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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 28, 2013 FBO #4114
SOLICITATION NOTICE

R -- Pharmacy Cleanroom Compliance Project

Notice Date

2/26/2013
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

Contracting Office

Department of Veterans Affairs;Southeast Louisiana Veterans HCS;1555 Poydras Street;New Orleans LA 70114
 

ZIP Code

70114
 

Solicitation Number

VA25613R0457
 

Response Due

3/6/2013
 

Archive Date

4/5/2013
 

Point of Contact

Michelle D. Bocage
 

E-Mail Address

le.bocage@va.gov<br
 

Small Business Set-Aside

Total Small Business
 

Description

This is a combined Synopsis/Solicitation notice for the Department of Veterans Affairs, New Orleans, LA to obtain Pharmacy Cleanroom Compliance Services. This is a 100 percent set-aside for Small Business concerns. The services performed shall be aligned with all applicable Department of Veterans Affairs regulations and policies. The contract start date is anticipated to be two weeks ARO. Payment will be made for services performed via monthly invoices in the arrears. Partial payments are not authorized. The North American Industry Classification System (NAICS) code for this requirement is 541990 and the size standard is $10M. The entire solicitation will be available on the Federal Business Opportunities (FBO) website at http://www.fbo.gov on February 26, 2013. Paper copies will not be issued. Award will be made based on Lowest Price Technically Acceptable. The Contractor's proposal shall include a price section and a technical section based on the Statement of Work requirements. Each CLIN in the pricing proposal must be priced. The Government reserves the right to award without discussions. If the Government decides to award without discussions, the Contractor will be notified as soon as possible. To be eligible for contract award, offerors must be registered in the System for Award Management (SAM) database. Register via the SAM website at https://www.sam.gov and all offerors must submit their representations and certifications at the Online Representations and Certifications Applications (ORCA) website at http://orca.bpn.gov. All responsible Small Businesses must submit a proposal to be considered for this solicitation. Also, the Government will not reimburse any interested parties for monies spent to provide a response to the subsequent solicitation notice. Any questions regarding this notice should be directed to Michelle Bocage, at (504) 412-3700 ext 8010, or via email at michelle.bocage@va.gov STATEMENT OF WORK A.GENERAL INFORMATION 1. Title of Project: Pharmacy Cleanroom Compliance Project The Southeast Louisiana Veterans Healthcare System is seeking potential sources capable of providing third party expert Pharmacy Chemotherapeutic/ Antineoplastic/ IV Prep Areas for compliance. 2. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in the statement of work (SOW), except as may otherwise be specified. A.Cleanroom Engineering/Environmental Controls- Perform an Independent expert assessment of engineering/environmental controls to ensure compliance with: Clean rooms (Safety), Biological safety cabinets (Safety), HEPA/HVAC unit (Facilities), miscellaneous instrumentation (Facilities/Safety). The assessment will comply with the standards in Section 3. See Diagram 1 attached: Cleanroom Floor Layout. Sixteen (16) hours of independent expert assessments is needed. B.Cleanroom training: The cleanroom curriculum will cover topics including but not limited to: proper gowning, cleaning products, wiping procedures, recordkeeping etc. The curriculum will comply with the standards in Section 3. The training will be will have a mandatory face-to-face and hands on component and may or may not include computer based training. The course for each employee will consist of classroom discussion (a conference room will need to be provided), hands on demonstration and a tour of the cleanrooms to discuss practical application of cleanroom procedures by job title. The training is targeted to the following job titles: Pharmacy staff (and supervisors, Infection Control, Industrial Hygienist, Facilities Maintenance staff, and Housekeeping. A signed certificate of completion will be presented to the COR for each employee trained. Three (3) hours of independent expert training per person is needed. (46 Trainees) C.Aseptic Manipulation Competency Testing- An AIHA Accredited Laboratory will provide media fill kits and glove tip sampling for risk level testing. Trained SLVHCS supervisory personnel will have personnel perform aseptic manipulation per USP797 guidelines and ship samples directly to Vendor test lab. The vendor will train supervisory personnel to proctor testing. Vendor will provide shipping containers/labels and prepaid shipping. Vendor will provide analysis via an AIHA Accredited Laboratory. The laboratory report will state positive or negative turbidity findings. Accredited lab USP797, 14-day incubation report. The vendor will provide written interpretation and recommendations based assessments and results. All methodology will comply with the standards in Section 3. Eight (8) Aseptic Manipulation Competency Tests are required. D.Cleanroom engineering/Environmental Testing- Perform air and surface testing to ensure compliance with the standards below. Certification of Environmental Controls- Contractor shall conduct testing and certification of specialized room ventilation systems, fume hoods and biological safety cabinets to provide a safe environment for pharmacy and laboratory personnel in compliance with OSHA laboratory and other regulatory standards. This service includes environmental sampling, HEPA filter leak tests, down flow velocity profile, inflow velocity, visual smoke test, ultraviolet lamp intensity, task lighting intensity, sound levels, and cabinet electrical safety (NOTE: Repair of fume hoods and bio-safety cabinets is not included).Contractor shall provide a certification tag and clear adhesive sleeve for each specialized room ventilation system, fume hoods and biological safety cabinets, written reports with a summary of room HVAC, fume hood and bio-safety cabinet performance and a detailed discussion of any deficiencies encountered. Contractor shall inspect fume hoods and bio-safety cabinets in all areas to ensure conformance to applicable safety standards and effective overall performance. Cleanroom engineering/Environmental Testing (8 rounds @4hrs ea) (tests and sampling 7 air, 7 wipe, 3 BSC, 4 rooms) (32 Tests) E.See Diagram 1 attached: Cleanroom Floor Layout F.Aseptic Manipulation Competency Testing- AIHA Accredited Laboratory will provide media fill kits (40 ea) and glove tip (40 ea) for risk level testing. SLVHCS will have personnel perform aseptic manipulation per USP797 guidelines and ship samples directly to Vendor test lab. G.Air Samples (56 ea) H.Wipe Samples (56 ea) 3. Background: Certification shall be performed in accordance with current NSF/ANSI 49, ANSI/ASHRAE 110, USP 797 and US EPA Performance Requirements for Laboratory Fume Hoods dated February 26, 2009, United States Pharmacopeia 797 (USP 797), American Biological Safety Association (ABSA), American Industrial Hygiene Association (AIHA), American National Standards Institute (ANSI), American Society for Heating, Refrigeration and Air-Conditioning Engineers (ASHRAE), American Society for Testing and Materials (ASTM), Canadian Centre for Occupational Health Safety (CCOHS), Centers for Disease Control and Prevention (CDC), Clinical Laboratory Management, Department of Defense, Safety and Health, Department of Energy (DOE), DOE Nuclear Air Cleaning Handbook (DOE HDBK-1169-2003), The Eagleson Institute, Institute of Environmental Sciences and Technology (IEST), ISPE, Labs for the 21st Century, Joint Commission (JC), National Environmental Balancing Bureau (NEBB), National Library of Medicine (NLM), National Safety Council, National Technical Information Service (NTIS), National Institutes of Health (NIH), National Institute for Occupational Safety and Health (NIOSH), NSF International, Occupational Health and Safety Administration (OSHA), Scientific Equipment &Furniture Association (SEFA), US Food Drug Administration (FDA) and the World Health Organization (WHO). 4. Performance Period: The period of performance for items 2A and 2B is within two (2) weeks of date of award. The period of performance for items 2C and 2D is within four (3) weeks of date of award. Services are to be performed during business hours between 7:30 a.m. and 4:00 p.m. central time. Work at the government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO). 5. Type of Contract: Firm-Fixed-Price. 6. Place of Performance: New Orleans VA Outpatient Clinic 1601 Perdido St. New Orleans, LA 70112 7. Performance Based Contract: This contract requires the application of an Earned Value Management System that is compliant with the American National Standards Institute /Electronics Industries Alliance (ANSI/EIA) Standard-748, Earned Value Management Systems. [See paragraph Q.] B. CONTRACT AWARD MEETING The contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kick off meeting or has advised the contractor that a kick off meeting is waived. C. GENERAL REQUIREMENTS 1. For every task, the contractor shall identify in writing all necessary subtasks (if any), associated costs by task, and together with associated sub milestone dates. The contractor's subtask structure shall be reflected in the technical proposal and detailed project management plan (PMP). 2. All written deliverables will be phrased in layperson language. Statistical and other technical terminology will not be used without providing a glossary of terms. 3. Where a written milestone deliverable is required in draft form, the VHA will complete their review of the draft deliverable within 7 calendar days from date of receipt. The contractor shall have 7 calendar days to deliver the final deliverable from date of receipt of the government's comments. D. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES Description of Tasks and Associated Deliverables: The contractor shall provide the specific deliverables described below within the performance period stated in Section A.4 of this SOW. Task One: Perform an Independent expert assessment of engineering/environmental controls to ensure compliance with : Clean rooms (Safety), Biological safety cabinets (Safety), HEPA/HVAC unit (Facilities), Miscellaneous instrumentation (Facilities/Safety). The assessment will comply with the standards in Section 3. See Diagram 1 attached: Cleanroom Floor Layout Deliverable One: Contractor shall provide written reports with a detailed discussion of any findings or deficiencies encountered. Expert opinion and recommendations must be included in the report. Reports are to be submitted to the Contracting Officer Representative (COR) within five (5) calendar days after inspections are completed. Task Two: Cleanroom training: Perform standard compliant training for the following job titles: Pharmacy staff (and supervisors, Infection Control, Industrial Hygienist, Facilities Maintenance staff, and Housekeeping. Deliverable Two: The cleanroom curriculum will cover topics as: proper gowning, cleaning products, wiping procedures, recordkeeping etc. The curriculum will comply with the standards in Section 3. The training will have a mandatory face-to-face and hands on component and may or may not include computer based training for 46 trainees. The course for each employee will consist of classroom discussion (a conference room will need to be provided) and a tour of the cleanrooms to discuss practical application of cleanroom procedures by job title. Certificates will be issued for each trainee upon successful completion of the each course. Unsuccessful trainees will be allowed to retrain twice within 2 working days with sessions not to exceed normal working hours. Task Three: Aseptic Manipulation Competency Testing- AIHA Accredited Laboratory will provide media fill kits and glove tip for risk level testing. SLVHCS will have personnel perform aseptic manipulation per USP797 guidelines and ship samples directly to Vendor test lab. Deliverable Three: Vendor will provide shipping containers/labels and prepaid shipping. The lab report will state positive or negative turbidity findings. Accredited lab USP797, 14-day incubation report. The assessment will comply with the standards in Section 3. Task Four: Cleanroom Engineering/Environmental Testing- Perform air and surface testing to ensure compliance with the following standards in Section 3. Certification of Environmental Controls- Contractor shall conduct testing and certification of specialized room ventilation systems, fume hoods and biological safety cabinets to provide a safe environment for pharmacy and laboratory personnel in compliance with OSHA laboratory and other regulatory standards. Deliverable Four: This service includes environmental sampling, HEPA filter leak tests, down flow velocity profile, inflow velocity, visual smoke test, ultraviolet lamp intensity, task lighting intensity, sound levels, and cabinet electrical safety (NOTE: Repair of fume hoods and bio-safety cabinets is not included).Contractor shall provide a certification tag and clear adhesive sleeve for each specialized room ventilation system, fume hoods and biological safety cabinets, detailed written reports with a summary of room HVAC, fume hood and bio-safety cabinet performance and a detailed discussion of any deficiencies encountered. Contractor shall inspect fume hoods and bio-safety cabinets in all areas to ensure conformance to applicable safety standards and effective overall performance. See Diagram 1 attached attached: Cleanroom Floor Layout E. EVALUATED OPTIONAL TASKS AND ASSOCIATED DELIVERABLES Not applicable. F. SCHEDULE FOR DELIVERABLES 1. The contractor shall complete the Delivery Date column in Attachment A for each deliverable specified. 2. Unless otherwise specified, the number of draft copies and the number of final copies shall be the same. 3. If for any reason the scheduled time for a deliverable cannot be met, the contractor is required to explain why (include the original deliverable due date) in writing to the CO, including a firm commitment of when the work shall be completed. This notice to the CO shall cite the reasons for the delay, and the impact on the overall project. The CO will then review the facts and issue a response in accordance with applicable regulations. G. CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor. H. REPORTING REQUIREMENTS 1. The contractor shall provide the Task Order Project Manager (TOPM) with daily written progress reports (original plus 1 copies). These are due to the TOPM by the second workday following the end of each calendar month throughout the project's duration. 2. The progress report will cover all work completed during the preceding month and will present the work to be accomplished during the subsequent month. This report will also identify any problems that arose and a statement explaining how the problem was resolved. This report will also identify any problems that have arisen but have not been completely resolved with an explanation. I. TRAVEL Travel will be furnished by the contractor to VA site locations listed in A6 above. Travel and per diem shall be reimbursed in accordance with VA/Federal Travel Regulations. Travel must be priced separately in the price schedule. J. GOVERNMENT RESPONSIBILITIES Not applicable. K. CONTRACTOR EXPERIENCE REQUIREMENTS - KEY PERSONNEL The project manager will provide oversight and evaluate all work performed under this contract. The project manager must perform at an expert level which requires specific expertise in analytical chemistry, analytical biochemistry, measurement science, food and dietary supplement science, or other applied sciences. The expert will have advanced degrees (doctoral degrees or the equivalent based on extensive experience), and are actively working in related scientific and/or regulatory disciplines. The expert will possess licensure, certifications, knowledge, skill and abilities to comply with the standards in Section 3. Support staff may consist of skilled experienced professional and/or technical personnel. These may be essential for successful contractor accomplishment of the work to be performed under this contract and subsequent task orders and option. Expert and support staff is defined as key personnel and are those persons whose resumes were submitted. The support staff will possess licensure, certifications, knowledge, skill and abilities to comply with the standards in Section 3. The contractor agrees that the key personnel shall not be removed, diverted, or replaced from work without approval of the CO and TOPM. Any personnel the contractor offers as substitutes shall have the ability and qualifications equal to or better than the key personnel who are being replaced. Requests to substitute personnel shall be approved by the TOPM and the CO. All requests for approval of substitutions in personnel shall be submitted to the TOPM and the CO within 30 calendar days prior to making any change in key personnel. The request shall be written and provide a detailed explanation of the circumstances necessitating the proposed substitution. The contractor shall submit a complete resume for the proposed substitute, any changes to the rate specified in the order (as applicable) and any other information requested by the CO needed to approve or disapprove the proposed substitution. The CO will evaluate such requests and promptly notify the contractor of approval or disapproval thereof in writing. P. SECURITY 1. Background investigations are not required. P. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: 1. The preliminary and final deliverables and all associated working papers, application source code, and other material deemed relevant by the VA which have been generated by the contractor in the performance of this task order are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. 2.The CO will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order presented to the contractor shall be submitted to the CO for response. 3. Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/NOrVAMC/VAMCCO80220/VA25613R0457/listing.html)
 

Place of Performance

Address: Southeast Louisiana Veterans Healthcare System;New Orleans, LA

Zip Code: 70112
 

Record

SN02995930-W 20130228/130226234157-4553c4b44659b86602ba6ac356b1bdbd (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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