sterile compounding pharmacies: guidance for … · continuing education ... bj bartleson, rn, ms,...

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Sterile Compounding Pharmacies: Guidance for Implementing Regulatory Changes Webinar

April 17, 2018

Welcome

Robyn ThomasonCalifornia Hospital Association

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Continuing Education

Continuing education will be offered for this program for compliance and health care executives.

Full attendance and completion of the online evaluation and attestation of attendance are required to receive CEs for this webinar. CEs are complimentary and available for the registrant only.

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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.

Debby Rogers, RN, MS, FAEN is CHA’s vice president of clinical performance and transformation. Ms. Rogers provides leadership in developing policy on clinical performance issues related to quality and quality measurement, case management, licensing and certification, and electronic health records. She also offers clinical and regulatory expertise in the transformation of health care delivery.

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Program Overview and Introductions

BJ Bartleson, RN, MS, NEA-BC,Vice President, Nursing & Clinical Services

Debby Rogers, RN, MS, FAENVice President, Clinical Performance & Transformation

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 boards 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

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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Sterile Compounding Pharmacies

California State Board of Pharmacy

Christine Acosta, PharmD, Supervising Inspector, California Board of Pharmacy

Richard Tannahill, Senior Architect, Office of Statewide Health Planning and Development

Cari Lee, PharmD, Pharmaceutical Consultant Unit Chief, California Department of Public Health

Agenda

• Timeline• Brief overview of the BoP waiver process• Moving pharmacy to a new location• Mobile unit• BoP temporary permit• OSHPD submittal• Centralized Applications Unit (CAU) application• Pharmacy Consultant Unit (PCU) application• Lessons learned/common mistakes• Who to contact if there are issues

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Pharmacy Compounding Timeline

BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval

OSHPD Building Permit

Construction Start

Construction Completion

OSHPD Certificate of Occupancy

BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks

Apply to PCU 90 days

Apply to CAU 120 days

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Brief Overview of the BoP Waiver Process

• CCR 1735.6 (f) allows the board or its designee to grant a waiver when, in its

discretion, good cause is demonstrated for such waiver.

• A waiver or delay in compliance may only be granted when at least

the following are met:

• Good cause is demonstrated

• Location requesting the waiver requires physical construction or alteration

to a facility or physical environment

• A request is made in writing which includes at least:

• The provision(s) requiring physical construction or alteration

• The timeline for any such change(s)

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• A waiver or delay in compliance only allows a location to continue compounding while out of compliance with the specific provision(s) identified in the granted waiver

• Nothing allows for the location to be non-complaint with any other provisions or applicable laws

• Nothing allows in the waiver extends to any agency except

the Board of Pharmacy

Brief Overview of the BoP Waiver Process

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BoP Licensing Overview

• LSC (sterile compounding permits) (Licensed Sterile Compounding permit)

• BPC 4127.1(a) are not transferable, if moving a new permit is required

• BPC 4127.1(c) require an inspection before license issuance

• BPC 4127.8 temporary permit may be available, still require an inspection before issuance

• PHY or HSP (Pharmacy permit)

• BPC 4110(a) if moving, a new permit is required

• BPC 4110(b) temporary permit may be available but has a special application• Mobile Compounding Unit (MCU)

• Will license like any other LSC

• Address of LSC to include “Mobile Compounding Unit” or (MCU)

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BoP Timeline

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

• Temporary permit initial processing: 7 days

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


• Inspection requests:

• 6-8 weeks notice

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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


Construction Start



BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks



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OSHPD Project Requirements

• When/how to get a number

• eCA – electronically through eServices Portal

• Paper application

• Length of Use

• Must submit either preliminary submittal or final construction documents within 10 days or project number will be cancelled

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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


Construction Start



BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks



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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


Construction Start



BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks



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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 and specifications)

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OSHPD Functional Program

• Projects associated with alterations to existing pharmacies and creation of new pharmaceutical service space must include a clear and thorough functional program per California administrative code (CAC) section 7-119. The functional program must identify:

• Compounding environment type(s)• Beyond use date (buds)• All compounding environment types and their core features including:

• Plan(s) illustrating placement within the hospital. Also illustrate mechanical equipment placement and duct chase locations at all impacted areas/floors

• Type(s) of primary engineering control (pec) workstations• Description of secondary engineering control (SEC) buffer rooms/clean

room(s), including mechanical provisions• Description of anteroom(s), including mechanical provisions.• Description of segregated sterile compounding area(s), if applicable,

including mechanical provisions• Interim provisions for maintaining operations during construction• Complete project timeline

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OSHPD Functional Program (cont.)

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 OSHPDA2 Guide?

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


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


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


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Mobile Sterile CompoundingUnit (MSCU)MSCU may be approved for temporary use during clean room remodeling project for up to 12 months

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Mobile Sterile Compounding UnitApproval Process

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MSCU Approval

Inform CDPH of intent to use mobile sterile compounding unit prior to delivery of the mobile unit by emailing to:

[email protected]

• Submit Form HS 200 to Central Application Unit (CAU)

• Hospital to submit Program Flexibility Request (Form 5000) for CCR, Division 5, Chapter1, Section 70267 (a), to the local district office for approval

§ 70267. Pharmaceutical Service Equipment and Supplies

(a) There shall be adequate equipment and supplies for the provision of pharmaceutical services within the hospital

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CDPH CAU Checklist – Mobile Units

• Vehicle Registration including ID, type & manufacturer

• Control of Mobile Unit (Title, Lease, etc.)

• Site Plan showing where mobile unit will be located

• Photos of the mobile unit to include identifying information (VIN, license plate, Housing and Community Development (HCD) Insignia)

• CDPH approval of program flex for temporary use of mobile unit to meet patients’ medication needs. (Title 22, 70267(a))

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Mobile Sterile Compounding Unit Program Flex Request

The program flexibility request (Form 5000) shall include:

• Reason for use and intended duration of use

• A diagram indicating location of the mobile unit

• Model of MSCU and interior design of the mobile unit

• A hospital approved P&P on use of MSCU

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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


Construction Start



BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks



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Pharmacy Summary ChecklistAppendix B of A2 Guide

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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


Construction Start



BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks



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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


Construction Start



BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks



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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


Construction Start



BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks



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CDPH Timeline: Pharmacy Clean Room Project Approval

Obtain Plan Approval from OSHPD

Construction Begins

Upon review of all the required documents, CDPH Pharmaceutical Consultant Unit will either conduct an onsite visit or recommend approval without an onsite visit

120 days before project completion, submit CAU application (Refer to CAU application checklist)

90 days before project completion: Inform CDPH Pharmaceutical Consultant Unit (PCU) by emailing to Hospital Lead Consultants, Art Woo and Rajvir Sajjan at:[email protected]

Submit Certificate of Occupancy from OSHPD to CAUSubmit the following to PCU: Clean room certification

report by third party company

BoP Inspection report All other documents

requested by PCU of CDPH

For mobile sterile compounding units, please refer to Mobile Sterile Compounding unit Approval Process

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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


Construction Start



BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks



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What Types of Projects Require CDPH Approval

§ 70105. Application Required

(a)(3) Added service or change from one service to another.

Example:• Adding a sterile compounding pharmacy to provide service to a new

outpatient infusion clinic on the hospital license

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§ 70805. Space Conversion

Spaces approved for specific uses at the time of licensure shall not be converted to other uses without the written approval of the Department.

Example:• Converting an old OR to a clean room or segregated compounding area• Converting a negative pressure isolation room to a clean room for hazardous

drug compounding• Converting a patient room/conference room/an office to a clean room

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§ 70803. Application for Architectural Plan Review

(a) Drawings and specifications for alterations to existing buildings or new construction shall be submitted to the Department for approval and shall be accompanied by an application for plan review on forms furnished by the Department.

Examples:• Adding a satellite sterile compounding pharmacy in the hospital• Remodeling of existing sterile compounding space (adding anteroom, externally

venting C-PEC, adding wall/door/sink to achieve compliance)

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What Types of Projects DO NOT Require CDPH Approval

Example:• Replacement of PEC or relocation of CAI/CACI that does not

involve alteration to the design of the sterile compounding space or change in HVAC system

Note: Recertification of equipment and environment may still be required

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CDPH Two-Step Approval Process

CAU Application:Licensure

Requirements

PCU Administrative Review

Recommend approval – No

onsite visit required

Onsite project sign-off visit by

PCU

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CDPH Two-Step Approval Process

Centralized Applications Unit (CAU)• Submit application 120 days prior to anticipated project completion

date

Pharmaceutical Consultant Unit (PCU)• Notify PCU by email 90 days before anticipated project completion

date

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Step1: CDPH Centralized Applications Unit

• Submit application packages to:

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

• Include “Hospital Sterile Compounding Project” in cover letter subject line to facilitate timely assignment.

• CAU will review the application package for completion. Once the application package has been approved by the CAU, the local district office and PCU will be notified to schedule the sign-off visit.

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CDPH CAU Checklist

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CDPH CAU Checklist

• Form HS 200 (Licensure and Certification Application)

• Floor Plan

• STD 850 (Fire Safety Inspection)

• Certificate of Occupancy

• Mobile Sterile Compounding Unit Requirements

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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


Construction Start



BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks



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Step 2: CDPH Pharmaceutical Consultant Unit (PCU) Review

• Approximately 90 days prior to project completion, notify Hospital Lead Consultants Art Woo and Raj Sajjan by email to:

[email protected]

• Based on project type, a list of required documents will be requested by the PCU for administrative review

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PCU Document Request List

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Pharmaceutical Consultant Unit (PCU) Administrative Review

Sample required documents for administrative review may include:

• 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

• Temperature (room and refrigerator/freezer) logs since date of certification to current

• Differential pressure monitoring logs

• All approved P&P for sterile IV compounding

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Sample Required Documents for Administrative Review

• 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

• Employee competency including competency for new equipment and processes

• Digital images of the completed project showing ante and buffer areas, all doors, windows, pass-throughs, walls, sinks, refrigerators, pressure monitoring devices, ceiling lights, air supply, air returns, and PEC placement

• Certificate of Occupancy (if required)• California Board of Pharmacy sterile compounding license and

inspector’s report

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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


Construction Start



BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks



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BoP Timeline

• Average PHY initial processing: 30-45 days


• Average LSC initial processing: 30-45 days


• Inspection requests:• 6-8 weeks

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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


Construction Start



BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks



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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


Construction Start

Construction CompletionOSHPD Certificate of Occupancy

BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks



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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


Construction Start



BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks



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BoP Application

Get OSHPD #

OSHPD Submittal

OSHPD Review

PSC Review

OSHPD Plan Approval


Construction Start



BoP Sign Off

CDPH Sign Off

Schedule BoP

6-8 weeks



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PCU Administrative Review

Administrative Review

Recommend approval – No

onsite visit required

Schedule onsite project sign-off visit by PCU

PCU Notify District Office of Project

Approval

PCU Notify District Office of Project

Approval

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BoP Lessons Learned &Common Mistakes

• Not completing application fully

• Incorrect person signing forms

• Not all forms are to be completed by the Pharmacist-in-charge (PIC)

• Not providing all required documents

• PHY:

• Completed figure prints

• LSC:

• Self-assessment

• Room number for sterile compounding area

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OSHPD Lessons Learned

• Use the Guide and Checklists!!!

• Complete and thorough Functional Program

• Complete and thorough Checklist with Sheet/Detail Information

• Complete the Pharmacy Summary Checklist

• Preliminary Submittal for OSHPD Review (optional)

• Complete and thorough Construction Documents• Put what’s in the checklist in the plans

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OSHPD Lessons Learned, cont.

• Expedient Back Check responses• Use red clouds to identify revisions

• Comprehensive Project Schedule• Project Scoping and Design• Plan review and permitting• Construction duration• Licensing and Acceptance

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CPDH Lesson Learned

• 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 documentedcommencing the certification date

• Certification must be done under dynamic operating conditions

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CPDH Lesson Learned

• Sampling plan shall be developed for viable air sampling to include locations with each ISO Class 5 environment and in the ISO 7 and 8 areas, and in the segregated compounding areas at greatest risk of contamination

• If microbial growth is identified in viable samples, identification of the microorganisms recovered (at least the genus level) is required. Highly pathogenic microorganisms must be immediately remedied, regardless of CFU count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist

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CPDH Lesson Learned

• Issues identified during certification and how they were resolved should be

documented in the reports

• If differential pressure and/or refrigerators/freezers temperatures are being

monitored electronically, be sure alarm settings are correct.

Periodic testing/calibration should be performed

• Licensing and Certification will not schedule an onsite inspection

until a Centralized Application Unit (CAU) application

has been completed and approved

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Who to Contact if There Are Issues

• [email protected]

• All sterile compounding license questions


• Waiver related questions

• www.pharmacy.ca.gov

• Locate the applications/instructions

• California State Board of Pharmacy

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• All sterile compounding OSHPD questions


• OSHPD standards questions

• www.osphd.ca.gov

• Locate the applications/instructions/guides

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• CAU mailbox at [email protected]• Phone: (916) 552-8632

• PCU mailbox at [email protected]

• An AFL will be issued with instructions and requirements

on clean room project applications

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Reference Documents

• Advisory Guide A2 – Sterile Compounding Pharmacies for Hospital Facilities• https://oshpd.ca.gov/FDD/Training_Education/index.html

• Pharmacy Summary Checklist (in the A2 Guide above)

• https://oshpd.ca.gov/FDD/Training_Education/index.html

• Form HS 200 to CAU for Trailer

• An AFL will be issued with instructions and requirements on clean room project applications

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Questions?

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Thank You

Richard [email protected]

Christine Acosta, PharmDCalifornia State Board of [email protected]

Cari Lee, [email protected]

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Questions

Online questions:Type your question in the

Q & A box, press enter

Phone questions:To ask a question, press *1

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Upcoming Programs

Consent Law Seminar

April 24, Fresno May 30, SacramentoMay 9, San Diego May 31, San RamonMay 10, Ontario June 5, PasadenaMay 15, Costa Mesa

CHA’s Consent Law seminar will keep you informed and prepared for those challenging cases hat demand immediate action. Expert faculty will help you understand changes in the laws surrounding patient treatment, and hone your critical thinking skills with scenarios that apply to real-world experience.

All attendees receive a 2018 Consent Manual-both in print and PDF versions.

For more information, visit: www.calhospital.org

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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].

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