Architects
Bernstein & Associates, Architects - Architecture firm specializing in healthcare and lab design. This architecture firm also has a sub-specialty in pharmacy design, including the design and construction of usp 797 compliant pharmacies, utilizing the usp 797 2008 version guidelines. USP 797 consulting, USP 797 compliance action plans, and USP 797 architectural and engineering plans.
Bernstein & Assoc., Architects, PLLC
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-8200 / Fx : 212-463-9898 / info@bernarch.com
www.bernarch.com
Wednesday, December 24, 2008
Thursday, December 11, 2008
10/14/08: EMLab P&K Provides Lab Services & Supplies for USP 797 Compliance
10/14/08: EMLab P&K Provides Lab Services & Supplies for USP 797 Compliance
PHOENIX, AZ, Oct 14, 2008 - The United States Pharmacopoeia (USP) recently released a new General Chapter <> providing procedures and requirements forcompounding sterile preparations. The standards in USP 797 apply to allpeople and facilities that prepare "compounding sterile preparations"including pharmacies, health care clinics and hospitals. Theserequirements include routine biological monitoring of the compoundingarea, including identification by an appropriately credentialed laboratoryof any microorganisms recovered. EMLab P&K is proud to provide analyticallab services, customer support, and the BioCassette, a sampler with designfeatures advantageous for USP 797 compliance.
EMLab P&K carries AIHA EMLAP accreditation for fungal as well as bacterialanalysis in labs across the United States. Further, it developed theBioCassette -- a patented sampling device that by design avoids highcapital expense and, importantly in the case of USP 797, is less prone tocontamination issues during the sampling process.
Belinda Vega, EMLab P&K's President, said, "EMLab P&K is not a newcomer toUSP 797. We have been providing these lab services for many years,developed the BioCassette with its intrinsic sampling advantages, and arestaying abreast of changes in the USP 797 compliance specifications. Withour highly qualified analysts and experience in providing analysis andsupport for USP 797, we are here to help CSP personnel and facilities whoare working on USP 797 compliance requirements."
EMLab P&K is recognized as one of the leading commercial indoor airquality laboratories in North America, specializing in analyzing air andsurface samples for mold, bacteria, asbestos and allergens. EMLab P&K hasreceived accreditations from AIHA, A2LA, NVLAP and CA-ELAP. For moreinformation, visit the official website at http://www.emlabpk.com or call(866) 888-6653.
CONTACT:
Cole S. Mackelprang
Director of Marketing
(858) 268-2762
WEB SITE: http://www.emlabpk.com
PHOENIX, AZ, Oct 14, 2008 - The United States Pharmacopoeia (USP) recently released a new General Chapter <> providing procedures and requirements forcompounding sterile preparations. The standards in USP 797 apply to allpeople and facilities that prepare "compounding sterile preparations"including pharmacies, health care clinics and hospitals. Theserequirements include routine biological monitoring of the compoundingarea, including identification by an appropriately credentialed laboratoryof any microorganisms recovered. EMLab P&K is proud to provide analyticallab services, customer support, and the BioCassette, a sampler with designfeatures advantageous for USP 797 compliance.
EMLab P&K carries AIHA EMLAP accreditation for fungal as well as bacterialanalysis in labs across the United States. Further, it developed theBioCassette -- a patented sampling device that by design avoids highcapital expense and, importantly in the case of USP 797, is less prone tocontamination issues during the sampling process.
Belinda Vega, EMLab P&K's President, said, "EMLab P&K is not a newcomer toUSP 797. We have been providing these lab services for many years,developed the BioCassette with its intrinsic sampling advantages, and arestaying abreast of changes in the USP 797 compliance specifications. Withour highly qualified analysts and experience in providing analysis andsupport for USP 797, we are here to help CSP personnel and facilities whoare working on USP 797 compliance requirements."
EMLab P&K is recognized as one of the leading commercial indoor airquality laboratories in North America, specializing in analyzing air andsurface samples for mold, bacteria, asbestos and allergens. EMLab P&K hasreceived accreditations from AIHA, A2LA, NVLAP and CA-ELAP. For moreinformation, visit the official website at http://www.emlabpk.com or call(866) 888-6653.
CONTACT:
Cole S. Mackelprang
Director of Marketing
(858) 268-2762
WEB SITE: http://www.emlabpk.com
Architect's New Cancer Center Pharmacy Goes into Construction
Bernstein & Associates, Architects, is pleased to announce that a new usp 797 compliant pharmacy, designed by the firm, is now in the construction phase. The phased pharmacy construction project is located at the Roswell Park Cancer Institute, one of the nation's premier cancer centers.
The pharmacy project is a complete reconstruction of the pharmacy. The renovation had to be phased, to allow continuous, uninterrupted operation of the pharmacy. The project includes all new iso 7 anteroom, iso 7 hazardous compounding room, and iso 7 non-hazardous compounding room. The facility is a state-of-the-art pharmacy, that includes the latest pharmacy automation equipment.
About Roswell Park Cancer Institute:
Roswell Park Cancer Institute (RPCI), is America's first cancer center founded in 1898 by Dr. Roswell Park. RPCI is the only upstate New York facility to hold the National Cancer Center designation of "comprehensive cancer center" and to serve as a member of the prestigious National Comprehensive Cancer Network. Over its long history, Roswell Park Cancer Institute has made fundamental contributions to reducing the cancer burden and has successfully maintained an exemplary leadership role in setting the national standards for cancer care, research and education.
About Bernstein & Associates, Architects:
Bernstein & Associates, Architects has specialized in healthcare and lab design and construction since the firm's founding in 1990. This well-known healthcare design firm has a sub-specialty in usp 797 compliant pharmacy design and construction. The firm's principal --- William N. Bernstein, AIA --- is a well known pharmacy architect who has written extensively on pharmacy design and construction including usp 797 compliant pharmacies. mr. Bernstein's usp 797 articles can be found on the usp 797 website http://www.usp797.org/.
For more information about healthcare and hospital design and construction, contact Bernstein & Associates, Architects at:
Bernstein & Associates, Architects - PLLC
59 West 19th Street - 6A, New York, NY 10011
Tel: 212.463.8200 Fax: 212.463.9898E
mail: info@bernarch.com
www.bernarch.com
The pharmacy project is a complete reconstruction of the pharmacy. The renovation had to be phased, to allow continuous, uninterrupted operation of the pharmacy. The project includes all new iso 7 anteroom, iso 7 hazardous compounding room, and iso 7 non-hazardous compounding room. The facility is a state-of-the-art pharmacy, that includes the latest pharmacy automation equipment.
About Roswell Park Cancer Institute:
Roswell Park Cancer Institute (RPCI), is America's first cancer center founded in 1898 by Dr. Roswell Park. RPCI is the only upstate New York facility to hold the National Cancer Center designation of "comprehensive cancer center" and to serve as a member of the prestigious National Comprehensive Cancer Network. Over its long history, Roswell Park Cancer Institute has made fundamental contributions to reducing the cancer burden and has successfully maintained an exemplary leadership role in setting the national standards for cancer care, research and education.
About Bernstein & Associates, Architects:
Bernstein & Associates, Architects has specialized in healthcare and lab design and construction since the firm's founding in 1990. This well-known healthcare design firm has a sub-specialty in usp 797 compliant pharmacy design and construction. The firm's principal --- William N. Bernstein, AIA --- is a well known pharmacy architect who has written extensively on pharmacy design and construction including usp 797 compliant pharmacies. mr. Bernstein's usp 797 articles can be found on the usp 797 website http://www.usp797.org/.
For more information about healthcare and hospital design and construction, contact Bernstein & Associates, Architects at:
Bernstein & Associates, Architects - PLLC
59 West 19th Street - 6A, New York, NY 10011
Tel: 212.463.8200 Fax: 212.463.9898E
mail: info@bernarch.com
www.bernarch.com
RJLG announces updates on USP 797 services:
RJLG is currently working for multiple clients in assessing the health, safety and environmental ‘fitness’ of construction sites. The work moved forward as a result of USP 797 related assessments of multiple hospital pharmacy sites.
Current examples of work performed for area health care systems include :
- Assessment of approximately 25 pharmacies for USP compliance
- Health and Safety Audit of a major construction project involving a neonatal intensive care unit, emergency department and parking garage
- Environmental, Health and Safety Training for facilities, safety and administrative staff - Environmental Assessment involving a hospital construction project
- We have also recently been contacted about performing Health and Safety audits for two major hospitals in Manhattan.
For more information, contact Dr. Farrell Melnick at fmelnick@rjlg.com.
About RJLG (www.rjlg.com):
RJLG is an organization of experts who provide the highest quality analytical and consulting services to our clients and partners. Our services are based on the highest level of expertise in microscopy, analytical instrumentation and software development.Leading organizations come to RJLG for more than data and information; they come for an innovative approach and technical solutions developed through our commitment to quality, reliability and customer satisfaction.
Contact:
Dr. Farrell Melnick
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
fmelnick@rjlg.com
Current examples of work performed for area health care systems include :
- Assessment of approximately 25 pharmacies for USP compliance
- Health and Safety Audit of a major construction project involving a neonatal intensive care unit, emergency department and parking garage
- Environmental, Health and Safety Training for facilities, safety and administrative staff - Environmental Assessment involving a hospital construction project
- We have also recently been contacted about performing Health and Safety audits for two major hospitals in Manhattan.
For more information, contact Dr. Farrell Melnick at fmelnick@rjlg.com.
About RJLG (www.rjlg.com):
RJLG is an organization of experts who provide the highest quality analytical and consulting services to our clients and partners. Our services are based on the highest level of expertise in microscopy, analytical instrumentation and software development.Leading organizations come to RJLG for more than data and information; they come for an innovative approach and technical solutions developed through our commitment to quality, reliability and customer satisfaction.
Contact:
Dr. Farrell Melnick
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
fmelnick@rjlg.com
Thursday, December 4, 2008
Workshops on USP 797
Workshops: Practical Application of USP's General Chapter <797>
Course Description
USP <797> workshops will provide in-depth analysis of current compounding issues and insight into pharmacy-related content from the USP Pharmacists' Pharmacopeia and the USP–NF. The workshops will focus on the application of USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, and feature USP expert committee members and staff to provide guidance and address questions regarding the intent of the chapter. These workshops will also provide a forum for discussion of the current issues affecting facilities and practitioners. All workshops will be ACPE accredited.
Agenda (49KB)
Who Should Participate
Healthcare practitioners, particulary compounding professionals; regulatory/accrediting bodies; engineers, architects, environmental quality certifiers; and vendors of clean-room products and services
Format
2- Day Workshop
Content to be Covered
Hands on training and/or video training on facility designs, media fill test procedures, types of isolators, and clean rooms Developing a time line to meet the official date Facility's design and placement of primary engineering controls Clean room, buffer area, and ante room Compounding aseptic isolator (CAI) Compounding aseptic containment isolator (CACI) Developing gap analysis) CSP Microbial Contamination (low, medium, and high risk levels and 12 hour beyond use dating) Specialty CSPs Single-dose and multiple dose containers Immediate use Sterilization methods (sterilizing high-risk CSPs) Personnel cleaning and garbing Developing and implementing SOPs Disinfectants and cleaning Environmental quality and control Verification of compounding accuracy and sterility Training employees Please note that the workshops will have sessions providing hands on training relating to some of the key items listed above in addition to an extensive question and answer session with faculty members.
http://www.usp.org/education/pe/courses/genChapter797.html
***************************************************
For more information about usp 797, visit: www.usp797.org
Course Description
USP <797> workshops will provide in-depth analysis of current compounding issues and insight into pharmacy-related content from the USP Pharmacists' Pharmacopeia and the USP–NF. The workshops will focus on the application of USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, and feature USP expert committee members and staff to provide guidance and address questions regarding the intent of the chapter. These workshops will also provide a forum for discussion of the current issues affecting facilities and practitioners. All workshops will be ACPE accredited.
Agenda (49KB)
Who Should Participate
Healthcare practitioners, particulary compounding professionals; regulatory/accrediting bodies; engineers, architects, environmental quality certifiers; and vendors of clean-room products and services
Format
2- Day Workshop
Content to be Covered
Hands on training and/or video training on facility designs, media fill test procedures, types of isolators, and clean rooms Developing a time line to meet the official date Facility's design and placement of primary engineering controls Clean room, buffer area, and ante room Compounding aseptic isolator (CAI) Compounding aseptic containment isolator (CACI) Developing gap analysis) CSP Microbial Contamination (low, medium, and high risk levels and 12 hour beyond use dating) Specialty CSPs Single-dose and multiple dose containers Immediate use Sterilization methods (sterilizing high-risk CSPs) Personnel cleaning and garbing Developing and implementing SOPs Disinfectants and cleaning Environmental quality and control Verification of compounding accuracy and sterility Training employees Please note that the workshops will have sessions providing hands on training relating to some of the key items listed above in addition to an extensive question and answer session with faculty members.
http://www.usp.org/education/pe/courses/genChapter797.html
***************************************************
For more information about usp 797, visit: www.usp797.org
Monday, December 1, 2008
2008 IV Update: USP <797> Final Revision
2008 IV Update: USP <797> Final Revision:
2008 IV Update: USP <797> Final Revision:. Pharmacy Practice Seminar Pre- Conference Course. About the Course: The IV Update Course is designed for IV ...
www.utexas.edu/pharmacy/ce/iv.pdf - Similar pages
http://www.utexas.edu/pharmacy/ce/iv.pdf
2008 IV Update: USP <797> Final Revision:. Pharmacy Practice Seminar Pre- Conference Course. About the Course: The IV Update Course is designed for IV ...
www.utexas.edu/pharmacy/ce/iv.pdf - Similar pages
http://www.utexas.edu/pharmacy/ce/iv.pdf
New USP 797 Construction Compliance Project
Y--USP 797 Pharmacy Compliance, Project Numer 540-05-401 (Construction)
Solicitation Number: VA-244-08-RP-0292
Agency: Department of Veterans AffairsOffice: Clarksburg VAMCLocation: Department of Veterans Affairs Medical Center
Copy or Bookmark this Page
Copy the url below for a direct link to this page.
Bookmark this page by right-clicking here and choosing "Add to Favorites"
Notice Details
Packages
Interested Vendors List
Opportunity History
Complete View
Original Synopsis
Presolicitation
Nov 07, 2008
2:42 pm
Changed
Nov 21, 2008
12:24 pm
Solicitation Number:
VA-244-08-RP-0292
Notice Type:
Presolicitation
Synopsis:
Added: Nov 07, 2008 2:42 pm Solicitation will be released on or about Nov 21, 2008. All labor, materials, equipment and supervision to convert existing space to 797 Pharmacy Compliance Cleanroom Construction at the Louis A Johnson, VAMC 1 Medical Center Dr., Clarksburg, WV. 26301-4199. Work will include the demolition and removal of existing structures and associated electrical, mechanical, structural work as required by drawings and specifications.Project Name: USP 797 Pharmacy ComplianceProject Number: 540-05-401A 100% service disabled Veteran Owned Small Business set-a-side pursuant to 38 USC 8127 (c) and PL 109-461.IAW FAR paragraph 36.204, disclosure of the magnitude of this construction project is between $2,000,000.00 and $5,000.000.00Pending the availability of funds.
Please consult the list of document viewers if you cannot open a file.
VA-CONSTRUCTION-SOLICITATION
Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
VA-CONSTRUCTION-SOLICITATION
Posted Date:
November 21, 2008
https://www.vendorportal.ecms.va.gov/FBODocumentServ...
https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=36082&FileName=VA-244-08-RP-0292-000.DOCTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
Description: VA-244-08-RP-0292 VA-244-08-RP-0292.DOC
https://www.vendorportal.ecms.va.gov/FBODocumentServ...
https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=36083&FileName=VA-244-08-RP-0292-001.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% SPECIFICATIONS.ZIP
https://www.vendorportal.ecms.va.gov/FBODocumentServ...
https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=36084&FileName=VA-244-08-RP-0292-002.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 1 OF 8 G1 AS1-3.ZIP
https://www.vendorportal.ecms.va.gov/FBODocumentServ...
https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=36085&FileName=VA-244-08-RP-0292-003.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 2 OF 8 AS4-6.ZIP
https://www.vendorportal.ecms.va.gov/FBODocumentServ...
https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=36086&FileName=VA-244-08-RP-0292-004.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 3 OF 8 PL1 MH1-3.ZIP
https://www.vendorportal.ecms.va.gov/FBODocumentServ...
https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=36087&FileName=VA-244-08-RP-0292-005.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 4 OF 8 MH4-8.ZIP
https://www.vendorportal.ecms.va.gov/FBODocumentServ...
https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=36088&FileName=VA-244-08-RP-0292-006.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 5 OF 8 MH9.ZIP
https://www.vendorportal.ecms.va.gov/FBODocumentServ...
https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=36089&FileName=VA-244-08-RP-0292-007.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 6 OF 8 MH10-11.ZIP
https://www.vendorportal.ecms.va.gov/FBODocumentServ...
https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=36090&FileName=VA-244-08-RP-0292-008.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 7 OF 8 ES1-3.ZIP
https://www.vendorportal.ecms.va.gov/FBODocumentServ...
https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=36091&FileName=VA-244-08-RP-0292-009.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 8 OF 8 ES4-6.ZIP
Contracting Office Address:
Department of Veterans Affairs;Louis A Johnson, VAMC;Contracting Office (90C);1 Med Center DR;Clarksburg WV 26301-4199
Place of Performance:
Department of Veterans Affairs;Louis A Johnson, VA Medical Center;1 Medical Center Drive;Clarksburg, West Virginia26301-4199USA
Point of Contact(s):
Charles E LoarClarksburg(304) 623-3461Contracting
All Files
VA-CONSTRUCTION-SOLICITATION
Nov 21, 2008
VA-244-08-RP-0292 VA...
VA-244-08-RP-0292 VA-244-08-RP-0292.DOCTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
VA-244-08-RP-0292 P0...
VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% SPECIFICATIONS.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
VA-244-08-RP-0292 P0...
VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 1 OF 8 G1 AS1-3.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
VA-244-08-RP-0292 P0...
VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 2 OF 8 AS4-6.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
VA-244-08-RP-0292 P0...
VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 3 OF 8 PL1 MH1-3.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
VA-244-08-RP-0292 P0...
VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 4 OF 8 MH4-8.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
VA-244-08-RP-0292 P0...
VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 5 OF 8 MH9.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
VA-244-08-RP-0292 P0...
VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 6 OF 8 MH10-11.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
VA-244-08-RP-0292 P0...
VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 7 OF 8 ES1-3.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
VA-244-08-RP-0292 P0...
VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 8 OF 8 ES4-6.ZIPTo copy full link address, right-click and select "Copy Shortcut" or "Copy Link Location."
General Information
Notice Type:
Presolicitation
Original Posted Date:
November 7, 2008
Posted Date:
November 21, 2008
Response Date:
December 22, 2008
Original Response Date:
December 22, 2008
Archiving Policy:
Automatic, on specified date
Original Archive Date:
January 6, 2009
Archive Date:
January 6, 2009
Original Set Aside:
Service-Disabled Veteran-Owned
Set Aside:
Service-Disabled Veteran-Owned
Classification Code:
Y -- Construction of structures and facilities
NAICS Code:
236 -- Construction of Buildings/236220 -- Commercial and Institutional Building Construction
Help Desk
Accessibility
************end rfp **********************************
For more information about usp 797, go to: www.usp797.org
Subscribe to:
Posts (Atom)