

New Year’s Day;

Martin Luther King’s Birthday;

Presidents Day;

Memorial Day;

Independence Day;

Labor Day;

Columbus Day;

Veterans Day;

Thanksgiving;

Christmas; and any other day specifically declared by the President of the United States to be a national holiday.

g. Quality Control

(1) CONTRACT PERFORMANCE MONITORING. The COR(s)s may perform surveillance of services by any of the methods listed below:

a) Observing actual performance;

b) Inspecting the services to determine whether the performance meets the performance standards; and

c) Review of any other appropriate records.

d) When unacceptable performance occurs, the POC shall inform the Contractor and the Contracting Officer. This will normally be in writing unless circumstances necessitate verbal communication. In any case the POC shall document the discussion and place it in the POC file. When the POC determines that formal written communication is required, the POC shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor program manager. 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 must present this corrective action plan to the POC. The Government shall review the Contractor corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer.

e) Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer representative(s); The Government shall periodically evaluate the Contractor performance by appointing a POC to monitor performance to ensure services are received. The Government representative(s) shall evaluate the Contractor performance through inspections of observations, inspection of services or any other form of documentation and all complaints from VA personnel. The Government may inspect as each task is completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures or because of repeated customer complaints. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates. The Government Contracting Officer shall make final determination of the validity of customer complaint(s).

f) 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 increase in contract amount. 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 at no additional cost to the Government.

g) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government.

h. Contract Security

The C&A requirements do not apply and a Security Accreditation Package is not required. Also, no BAA required.