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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 16, 2013 FBO #4102
DOCUMENT

H -- Pharmacy Cleanroom Compliance Project - Attachment

Notice Date

2/14/2013
 

Notice Type

Attachment
 

NAICS

541690 — Other Scientific and Technical Consulting Services
 

Contracting Office

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

ZIP Code

70114
 

Solicitation Number

VA25613I0405
 

Archive Date

3/16/2013
 

Point of Contact

Michelle Bocage
 

E-Mail Address

michelle.bocage@va.gov
(michelle.bocage@va.gov)
 

Small Business Set-Aside

N/A
 

Description

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. 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. 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. 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. See Diagram 1 attached: Cleanroom Floor Layout 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), and 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 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. Q. Earned Value Management System 1. An Earned Value Management System (EVMS) is required for major acquisitions for development, in accordance with OMB Circular A-11. The Government may also require an EVMS for other acquisitions, in accordance with agency policy contained in VA Directive 6061. Contractors that are required to have their own EVMS shall follow procedures contained in the VA EVMS Application Guide. 2. The following paragraphs reflect EVMS requirements and may be modified as necessary for selected use. [Choose one of the subparagraph a's below.] a. Integrated Contractor Services. This contract requires that contractors providing direct support services to VA staff will be required to participate in the VA EVMS and submit timesheets. Contractor personnel integrated into VA Staff and providing direct support in the completion of VA project tasks as part of the Government Earned Value Management System must provide assigned task planning, executing, controlling, and closing information to government project management staff. Gathering this information would include having individual contractor resources enter their planned and actual work time against their assigned activities into the government project tracking/timesheet application. The contractor shall be responsible for ensuring all work information is correct. Or- a. Contractor Independent Deliverables. This contract requires the contractor to operate as a distinct entity to produce a deliverable(s). The contractor is required to have its own compliant EVMS, per VA Directive 6061, Table B-1, and provide EVM reports to the VA. (1). Non-Compliant EVMS. If the offeror proposes to use a system that has not been determined to be in compliance with the American National Standards Institute /Electronics Industries Alliance (ANSI/EIA) Standard-748, Earned Value Management Systems, the offeror shall submit a comprehensive plan for compliance with these EVMS standards. Offerors shall not be eliminated from consideration for contract award because they do not have an EVMS that complies with these standards. (2). EVMS Reports. As a minimum, contracting officers shall require contractors to submit EVMS monthly reports for those contracts for which an EVMS applies. (3). Subcontractors. EVMS requirements will be applied to subcontractors using the same rules as applied to the prime contractor. VA will decide the flow down of the EVM requirement to subcontractors. In all cases, the prime contractor is responsible for reporting EVM data. (4). EVMS Plan. When an offeror is required to provide an EVMS plan as part of its proposal, the contracting officer will determine the adequacy of the proposed EVMS plan prior to contract award. (5). Performance Measurement Baseline. Contractors are required to resource load schedules in order to set a performance measurement baseline. Resources do not have to be specifically named. (6). Program Management Reviews. The Contractor shall conduct Program Management Review (PMR) meetings at mutually agreed upon dates and locations. During these reviews, the contractor shall present integrated cost, schedule, and technical performance status. Government Integrated Product Team (IPT) leads or functional managers shall include cost information in discussions of schedule status, technical performance, and risk using earned value as an integrating tool. The following shall be addressed: Cost/schedule trends, significant cost/schedule/technical variances, projected impacts, quantified risk assessments, and corrective action plans. (7). Contractor Earned Value Management. The Cost Performance Report Description (VA-DI-MGMT-81466A), and Integrated Master Schedule Description (VA-DI-MGMT-81650) shall be developed, maintained, updated/statuses and reported on a monthly basis per deliverable requirements, respectively. The contractor shall establish, maintain, and use in the performance of this contract, an integrated management system compliant with the Industry Guidelines for Earned Value Management Systems (EVMS) ANSI/EIA-748 as determined by the Government. An EVMS that has been formally validated and accepted by the cognizant contracting officer is required for all (fixed price, cost, or incentive) contracts, subcontracts, and other agreements valued at or greater than $50 million in then-year dollars. The application of these concepts shall provide for early indicators of contract cost and schedule problems. For contracts valued at or greater than $20 million but less than $50 million then-year dollars, the following statement applies: The contractor is required to have an Earned Value Management System that complies with ANSI/EIA-748; however, the government will not formally validate/accept the contractor's management system (no formal review). The contractor will submit an EVMS description and proof of prior certification with its bid. (8). Integrated Baseline Review (IBR). The contractor shall review its performance measurement baseline plan with the Government within six months of contract award or initiation of an Undefinitized Contract Action, and subsequently, when required, following major changes to the baseline. The Government will verify during the IBR, and follow-on IBRs when required that the contractor has established and maintains a reliable performance measurement baseline. The contractor will ensure that the baseline includes the entire contract technical scope of work consistent with contract schedule requirements, and has adequate resources assigned. The contractor will assure the Government that effective earned value methodologies are used to accurately measure work accomplished and determine contract cost, schedule, and technical performance. The IBR will be used to achieve a mutual understanding of the baseline plan, cost and schedule risk, and the underlying management processes used for planning and controlling the project. (9). Subcontract Cost/Schedule Management and Reporting. Subcontracts exceeding $20M in then-year dollars will apply the requirements of the Integrated Master Schedule Description (VA-DI-MGMT-81650) and the Cost Performance Report Description (VA-DI-MGMT-81466). For contracts valued at or greater than $20 million but less than $50 million, the following statement applies: The contractor is required to have an Earned Value Management System that complies with ANSI/EIA-748; however, the Government will not formally validate/accept the contractor's management system (no formal review). EVMS flow down to contracts of less than $20M in then-year dollars or Firm Fixed Price contracts that exceed 12 months duration is a risk-based decision and will be as mutually agreed between the contractor and the Government. (10). Contract Work Breakdown Structure (CWBS). The contractor shall develop and maintain the CWBS and CWBS dictionary. (11). over Target Baseline (OTB)/Restructure. The contractor may conclude the baseline no longer represents a realistic plan in terms of budget/schedule execution. In the event the contractor determines an OTB/Restructuring action is necessary, the contractor must obtain Government approval prior to implementing an OTB/Restructuring action. The request should also include detailed implementation procedures as well as an implementation timeframe. The contractor will not implement the OTB/Restructuring prior to receiving written approval from the Contracting Officer. (12). Award Fee Criteria. For contracts that include an award fee, the contractor will demonstrate the use of Earned Value Management (EVM) as a tool for cost and schedule control and as a basis for communicating with the Government. The Government will determine the eligibility for of and amount of any award fee granted. In addition to demonstrating the use of EVM award fee criteria for the contractor will include the following: (a). Maintain timely detail planning as far in advance as practical; (b). Ensure the system provides accurate cost/schedule performance status, reliable and timely cost/schedule projections, and quantified risk assessments; (c). Provide clear and comprehensive explanations of performance problems and associated impacts, and establish and carry out effective recovery plans; (d). Control and minimize changes to the baseline particularly in the near term; (e). Ensure all subcontractor-authorized effort is detail planned into measurable objective work packages to the extent possible; (f). Provide program-level Estimate at Completion (EAC) assessments that include consideration of potential risks and cost containment plans; and (g). Demonstrate responsiveness regarding management system and cost/schedule performance questions and issues/concerns raised by the Government. Attachment A Schedule of Deliverables Deliverable No. OneItem A detailed PMP and briefing Quantity Delivery Date Within 5 calendar days after award Twoetc.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/NOrVAMC/VAMCCO80220/VA25613I0405/listing.html)
 

Document(s)

Attachment
 

File Name: VA256-13-I-0405 VA256-13-I-0405.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=619529&FileName=VA256-13-I-0405-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=619529&FileName=VA256-13-I-0405-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: 1601 Perdido;New Orleans, Louisiana

Zip Code: 70112
 

Record

SN02988515-W 20130216/130214234915-45160acf0ffe2b8fceeaa9bf7a2c44ef (fbodaily.com)
 

Source

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

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