As the economy slows, and construction budgets and schedules are cut, clients may wish to consider Just-in-Time Hospital Project Management.
Unlike conventional Hospital Project Management services --- which start at the beginning of the project and conclude at the close-out ---
Just-in-Time Hospital Project Management is essentially an a la carte program for introducing hospital project management services at what are often crisis points in the life of a construction project.
The most common target of Just-in-Time Hospital Project Management is a project that is in trouble, as an example: a project that is over-budget, missing critical project deadlines and/or where construction team dynamics have deteriorated and need to be reconstituted to allow the team to function more effectively.
The most common insertion points for Just-in-Time Hospital Project Management are as follows:
- site selection
- programming
- design
- construction bid and award
- construction phase
- post construction
The most common Just-in-Time Hospital Project Management services fall into one or more of these areas:
- Cost: Cost Reduction, Cost Control, and Cost Monitoring
- Schedule: Schedule Reduction, Schedule Control, Schedule Monitoring
- Approvals: Expediting approval at the Planning Department, Building Department, Fire Department and/or State Health Department
- Close Out: Punchlist, Close Out Procedures and Documents, Commissioning, Financial Reconciliation/Resolution
For more information about Just-in-Time Hospital Project Management, please contact hospital project management consultants and hospital owner's representatives, Empire Projects, Inc.:
William N. Bernstein, PMI, AIA -
President
Empire Projects, Inc.
(Hospital Project Management Consultants and Owner's Representatives)59 West 19th Street -
New York, NY 10011
Phone: 212-463-0800
Fax: 212-463-9898
Email: info@empireprojects.com
www.empireprojects.com
Tuesday, December 30, 2008
Monday, December 29, 2008
New Program to Reduce Hospital Construction Costs in 2009
For Immediate Release
With a greater need than ever to cut hospital costs, more and more hospital clients have asked well-known hospital project management firm, Empire Projects, Inc, a simple question: "How Can We Reduce Construction Costs in 2009?"
In response, the firm has developed a concise Construction Cost Reduction Program for clients looking to reduce their hospital capital costs for construction in 2009.
The cost control program is set up to value engineer projects in detail, at (5) critical project stages: programming, schematic design, construction documents, construction bidding, and construction.
The program can be utilized for all (5) critical project phases, or can be employed at just one or more of the phases.
Potential hospital construction cost savings are usually a minimum of 5% of construction cost, and can exceed 20% in certain cases.
The construction cost savings generated through this program greatly exceed the fees charged by EPI to implement it. In addition, the value engineering process creates leaner and better projects.
For more information on how this program can help control and reduce your hospital construction costs in 2009, please contact:
William N. Bernstein, AIA -
President
Empire Projects, Inc.
(Hospital Project Management and Owner's Representative Services for Design and Construction Projects)59 West 19th Street -
New York, NY 10011
Phone: 212-463-0800 I
Fax: 212-463-9898 I
Email: info@empireprojects.com
www.empireprojects.com
With a greater need than ever to cut hospital costs, more and more hospital clients have asked well-known hospital project management firm, Empire Projects, Inc, a simple question: "How Can We Reduce Construction Costs in 2009?"
In response, the firm has developed a concise Construction Cost Reduction Program for clients looking to reduce their hospital capital costs for construction in 2009.
The cost control program is set up to value engineer projects in detail, at (5) critical project stages: programming, schematic design, construction documents, construction bidding, and construction.
The program can be utilized for all (5) critical project phases, or can be employed at just one or more of the phases.
Potential hospital construction cost savings are usually a minimum of 5% of construction cost, and can exceed 20% in certain cases.
The construction cost savings generated through this program greatly exceed the fees charged by EPI to implement it. In addition, the value engineering process creates leaner and better projects.
For more information on how this program can help control and reduce your hospital construction costs in 2009, please contact:
William N. Bernstein, AIA -
President
Empire Projects, Inc.
(Hospital Project Management and Owner's Representative Services for Design and Construction Projects)59 West 19th Street -
New York, NY 10011
Phone: 212-463-0800 I
Fax: 212-463-9898 I
Email: info@empireprojects.com
www.empireprojects.com
Saturday, December 27, 2008
Negative Pressure Rooms Required in Low Volume Hazardous Compounding Rooms
* RJLG Question 8: We are a small home infusion pharmacy. Approximately 2% of our patient base receives chemotherapy medications (primarily 5FU). Do we need a negative pressure room if: we compound/mix in a BSC, maintain a “safety zone” around the BSC within the clean room and utilize the PhaSeal product line when compounding?
* RJLG Answer 8: The Hazardous Drugs as CSPs section of USP797 allows low volume hazardous drug compounding in a non-negative pressure buffer or clean room if two tiers of containment are used, e.g., using a closed-system transfer device (CSTD) within a biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI). This is not an exemption from training and personal protective equipment (PPE) requirements, or recommended environmental sampling.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
***************
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:
Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com
*********************
For more information about USP 797, visit the USP 797 website: www.usp797.org.
* RJLG Answer 8: The Hazardous Drugs as CSPs section of USP797 allows low volume hazardous drug compounding in a non-negative pressure buffer or clean room if two tiers of containment are used, e.g., using a closed-system transfer device (CSTD) within a biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI). This is not an exemption from training and personal protective equipment (PPE) requirements, or recommended environmental sampling.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
***************
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:
Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com
*********************
For more information about USP 797, visit the USP 797 website: www.usp797.org.
Surface Sampling Inside a CACI
Questions and Answers on USP 797
* RJLG Question 7: If a CACI is used as the PEC (The gloves used are part of the equipment) is gloved fingertip sampling required? Is surface sampling required inside a CACI? If so how frequently?
* RJLG Answer 7:
All compounding personnel must undergo performance evaluations including gloved fingertip sampling. Your site-specific standard operating procedures should be modified for CACI use. Periodic surface sampling is required in all ISO-classified environments including a CACI.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
*
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:
Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com
*********************
For more information about USP 797, visit the USP 797 website: www.usp797.org.
* RJLG Question 7: If a CACI is used as the PEC (The gloves used are part of the equipment) is gloved fingertip sampling required? Is surface sampling required inside a CACI? If so how frequently?
* RJLG Answer 7:
All compounding personnel must undergo performance evaluations including gloved fingertip sampling. Your site-specific standard operating procedures should be modified for CACI use. Periodic surface sampling is required in all ISO-classified environments including a CACI.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
*
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:
Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com
*********************
For more information about USP 797, visit the USP 797 website: www.usp797.org.
Hospital Safety Website
I wanted to post about a new hospital safety website that is a good resource for anyone working in, staying in, or working for a hospital. The address of the site is www.hospitalsafety.com.
Construction safety is an important topic for all involved in the design and construction industry, whether you are an architect, designer, engineer, contractor, sub-contractor, manufacturer, equipment supplier, facility manager or owner. Construction accidents can be reduced through knowledge, preparation, and execution of safe construction practices on every job site.
This website about construction safety offers every member of the design and construction team the opportunity to learn more about construction safety. Help to make your construction site safer starting today. Safe construction sites and safe construction practices help to prevent accidents. As a further benefit, a focus on construction safety contributes to a more professional work environment, leading to better quality work with fewer delays.
What you will find on www.constructionsafety.org: Construction Safety News, Products and Services Focused on Construction Safety, Services Focused on Construction Safety, Construction Safety Training and Books and Articles Written About Construction Safety.
Construction safety is an important topic for all involved in the design and construction industry, whether you are an architect, designer, engineer, contractor, sub-contractor, manufacturer, equipment supplier, facility manager or owner. Construction accidents can be reduced through knowledge, preparation, and execution of safe construction practices on every job site.
This website about construction safety offers every member of the design and construction team the opportunity to learn more about construction safety. Help to make your construction site safer starting today. Safe construction sites and safe construction practices help to prevent accidents. As a further benefit, a focus on construction safety contributes to a more professional work environment, leading to better quality work with fewer delays.
What you will find on www.constructionsafety.org: Construction Safety News, Products and Services Focused on Construction Safety, Services Focused on Construction Safety, Construction Safety Training and Books and Articles Written About Construction Safety.
Wednesday, December 24, 2008
Healthcare Design and Construction Resources
Healthcare Design and Construction Resources:
Hospital Safety - This is the world's most comprehensive Hospital Safety resource. What you will find on HospitalSafety.com: Hospital Safety regulations, Hospital Safety Vendors, Hospital Safety Products, Hospital Safety Articles, Hospital Safety Software, and How Safe is Your Hospital.
hospitalsafety.com 59 West 19th Street - 6A, New York, NY 10011Ph : 212-463-0800 / Fx : 212-463-9898 / info@hospitalsafety.org HospitalSafety.org
Safest Hospital - SafestHospital.org is a privately-owned resource developed to help increase safety in the design, construction and operation of hospitals. It was founded to provide information and resources related to the The Safest Hospital Alliance, which was formed to combat the growing epidemic of medical errors in hospitals by developing the first comprehensive approach to patient safety. What you will find on SafestHospital.org : Safest Hospital regulations - Safest Hospital Vendors - Safest Hospital Products - Safest Hospital Articles - Safest Hospital software.Safest Hospital 59 West 19th Street - 6A, New York, NY 10011Ph : 212-463-0800 / Fx : 212-463-9898 / info@safesthospital.orghttp://www.safesthospital.org/
rx3d.com - Rx3D is a comprehensive directory for all products and services needed to design build and equip healthcare and laboratory facilities. What you will find on Rx3D: Healthcare and lab regulations – Healthcare and lab vendors – Healthcare and lab products – Healthcare and lab articles. rx3d.com 59 West 19th Street - 6A, New York, NY 10011Ph : 212-463-0800 / Fx : 212-463-9898 / info@rx3d.com http://www.rx3d.com/
Hospital Safety - This is the world's most comprehensive Hospital Safety resource. What you will find on HospitalSafety.com: Hospital Safety regulations, Hospital Safety Vendors, Hospital Safety Products, Hospital Safety Articles, Hospital Safety Software, and How Safe is Your Hospital.
hospitalsafety.com 59 West 19th Street - 6A, New York, NY 10011Ph : 212-463-0800 / Fx : 212-463-9898 / info@hospitalsafety.org HospitalSafety.org
Safest Hospital - SafestHospital.org is a privately-owned resource developed to help increase safety in the design, construction and operation of hospitals. It was founded to provide information and resources related to the The Safest Hospital Alliance, which was formed to combat the growing epidemic of medical errors in hospitals by developing the first comprehensive approach to patient safety. What you will find on SafestHospital.org : Safest Hospital regulations - Safest Hospital Vendors - Safest Hospital Products - Safest Hospital Articles - Safest Hospital software.Safest Hospital 59 West 19th Street - 6A, New York, NY 10011Ph : 212-463-0800 / Fx : 212-463-9898 / info@safesthospital.orghttp://www.safesthospital.org/
rx3d.com - Rx3D is a comprehensive directory for all products and services needed to design build and equip healthcare and laboratory facilities. What you will find on Rx3D: Healthcare and lab regulations – Healthcare and lab vendors – Healthcare and lab products – Healthcare and lab articles. rx3d.com 59 West 19th Street - 6A, New York, NY 10011Ph : 212-463-0800 / Fx : 212-463-9898 / info@rx3d.com http://www.rx3d.com/
Gap Analysis Companies
Gap Analysis
Environmental Microbiology Laboratory, Inc. - We specialize in the analysis of air and surface samples for fungi, mold, bacteria, and allergens.
Environmental Microbiology Laboratory, Inc.1150 Bayhill Dr, #100, San Bruno, CA 94066 Ph : (866) 888-6653.http://www.emlab.com/
MicroTest Laboratories - MicroTest Laboratories provides complimentary Gap-Analysis compliance audits, certification and routine Environmental Microbiology monitoring [including viable/nonviable air and surface testing] of hoods and clean-rooms, on-site personnel training to USP<797>compliance [contamination control/aseptic technique], development of client-specific USP related SOP documentation and Low/Medium/High risk media-fill test programs. In addition, we offer end-product testing for sterility, endotoxin, purity and other analytical testing. MicroTest Laboratories is an FDA and DEA registered contract testing and manufacturing facility. MicroTest Laboratories, Inc.104 Gold Street, Agawam, MA 01001Ph : 413-786-1680 / Fx : 413-789-4334 / e-mail Info@microtestlabs.com http://www.microtestlabs.com/
Environmental Microbiology Laboratory, Inc. - We specialize in the analysis of air and surface samples for fungi, mold, bacteria, and allergens.
Environmental Microbiology Laboratory, Inc.1150 Bayhill Dr, #100, San Bruno, CA 94066 Ph : (866) 888-6653.http://www.emlab.com/
MicroTest Laboratories - MicroTest Laboratories provides complimentary Gap-Analysis compliance audits, certification and routine Environmental Microbiology monitoring [including viable/nonviable air and surface testing] of hoods and clean-rooms, on-site personnel training to USP<797>compliance [contamination control/aseptic technique], development of client-specific USP related SOP documentation and Low/Medium/High risk media-fill test programs. In addition, we offer end-product testing for sterility, endotoxin, purity and other analytical testing. MicroTest Laboratories is an FDA and DEA registered contract testing and manufacturing facility. MicroTest Laboratories, Inc.104 Gold Street, Agawam, MA 01001Ph : 413-786-1680 / Fx : 413-789-4334 / e-mail Info@microtestlabs.com http://www.microtestlabs.com/
Compliance Action Plans
Compliance Action Plans
Bernstein & Associates, Architects - Architecture firm Specializing in Healthcare and lab design with a subspecialty in USP 797 consulting, USP 797 compliance action plans, and USP 797 architectural and engineering plans.
Bernstein & Assoc., Architects, PLLC59 West 19th Street - 6A, New York, NY 10011Ph : 212-463-8200 / Fx : 212-463-9898 / info@bernarch.comwww.bernarch.com
Clinical IQ, LLC - Clinical IQ, LLC aims to serve as the trusted source for pharmacy information services and product solutions for all our customers who range from local start-up operations to established national companies in the hospital, home care, and specialty compounding industries. With this aim, Clinical IQ creates software, classroom training, web based training, audit tools, and many other informational products to make sterile compounding and related areas of pharmacy safer. Our mission is about improving patient safety through better standards-setting in sterile compounding and other practice areas is not our only goal, though it is the highest goal. Another goal is to improve the professional life ofpharmacists and technicians as we carry out our craft with the comforting knowledge of reduced probability of causing harm. You see, Clinical IQ and our partners are practitioners. We have real on-the-floor experience. We are aware of how the rigors and pressures of daily work and work habits impact quality beyond textbook formulas. Clinical IQ and our partners are on a mission to change pharmacy for the better and our work is never done. We hope you will join us.Clinical IQ, LLC184 Columbia Turnpike, #282, Florham Park, NJ 07932Ph : 973-765-9393 / Fx : 866-538-4783 / moreinfo@clinicaliq.com /www.clinicaliq.com
Global Quality Alliance, LLC - GQA is able to provide Compounding Pharmacies with services such as Gap Assessment of current facilities, procedures and systems with respect to <797> and all other USP requirements, create or update procedures required for compliance to <797>, assess the USP Risk Levels for current products, and provide on-site training for staff members on aseptic technique, environmental monitoring and other USP <797> requirements. Whether you are looking to become PCAB accredited, or simply desire to improve quality and compliance to offer greater assurance of patient safety, GQAs extensive experience in the pharmaceutical industry has provided an excellent evolution into the sterile compounding industry where we continue to provide expert service and advice.
Global Quality Alliance, LLC 300 Center Drive, Suite G, #310, Superior, Colorado 80027 In Colorado Ph: 303-459-2382 / Outside Colorado Ph : 866-216-2815 / Fx : Fax: 303-459-2382 / info@gqaconsulting.com www.gqaconsulting.com
Lasco Services - We’ll evaluate your space to design a new clean environment or renovate your existing compounding area. All work is done quickly, with minimal disturbance, with less expense than you might think and USP <797> compliant...guaranteed. Learn how Lasco Services can make it easy for you to be USP <797> compliant.
Lasco Services 601 Compton Irving, TX. 75061 Ph : 800-815-2726 / Fx : 972-513-1877 / info@lascoservices.com www.lascoservices.com
Quality Solutions, LLC - is a turn-key solutions provider offering USP 797 compliance in a cost-effective manner. Drawing from its compliance, validation and technical services background in the highly regulated Biotech/Pharma industry, Quality Solutions, LLC can assist your pharmacy in performing a GAP analysis, assess risk levels, create the supporting Quality Assurance plans, and execute all required testing. Furthermore, all HEPA and Laminar Flow Certifications are conducted using NSF certified engineers. Quality Solutions, LLCBaltimore, MD 21286Phone : 443-416-6102 / Fx: 410-823-5226 / Usp797@qualsolve.net www.qualsolve.net
RJ Lee Group, Inc. offers a wide variety of USP 797 compliance and consulting services with the understanding that each institution may face unique challenges when working toward compliance. Our scientific and technical staff coupled with consulting pharmacists offers years of experience with USP 797 related projects to help you formulate a compliance action plan that will fit your individual needs and budget.
RJ Lee Group, Inc.350 Fifth Avenue, Suite 5820 New York, New York 10118Ph : 212-613-2700 / Fx: 212-613-2701 / email: info@rjlg.com www.rjlg.com
Bernstein & Associates, Architects - Architecture firm Specializing in Healthcare and lab design with a subspecialty in USP 797 consulting, USP 797 compliance action plans, and USP 797 architectural and engineering plans.
Bernstein & Assoc., Architects, PLLC59 West 19th Street - 6A, New York, NY 10011Ph : 212-463-8200 / Fx : 212-463-9898 / info@bernarch.comwww.bernarch.com
Clinical IQ, LLC - Clinical IQ, LLC aims to serve as the trusted source for pharmacy information services and product solutions for all our customers who range from local start-up operations to established national companies in the hospital, home care, and specialty compounding industries. With this aim, Clinical IQ creates software, classroom training, web based training, audit tools, and many other informational products to make sterile compounding and related areas of pharmacy safer. Our mission is about improving patient safety through better standards-setting in sterile compounding and other practice areas is not our only goal, though it is the highest goal. Another goal is to improve the professional life ofpharmacists and technicians as we carry out our craft with the comforting knowledge of reduced probability of causing harm. You see, Clinical IQ and our partners are practitioners. We have real on-the-floor experience. We are aware of how the rigors and pressures of daily work and work habits impact quality beyond textbook formulas. Clinical IQ and our partners are on a mission to change pharmacy for the better and our work is never done. We hope you will join us.Clinical IQ, LLC184 Columbia Turnpike, #282, Florham Park, NJ 07932Ph : 973-765-9393 / Fx : 866-538-4783 / moreinfo@clinicaliq.com /www.clinicaliq.com
Global Quality Alliance, LLC - GQA is able to provide Compounding Pharmacies with services such as Gap Assessment of current facilities, procedures and systems with respect to <797> and all other USP requirements, create or update procedures required for compliance to <797>, assess the USP Risk Levels for current products, and provide on-site training for staff members on aseptic technique, environmental monitoring and other USP <797> requirements. Whether you are looking to become PCAB accredited, or simply desire to improve quality and compliance to offer greater assurance of patient safety, GQAs extensive experience in the pharmaceutical industry has provided an excellent evolution into the sterile compounding industry where we continue to provide expert service and advice.
Global Quality Alliance, LLC 300 Center Drive, Suite G, #310, Superior, Colorado 80027 In Colorado Ph: 303-459-2382 / Outside Colorado Ph : 866-216-2815 / Fx : Fax: 303-459-2382 / info@gqaconsulting.com www.gqaconsulting.com
Lasco Services - We’ll evaluate your space to design a new clean environment or renovate your existing compounding area. All work is done quickly, with minimal disturbance, with less expense than you might think and USP <797> compliant...guaranteed. Learn how Lasco Services can make it easy for you to be USP <797> compliant.
Lasco Services 601 Compton Irving, TX. 75061 Ph : 800-815-2726 / Fx : 972-513-1877 / info@lascoservices.com www.lascoservices.com
Quality Solutions, LLC - is a turn-key solutions provider offering USP 797 compliance in a cost-effective manner. Drawing from its compliance, validation and technical services background in the highly regulated Biotech/Pharma industry, Quality Solutions, LLC can assist your pharmacy in performing a GAP analysis, assess risk levels, create the supporting Quality Assurance plans, and execute all required testing. Furthermore, all HEPA and Laminar Flow Certifications are conducted using NSF certified engineers. Quality Solutions, LLCBaltimore, MD 21286Phone : 443-416-6102 / Fx: 410-823-5226 / Usp797@qualsolve.net www.qualsolve.net
RJ Lee Group, Inc. offers a wide variety of USP 797 compliance and consulting services with the understanding that each institution may face unique challenges when working toward compliance. Our scientific and technical staff coupled with consulting pharmacists offers years of experience with USP 797 related projects to help you formulate a compliance action plan that will fit your individual needs and budget.
RJ Lee Group, Inc.350 Fifth Avenue, Suite 5820 New York, New York 10118Ph : 212-613-2700 / Fx: 212-613-2701 / email: info@rjlg.com www.rjlg.com
Healthcare Project Management Including Pharmacy Design and USP 797 Compliant Pharmacies
Healthcare Project Management Including Hospital Pharmacy and Retail Pharmacy Construction ... USP 797 Compliant Pharmacies a Specialty
Project Management
Empire Projects, Inc. - Project management company specializing in healthcare construction and laboratory project management, with a subspecialty in pharmacy construction, including USP 797 compliance, USP 797 regulations, USP 797 construction, and USP 797 project management.
Empire Projects, Inc.
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-0800 / Fx : 212-463-9898 /
info@EmpireProjects.com
http://www.empireprojects.com/
Project Management
Empire Projects, Inc. - Project management company specializing in healthcare construction and laboratory project management, with a subspecialty in pharmacy construction, including USP 797 compliance, USP 797 regulations, USP 797 construction, and USP 797 project management.
Empire Projects, Inc.
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-0800 / Fx : 212-463-9898 /
info@EmpireProjects.com
http://www.empireprojects.com/
Architects Specializing in Pharmacy Design and USP 797 Compliant Pharmacies
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
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
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
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Notice Details
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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.
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VA-CONSTRUCTION-SOLICITATION
Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
VA-CONSTRUCTION-SOLICITATION
Posted Date:
November 21, 2008
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Description: VA-244-08-RP-0292 VA-244-08-RP-0292.DOC
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Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% SPECIFICATIONS.ZIP
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Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 1 OF 8 G1 AS1-3.ZIP
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Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 2 OF 8 AS4-6.ZIP
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Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 3 OF 8 PL1 MH1-3.ZIP
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Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 5 OF 8 MH9.ZIP
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Description: VA-244-08-RP-0292 P01 PHARMACY 540-05-401 100% 7 OF 8 ES1-3.ZIP
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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
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VA-CONSTRUCTION-SOLICITATION
Nov 21, 2008
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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
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************end rfp **********************************
For more information about usp 797, go to: www.usp797.org
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