November 12, 2019 · • Laminar Airflow System (LAFS): an LAFS provides an ISO Class 5 or better environment for sterile compounding. The LAFS provides a unidirectional HEPA-filtered

Sterile Compounding Member Forum

November 12, 2019

Welcome

Robyn ThomasonCalifornia Hospital Association

CHA Faculty

BJ Bartleson, RN, MS, NEA-BC is CHA’s vice president of nursing and clinical services. Ms. Bartleson provides leadership in developing, communicating and implementing CHA policy related to nursing, emergency services, trauma and medication safety.

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Faculty

Richard Tannahill is a senior architect with the Office of Statewide Health Planning and Development. A licensed architect since 1995, he has over 28 years of architectural experience of which over 23 years is in healthcare specializing in project management, building code, and construction administration. Mr. Tannahill is a past board member of the Hospital Building Safety Board and continues to be an active staff participant. He has been with the Office of Statewide Health Planning and Development since April 2015 and is currently assisting in developing the Pharmacy Guidelines.

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Faculty

Christine Acosta, PharmD, is a supervising inspector with the California Board of Pharmacy where she provides guidance and directs investigative case plans and oversees investigations. Dr. Acosta trains the board’s inspector staff and provides consultation to the board’s executive staff on complex enforcement and licensing activities. Dr. Acosta has been principally involved in the development of the board’s forthcoming compounding and sterile compounding regulations, and often serves as a subject matter expert for the board in testimony and in emerging policy of the board. Prior to joining the Board of Pharmacy, Dr. Acosta worked as a pharmacist-in-charge in a retail pharmacy, and as a clinical pharmacist in the inpatient setting.

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Faculty

Anne Sodergren was appointed interim executive officer of the California State Board of Pharmacy in January 2019. She has served with the board for more than 25 years, including 10 years as assistant executive officer. In addition to overseeing day-to-day operations and an annual budget of more than $25 million, she is involved in shaping public policy and implementing laws and regulations to carry out the board’s consumer protection mandate.

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Faculty

Cari Lee, PharmD. is a pharmaceutical consultant unit chief with the California Department of Public Health(CDPH). She oversees the Pharmaceutical Consultant Unit and is responsible for program and policy matters related to the provision of pharmaceutical services in all licensed health care facilities. Prior to joining CDPH, Dr. Lee had worked as an ambulatory care clinical pharmacist for a northern California medical center.

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Medication Safety Sterile Compounding Survey Report

BJ BartlesonCalifornia Hospital Association

CHA Medication Safety Sterile Compounding Survey

On August 6, 2019, CHA surveyed approximately 148 hospitals with 208 clean rooms to understand where hospitals were relative to compliance with the new sterile compounding regulations slated to go into effect on Dec.1, 2019.

Questions were focused on key components of the construction process, barriers to starting construction, barriers to completing construction, and barriers to full construction completion, and, regulatory sign off

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CHA Medication Safety Sterile Compounding Survey Results

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CHA Medication Safety Sterile Compounding Survey Results (cont.)

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0

5

10

15

20

25

30

Construction Process Not Started- Other


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13

0

5

10

15

20

25

30

Project Not Started Yet Awaiting Agency Approvals Project Complete Not Applicable

Date of Construction Completion - Other


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0

5

10

15

20

25

30

35

40

45

Alreadycompleted

Complete by12/1/19

Complete by3/31/20

Complete by6/30/20

Complete by9/30/20

Complete by12/21/20

Complete2021 or later

NotCompounding

n/a

Estimated Date of Construction Completion


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USP Postponement

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USP Postponement (cont.)

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Richard TannahillOSHPD

OSHPD Guide to Compliance

Pharmacy Compounding Timeline

BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval

OSHPD Building PermitConstruction

(varies)

OSHPD Certificate of Substantial Compliance BoP Site Visit

CDPH Approval(December 1, 2019)

Call to CDPH PCU

Schedule BoP(8-12 weeks)

- Room/Equipment Certifications Completed or PlannedBoard of Pharmacy Site Visit Preparation:

- Updated PNP- Process Validation & Training

BoP Approval

(100 Calendar Days)

Where is/are your Pharmacy Project(s)?

Apply to CDPH CAB

(120 Calendar Days)

Pharmacy Compounding Timeline (cont.)

BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


(varies)



Call to CDPH PCU




BoP Approval

(100 Calendar Days)


Apply to CDPH CAB

(120 Calendar Days)

OSHPD Submittal Requirements

• What is required• A2 checklist (suggested)• Application for plan review (if paper submittal)• Construction documents (plans, specifications & TIO) or preliminary submittal

• Functional program required on ALL pharmacy compounding projects• Time restrictions/deadlines

• Pharmacy Summary Checklist (PSC) required on ALL pharmacy compounding projects

• For those projects which affect the building exterior, evidence of local planning and zoning approval is required prior to OSHPD approval

• Facilities intending to use modular unit(s) for either interim or final placement of sterile compounding must ensure that the modular units meet all applicable codes related to construction, remodeling and alteration of hospital buildings and structures as noted in the CBC and OSHPD CAN-1

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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD ReviewPSC Review

OSHPD Plan Approval


(varies)



Call to CDPH PCU




BoP Approval

(100 Calendar Days)


Apply to CDPH CAB

(120 Calendar Days)

OSHPD Preliminary vs. Final Submittal

• Preliminary submittal• 21 day turnaround• Heads off major conflicts early• 10% of fee but deducted from Final Submittal fee• Must allow time to respond to comments• Can reduce number of back checks

• Final submittal• Standard review times• Must have complete submittal package (drawings,

specifications, TIO and structural calculations if applicable)

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OSHPD Functional Program

Timelines• Project timeline to include all phases of project implementation including all

interim provisions and final scope of work. Timeline shall indicate for each phase:

• Project scoping and design• Plan review and permitting

• OSHPD plan review programs (60/30/30 or rapid review)• Construction duration

• Building permit application• Notice of start of construction• Completion/occupancy & closure

• Acceptance and licensing

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What’s new in the California Building Code?

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Title 24, Parts 2, 3, 4 and 5 updated

What’s New in the OSHPD A2 Guide?

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Where to Find the OSHPD A2 Guide?

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What’s New in the A2 Guide?

• Laminar Airflow System (LAFS): an LAFS provides an ISO Class 5 or better environment for sterile compounding. The LAFS provides a unidirectional HEPA-filtered airflow that is designed to prevent contamination of a sterile compounding environment. If used to prepare only Category 1 CSPs, the ISO Class 5 PEC may be located in an unclassified SCA. If used to prepare Category 2 CSPs, the LAFS must be located within a cleanroom suite with an ISO Class 7 or better buffer room and ISO Class 8 or better ante-room. [USP 797]

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What’s New in the A2 Guide? (cont.)

• Sprinkler systems should be recessed, covered and must be easily cleanable. [USP<797>4.4]

• [USP <797> 4.3] If ceilings consist of inlaid panels, the panels must be caulked or otherwise sealed and secured around each panel to seal them to the support frame. Ceiling panels must be washable, scrubbable and soil resistant, and designed for use in a cleanroom environment.

• Only furniture, equipment, and other materials necessary for performing compounding activities are permitted in the classified area or SCA, and they should be low-shedding and easily cleaned and disinfected. [USP<797>4.5]

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• HEPA-filtered supply air shall be at the ceiling in Ante and Buffer Rooms.

• A required sink capable of hand-washing up to the elbows must be placed on the clean side of the line of demarcation and a minimum of one meter away from the entrance to the HD buffer room.

• The surfaces of ceilings, walls, floors, doors, door frames, fixtures, shelving, work surfaces, counters, and cabinets in the buffer area shall be smooth, impervious, free from cracks and crevices, and non-shedding.

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• Airlocks and interlocking doors can be used to facilitate better control of air balance between areas of differing ISO classification (e.g., between the buffer room and ante-room), or between a classified area and an unclassified area (e.g., between the anteroom and an unclassified area such as a hallway). If a passthrough is used, both doors must never be opened at the same time, and doors should be interlocking.

• When designing doors, consider the placement of door closures, door surfaces, and the movement of the doors, all of which can affect airflow. Seals and sweeps should not be installed at doors between buffer and ante-rooms. Access doors should be handsfree.

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• The ante-room shall not contain floor drains. [USP <797>4.4]• Ante-area for non-hazardous sterile compounding rooms shall be no

less than 20 air changes per hour [USP <797>]• All surfaces (e.g., walls, floors, counters, and equipment) in the SCA

must be clean, uncluttered, and dedicated to compounding. [USP<797>4.3]

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Review of the A2 Guide?

• HD drug storage• Pharmacy Permit Exemption Drug Room • Pharmacy Summary Checklist with plans

(appendix B of A2 guide)• Mobile Compounding Units (trailers)

• For interim use during construction only• Subject to approval by the BoP and CDPH• OSHPD submittal per the guidelines listed in pin 34

review of mobile units used for outpatient hospital services with an AMC - Program Flex

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Mobile Sterile CompoundingUnit (MSCU)MSCU may be approved for temporary use during clean room remodeling project for up to 6 months with the option of one six month extension (12 months total) .

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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


(varies)



Call to CDPH PCU




BoP Approval

(100 Calendar Days)


Apply to CDPH CAB

(120 Calendar Days)

Pharmacy Summary ChecklistAppendix B of A2 Guide

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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


(varies)



Call to CDPH PCU




BoP Approval

(100 Calendar Days)


Apply to CDPH CAB

(120 Calendar Days)


BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


(varies)



Call to CDPH PCU




BoP Approval

(100 Calendar Days)


Apply to CDPH CAB

(120 Calendar Days)

Common Design Mistakes

• Pass-through to non-classified spaces• Location of trailers• Wood furniture• No storage for cleaning supplies• No doffing area in HD Buffer Rooms• Extra doors from Buffer Rooms direct to

corridors• Handwashing fixtures on dirty side of LOD

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Best Practices

• Use Pharmacy Summary Checklist!• Pharmacist in Charge to be involved with whole project

(design and construction)• Dimension all anchored equipment• If checked off in A2 Guide – show on plans• Include detailed enlarge plan in PSC• Identify individual equipment• Show ISO ratings• Use code terminology for room names• Dimension sink to HD Buffer Room door if applicable

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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


(varies)



Call to CDPH PCU




BoP Approval

(100 Calendar Days)


Apply to CDPH CAB

(120 Calendar Days)

Christine AcostaAnne SodergrenBoard of Pharmacy

Board of Pharmacy Setting Expectations

Board Policy Statement

In light of USP’s September 23, 2019, announcement regarding the appeals and postponement of the official dates of the revised Chapters 795 and 797 and the new Chapter 825, the California State Board of Pharmacy (board) wishes to ensure stakeholders have a clear understanding of the legal requirements for pharmacies compounding drug preparations.

At minimum, all pharmacies must adhere to all relevant sections of Pharmacy Law and regulation – including but not limited to the board’s current regulations, California Code of Regulations, title 16, sections 1735 et. seq, 1751 et. seq, and 1708.3-1708.5. Further, effective January 1, 2020, in addition to the board’s compounding regulations, all pharmacies must adhere to current USP Chapters relating to compounding, including Chapters 795 and 797.

Although USP has indicated that Chapter 800 is informational while USP reviews the appeals of related compounding chapters, the board’s current regulations on compounding hazardous drug preparations remain in effect. Like USP, the board encourages utilization of Chapter 800 in the interest of advancing public health.

Waivers previously granted to allow for physical construction or alteration of a facility pursuant to California Code of Regulations, title 16, sections 1735.6 or 1751.4 will not be extended and will sunset on December 1, 2019. While the USP appeals are under consideration, where physical construction or alteration is not yet complete, the board will consider mitigation, including a licensee’s efforts to achieve compliance.

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Board of Pharmacy Processing Times

• Average PHY initial processing: 30-45 days (Pharmacy permit)• Average LSC initial processing: 30-45 days (Licensed Sterile

Compounding permit)• Inspection requests: 8-12 weeks notice

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Cari Lee, Pharm.D.Chief Pharmaceutical Consultant Center for Healthcare Quality

BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


(varies)



Contact CDPH PC Unit


BoP Approval

(100 Calendar Days)

CAB: [email protected] Unit: [email protected]

Apply to CDPH CAB

(120 Calendar Days)

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Effective August 14, 2018, the former CAU expanded and reorganized to the new Centralized Applications Branch (CAB)

Tutorial for HS 200: https://www.youtube.com/watch?v=N4Y1LDU3zNU&feature=youtu.be

New email address: [email protected] Address remains:

California Department of Public Health Licensing and Certification Program Centralized Applications Branch P.O. Box 997377, MS 3207 Sacramento, CA 95899-7377

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AFL 18-52: Effective January 1, 2019, written applications submitted by hospitals are required to be reviewed and approved or denied by CDPH within 100 days of receipt, including all related activities.

AFL 19-19: Supersedes AFL 18-20 regarding clean room project applications and complete application requirements.

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Completed application:◦ Form HS 200 (Licensure and Certification

Application)◦ Floor Plan◦ STD 850 (Fire Safety Inspection)◦ Certificate of Occupancy◦ Board of Pharmacy Licensure (LSC)◦ Mobile Sterile Compounding Unit requires

additional approval by other state and local agencies*

Once the above items are submitted, the clock starts

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May be used to provide IV service during clean room upgrade project for up to 12 months.

Requires program flex approval by Regional Office. More complicated approval process (location site

evaluation, technical support, security, DMV, city approval, medication transportation path, gray water handling.)

Not necessary for all upgrade projects. Expensive. Contact Pharmaceutical Consultant Unit Project

Leads at: [email protected].

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CAB forwards completed applications to Pharmaceutical Consultant (PC) Unit.

Hospitals may contact PC Unit Clean Room Project Leads up to 120 days prior to project completion [email protected].

Documents, records, reports and photos for administrative review.

Once project site is ready for survey, an onsite visit can be scheduled within 1 to 3 weeks.

Correction items. PC Unit recommends approval if all pending issues

corrected prior to 100-day deadline.

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Drawing of compounding space to include location of HVAC supply and returns, doors, air pressure monitoring devices, hoods, pass-throughs, water sources (sinks), refrigerators, cabinets and countertops.

Certification reports done under dynamic operating conditions. If there were issues, include documentation on how they were resolved.

All cleaning logs from the date of certification to current.

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Temperature logs since date of certification to current Differential pressure monitoring logs All approved P&P for sterile IV compounding Employee competency Digital images of the clean room Certificate of Occupancy (if required) California Board of Pharmacy sterile compounding license and

inspector’s report

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Infrequent Requires withdrawal of application and resubmission when

ready Voluntary withdrawal

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Make sure all P&Ps have been implemented, with the required documentation, from the date of the current environmental and equipment certification.

All required cleaning and monitoring must be performed and documented commencing the certification date.

Certification must be done under dynamic operating conditions.

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Appropriate sampling plan for design of cleanroom (buffer room, anteroom, segregated compounding area, antechamber/pass-through)

Remediation of microbial growth by collaborating with microbiologist, infection control professional, or industrial hygienist

Proper cleaning process/technique Caulking issues Staff competency Cleaning around fixed equipment

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Issues identified during certification and how they were resolved should be documented in the reports

Alarm setting of differential pressure and/or refrigerators/freezers temperatures monitors.

Periodic testing/calibration should be performed.

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Revised <795>, <797> and new <825> were released on June 1st, 2019 with effective date of December 1st, 2019

Due to appeals on certain provision in <795>, <797> and <825>, USP announced in September the postponement of the official dates of the revised <795> and <797>, and the new general chapter <825> until further notice

<800> not appealed but not compendially applicable

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Released on October 22:https://www.usp.org/sites/default/files/usp/document/FAQs/faqs-on-compounding-appeals.pdf

How can facilities implement <800> in-light-of conflicts with provisions in currently official <797>?1. Segregated Compounding Area (SCA)2. “Low volume” hazardous drug compounding

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Thank You

BJ BartlesonCalifornia Hospital [email protected]

Richard [email protected]

Christine AcostaCalifornia State Board of [email protected]

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Anne SodergrenCalifornia State Board of [email protected]

Cari Lee, [email protected]

Questions

Online questions:Type your question in theQ & A box, press enter

Phone questions:To ask a question, press *1

Thank You and Evaluation

Thank you for participating in today’s seminar. An online evaluation will be sent to you shortly.

For education questions, contact Robyn Thomason at (916) 552-7514 or [email protected].