Inactive

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," ... 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 in Buffalo, NY for the purpose of collecting information about Pharmacy Hood CETA Certification for the Buffalo 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 small businesses that may be able to provide for this requirement. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the Buffalo VA Medical Center. Please note at least 50 percent of the cost of personnel for contract performance shall be spent for employees of the concern for a proposal to be considered for a small business set-aside. Contractors that are able to meet the requirements in the attachment are encouraged to email a capability statement and full information to Janine Childs at Janine.Childs@va.gov. Please send all inquiries to: Janine.Childs@va.gov by 12:00 pm EST Tuesday, May 6, 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 any Federal Supply Schedules that may carry the desired services. - Contractors shall identify pertinent point of contact for company, contractor DUNS number for size standard and socioeconomic verification in SAM and VIP. - Contractors shall include any relevant comments about the Attachment(s) if applicable. STATEMENT OF WORK PHARMACY HOOD CETA CERTIFICATION BUFFALO VA MEDICAL CENTER This requirement is for U.S. Pharmacopeia (USP) Compliant Pharmacy Certification for the Buffalo trsmws Medical Center (VAMC), 3495 Bailey Ave, Buffalo, NY 14215. Period of performance anticipated to be from May 1, 2021 April 30, 2022 with the provision of four option years. I. Background: This service shall provide USP compliant certification for the Sterile Compounding Pharmacy suite and Laboratory equipment. This shall also include monthly viable sampling in the compounding pharmacy. II. Hours of Work: Normal business hours: 8:00 am 4:30 pm Monday Friday (excluding Federal Holidays). The following are Federal Holidays observed by the facility and the Contractor shall not expect access to the VA Facility of VA employees on these dates unless notified otherwise by the COR. Preventive maintenance or other services are not to be scheduled on these dates: New Year's Day, Martin Luther King, Jr. Day, Washington s Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day. The Contractor shall notify the Contracting Officers Representative (COR) a minimum of five (5) working days prior to visiting the hospital for inspection purposes. This notification is required to ensure that potential hazards of the hoods being inspected will be communicated to the COR prior to beginning inspection. The contractor will be responsible for communicating the potential hazards to the COR. Pharmacy-specific certification scheduling will be approved in advance by Pharmacy Chief. III. Scope of Work (Pharmacy): All pharmacy-specific equipment will obtain Controlled Environment Testing Association (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: Pharmacy Primary Space(s) (B13E4 Anteroom, B13E3 non-HD buffer room, and B13E2 HD buffer room): one (1) biological safety cabinet, three (3) laminar Airflow Workbenches, and six (6) ceiling mount HEPA filters. Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Buffalo 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 course of the contract, a different individual(s) are 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 and monthly per USP 797 standards. Sampling must be performed at the end of compounding activity but before the area has been cleaned & disinfected. IV. 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. Contractor shall replace any damaged HEPA filters with brand new filters. Repairing damaged HEPA filters with patches or other means is UNACCEPTABLE. Personal Protective Equipment (PPE): Contractor will follow BUVAMC 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 sterile isopropyl alcohol (sIPA) 70%. Primary Engineering Controls: Bio-Safety Cabinets (BSCs) and Laminar Flow Workbenches (LAFWs) Non-viable particle count testing (0.5 micron and larger) in Dynamic operating conditions. Dynamic smoke testing (video recorded and provided to us on a DVD) 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 and monthly surface sampling for microorganisms (bacterial & fungal), including counts and ID s. 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. One (1) Biological Safety Cabinet (1 air bacterial, 1 air fungal, 1 surface bacterial, & 1 surface fungal) Baker SterichemGard III Advance Model Number: SG603TX Serial Number: 85252 Three (3) Laminar Flow Benches (1 air bacterial, 1 air fungal, 1 surface bacterial, & 1 surface fungal) Labconco Purifier Horizontal Clean Bench 3818500 Model Number: 3873000 Serial Number: 140187187C Labconco Purifier Horizontal Clean Bench 3818500 Model Number: 3888400 Serial Number: 131083639B Labconco Purifier Horizontal Clean Bench 3818500 Model Number: 3873000 Serial Number: 131285433C Secondary Engineering Controls: B13E4 ISO Class 8 Sterile Preparation Anteroom B13E3 ISO Class 7 Non-Hazardous Compounding Buffer Room B13E2 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 and monthly surface sampling for microorganisms (bacterial & fungal), including counts and ID s. 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. B13E4 ISO Class 8 Sterile Preparation Anteroom (1 air bacterial, 1 air fungal, 1 surface bacterial, & 1 surface fungal) B13E3 ISO Class 7 Non-Hazardous Compounding Buffer Room (1 air bacterial, 1 air fungal, 1 surface bacterial, & 1 surface fungal) B13E2 ISO Class 7 Hazardous Compounding Buffer Room (1 air bacterial, 1 air fungal, 1 surface bacterial, & 1 surface fungal) Measure and document space pressurization in relationship to adjacent room(s). Measure and document average air temperature and relative humidity in each room. Perform semi-annual ceiling HEPA filter leak / challenge testing. Six (6) total ceiling HEPA filters Non-viable particle count testing (0.5 micron and larger) in Dynamic operating conditions. 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). Reporting (Pharmacy Results Only): 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. Designated testing criteria should include room differential pressure, room air change rates, HEPA Filter leak challenge test, non-viable air particulate, room temperature, and relative humidity. V. Laboratory Equipment Certifications: A. Perform annual certification of three (3) Biological Safety Cabinets in accordance with the following standards and per manufacturer specifications: a. NSF / ANSI 49 (Biological Safety Cabinets) b. IEST-RP-CC034.3 (HEPA Filter Leak Testing) VI. Telephone/On-site Support: Telephone support: Contractor shall respond by telephone to any report of a malfunction requiring repair within one hour of notification. Telephone Technical support shall be available 24/7, 365 days per year. On-Site: Contractor shall provide on-site support within 24 Hours of notification unless unforeseen circumstances should prevent so. Equipment diagnostics: Equipment diagnostics and remote equipment support shall be available during hours of work listed above. VII. Parts, Labor and Travel: Parts: Contractor shall maintain replacement repair parts and materials necessary to perform each repair or supply said parts and Materials within 1 day unless unforeseen circumstances should arise. In such a case, the contractor is expected to provide daily situational updates to the medical center and will try to resolve the matter in an expeditious manner. All compensation for parts and materials is included in contract price. Parts and Supplies provided under this contract shall be new OEM parts. Labor: All compensation for labor is included in the contract price. If services become necessary to be performed beyond the contract agreement, VA WNY shall be notified prior to performance. Travel: Contractor shall be responsible for its service-related trip expenses including round trip travel, mileage, and overnight living expenses. VIII. 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. 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. The building engineer, to ensure compatibility with the Medical Center's electrical wiring and equipment, must approve contractor electrical equipment. IX. Reports and Inspection: Contractor shall furnish a written or electronic vendor supplied Field Service Report (FSR). VA shall monitor any sign-in sheets and inspect the quality of contractor s work. Should contractor be required to repeat any work performed, due to non-compliance, the cost shall be on the burden of the vendor.