SOURCES SOUGHT
H -- USP Compliant Pharmacy, Lab BSC and Fume Hood Certification Services
- Notice Date
- 8/10/2021 10:39:03 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
- 36C24221Q1307
- Response Due
- 8/16/2021 2:00:00 PM
- Archive Date
- 09/15/2021
- Point of Contact
- Lisa Harris, Contract Specialist, Phone: Lisa.Harris4@va.gov
- E-Mail Address
-
Lisa.Harris4@va.gov
(Lisa.Harris4@va.gov)
- Awardee
- null
- Description
- 2 This is a Sources Sought Notice. (a) The Government does not intend to award a contract on the basis of this Sources Sought or to otherwise pay for the information solicited. (b) Although ""proposal,"" ""offeror,"" contractor, and ""offeror"" may be used in this Sources Sought notice, any response will be treated as information only. It shall not be used as a proposal. (c) Any information received from a contractor in response to this Sources Sought may be used in creating a solicitation. Any information received which is marked with a statement, such as ""proprietary"" or ""confidential,"" intended to restrict distribution will not be distributed outside of the Government, except as required by law. (d) This Sources Sought is issued by VISN 2 Contracting Office for the purpose of collecting information about USP compliant Certification for the Sterile Compounding Pharmacy areas and Annual BSC/Fume hood Recertifications for the Albany (Stratton) VA Medical Center. The VA is seeking to provide for this requirement within 60 days of the award of the contract. The NAICS code identified for this requirement is 621511 Medical Laboratories. The requirement is detailed in the Statement of Work section of this document. (e) Cursory market research has identified several businesses that may be able to provide for this requirement. Contractors that are able to meet the requirements in the attachment are encouraged to email a capability statement and full information to Lisa Harris at Lisa.Harris4@va.gov. Please send all inquiries to: Lisa.Harris4@va.gov by 5:00 pm EST on Monday, August 16, 2021. Phone calls will not be accepted. - Part of the purpose of this Sources Sought is to determine the viability of set aside to a specific socio-economic category. Contractors shall identify the NAICS code for the services being offered as well as their size status under said NAICS. This information will be used to determine the viability of a set aside for this requirement. Contractors Shall Also Identify: Federal Supply Schedules that may carry the desired services. Pertinent point of contact for company, contractor DUNS number for size standard and socioeconomic verification in SAM and VIP. Include any relevant comments about the Attachment(s) if applicable. Stratton VA Medical Center Albany, New York Request for Services - Statement of Work (SOW) USP Compliant Pharmacy Certification/& Lab BSC/Fume Hood Certification Services 1. Background. Albany VAMC 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 throughout the Medical Center. 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: 1B Pharmacy Primary Space(s) B126a: one (1) Ductless Double Filter Fume Hood, Containment Ventilated Enclosure Test to manufacturer specifications Perform smoke pattern testing with video recording Check velocity Check HEPA filter integrity B122a Anteroom B122b: HD buffer room, three (3) Laminar Airflow Workbenches, and tone (1) ceiling mounted HEPA filter outside cleanroom suite. Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Albany VA Medical Center. 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) 9A Pharmacy Primary Space(s) A921 Anteroom, one (1) ceiling mounted HEPA filter. A920 HD buffer room: two (2) biological safety cabinets and two (2) ceiling mounted HEPA filters. Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Albany VA Medical Center. 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 11A Pharmacy Space (s) 11A Anteroom (shared) , one (1) ceiling mounted HEPA filter. 11A HD buffer room: one (1) biological safety cabinets and two (2) ceiling-mounted HEPA filters. 11A non -HD buffer room one (1) LAFW and one (1) ceiling-mounted HEPA filter Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Albany VA Medical Center. 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 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 Albany VAMC 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 (BSCs and LAFWs) 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) Biological Safety Cabinet (1 air bacterial, 1 air fungal, 1 surface bacterial, & 1 surface fungal) Baker Steril Guard E3 BioSafety Cabinet Model Number: SG604) Serial Number: 129000 Baker Steril Guard E3 BioSafety Cabinet Model Number: SG604) Serial Number: 128979 (3) Laminar Flow Benches (1 air bacterial, 1 air fungal, 1 surface bacterial, & 1 surface fungal) Baker Edgegard Laminar Flow Clean Bench, 4FT Model Number: EG4320) Serial Number: 102010 Baker Edgegard Laminar Flow Clean Bench, 6FT Model Number: EG6320) Serial Number: 102034 Baker Edgegard Laminar Flow Clean Bench, 6FT Model Number: EG6320 Serial Number: 102065 Baker Steril Guard E3 BioSafety Cabinet Model Number: SG404 Serial Number: 137983 Baker Edgegard Laminar Flow Clean Bench, 4FT Model Number: EG4320 Serial Number: 137953 Secondary Engineering Controls (SECs) 1B Pharmacy Secondary Engineering Controls B122a ISO Class 8 Sterile Preparation Anteroom B122b ISO Class 7 Compounding Buffer 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 (1 in adjacent room) Pressure differentials between each pair of SECs and between ante room and general pharmacy 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 9A Pharmacy Primary Space(s) A921 ISO Class 7 Sterile Preparation Anteroom A920 ISO Class 7 Hazardous Compounding Buffer 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 in-ceiling filters (1 anteroom, 2 buffer room) Pressure differentials between each pair of SECs and between ante room and general pharmacy 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 11A Pharmacy Primary Space(s) A1106a ISO Class 7 Anteroom A1106b ISO Class 7 HD Buffer room A1106c ISO Class 7 non -HD Buffer 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 in-ceiling filters (1 anteroom, 1 in positive pressure buffer room, 2 in negative pressure buffer room) Pressure differentials between each pair of SECs and between ante room and general pharmacy area Smoke pattern testing with video recording of airflow between each pair of SECs and between anteroom and general pharmacy area (and any passthroughs) 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 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 twelve (12) 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. 4. Research Equipment Perform annual certification of six (6) Fume Hoods in accordance with the following standards and per manufacturer specifications: ANSI/ASHRAE STANDARD 110-2016 Inventory Equipment Name Model Serial Location CHEMICAL FUME HOOD UNK FUME010 119 FUME HOOD 4' UNK FUME015 A610 BATERIOLOGICAL SAFETY HOOD (FUME HOOD) UNK F UME016 A610 SAFEAIRE 4' CHEM FUME HOOD 54L502 FUME007 143F (ARF) SAFEAIRE 4' CHEM FUME HOOD 54L502 FUME008 143A (ARF) SAFEAIRE 4' CHEM FUME HOOD 54L502 FUME009 143B (ARF) 5. Dental/Prosthetics Equipment Perform annual certification of (2) Fume Hoods in accordance with the following standards and per manufacturer specifications: ANSI/ASHRAE STANDARD 110-2016 Inventory. Equipment Name Model Serial Location FIBERGLASS 30 LABORATORY FUMEHOOD 3030002 12060004 A106 MOTT FUME HOOD 7221000 44069 A316 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 Stratton VAMC 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. Stratton VAMC 113 Holland Ave Albany, NY 12208 17. Period of Performance. Base plus four (4) option years Base: 1 Oct 2021-30 Sep 2022 Opt Yr 1: 1 Oct 2022-30 Sep 2023 Opt Yr 2: 1 Oct 2023-30 Sep 2024 Opt Yr 3: 1 Oct 2024-30 Sep 2025 Opt Yr 4: 1 Oct 2025-30 Sep 2026 Attch: 1A Layout 9A Layout 11A Layout 1A layout 9A Layout 11A Layout
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/ae9d4a20faae48e1a24046e6c36f454b/view)
- Place of Performance
- Address: Department of Veterans Affairs Stratton VA Medical Center 113 Holland Ave, Albany 12208, USA
- Zip Code: 12208
- Country: USA
- Zip Code: 12208
- Record
- SN06092469-F 20210812/210811201715 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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