* 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.
Saturday, December 27, 2008
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/
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