Draft PWS Viable Surface Sampling VA Central California FY27.docx
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- Attached to
- H966--MONTHLY VIABLE SURFACE SAMPLING
- Solicitation number
- 36C26127Q0104
About this file
This is a Draft Performance Work Statement (PWS) for monthly viable surface sampling services at VA Central California Healthcare System's sterile compounding pharmacy facilities.
The contractor shall provide all labor, supplies, equipment, information technology, transportation, and supervision to conduct monthly viable surface sampling in Buildings 1 and 24 located at 2615 E. Clinton Ave, Fresno, CA 93703. The contract will run from January 1, 2027 through December 31, 2031, consisting of a base year (2027) and four option years (2028-2031). The contractor must employ CETA-certified technicians to perform dual incubation testing for bacterial and fungal growth detection across 14 locations plus 1 control in Building 1 and 26 locations plus 1 control in Building 24, which include chemotherapy IV compounding rooms with biological safety cabinets, non-hazardous IV compounding rooms with laminar flow hoods, and ante rooms. Testing must comply with USP Chapters 797 and 800, CETA CAG-003-2006 or successor standards, and other applicable codes. Work shall be performed during standard operating hours (7:00 AM to 4:30 PM, Monday through Friday, excluding federal holidays) unless otherwise requested at no additional cost. The contractor must provide field reports before departing the facility, with formal test result summaries including sampling diagrams, room and HEPA filter maps, and calibration certificates delivered within 60 days. Monthly testing must be scheduled so that if the last inspection occurred on the first of a month, the next sampling must be completed between the first and last day of the following month. Deliverables include individual monthly sampling reports in digital format submitted to the Contracting Officer with pass/fail status and reasons for any failures. The contractor must possess minimum five years of experience in maintenance, inspection, testing, and repair of fume hoods, biosafety cabinets, and pharmacy clean rooms, and must provide a designated Contract Manager available within 24 hours of request. The government will provide electricity, fresh water, sewage service, and non-hazardous refuse collection at existing outlets, while the contractor is responsible for all other facilities, tools, equipment, materials, and disposal of debris. Payment will be made monthly in arrears upon verification that all work, reports, and requirements have been completed in accordance with contract specifications.
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| File | Type | Posted |
|---|---|---|
| OPPORTUNITIES-MONTHLY VIABLE SURFACE SAMPLING.pdf | ||
| 36C26127Q0104.docx | DOCX document |
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Text version
PERFORMANCE WORK STATEMENT
Monthly Viable Surface Sampling
1. PURPOSE:
The contractor shall provide all labor, supplies, equipment, information technology, transportation, and supervision necessary to conduct a clean room monthly surface viable sampling of pharmacy sterile compounding suites in Building 1 and Building 24. This testing is to detect any microbial contamination and provide information on the environmental quality of the sterile compounding areas. The testing will help with the certification to ensure compliance with USP <797>, USP <800>, and Joint Commission standards for sterile compounding clean rooms.
2. PLACE OF PERFORMANCE:
VA Central California Healthcare System (VACCHCS), 2615 E. Clinton Ave, Buildings 1 & 24, Fresno, CA 93703.
3. PERIOD OF PERFORMANCE:
| Base Year | 1/1/2027-12/31/2027 |
| Option Year 1 | 1/1/2028-12/31/2028 |
| Option Year 2 | 1/1/2029-12/31/2029 |
| Option Year 3 | 1/1/2030-12/31/2030 |
| Option Year 4 | 1/1/2031-12/31/2031 |
Note: This facility is not subject to local or State requirements. Vendor will ensure compliance with Federal requirements only.
4. PERFORMANCE OF WORK:
The awarded contractor must provide CETA certified technician(s) to complete the following clean room testing monthly USP Chapter <797> & <800> compliance testing of the facility Sterile Compounding Suites.
The suites consist of three areas: (1) chemotherapy IV compounding room(s), which contains biological safety cabinets, (2) non-hazardous IV compounding rooms which include laminar flow hoods, and (3) ante rooms. Surface viable sampling includes dual incubation for bacterial and fungal growth detection, count, and colony identification when warranted. Building 1: 14 locations, 1 control. Building 24: 26 locations, 1 control. The vendor’s technician shall provide copies of the all-field reports before departing VACCHCS. Any viable samples taken will have results sent within 10 business days upon receipt by the lab. If any organism identification is requested for the viable samples taken to the Genus or Species, there will be associated costs additional to the base price. If the ID is requested, the vendor will need to be notified as the lab that processes the samples only holds on to them for 30 days once the lab receives the samples. The vendor shall summarize all test results and send a Formal Report Summary that will have all test data, sampling diagrams, room and HEPA filter maps, copies of calibration certificates of all standards used, and applicable test criteria/standards. Standard turnaround should be within 60 days.
For this contract, the standard operating hours or duty hours are the hours between 7:00 AM to 4:30 PM, Monday through Friday, except Federal Holidays. Contractor to limit all work within the standard operating hours, unless requested by the government at no extra cost to the government.
| January 1 |
| New Year’s Day |
| Birthday of Martin Luther King, Jr |
| Third Monday in January |
| Washington’s Birthday (Presidents Day) |
| Third Monday in February |
| Memorial Day |
| Last Monday in May |
| Juneteenth National Independence Day |
| June 19 |
| Independence Day |
| July 4 |
| Labor Day |
| First Monday in September |
| Columbus Day |
| Second Monday in October |
| Veterans Day |
| November 11 |
| Thanksgiving Day |
| Fourth Thursday in November |
| Christmas Day |
| December 25 |
5. CODES AND STANDARDS:
5.1 Publications listed below form a part of this Contract. The Contractor shall meet the requirements of current code editions published, all manufacturer guidelines, Veteran’s Affairs (VA) memorandums, and industry standards, as applicable, and in the case of conflicting standards the most stringent shall apply.
| 5.1.1 | USP Chapter 797 – Pharmaceutical Compounding – Sterile Preparations |
| 5.1.2 | USP Chapter 800 – Hazardous Drugs – Handling in Healthcare Settings |
| 5.1.3 | CAG-003-2006 or successor - CETA Certification Guide for Sterile Compounding Facilities |
| 5.1.4 | National Sanitation Foundation No. 49 |
| 5.1.5 | OSHA Standard 29 CFR 1910 |
| 5.1.6 | International Building Code (IBC) |
| 5.1.7 | National Fire Protection Association (NFPA) |
| 5.1.7.1 | NFPA 70 – National Electrical Code (NEC) |
| 5.1.7.2 | NFPA 70E – Electrical Safety in the Workplace |
| 5.1.7.3 | NFPA 72 – National Fire Alarm and Signaling Code |
| 5.1.7.4 | NFPA 101 – Life Safety Code |
5.1.7.5 NFPA 99 – Health Care Facilities Code
5.1.7.6
6. DEFINITIONS & ACRONYMS
| I. | ANSI – American National Standards Institute |
| II. | ASME – American Society of Mechanical Engineers |
| III. | CETA – Controlled Environmental Testing Association |
| IV. | CO – Contracting Officer |
| V. | COR - Contracting Officer Representative |
| VI. | FAR – Federal Acquisition Regulation |
| VII. | HEPA – High Efficiency Particulate Air filter |
| VIII. | MSDS – Material Safety Data Sheet |
| IX. | MOD – Modification of contract |
| X. | NEC – National Electric Code |
| XI. | NFPA - National Fire Protection Association |
| XII. | NTP – Notice to Proceed |
| XIII. | OEM - Original Equipment Manufacturer |
| XIV. | OSHA - Occupational Safety and Health Administration |
| XV. | PEC – Primary Engineering Control |
| XVI. | PO – Purchase Order |
| XVII. | POC - Point of Contact |
| XVIII. | PM - Preventative Maintenance |
| XIX. | PMI - Preventative Maintenance Inspection |
| XX. | PPE – Personal Protective Equipment |
| XXI. | PWS - Performance Work Statement |
| XXII. | SEC – Secondary Engineering Control |
| XXIII. | QASP – Quality Assurance Surveillance Program |
| XXIV. | QCP – Quality Control Program |
| XXV. | USP – United States Pharmacopeia |
| XXVI. | VA – United States Veterans Affairs |
| XXVII. | VAPAHCS - Veterans Affairs Palo Alto Health Care System |
7. EXCLUSIONS:
| 7.1 | Equipment, components, and parts not installed under this Contract shall not be removed, replaced, or deficiencies corrected while still under the manufacturers or installer’s warranty, without prior approval of the COR. |
| 7.2 | Installation of new attachments recommend or required by inspectors, insurance agencies, or VA/Government Authorities. |
| 7.3 | The CO must approve, in advance, all repairs not covered under this contract. The Contractor shall prepare an estimate of parts, labor, transportation, and shipping costs for review prior to performing the repairs. If approved, CO/COR shall issue a modification (MOD) in advance of undertaking such work. No invoice will be paid without prior approval and specific MOD issued in advanced of work. |
7.4 There shall be no borrowing of parts (i.e., removing of parts from one PEC, whether it is in service or not, to correct a deficiency on another PEC) except in an emergency or with written consent from the COR.
8. GOVERNMENT FURNISHED PROPERTY, MATERIALS, and SERVICES
| 8.1 | The Government will not provide office space or operational facilities to the Contractor. The Contractor shall secure and maintain the necessary office space and other facilities required for performance of this Contract at their own expense. |
| 8.2 | The Government will not provide tools or equipment to the Contractor. The Contract shall furnish all tools required for the performance of this Contract. |
| 8.3 | The Government will not provide any materials to the Contractor. |
| 8.4 | The Government will furnish the following services at existing outlets, for use in those facilities provided by the Government and as required for the work to be performed under this Contract: electricity, fresh water, sewage service, and non-hazardous refuse collection (from existing collection points). Disposal of equipment and construction debris is the responsibility of the Contractor. |
9. CONTRACTOR REQUIREMENTS
9.1 Contractor shall have technical training, track records of working experience in maintenance, inspection, testing and repairing of fume, bio safety cabinets, and pharmacy clean rooms. Experience shall be within healthcare, industrial, research, educational and commercial facilities for a minimum of five (5) years.
9.2 Contractor’s technicians shall possess certificates on equipment which work will be performed. Certificates and documents shall be presented with submission package. VA reserves the right to request proof of appropriate training and experience from vendor/contractor personnel for servicing the equipment on the schedule for the duration of the contract. Contractor shall provide certificates and documents within two days of request.
9.3 The servicing technician shall be NSF and CETA certified. Servicing technicians must also have the applicable manufacturer’s diagnostic software to diagnose problems.
9.4 The Contractor shall provide a Contract manager who shall be responsible for performance of the contract work. Name of the Contract manager and an alternate shall be designated in writing to the CO/COR prior to contract start date. Changes to personnel shall be submitted to the Government within five (5) workdays of the changes. The Contract Manager or alternate shall have full authority to act on contract matters relating to daily operation of the Contract. The Contract Manager or alternate shall be available to speak/meet with the CO or COR, within 24 hours of request during normal operating hours and or within the next business day.
9.5 The selection, assignment, and management of Contractor’s employees is the responsibility of the Contractor. The Contractor shall not employ any individual identified as a potential threat to the health, safety, security, and general wellbeing, or operation of the VAPAHCS facilities or personnel. The Contractor is fully responsible for performance and conduct of his/her employees. The Contractor shall not allow any employee to perform work under this Contract while under the influence of alcohol, drugs, or any other incapacitating agent.
9.6 If the prime contractor is using a sub-contractor to provide the actual inspection and maintenance service then the requirements for experience, technical training, and certification as stated in section 9 apply to the sub-contractor and their employees. The prime contractor must have at least one year of successful experience working with the sub-contractor on another contract providing the same service.
10. EMERGENCY TELEPHONE NUMBERS:
10.1 The Contractor shall provide the CO/COR with pertinent emergency telephone numbers to summon assistance in the event of an emergency. At least one of the emergency telephone numbers, and one alternate telephone number. This information shall be provided in writing to the CO/COR.
11. SPECIFIC SERVICES
11.1 Provide viable surface sampling to Biological Safety Cabinets, Laminar Flow Hoods, and Pharmacy segregated compounding areas, all PEC, and SEC applicable per USP, Chapter 797 & 800 as applicable. Testing shall be conducted monthly For example, if last inspection was performed January 1st, the next sampling must be completed between February 1st and February 28th of the same calendar year. The contractor is responsible for scheduling all certification/testing visits prior to the end of the month in which they are due.
11.2 Contractor shall contact COR prior to any service performed.
11.3 All testing within Pharmacy spaces shall comply with Controlled Environmental Testing Association (CETA) CAG-003-2006 or most recent edition and USP 797/800.
12. DELIVERABLE:
12.1 A full year of monthly testing with building number and number of areas sampled.
12.2 Individual sampling reports will be submitted to the COR in digital format.
12.3 Each month, government will be provided with an updated report with last test date and comment on status as pass or fail with reason for fail.
12.4 All deliverables shall be in digital format and via email to COR and any additional designated individuals. Failure to deliver the above shall result in delay in payment for services till deliverables are received.
13. ADDITIONAL SERVICES
13.1 Additional services are defined as any work requested and authorized by the Government that is within the scope of this contract but in addition to the contract requirements. Any work of this nature detected by the Contract shall be immediately reported to the COR, but work shall not be performed until the Contractor and the CO or COR as appropriate have reached an agreement on the price to accomplish the project. Work shall be performed immediately, if necessary (i.e., an emergency) although typically a 48-hour notice will be given.
13.2 Labor Costs - The Contractor shall price labor hours within the Additional Unexpected Repair Services. The Contractor’s expenses for overhead, General and Administrative (G&A), and profit are already included in this CLIN. Thus, no separate allowances for travel time, parking, overhead, G&A or profit can be applied.
13.3 Materials and Parts – Contractor shall provide list of parts with part number and quantities required for any repair with a quote for parts, separate form labor. The Government reserves the right to furnish any or all parts and/or materials required for a particular repair/replacement. Government may pay for the parts separately to the contractor either using government purchase card or by modifying the contract.
13.4 All orders for maintenance repair/replacement work must be placed or confirmed by issuance of a SF30. The SF30 will describe the work to be performed, the time for completion, and the total price for the work. In emergency situations oral orders are permitted, which will be confirmed within 5 working days by issuance of a SF30. Orders of $2,500.00 or less may be processed using the Governmentwide commercial purchase card, which is the preferred method to purchase and to pay for micro purchases.
13.5 The Government reserves the right to perform the work using whatever resources are available.
14. SAFETY, INSPECTION, and TESTING
Injury and Accident Reports
| A. | Contractor shall immediately report to the CO/COR in a manner and on the forms prescribed by the Government, accidents resulting in injury, trauma, death, hazardous exposures, and occupational disease involving the performance of this PWS. | |
| B. | Written reports for incidents shall be provided within five (5) working days and include the cause, what, where, and when the incident occurred as well as repairs and tests performed to correct the cause of the incident. | |
| C. | Contractor shall adhere to OSHA, EPA, NFPA Life Safety Codes, and other regulatory requirements. Safety shall be the Contractor’s highest priority. The Contractor shall be solely responsible for compliance with (Federal) OSHA regulations. | |
| D. | Contractor shall provide a detailed explanation as to how contract work will be implemented and managed to ensure compliance with OSHA Construction Standards, Life Safety issues, and security measures. Contractor shall have a Site Safety and Health Officer (SSHO) assigned to the contract/project to ensure their technicians are meeting OSHA requirements. The SSHO shall be well versed in OSHA requirements and regulations. The SSHO will perform regular safety inspections on the job site to ensure technician compliance and quality of work is at a high level, presenting no risks to staff or patrons. Safety inspections will include fall protection and electrical hazards and end with job safety meetings with the entire crew. The Contractor shall provide the CO/COR copies of the safety inspection reports upon request at no additional cost to the Government. | |
| E. | During contract performance, the Contractor shall follow Government’s safety policy and standards for safe work practices and take such safety precautions as the VAPAHCS Safety Officer or designee or the CO/COR may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contractor shall comply with VAPAHCS smoking policy. | |
| F. | Patient, employee, visitor, and Contractor personnel safety shall be always maintained. The Contractor is responsible for the safety and health of his/her employees. | The Contractor shall replace all safety guards, equipment, devices, etc. removed to service, inspect, or repair the equipment in this PWS immediately after completion of work or when leaving the job unattended. |
| G. | The Contractor shall submit to the Contracting Officer (CO), prior to the start of the Contract, the Safety Data Sheets (SDS) for potentially hazardous materials (lubricants, cleaners, fluids, etc.) to be used in the facility during performance of the Contract and will not use materials which have not been approved in advance by the Government. SDS for new chemicals shall be furnished prior to the arrival of the chemical on site. The Contractor shall maintain a copy of all SDS to assure compliance with laws and requirements regarding the Right to Know law (OSHA Hazard Communication Standard (29 CFR 1910.1200). | |
| H. | Contractor is responsible to identify, provide and maintain personal protective equipment (PPE) required to perform the duties outlined in the Contract. In addition, the Contractor is responsible for identifying and providing applicable safety programs required to perform the work i.e., lockout/tag out, confined space entry, universal precautions, etc. Training required for safety programs and proper use of PPE shall be provided by employer, and documentation maintained by the Contractor. | |
| I. | The Contractor shall obtain a Hot Work Permit from the Government (VAPAHCS Safety Staff) or the CO/COR in advance whenever soldering, welding, grinding, and using a cutting torch, or other open flame, spark or heat producing equipment is used. The Contractor is required to follow requirements outlined for the issuance of the Hot Work Permit. | |
| J. | Contractor shall be notified of any non-compliance with safety regulations. The Contractor shall, after receipt of such notice, immediately correct the condition and notify the CO in writing that the condition has been corrected. If, in the opinion of the CO/COR or the Government’s Safety Officer, the condition is life threatening he/she shall instruct the Contractor to stop work until the condition has been corrected. If the Contractor fails or refuses to comply promptly, the CO may issue an order halting all or any part of the work. The Contractor bears all costs of stop-work time and correcting safety hazards. |
15. QUALITY CONTROL
15.1 Contractor shall establish a Quality Control Program to assure the requirements of the Contract are provided as specified. The Contractor shall submit this program to the CO/COR, for acceptance within ten (10) days of Notice to Proceed. The program shall include the following:
| A. | An inspection system covering the services described in the Contract. A checklist used for inspecting Contract performance during scheduled or unscheduled inspections and the name(s) of the individual(s) who will perform the inspection. |
| B. | The checklist shall include every area of the Contractor’s operation as well as every task required to be performed. |
| C. | A system for identifying and correcting deficiencies before the level of performance becomes unacceptable and/or the Government inspectors point out deficiencies. |
| D. | A file of inspections conducted by the Contractor and the corrective action taken. This documentation shall be made available to the CO/COR upon request, at any time during the term of the Contract. |
15.2 Site Investigation and Conditions Affecting the Work:
| A. | The Government assumes no responsibility for any conclusions or interpretations made by the Contractor based on the information made available by the Government. Nor does the Government assume responsibility for any understanding reached or representation made concerning conditions which can affect the work by any of its officers or agents before the execution of this contract, unless that understanding, or representation is expressly stated in this contract. |
| B. | Contractor has the responsibility to make the determination and request a site walk. Failure to perform a site walk shall not relieve the contractor to complete the contract on time and within budget. |
16. PAYMENT
16.1 PAYMENT FOR VERIFIABLE WORK COVERED UNDER THE CONTRACT
A. Payment for work covered under this Contract shall be billed monthly.
B. Payment will be made in arrears of the specified billing period after receipt of a properly prepared invoice, all required work, including preventative maintenance, submission of reports and all other requirements for the period in question have been performed in accordance with contract stipulations, and can be verified with service reports signed by the COR or COR designee.
C. The Contractors failure to schedule and perform a PM within the specified time interval shall be considered non-compliance with terms of contract, and Government will take corrective action as defined the Federal Acquisition Regulations (FAR). Payment withholding will be in compliance with the FAR. Continued Contractor failure to perform will necessitate holding Contractor in default and the Government obtaining suitable service via separate means.
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