SOURCES SOUGHT
H -- HV USP Compliant Pharmacy certification/Lab BSC/Fume Hood Cert base year
- Notice Date
- 12/21/2021 7:58:37 AM
- Notice Type
- Sources Sought
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- 242-NETWORK CONTRACT OFFICE 02 (36C242) ALBANY NY 12208 USA
- ZIP Code
- 12208
- Solicitation Number
- 36C24222Q0236
- Response Due
- 12/27/2021 6:00:00 AM
- Archive Date
- 02/25/2022
- Point of Contact
- Evelyn Peguero, Contract Specialist, Phone: 914-737-4400
- E-Mail Address
-
Evelyn.Peguero@va.gov
(Evelyn.Peguero@va.gov)
- Awardee
- null
- Description
- Synopsis: Please note that this is NOT a request for quotes or proposals, the Government is seeking information for market research purposes only. Network Contracting Office (NCO) 2 of the Department of Veterans Affairs is currently conducting a market survey for qualified firms capable of providing USP compliant certification for the Sterile Compounding Pharmacy areas and Annual BSC/Fume hood recertifications at Castle Point & Montrose Campus Healthcare Centers for VA Hudson Valley Health Care System Montrose and Castle Point. The contractor shall furnish all labor, materials, parts, supplies, equipment, supervision and transportation necessary to accomplish the services. The North American Industry Classification Systems (NAICS) is 621511. Responses to this notice must be submitted in writing (email) and must be received no later than December 24, 2021 at 4:00pm. Email: Evelyn.Peguero@va.gov. No telephone inquiries will be accepted. Interested parties MUST provide company/individual name, a capability statement, examples of same or similar work performed at other facilities, DUNS number and address, point of contact and social-economic category. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, women owned small business, HUB Zone, 8(a), small business or large business), relative to NAICS 621511. Responses to this notice will be used by the Government to make appropriate acquisition decisions. A solicitation is not currently available. If a solicitation is issued, it will be announced on beta.SAM.gov at a later date, all interested parties must respond to that solicitation announcement separately from the responses to this announcement. See additional information below: STATEMENT OF WORK Hudson Valley VA Healthcare System Castle Point & Montrose Campus Request for Services - Statement of Work (SOW) USP Compliant Pharmacy Certification/& Lab BSC/Fume Hood Certification Services 1. Background. Hudson Valley VA Healthcare System requires a contract to provide all labor, materials and travel to perform the USP compliant certification for the Sterile Compounding Pharmacy areas and Annual BSC/Fume hood recertifications at Castle Point & Montrose Campus Healthcare Centers. This is a Base plus four (4) year contract. 2. Scope (Pharmacy). All pharmacy-specific equipment will obtain CETA certification every six (6) calendar months from the date of the last certification/testing of biological safety cabinets(s), laminar flow hoods, ceiling mounted HEPA filters, and room spaces/environments in accordance with VHA Directive 1108.12, and USP 797 & 800. Recertification may be required sooner if equipment is relocated/altered or a major service is performed. Pharmacy specific spaces and equipment are as follows: Montrose Campus Pharmacy Primary Space Segregated Compounding Area with Compounding Aseptic Isolator Test to manufacturer specifications Perform smoke pattern testing with video recording Check velocity Check HEPA filter integrity Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Hudson Valley VA HCS. Certification and testing shall conform to USP and OSHA standards. The contractor shall comply with Federal, State, and Local Laws, plus and federal regulations as applicable to the performance of this contract; to include USP 797 and USP 800. The individual performing the testing shall be CETA certified to perform this work. The technician/contractor shall provide a copy of the individuals CETA credentials at time of offer. If, during the contract, a different individual(s) is designated by the contractor, CETA certification of the individual(s) must be provided to the CO and COR and approved prior to the start of work. Volumetric air sampling for viable airborne particles must be completed in all classified areas (ISO 5 PEC, ISO 7 & 8 rooms) and must be done using an impaction device during dynamic operating conditions at least every 6 months. Surface sampling of all classified areas and pass-through chambers for microbial contamination must be conducted semi-annually during certification. Sampling must be performed at the end of compounding activity but before the area has been cleaned & disinfected. Sampling must include identification (to genus level) of any resulting microorganisms) Castle Point Campus Pharmacy Primary Space Sterile Preparation Anteroom with two (2) Fan Powered HEPA filter. Non Hazardous Compounding room: One (1) Compounding Aseptic Isolator and two (2) Fan Powered HEPA filter. Hazardous Compounding room: One (1) Compounding Aseptic Containment Isolator and three (3) Fan Powered HEPA filter. Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Hudson Valley VA Health Care System. Certification and testing shall conform to USP and OSHA standards. The contractor shall comply with Federal, State, and Local Laws, and federal regulations as applicable to the performance of this contract; to include USP 797 and USP 800. The individual performing the testing shall be CETA certified to perform this work. The technician/contractor shall provide a copy of the individuals CETA credentials at time of offer. If, during the contract, a different individual(s) is designated by the contractor, CETA certification of the individual(s) must be provided to the CO and COR and approved prior to the start of work. Volumetric air sampling for viable airborne particles must be completed in all classified areas (ISO 5 PEC, ISO rooms) and must be done using an impaction device during dynamic operating conditions at least every 6 months. Surface sampling of all classified areas for microbial contamination must be conducted semi-annually during certification. Sampling must be performed at the end of compounding activity but before the area has been cleaned & disinfected. Sampling must include identification (to genus level) of any resulting microorganisms Additional Requirements: The contractor shall: Obtain all necessary licenses and/or permits required to perform the work herein. Measure and document HEPA filter(s) air volumes and velocities PPE Contractor will follow Hudson Valley VA HCS protocols for use of PPE in the classified spaces and understands the risks associated with facilities and equipment designed for storage and preparation of hazardous drugs. All equipment brought into the cleanroom suite must be disinfected and sanitized prior to entry (with Caviwipe, followed by sterile 70% isopropyl alcohol or as per current standard operating procedure for the cleanroom suite). Primary Engineering Controls (CAIs and CACIs) HEPA filter leak tests and patching if necessary Prefilter check Non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating Dynamic smoke testing (video recorded and provided to us on a DVD or made available for download on a secure website) for all primary engineering controls; must have sufficient smoke to demonstrate unidirectional airflow and sweeping action over and away from any preparation Perform semi-annual Air & Surface Viable Environmental Sampling (bacterial & fungal) from inside each PEC, including counts and microbial identifications. All environmental testing to be performed by an accredited laboratory and their report issued. Samples must be labeled, and a diagram of sampling locations provided (2) Compounding Aseptic Isolator (1 air bacterial, 1 air fungal, 1 surface bacterial, & 1 surface fungal) Baker Compounding Aseptic Isolator Model Number: SS 500 Serial Number: 85172 Baker Compounding Aseptic Isolator Model Number: SS 500 Serial Number: 92440 (1) Compounding Aseptic Containment Isolator (1 air bacterial, 1 air fungal, 1 surface bacterial, & 1 surface fungal) Baker Compounding Aseptic Containment Isolator Model Number: CS 500 Serial Number: 96340 Secondary Engineering Controls (SECs) Castle Point Campus Pharmacy Primary Space(s) ISO Class 7 Sterile Preparation Anteroom ISO Class 7 Hazardous Compounding Room ISO Class 7 Non- Hazardous Compounding Room Perform room calculations to determine air changes per hour (ACPH) in each room. Documented on the certification report should include ACPH for HVAC, ACPH contributed from PEC, and the total ACPH. Perform semi-annual Air & Surface Viable Environmental Sampling for microorganisms (bacterial & fungal), including counts and microorganism identification. All environmental testing to be performed by an accredited laboratory and their report issued. Samples must be labeled, and a diagram of sampling locations provided. Sample to be taken from at least one high-touch area of each SEC Non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions to calculate room ISO rating HEPA filer leak test for Fan Powered HEPA Filters (2 in the anteroom, 3 in the Hazardous Compounding Rm., 2 in the Non-Hazardous Compounding Rm. room) Pressure differentials between SECs and the ante room and the Hospital common area Smoke pattern testing with video recording of airflow between each pair of SECs and between anteroom and general pharmacy area Temperature and humidity testing Perform calibration of room pressure differential gauges. Gauges will be affixed with calibration sticker. Instruments used for testing will be specified and along with most recent calibration date and date next calibration is due. CAG-003-006 or successor will be followed (per PBM 4/23/18 guidance: Veterans Health Administration Guidance for Defining, Certifying, and Procuring PECs for Compounded Sterile Preparations) along with VHA Directive 1108.12, and United States Pharmacopeia General Chapters 797 and 800 and Institute of Flow Clean Air Devices, IEST-RP-CC-002.4. Reporting (Pharmacy Results Only) All reports must be sent via email or CD Disk directly to the COR and to the CSP pharmacist Contractor shall provide a written report of all testing and certification results, no later than seven (7) business days following completion of all work (except for viable sampling results).At a minimum, this report must contain: Name of CETA-certified technician performing the testing List of equipment used for the testing: manufacturer, model, serial number and calibration due date Type, make, model and serial number for each PEC Each PEC and SEC nonviable particulate counts (including sample volume and time) and ISO classification Measured air velocity data for PEC, including CFM, average and standard deviation of air velocity measurements and acceptance criteria PEC blower setting and pressure gauge reading (if any) For BSCs: measured downflow air velocity data, acceptance criteria and pass/fail result For BSCs: measured exhaust damper acceptance criteria and pass/fail result For BSCs: inflow velocity test method, measurements and results Total Air Changes Per Hour (ACPH) for each SEC, with indication of ACPH supplied by the PECs Pressure differentials between each SEC and the anteroom/pharmacy Results of HEPA leak tests for all filters tested, as well as the results of any patching that was performed If leaks were detected and sealed, include a diagram showing approximate location of sealed leaks Prefilter type, size and condition for each PEC Viable testing results (once available) SEC temperature and relative humidity Video recording of all smoke pattern testing (airflow and dynamic) Alarm test results (if any) A diagram of the areas tested, noting the approximate location of surface, air and particle counts Any recommendations for HEPA replacement/HEPA lifespan Performance standard used for testing The Microbiology report must include: Sampling location and any organisms identified to the genus level Incubation temperature and duration Manufacturer, lot number and expiration for each media lot Positive and negative controls Determination of whether findings are actionable (pass/fail) Chain of custody for samples The pharmacy must be notified of any microbial growth immediately after it is identified (no later than 48 hours after the report is received by the contractor from the laboratory). The certification tag must be updated on each of the PECs that passes certification Response Time (Pharmacy Only) Contractor shall use commercially reasonable efforts to: Respond by telephone to any report of a malfunction requiring repair within one hour of notification. Provide on-site support within 24 hours of notification unless prevented by unforeseen circumstances 3. Laboratory Equipment Certification: Perform annual certification of two (2) Biological Safety Cabinets in accordance with the following standards and per manufacturer specifications: NSF / ANSI 49 (Biological Safety Cabinets) IEST-RP-CC034.3 (HEPA Filter Leak Testing) Inventory. Equipment Name Model Serial Location (Campus / Room/ EE#) Biological Safety Cabinet Class II, Type A/B3 L1 Baker B40-112 SP-31653 CP / C-114 / 33193 Biological Safety Cabinet Class II, Type A/B3 L2 Baker B40-112 SP-31652 CP / C-114 / 33194 4. Research Equipment Perform annual certification of two (2) Fume Hoods in accordance with the following standards and per manufacturer specifications: ANSI/ASHRAE STANDARD 110-2016 Inventory Equipment Name Model Serial Location (Campus / Room/ EE#) FUME HOOD WORKSTATION- L10 MB100 MB100LOO1 CP / E-40 / 56965 FUME HOOD - L13 LOC SCIENTIFIC UNK CP / E-40 5. Dental/Prosthetics Equipment Perform annual certification of (1) Fume Hoods in accordance with the following standards and per manufacturer specifications: ANSI/ASHRAE STANDARD 110-2016 Inventory Equipment Name Model Serial Location (Campus / Room/ EE#) FUME HOOD SAS UNK CP / Dental Suite Reporting Contractor shall provide a written report of all testing and certification results, no later than seven (7) business days following completion of all work (except for viable sampling results). Contractor shall include Summary tables listing all rooms or areas tested and the acceptable limits, actual readings and indication of testing results (e.g. pass/fail) for the designated testing criteria for compliance. 6. Travel and Related Expenses Contractor shall be responsible for its service-related trip expenses including round trip travel, mileage, and overnight living expenses. 7. Title to Equipment Contractor shall not assume possession or control of any part of the equipment. The Government retains ownership to title thereof. 9. Utilities Contractor may use Government utilities, (e.g., electrical power, compressed air, and water) which are available and required for any service performed under this contract. 10. Access to Equipment Contractor shall be provided reasonable access to all equipment that is to be serviced and utility outlets required to do the service. The contractor shall be free to start and stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on duty personnel responsible for such equipment. 11. Technical Support Technical support shall be made available from the Contractor to Hudson Valley VA HCS 24/7, 365 days a year via telephone. 13. Parts and Materials All compensation for parts and materials is included in contract price. 14. Parts/Supplies Quality Parts and Supplies provided under this contract shall be new OEM parts. 15. Field Service Reports Contractor shall furnish a written or electronic vendor supplied Field Service Report (FSR). 16. Place of Performance. Hudson Valley VA Healthcare System Castle Point Campus 41 Castle Point Road, Wappinger Falls 12590 & Montrose Campus 2094 Albany Post Road, Montrose, New York 10548 17. Estimated Period of Performance: 1/15/2021-1/14/2022 with four (4) provisional option years. Attch: Montrose Campus Pharmacy Layout Castle Point Campus Pharmacy Layout Montrose Campus Pharmacy layout Castle Point Campus Pharmacy layout DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/1cadbf124acf409d866bb200493e96ad/view)
- Place of Performance
- Address: VA Hudson Valley Health Care System 2094 Albany Post Rd., Montrose, NY 10548, USA
- Zip Code: 10548
- Country: USA
- Zip Code: 10548
- Record
- SN06203104-F 20211223/211221230119 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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