Friday, February 24, 2017

Developing a USP 800 Compliance Gap Analysis

Developing a USP 800 <800>Compliance Gap Analysis

This article was written by David Aguero, manager of pharmacy operations and technology at St. Jude Children’s Research Hospital, and Kristin Marge, PharmD, BCPS,  PGY1 residency program director at Inova Health System Mount Vernon Hospital.

This article recounts the systematic process that Inova Health System went through to document its current system relative to USP 800 compliance.

To read the full article: https://www.pppmag.com/article/1989

Additional Resources:

Follow USP.org:

USP.org on Twitter: https://twitter.com/uspharmacopeia
USP.org Blog: http://qualitymatters.usp.org/
USP.org on LinkedIn: https://www.linkedin.com/company/uspharmacopeia
USP.org on Facebook: https://www.facebook.com/USPharmacopeia

Follow USP800.guru:

USP800.guru on Twitter: https://www.twitter.com/usp800
USP800.org on Blogger: http://usp800.blogspot.com/
USP800.org on LinkedIn: https://www.linkedin.com/company/usp800-guru
USP800.org on Facebook:  https://www.facebook.com/USP800

Follow USP797.org:

USP797.org on Twitter: https://www.twitter.com/usp797
USP797.org on Blogger: http://usp797org.blogspot.com/
USP797.org on LinkedIn: https://www.linkedin.com/company/usp797-org-inc-
USP797.org on Facebook: https://www.facebook.com/usp797

Follow PharmacyDesign.org:

PharmacyDesign.org on Twitter: https://twitter.com/pharmacydesign
PharmacyDesign.org on Blogger: http://pharmacydesigns.blogspot.com/
PharmacyDesign.org on LinkedIn: https://www.linkedin.com/company/pharmacy-design
PharmacyDesign.org on Facebook: https://www.facebook.com/pharmacydesigns/

To reach USP797.org:

USP797.org
1483 York Avenue - #20602
New York, NY 10021
T: 800-974-3109
E: info@usp797.org
W: www.usp797.org

New USP 797 Hospital Pharmacy Design Projects in New York

New USP 797 Hospital Pharmacy Design Projects in New York

Pharmacy design architect Bernstein & Associates, Architects (http://bernarch.com/healthcare-design-pharmacy/) is pleased that it has been awarded six new pharmacy design projects in the state of New York.

All six of the pharmacy projects will involve redesign and/or expansion of existing hospital pharmacies to address compliance with USP 797 and USP 800. Additionally some of the projects will involve addition of pharmacy automation equipment and additional pharmacy program requirements.

The pharmacy design projects will center around state-of-the-art ISO 7 compounding suites, with both hazardous compounding and non-hazardous compounding.

Pharmacy design services for these projects will include: pharmacy programming, pharmacy planning, pharmacy design, and pharmacy equipment planning.

About Bernstein & Associates, Architects (www.bernarch.com):

Bernstein & Associates, Architects has specialized in healthcare and lab design and construction since the firm's founding in 1990. This architecture firm is well-known for pharmacy planning, pharmacy design and pharmacy construction, and has designed over (35) hospital pharmacies in the last 10 years, which have included USP 797 compliant pharmacy design and construction. The firm's principal --- William N. Bernstein, AIA --- is a well-known architect of pharmacies. He has written extensively on pharmacy design and construction including USP 797 compliant pharmacies.

USP 800 compliant pharmacy design is also a specialty of Bernstein & Associates, Architects. The firm currently has (11) projects in the design and construction phase designed to comply with USP 800.

A new article on the architectural design of USP 800 compliant pharmacies was published in Health Facilities Management. The article can be found here:

http://www.hfmmagazine.com/articles/2526-handling-hazardous-drugs-in-health-care

Pharmacy design projects by Bernstein & Associates, Architects  are featured on:
www.bernarch.com/healthcare-design-pharmacy/ (Pharmacy Design by Bernstein & Assoc., Architects)
www.twitter.com/pharmacydesign (Pharmacy Design on Twitter)
www.pharmacydesign.org (the Pharmacy Design website)
https://www.linkedin.com/company/pharmacy-design (Pharmacy Design on LinkedIn)
https://www.facebook.com/pharmacydesigns/ (Pharmacy Design on Facebook)
www.usp797.org (USP 797 news, USP 797 education, and USP 797 vendors)
www.usp800.guru (USP 800 news, USP 800 education, and USP 800 vendors)

For more information about healthcare and hospital design and construction, including pharmacy design and pharmacy construction, contact Bernstein & Associates, Architects at:

New York (Headquarters)
Bernstein & Associates, Architects
122 E 42nd Street - 17th Floor
New York, NY 10168
T: 212-463-8200
F: 888-214-0670
Email: info@bernarch.com
Also in Hartford, Princeton, Charlottesville, and Los Angeles

Additional ways to follow Bernstein & Associates, Architects, include:

Bernstein & Associates, Architects on Twitter: https://twitter.com/bernsteinarch
Bernstein & Associates, Architects on Blogger: http://bernarch.blogspot.com/
Bernstein & Associates, Architects on LinkedIn: https://www.linkedin.com/company/bernstein-&-associates-architects
Bernstein & Associates, Architects on Facebook: https://www.facebook.com/bernsteinarchitects/

Best Practices for Garbing in HD Sterile Compounding: Part 2

Best Practices for Garbing in HD Sterile Compounding: Part 2

This article --- written by Kate Douglass, MS, RN, CRNI --- was published in the January 2017 issue of Pharmacy Purchasing & Products.

As per the article:

"In the November issue of Pharmacy Purchasing & Products, the article “Best Practices for Garbing in HD Sterile Compounding” demonstrated the donning requirements for hazardous drug (HD) sterile compounding. This follow-up article presents best practices for doffing personal protective equipment (PPE) and performing hand hygiene for HD sterile compounding, step-by-step instructions that are not widely available."

To read the full article, go to: https://www.pppmag.com/article/1988

Additional Resources:

Follow USP.org:

USP.org on Twitter: https://twitter.com/uspharmacopeia
USP.org Blog: http://qualitymatters.usp.org/
USP.org on LinkedIn: https://www.linkedin.com/company/uspharmacopeia
USP.org on Facebook: https://www.facebook.com/USPharmacopeia

Follow USP800.guru:

USP800.guru on Twitter: https://www.twitter.com/usp800
USP800.org on Blogger: http://usp800.blogspot.com/
USP800.org on LinkedIn: https://www.linkedin.com/company/usp800-guru
USP800.org on Facebook:  https://www.facebook.com/USP800

Follow USP797.org:

USP797.org on Twitter: https://www.twitter.com/usp797
USP797.org on Blogger: http://usp797org.blogspot.com/
USP797.org on LinkedIn: https://www.linkedin.com/company/usp797-org-inc-
USP797.org on Facebook: https://www.facebook.com/usp797

Follow PharmacyDesign.org:

PharmacyDesign.org on Twitter: https://twitter.com/pharmacydesign
PharmacyDesign.org on Blogger: http://pharmacydesigns.blogspot.com/
PharmacyDesign.org on LinkedIn: https://www.linkedin.com/company/pharmacy-design
PharmacyDesign.org on Facebook: https://www.facebook.com/pharmacydesigns/

To reach USP797.org:

USP797.org
1483 York Avenue - #20602
New York, NY 10021
T: 800-974-3109
E: info@usp797.org
W: www.usp797.org

USP 797 Compounding Pharmacy Design in Maryland

USP 797 Compounding Pharmacy Design in Maryland

Pharmacy design architect Bernstein & Associates, Architects (http://bernarch.com/healthcare-design-pharmacy/) is pleased to announce that it has been hired to provide compounding pharmacy architectural design services for a private compounding facility in Maryland.

Bernstein & Associates, Architects will be providing compounding pharmacy design services for this project including: compounding pharmacy programming, compounding pharmacy planning, compounding pharmacy design, and compounding pharmacy equipment planning.

The compounding pharmacy design is for a new, compounding suite for a privately owned company. It will include a state-of-the-art, ISO 7 compounding suite, with both hazardous compounding and non-hazardous compounding, designed to comply with USP 797 and USP 800 regulations.

About Bernstein & Associates, Architects (www.bernarch.com):

Bernstein & Associates, Architects has specialized in healthcare and lab design and construction since the firm's founding in 1990. This architecture firm is well-known for pharmacy planning, pharmacy design and pharmacy construction, and has designed over (35) hospital pharmacies in the last 10 years, which have included USP 797 compliant pharmacy design and construction. The firm's principal --- William N. Bernstein, AIA --- is a well-known architect of pharmacies. He has written extensively on pharmacy design and construction including USP 797 compliant pharmacies.

USP 800 compliant design is also a specialty of Bernstein & Associates, Architects. The firm currently has (11) projects in the design and construction phase which have been designed to comply with USP 800.

A new article on the architectural design of USP 800 compliant pharmacies was published in Health Facilities Management. The article can be found here:

http://www.hfmmagazine.com/articles/2526-handling-hazardous-drugs-in-health-care

Pharmacy design projects by Bernstein & Associates, Architects  are featured on:
www.bernarch.com/healthcare-design-pharmacy/ (Pharmacy Design by Bernstein & Assoc., Architects)
www.twitter.com/pharmacydesign (Pharmacy Design on Twitter)
www.pharmacydesign.org (the Pharmacy Design website)
https://www.linkedin.com/company/pharmacy-design (Pharmacy Design on LinkedIn)
https://www.facebook.com/pharmacydesigns/ (Pharmacy Design on Facebook)
www.usp797.org (USP 797 news, USP 797 education, and USP 797 vendors)
www.usp800.guru (USP 800 news, USP 800 education, and USP 800 vendors)

For more information about healthcare and hospital design and construction, including pharmacy design and pharmacy construction, contact Bernstein & Associates, Architects at:

New York (Headquarters)
Bernstein & Associates, Architects
122 E 42nd Street - 17th Floor
New York, NY 10168
T: 212-463-8200
F: 888-214-0670
Email: info@bernarch.com
Also in Hartford, Princeton, Charlottesville, and Los Angeles

Additional ways to follow Bernstein & Associates, Architects, include:

Bernstein & Associates, Architects on Twitter: https://twitter.com/bernsteinarch
Bernstein & Associates, Architects on Blogger: http://bernarch.blogspot.com/
Bernstein & Associates, Architects on LinkedIn: https://www.linkedin.com/company/bernstein-&-associates-architects
Bernstein & Associates, Architects on Facebook: https://www.facebook.com/bernsteinarchitects/

Refining PPE Usage for HD Compounding

Refining PPE Usage for HD Compounding: Part I

This article --- written by Kate Douglass, MS, RN, CRNI, Amanda Richter, CPhT, Melanie Dorey, CPhT, and Izzat Rizvi --- reviews PPE requirements relative to USP 800.

The article focuses on gowns and shoe covers, and is a useful article for pharmacists looking to provide the optimal PPE in the new regulatory environment of USP 800.

To read the full article: https://www.pppmag.com/article/2000

Additional Resources:

Follow USP.org:

USP.org on Twitter: https://twitter.com/uspharmacopeia
USP.org Blog: http://qualitymatters.usp.org/
USP.org on LinkedIn: https://www.linkedin.com/company/uspharmacopeia
USP.org on Facebook: https://www.facebook.com/USPharmacopeia

Follow USP800.guru:

USP800.guru on Twitter: https://www.twitter.com/usp800
USP800.org on Blogger: http://usp800.blogspot.com/
USP800.org on LinkedIn: https://www.linkedin.com/company/usp800-guru
USP800.org on Facebook:  https://www.facebook.com/USP800

Follow USP797.org:

USP797.org on Twitter: https://www.twitter.com/usp797
USP797.org on Blogger: http://usp797org.blogspot.com/
USP797.org on LinkedIn: https://www.linkedin.com/company/usp797-org-inc-
USP797.org on Facebook: https://www.facebook.com/usp797

Follow PharmacyDesign.org:

PharmacyDesign.org on Twitter: https://twitter.com/pharmacydesign
PharmacyDesign.org on Blogger: http://pharmacydesigns.blogspot.com/
PharmacyDesign.org on LinkedIn: https://www.linkedin.com/company/pharmacy-design
PharmacyDesign.org on Facebook: https://www.facebook.com/pharmacydesigns/

To reach USP797.org:

USP797.org
1483 York Avenue - #20602
New York, NY 10021
T: 800-974-3109
E: info@usp797.org
W: www.usp797.org

USP 797 Pharmacy Design Project in Connecticut

USP 797 Pharmacy Design Project in Connecticut

Pharmacy design architect Bernstein & Associates, Architects (http://bernarch.com/healthcare-design-pharmacy/) is pleased to announce that architectural and engineering construction documents for a new pharmacy project in Connecticut have been completed.

Bernstein & Associates, Architects provided pharmacy design services for this project including: pharmacy programming, pharmacy planning, pharmacy design, and pharmacy equipment planning.

The pharmacy design project is for a new, compounding suite for an inpatient, hospital pharmacy. It includes a state-of-the-art, ISO 7 compounding suite, with both hazardous compounding and non-hazardous compounding, designed to comply with USP 797 and USP 800 regulations.

About Bernstein & Associates, Architects (www.bernarch.com):

Bernstein & Associates, Architects has specialized in healthcare and lab design and construction since the firm's founding in 1990. This architecture firm is well-known for pharmacy planning, pharmacy design and pharmacy construction, and has designed over (35) hospital pharmacies in the last 10 years, which have included USP 797 compliant pharmacy design and construction. The firm's principal --- William N. Bernstein, AIA --- is a well-known architect of pharmacies. He has written extensively on pharmacy design and construction including USP 797 compliant pharmacies.

USP 800 compliant design is also a specialty of Bernstein & Associates, Architects. The firm currently has (11) projects in the design and construction phase which have been designed to comply with USP 800.

A new article on the architectural design of USP 800 compliant pharmacies was published in Health Facilities Management. The article can be found here:

http://www.hfmmagazine.com/articles/2526-handling-hazardous-drugs-in-health-care

Pharmacy design projects by Bernstein & Associates, Architects  are featured on:
- www.bernarch.com/healthcare-design-pharmacy/ (Pharmacy Design by Bernstein & Assoc., Architects)
- www.twitter.com/pharmacydesign (Pharmacy Design on Twitter)
- www.pharmacydesign.org (the Pharmacy Design website)
- https://www.linkedin.com/company/pharmacy-design (Pharmacy Design on LinkedIn)
- https://www.facebook.com/pharmacydesigns/ (Pharmacy Design on Facebook)
- www.usp797.org (USP 797 news, USP 797 education, and USP 797 vendors)
- www.usp800.guru (USP 800 news, USP 800 education, and USP 800 vendors)

For more information about healthcare and hospital design and construction, including pharmacy design and pharmacy construction, contact Bernstein & Associates, Architects at:

New York (Headquarters)
Bernstein & Associates, Architects
122 E 42nd Street - 17th Floor
New York, NY 10168
T: 212-463-8200
F: 888-214-0670
Email: info@bernarch.com
Also in Hartford, Princeton, Charlottesville, and Los Angeles

Additional ways to follow Bernstein & Associates, Architects, include:

Bernstein & Associates, Architects on Twitter: https://twitter.com/bernsteinarch
Bernstein & Associates, Architects on Blogger: http://bernarch.blogspot.com/
Bernstein & Associates, Architects on LinkedIn: https://www.linkedin.com/company/bernstein-&-associates-architects
Bernstein & Associates, Architects on Facebook: https://www.facebook.com/bernsteinarchitects/

Friday, November 4, 2016

USP 800 and USP 797: What is New and What is the Same

A new article on creating a USP 800 compliant pharmacy, by William N. Bernstein, AIA, has just been published in Health Facilities Management.

Entitled “USP 800 Brings New Regulations to Hospital Pharmacies”, the article is a comprehensive guide to designing clean room environments for sterile compounding and non-sterile compounding in accordance with the new USP 800 guidelines.

The USP 800 pharmacy design article can be found at:

http://www.hfmmagazine.com/articles/2526-handling-hazardous-drugs-in-health-care

Below are some of the topics covered in this USP 800 article:
History of USP 800
Deadline for compliance with USP 800
Relationship of USP 797 and USP 800
Changes in guidelines on sterile compounding of hazardous drugs relative to previous guidelines in USP 797
What does USP 800 mean when it refers to “hazardous drugs”
Latest list of USP 800 hazardous drugs
Frequency of review of list of USP 800 hazardous drugs
Introducing new hazardous drugs in a USP 800 compliant facility
Exceptions to list of USP 800 hazardous drugs
Discussion of investigational drugs in USP 800 guideline
Under what circumstances do hazardous drugs fall outside of USP 800 guidelines
Discussion of “assessment of risk” in USP 800 guidelines
Areas governed by USP 800
How does USP 800 address storage of hazardous drugs
How does USP 800 address compounding of hazardous drugs
When is a negative pressure room required under USP 800
How many air changes does USP 800 require
What additional space does USP 800 require
How does USP 800 address refrigeration of hazardous drugs
Locations of refrigerated storage of hazardous drugs in USP 800
Location of exhaust relative to refrigerator in USP 800
Discussion of details of storage room shelving in USP 800
Seismic considerations discussed in USP 800
Discussion of which drugs go into the USP 800 storage room
Storage of sterile and non-sterile hazardous drugs in USP 800
Under what circumstances can sterile and non-sterile drugs be stored in the same room in USP 800
Discussion of compounding vs. fixed formulations in USP 800
Types of controls related to the compounding process in USP 800
C-PEC in USP 800
C-SEC in USP 800
Closed-system, drug transfer device in USP 800
When is an ISO-5 environment required in USP 800
When is an ISO-7 environment required in USP 800
When is a negative-pressure room required in USP 800
USP 800 discussion of loss of power
USP 800 discussion of emergency power
Discussion of worker safety in USP 800
Types of Biosafety Cabinets discussed in USP 800
USP 800 eliminates available options that existed in USP 797
USP 800 discussion of signage
Location of spaces discussed in USP 800
Receipt and unpacking of hazardous drugs as discussed in USP 800
Water column measurements in USP 800
What has to be externally vented in a USP 800 compliant pharmacy
Air exchange rate requirements in USP 800
USP 800 discussion of maintaining power to ventilation systems in a power outage
Different USP 800 requirements for sterile compounding vs. non-sterile compounding
Definition of non-sterile compounding in USP 800
Definition of sterile compounding in USP 800
Under what circumstances does USP 800 permit both sterile and nonsterile compounding in the same room
Under what circumstances does USP 800 permit sterile compounding in a non-ISO space
USP 800 discussion of segregated compounding area (C-SCA).
USP 800 requirements for non-sterile compounding
Carry-over of certain requirements from USP 797 in terms of cleanroom design in USP 800
Discussion of USP 795, Pharmaceutical Compounding — Nonsterile Preparations, in USP 800
Under what circumstances does USP 800 permit sterile and nonsterile compounding in the same room
Relationship of storage and compounding spaces in USP 800

Author of this USP 800 article is William N. Bernstein, LEED AP, AIA, the principal of Bernstein & Associates Architects. His firm has been at the forefront of designing USP 797 and USP 800 compliant  pharmacies across the US. He can be reached at info@bernarch.com.

Follow Bernstein & Associates, Architects:
Pharmacy Architecture and Design: http://bernarch.com/healthcare-design-pharmacy/
USP 797 Architecture and Design: http://bernarch.com/healthcare-design-usp-797-compliant-pharmacy-design-and-consulting/
USP 800 Architecture and Design: http://bernarch.com/healthcare-design-usp-800-compliant-pharmacy-design-and-consulting/
Bernstein & Associates, Architects on Twitter: https://twitter.com/bernsteinarch
Bernstein & Associates, Architects on Blogger: http://bernarch.blogspot.com/
Bernstein & Associates, Architects on LinkedIn: https://www.linkedin.com/company/bernstein-&-associates-architects
Bernstein & Associates, Architects on Facebook: https://www.facebook.com/bernsteinarchitects/

Follow Empire Projects, Inc.:
Healthcare project management services, see: http://empireprojects.com/healthcare-project-management/
Hospital project management services, see: http://empireprojects.com/healthcare-project-management-hospitals/
Empire Projects, Inc. on Twitter: https://twitter.com/empireprojects
Empire Projects, Inc.on Blogger: http://empireprojects.blogspot.com/
Empire Projects, Inc. on LinkedIn: https://www.linkedin.com/company/empire-projects-inc.
Empire Projects, Inc. on Facebook: https://www.facebook.com/empireprojectsusa/

Follow USP.org:
USP.org on Twitter: https://twitter.com/uspharmacopeia
USP.org Blog: http://qualitymatters.usp.org/
USP.org on LinkedIn: https://www.linkedin.com/company/uspharmacopeia
USP.org on Facebook: https://www.facebook.com/USPharmacopeia

Follow USP797.org:
USP797.org on Twitter: https://www.twitter.com/usp797
USP797.org on Blogger: http://usp797org.blogspot.com/
USP797.org on LinkedIn: https://www.linkedin.com/company/usp797-org-inc-
USP797.org on Facebook: https://www.facebook.com/usp797

Follow USP800.guru:
USP800.guru on Twitter: https://www.twitter.com/usp800
USP800.org on Blogger: http://usp800.blogspot.com/
USP800.org on LinkedIn: https://www.linkedin.com/company/usp800-guru
USP800.org on Facebook:  https://www.facebook.com/USP800

Follow PharmacyDesign.org:
PharmacyDesign.org on Twitter: https://twitter.com/pharmacydesign
PharmacyDesign.org on Blogger: http://pharmacydesigns.blogspot.com/
PharmacyDesign.org on LinkedIn: https://www.linkedin.com/company/pharmacy-design
PharmacyDesign.org on Facebook: https://www.facebook.com/pharmacydesigns/

To reach USP797.org:
USP797.org
1483 York Avenue - #20602
New York, NY 10021
T: 800-974-3109
E: info@usp797.org 
W: www.usp797.org