Inactive

Bio-Safety Cabinets’ Certification, Maintenance and Repair

Inactive

This is a Sources Sought Synopsis; THERE IS NO SOLICITATION AVAILABLE. Requests for solicitation will not receive a response. Under FAR 52.219-14, Limitations on Subcontracting, at least 50% of the co... This is a Sources Sought Synopsis; THERE IS NO SOLICITATION AVAILABLE. Requests for solicitation will not receive a response. Under FAR 52.219-14, Limitations on Subcontracting, at least 50% of the cost of contract performance incurred shall be expended for the prime contractor employees of the concern or other businesses within the same socioeconomic category for service-type procurements. The Great Lakes Acquisition Center (GLAC) in Milwaukee, WI is conducting market research with the intent of determining the interest, capabilities, and qualifications of potential businesses for Bio-Safety Cabinets Maintenance and Repair services at the Edward Hines, Jr. VA Hospital. This Sources Sought Synopsis is published for market research purposes. This market research will be used to determine if a set-aside for any small business program is appropriate. Proposed project anticipates competitive, firm fixed price contract. Please review this announcement, including all attachments, in their entirety. Request that interested offerors complete and return a Capabilities Statement as described below. Capabilities Statement will be used to identify firms who possess both the capability and experience to provide Bio-Safety Cabinets Maintenance and Repair services at the Edward Hines, Jr. VA Hospital. The Government is in no way obligated to do business with or to enter into any form of contract with any person, firm or other entity that receives or responds to this announcement. The contractor shall provide all personnel, equipment, tools, labor, vehicles, materials, supervision, transportation and services necessary to effectively, economically, and satisfactorily perform all operations for Bio-Safety Cabinets Maintenance and Repair services in accordance with the DRAFT Statement of Work included in this posting. In addition to the information requested in the paragraph below, entitled "Capabilities Statement", responding parties must also indicate their size in relation to the applicable North American Industry Classification System (NAICS). The NAICS Code is 621511 Medical Laboratories with a Size Standard of $35 Million in revenue. CAPABILITIES STATEMENT Interested parties shall submit a Capabilities Statement, BRIEF and CONCISE, that clearly demonstrates ability to meet the stated requirements. The Capabilities Statement should present evidence that the interested party feels are relevant. All interested firms responding to this Sources Sought Notice are required to provide a capability statement which needs to include: - Company Name - Point of Contact Name, Phone Number and Email - Business Status (i.e., 8(a), HUBZone, Woman-owned, SDVOSB, Large, etc.) - Dunn & Bradstreet Number - Commercial and Government Entity (CAGE) Code - Indication of Current Systems for Awards Management (SAM) Registration - Capabilities statement (i.e., similar government and commercial contracts for landscaping services, etc.) The period of performance shall be for one (1) Base Year of approximately 12 months and four (4) 12-month option years. Prior Government contract work is not required for submitting a response under this source sought synopsis. Interested Firm's shall respond to this Sources Sought Synopsis no later than 4:00 p.m. local time on May 15, 2020. All interested firms must be registered in System for Award Management (SAM) at the time of award to be eligible for award of Government contracts. Email your response to leikiesha.williams@va.gov . POINT OF CONTACT: Leikiesha Williams, leikiesha.williams@va.gov, fax (414) 844-4890. Submit Capabilities Statements (e-mail preferred) by 4:00 p.m. Local Time on May 15, 2020. Contracting Office Address: Great Lakes Acquisition Center (NCO 12) Attn.: (GLAC) Leikiesha Williams 115 South 84th St, 1st Floor Milwaukee, WI 53214-1476 Places of Performance: Edward Hines, Jr. VA Hospital 5000 South 5th Ave Hines, IL. 60141-5000 Primary Point of Contact: Leikiesha Williams Contracting Officer leikiesha.williams@va.gov Fax: 414-844-4890 STATEMENT OF WORK Biosafety Cabinet and Clean Room Certification Provide all labor, materials, supervision, tools, equipment, inspections, and reports necessary to perform semi-annual certification services for biological safety cabinets, clean-benches, fume hoods, bedding disposal stations, barrier isolators, clean-rooms and equipment testing (see attachment A) that are located at the Edward Hines Jr. VA Hospital, 5000 s. 5th Avenue, Hines, IL. All work must be in accordance with all terms and conditions within this SOW. The contractor shall provide successful certification of biological safety cabinets, clean-benches, fume hoods, barrier isolators, clean-rooms and equipment testing, following all National Sanitation Foundation (NSF) standard Number 49 and CETA Certification Application Guide (CAG) to determine and ensure compliance with requirements for testing and certification. All work shall be performed in accordance with manufacturer s recommendations/specifications, USP 797, and all federal standards when applicable. Equipment and Service Summary (per site visit): Test and Certify an A1, A2, A/B3 Biological Safety Cabinet, quantity = 22 Test and Certify a B2 Biological Safety Cabinet, quantity = 2 (no change) Test and Certify a Laminar Flow Bench or Class 1 Hood, quantity = (7) and 3 bedding disposal stations Test and Certify a Chemical Fume hood or Grossing Table, quantity = 1 (no change) Test and Certify Ductless Chemical Workstation and Powder Hood, quantity = 2 Test and Certify a restricted access barrier system (RABS). CAI or CACI, quantity = 1 (no change) Clean-Room Package. ISO Classification, ACH, Pressure, HEPA Scans, quantity = 5 (no change) In Hood Particle Counts for Pharmacy Hood ISO Classification, quantity = (5 SEC requiring ISO classification, 5 PEC) Video recording of smoke tests for laminar airflow workstations, CAI isolator, and B2 biological safety cabinets located in Pharmacy and Oncology (per CAG 003-2006 recommendations; CAG 002-2006) = 5 Equipment Type and Standards: Certification indicates that the compounding area and primary engineering controls are meeting its design and air quality specifications. It is important to place special emphasis on certifying the ISO Class 5 areas. Pharmacy PECs must be certified using procedures outlined in the current Controlled Environment Testing Association (CETA) certified application guide (CAG) for Sterile Compounding Facilities (CAG-003-2006). CETA establishes industry based minimum set of criteria appropriate for the evaluating performance evaluations and certification of facility and environmental controls for compounding sterile preparations. 1. Work shall be performed in Pharmacy ISO classified areas at minimum every 6 months, in accordance with CETA Certification Application Guide (CAG 003-2006, CAG 002-2006, or equivalents), ISO-14644-1 Clean Rooms and Associated Controlled Environments Part I Classification of Air Cleanliness, ISO-14698-1, Institute for Environmental Sciences recommended practices for contamination control IES-RP-CC-002-86, and all applicable federal standards. Work shall include, but not limited to, the following: Airflow testing: Airflow testing is performed to determine acceptability of the air velocity and volume, the air exchange rate, and the room pressure differential in doorways between adjacent rooms to ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions. The ACPH from HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report. Airflow smoke pattern test is required under CAG-003-2006 to determine buffer and anteroom segregation where applicable around the opening of doors to ensure the proper air flow. These and other applicable tests must be performed and documented on the report of undisturbed airflow, with video documentation preferred. Dynamic airflow smoke pattern test: Smoke pattern tests must be performed with video documentation for each PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation(s). HEPA filter integrity testing: HEPA filters must be tested at every recertification, including but not limited to, post repair of any leak or installation of new HEPA filters to ensure proper functionality. Total particle count testing: Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment. Any other applicable certification test in accordance with industry standards. 2. Work shall be performed on all Biological Safety Cabinets in accordance with National Sanitation Foundation (NSF) standard Number 49 and any applicable CETA (CAG 003-2006) standard, two (2) times per year (every 6 months), per location. Locations are provided in attachment A, Hines BSC and Cleanroom List. 3. Work shall be performed on all Laminar Airflow workbenches (LAFW) in the pharmacy in accordance with the CAG standards (CAG 003-2006), manufacturer s specifications, IEST RP-CC-002.3, IEST-RP-CC-034.3, ISO-14644-1 Clean rooms and Associated Controlled Environments Part 1 Classification of Air Cleanliness, two (2) times per year (every 6 months), location provided in attachment A, Hines BSC and Cleanroom List. 4. Work shall be performed on all Laminar Flow Clean Air Bench/Hood in Laboratory and other departments listed on attachment A, in accordance with manufacturer s specifications, Federal Standard 209D and the Institute for Environmental Sciences recommended Practices for Contamination Control 1ES-RP-CC-002-S6, two (2) times per year, location provided in attachment A, Hines BSC and Cleanroom List. 5. Work shall be performed on Restricted Access Barrier Systems (RABS) in the Pharmacy to test in accordance with CAG standards including CAG 002-2006 CETA compounding Isolator Testing guide, manufacturer specifications, and standard industry practice, two (2) times per year (every 6 months), location provided in attachment A, Hines BSC and Cleanroom List. 6. Work shall be performed on HEPA filtered waste systems listed on attachment A in accordance with manufacturer s specifications, Federal Standard 209B and the Institute for Environmental Sciences Recommended Practices for Contamination Control 1ES-RPCC-002-86, two (2) times per year, location provided in attachment A, Hines BSC and Cleanroom List. 7. Prefilter maintenance: Evaluate and replace as deemed appropriate (once a year recommended based on evaluation). Approval is needed prior to replacement. Additional adjustments, such as air balancing, may be necessary by the certifier to ensure that the secondary engineering controls meet the proper requirements. 8. Re-certification [Contingency] 9. Installation and Repair services for failed equipment or filters. [Contingency] 10. Installation and repair services for HEPA filters. [Contingency] ADDITIONAL SERVICES Environmental Sampling (Pharmacy ISO Classified Areas Only) Environmental viable sampling for any ISO classified area is a part of requisite comprehensive quality assurance program for the facility. These results do not determine certification but will be used by the facility to identify environmental quality trends and potential routes of contamination. For further guidance on sampling, review CETA (CAG-009-00) and USP 797. Perform monthly environmental surface sampling in an aseptic manner minimizing contamination, to include bacterial & fungal samples for each of the ISO classified area(s), as determined by the facility s written environmental monitoring plan (Quality Assurance). All viable environmental sampling results taken must maintain a proper chain of custody to reduce any adverse effects on samples taken, be delivered to a local external lab with no financial affiliation with certifier and must be received within the next business day. Any growth found should, at minimum, be further speciated to genus level. The quantitative results and lab speciation results must be reported to Pharmacy within 10 days of initial test. Any lab report indicating significant quantitative growth and/or growth of a pathogenic microorganisms must be followed up by a phone call and/or email to the Pharmacy POC. Environmental air sampling must be performed at every certification visit during optimal conditions and in an aseptic manner. Routine Maintenance (Research) Inspection and cleaning of paper catch on BSCs. Any visual inspections and/or notes describing any work done on the paper catch should be outlined in the final report. Records and Reports required: 1. Upon successful completion of equipment testing in accordance with standards specific to the type of PEC certified, the certification sticker will be affixed the same day by the service representative to the equipment. The sticker will state the date of certification, name of the individual and contracting company that performed certification, the date of the next needed recertification, as well as the make, model serial number and location of the equipment. 2. If equipment cannot be successfully certified, the service representative will affix signage to the equipment, stating DO NOT USE! THIS EQUIPMENT IS NOT FUNCTIONING WITHIN SPECIFICATION . 3. A computerized written report shall be provided to the Edward Hines Jr. VA Hospital Contracting Officer s Representative (COR), detailing certification, repairs and other work performed, within ten (10) business days of completion of work. The report shall contain information required by applicable standards and the following: A general summary for all units on which work was performed, which includes identification and location of units that passed certification, and units (if any) that did not pass. If any units do not pass certification, the summary should include recommendations for additional necessary repairs or actions. The summary will list units following the order and format used in attachment A, Hines BSC and Cleanroom List. Individual detailed records/reports for each unit on which work was performed. Individual reports will be numbered to coincide with the summary and the order in which the units are listed under attachment A, Hines BSC and Cleanroom List. Separate reports must be generated based on services (Pharmacy, Research, Pathology), and sent out to the appropriate representative. The date of certification for each unit, name of the individual and contracting company that performed certification, the date of the next needed recertification, the type, make, model serial number and location of the equipment. Confirmation on the specific CAG referenced during certification will be required on the report. Measured flow rates for downflow and inflow velocity, HEPA filter leak test assessment, airflow smoke pattern test, low airflow alarm test, sash alarm test, fan speed, average face velocity, exhaust cfm, safe sash opening level, and general condition. Calculations used to obtain requirements described in these specifications (i.e. ACPH). The number of personnel present in the PEC and SEC during particle counts and smoke pattern tests must be documented on the Pharmacy report. Manufacturer s specifications for each unit and test equipment used (including calibration dates). Work performed on each unit, including decontamination, change of filters, other specified repairs, and adjustments made. A record that the service representative has simulated loss of exhaust air to assure proper operation of the buzzer warning device and adjusted if inoperable. Separate electronic file(s) shall be sent via email to pharmacy POC showing video documentation of each smoke pattern tests performed during at rest, followed by dynamic operations within the primary engineering controls and secondary engineering controls. Visual quality of videos must be visible enough to detect patterns and have the capacity to be stored electronically. 4. A list shall be provided to the POC within three (3) working days of completion of work with those hoods that could not be recertified along with the attempts made to adjust them. This information shall be given to the POC in writing on the day the decision is made not to recertify them and the reason why the unit did not pass. 5. The test equipment used for certification must be calibrated at no greater than a 12-month interval. Calibration certificates should be provided for every test instrument used and the specific model and serial number of each test instrument should be documented on the certification report. 6. The certifier must ensure that all the people and equipment he/she is employing are to standards. Certification procedures must be performed by a CETA National Board of Testing (CNBT) registered Cleanroom certified individual/company in accordance with certification procedures defined in CETA CAG-003-2006.Technicians should be accredited by both the CETA National Board of Testing and NSF International. Documentation of credentials must be furnished upon request. 7. Certification reports must be formatted in a manner that is easy to understand, with the ability to determine if the critical facility is in a state of control.