Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 05, 2015 FBO #4849
DOCUMENT

H -- Pharmacy IV Prep Area Microbiological Monitoring - Attachment

Notice Date

3/3/2015
 

Notice Type

Attachment
 

NAICS

541380 — Testing Laboratories
 

Contracting Office

Contracting Office (90C);Department of Veterans Affairs;Ralph H. Johnson VA Medical Center;325 Folly Road, STE 300;Charleston SC 29412
 

ZIP Code

29412
 

Solicitation Number

VA24715N0385
 

Response Due

3/13/2015
 

Archive Date

6/20/2015
 

Point of Contact

Janica Francis-Hunter
 

E-Mail Address

ment
 

Small Business Set-Aside

N/A
 

Description

Sources Sought Notice: Pharmacy IV Prep Area Microbiological Monitoring for USP 797 Compliance DESCRIPTION: This is a sources sought to determine the availability of potential sources having the skills and capabilities necessary to provide the SPECIFIED REQUIREMENT. All interested vendors are invited to provide information to contribute to this market survey/sources sought including commercial market information. THIS IS NOT A SOLICITATION ANNOUNCEMENT. This is a sources sought synopsis only. Questions should be submitted by email to Janica.Francis@va.gov. Provide only the requested information below. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classifications (Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), Hub zone, 8(a), small, small disadvantaged, woman owned small business, FSS/GSA contract schedule holders or large business) relative to NAICS 541380, Testing Laboratories (size standard $14 Million). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought synopsis, a solicitation announcement may be published on the FBO website. Responses to this sources sought synopsis are not considered adequate responses to the solicitation announcement. All interested offerors will have to respond to the solicitation announcement in addition to responding to this sources sought announcement. SPECIFIED REQUIREMENT: Network Contracting Office 7, Charleston, SC is seeking sources for a potential contractor to perform the following type of service: 1. Background: The Ralph H. Johnson Veterans Affairs Medical Center (RHJ VAMC) has a pharmacy on the first floor which includes three ISO class five cabinets: two horizontal laminar flow hoods in the main clean room and one vertical laminar flow hood in chemotherapy clean room. Microbiological sampling of clean rooms and anterooms (ISO Class 8) is required by United States Pharmacopeia, chapter 797 (USP 797) and VA information letter 10-2006-008. The sampling strategy recommended by USP 797 for recertification is to sample for fungi and bacteria using an impactor and agar plates in the anteroom, near both the main clean room and chemotherapy clean room doorways, inside the clean room twelve inches from the bio-safety cabinets/hoods. USP 797 recommends air sampling of clean rooms and anterooms semi-annually for medium risk compounding sterile preparation areas. USP 797 also recommends surface sampling and air sampling for fungi and bacteria inside ISO Class 5 bio-safety cabinets/hoods. According to USP 797, fungi and bacteria are not expected to be present in ISO Class 5 areas. The areas specified for testing are designated medium risk compounding sterile preparation areas. Baseline sampling has already been conducted for these areas. This information will be provided to the contractor as required. 2. Scope: The contractor shall perform sample air sampling quarterly for fungi and bacteria using high volume sampling pumps capable of achieving and maintaining the required flow rate of 28 liters per minute and impaction samplers to conduct the sampling. A sufficient volume of air (400 to 1000 liters) shall be tested at each location in order to maximize sensitivity. The manufacturer's guidelines for use of the electronic air sampling equipment should be followed. The contractor shall perform surface and glove tip samples for bacteria using Tryptic Soy Agar (TSA) contact plates and Malt Extract Agar (MEA) contact plates for sampling of fungi. 3. Task: An appropriate environmental sampling plan shall be developed by the contractor for airborne and surface sampling viable particles. Sampling shall be performed at locations that are prone to contamination during compounding activities and during other activities such as staging, labeling, gowning and cleaning. The contractor shall perform the following samples: a.Bacteria air sample analysis b.Fungi air sample analysis c.Bacteria and Fungi surface sample analysis d.Fungi glove dip sample analysis e.Bacteria glove dip sample analysis f.Prepare and submit laboratory test Sample Locations: 3.1. Performance: Perform all microbiological sampling for the RHJ VAMC pharmacy clean room in compliance with USP 35, Chapter USP-NF General Chapter 797, Pharmaceutical Compounding-Sterile Preparations standard and VA information letter 10-2006-008. a.All samples shall be analyzed by a laboratory accredited by AIHA in Environmental Microbiology. Sampling results will be compared to recommendation provided in the USP 797 guidance document. b. Each sampling session will be conducted during normal business hours, Monday thru Friday 8 AM thru 4:30 PM. Each session will be scheduled at least 5 working days in advance and is subject to the workload of the pharmacy and should be coordinated by the Associate Chief, Inpatient Pharmacy. Each session will be scheduled with Christina A. Delp, Industrial Hygienist, who will serve as the contracting officer's representative (COR). c.Any laboratory results equal to or greater than the action level will require notification of the COR immediately upon receipt of results. Laboratory results of these levels or above will require resampling to be performed after action deemed appropriate by the Associate Chief of Inpatient Pharmacy has been taken to correct the microbiological growth. Resampling for the areas at or above the action levels will be performed within five business days of notification by the COR. 4. Reports: A written report will be issued for each sampling session and an electronic copy via e-mail provided to COR, within 10 days of the receipt of laboratory results. Each session's report will include at a minimum the date, time and name of the Industrial Hygienist, narrative of work practices used, results of sampling, location where samples were collected, narrative interpretation of laboratory results, a comparison chart or table showing results of all quarterly sampling by date and sample location, laboratory results and a closed chain of custody. 5. Personnel Qualifications: This sampling shall be performed by an Industrial Hygienist certified by the American Board of Industrial Hygiene (ABIH). 6. Contractor Qualification: The contractor shall have at least 8 year of successful experience in conducting USP 797 pharmacy cleanroom sterile environment sampling and knowledgeable in VHA healthcare setting. Due to the timeliness of sampling and possible resampling, the contractor should be located within 300 miles radius of the RHJ VAMC. Experience shall be verified by having at least two pharmacy clean room references forwarded directly to the contracting officer. 7. Equipment: Contractor shall utilizing appropriate air sampling pumps that are capable of achieving and maintaining the required flow rate of 28.3 liters per minute (LPM), Anderson N-6 impactor or equivalent, Tryptic Soy Agar (TSA) and Malt Extract Agar (MEA) plates, and appropriate sterile sampling swabs or equivalent. 8. Place of Performance: Ralph H. Johnson VA Medical Center Charleston, 109 Bee Street, Charleston, SC 29401. Pharmacy IV Prep Area. 9. Period of Performance: Base Year plus 4-One Year Options. 10. Contract Performance Monitoring: The government reserves the right to monitor services in accordance with Performance Based Matrix. 11. Mandatory Electronic Invoicing: Vendors can comply with the VA mandatory electronic invoicing rule by using either of the two methods below: 1. The Financial Service Center uses a third-party contractor, OB10, to transition vendors from paper to electronic invoice submission. For information on OB10 electronic invoicing set-up, vendors should call 877-752-0900, or email USClientServices@ob10.com. 2. A system that conforms to the X12 electronic data interchange (EDI) format established by the Accredited Standards Center. For FSC e-invoicing information, please call 877-353-9791 or email vafsccshd@va.gov. Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor, validated by the Contracting Officer's Representative (COR), and submitted to VA FSC, P. O. BOX 149971, AUSTIN, TX 78714. A properly prepared invoice will contain: oInvoice Number and Date oContractor's Name and Address oAccurate Purchase Order Number oSupply or Service provided oTotal amount due 12. Records Management Language for Contracts The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract: a.Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. b.Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. c.Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. d.Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. e.Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. f.The Government Agency owns the rights to all data/records produced as part of this contract. g.The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. h.Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. i.No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. j.Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. REQUESTED INFORMATION: (1) STATEMENT OF CABABILITY: Submit a brief description, five (5) pages or less, that demonstrates how your company has the supervision, facilities, labor and experience to perform Water Sampling and Analysis for CFU according to ANSI/AAMI/ISO 23500:2011described above. Include past experience in performing these services to the VA, other Government (Federal or State) agency, or for a private facility. Please specify your availability to start date and your address. (2) BUSINESS SIZE AND SOCIO-ECONOMIC STATUS: (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Hub-zone firm (e) Indicate if your firm is a woman-owned or operated business (f) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) (g) Include the DUNS number of your firm. (h) State whether your firm is registered with the System for Award Management (SAM) at https://www.sam.gov/portal/public/SAM/ and/or the VetBiz Registry at http://vip.vetbiz.gov/. If not, please (i) NOTE that any future solicitation could only be awarded to a contractor who is registered in SAM and to receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry. Responses must be emailed to Janica.Francis@va.gov no later than 1:00 pm EST, Friday, March 13, 2015. Your response should include both the STATEMENT OF CABABILITY and BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained above. Please place "Attention: Pharmacy IV Prep Area Microbiological Monitoring for USP 797 Compliance" in the subject line of your email. This notice is to assist the VA in determining sources only. A SOLICITATION IS NOT CURRENTLY AVAILABLE. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/ChaVAMC/VAMCCO80220/VA24715N0385/listing.html)
 

Document(s)

Attachment
 

File Name: VA247-15-N-0385 VA247-15-N-0385.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1895224&FileName=VA247-15-N-0385-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1895224&FileName=VA247-15-N-0385-000.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: Ralph H Johnson VAMC;Department of Veterans Affairs;109 Bee Street;Charleston, SC

Zip Code: 29401
 

Record

SN03657248-W 20150305/150303234941-937ca6c3cf7c290cb41f3a9d179cb003 (fbodaily.com)
 

Source

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

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