Implementing USP Facility Equipment and Strategizing for USP Compliance

Implementing USP <797> Facility, Equipment and Strategizing for USP <797> Compliance Budget Approval Kate Douglass ASHP 2005 Summer Meeting June 13, 2005 #204-000-05-114-L04 Objectives At the end of this session learners will be able to: list the critical information and steps to follow to design or retrofit a sterile compounding pharmacy complex list the factors influencing design discuss and employ strategies for gaining budget approval at their hospitals make design and equipment decisions relevant to their hospital June 13, 2005 ASHP 2005 Summer Meeting 3 Start with an Overall Plan Determine Risk Level Matrix for all CSPs Perform a GAP Analysis comparing USP <797> requirements to actual pharmacy practice and P/P Develop Action Plan Communicate results of GAP analysis and proposed Action Plan to pharmacy staff as well as administrators June 13, 2005 ASHP 2005 Summer Meeting 4 Specific Physical Plant Requirements Based on CSP Risk Level Matrix (RLM) and GAP Analysis, identify changes required to physical plant Identify alternatives to alter current matrix Present Proposed Physical Plant changes in a White Paper format (see handout) Include alternatives and why they were ruled out June 13, 2005 ASHP 2005 Summer Meeting 5 Plan for Physical Plant Changes White Paper (proposal) must present rationale for changes that address Regulatory and Accreditation considerations Quality impact focusing on patient safety and risk management (lessening potential for litigation) Fiscal impact: in terms of human resource efficiency; capital expenditures; return on investment Strategic/Tactical considerations that may present a competitive advantage Alternatives considered June 13, 2005 ASHP 2005 Summer Meeting 6 Risk Level Matrix Helps you determine your needs based on your hospital’s practice Allows consideration of alternatives ∆ products used ∆ compounding methodology Shift workload (from unit to pharmacy; pharmacy to satellite) outsource strategic products Facility design criteria can not be established until you know what risk level CSPs require Facility Design Criteria fundamental to getting approval and driving design thru vendors June 13, 2005 ASHP 2005 Summer Meeting 7 CSP Risk Level Matrix CSP prepared in ISO Class 5 Cefazolin 1gm into Minibag TPN Morphine from powder for PCA “Snap togethers” Vial, adapter and diluent bag Bulk 10 gram vial Vancomycin distributed among 10 final doses Low 1:1 Medium* High 1 : Many or Many : 1 Non sterile, TS, outside ISO Class 5 X X X X X * Majority of hospital practice falls into Low/Medium Risk Level June 13, 2005 ASHP 2005 Summer Meeting 8 Facility Design Criteria See example in handouts Vendor selected should receive this and acknowledge in writing that their proposal will result in achievement of these functional criteria This document drives design and engineering meetings Based on Risk Level Matrix Must incorporate current and future offerings June 13, 2005 ASHP 2005 Summer Meeting 9 Derived from CSP Risk Level Matrix See full example in handouts provided Drives design and engineering meetings June 13, 2005 ASHP 2005 Summer Meeting 10 CSP Pharmacy Complex There is no neat answer that defines facility consideration based on hospital size Considerations need to be based upon the CSP Risk Level Matrix Alterations may be made to that matrix Facilities are designed to meet the Risk Level and volume required of a particular organization June 13, 2005 ASHP 2005 Summer Meeting 11 Factors influencing pharmacy design Volume of overall CSPs Types of CSPs prepared Staffing patterns Dose recycling programs Current physical plant Other planned remodeling June 13, 2005 Pharmaceutical care Existence of satellite pharmacies either on PCU or in specialty practices Current practices in organization Business environment: mergers/acquisitions ASHP 2005 Summer Meeting 12 Wall and General Considerations Epoxy coated gypsum board Interlocking panels made of cleanroom compatible materials Junction with floor to be coved and sealed. No ledge or gaps or right angles that makes cleaning difficult Avoid flat horizontal surfaces that can collect dust such as: Sills Horizontal exposed piping or conduit Large door jams and window frames Avoid cabinets; use carts restocked 1-2 times daily with essential supplies only June 13, 2005 ASHP 2005 Summer Meeting 13 June 13, 2005 ASHP 2005 Summer Meeting 14 Windows Worth the extra dollars Generally want to see into ISO Class 7 space Ideally: Aluminum jams and sill, aluminum frame Flush mounted (no sills) Sealed June 13, 2005 ASHP 2005 Summer Meeting 15 Ceilings Epoxy coated gypsum board Anodized aluminum T grid with Cleanroom ceiling tiles Tiles to be caulked in place to facilitate service/replacement Smooth, non-porous tiles that stand up to disinfectants Junction with walls to be coved or caulked June 13, 2005 ASHP 2005 Summer Meeting 16 June 13, 2005 ASHP 2005 Summer Meeting 17 Floors “Wide sheet vinyl flooring with heat-welded seams and coving to side walls” Must stand up to continuous cleaning with disinfectant agents No gaps or crevices for microorganisms to accumulate and grow Ideally coving and/or caulking at the base of all permanently mounted fixtures to facilitate cleaning If building from scratch, suggest line/s of demarcation built into floor with different color vinyl No floor drains June 13, 2005 ASHP 2005 Summer Meeting 18 June 13, 2005 ASHP 2005 Summer Meeting 19 June 13, 2005 ASHP 2005 Summer Meeting 20 Gauges Pressure differential from ISO Class 7 to non classed area should be ≥ .05 Measure clean room to gowning (anteroom) Gowning to Prep area Total must be ≥ .05 Recommend aiming for ≥ .08 June 13, 2005 ASHP 2005 Summer Meeting 21 Pass Throughs How will you get components in? How will you get finished CSPs out? Staff need to understand use Wall mounted, Cart pass thru June 13, 2005 ASHP 2005 Summer Meeting 22 Lighting Lighting: flush, sealed, change bulb within room; emergency lighting June 13, 2005 ASHP 2005 Summer Meeting 23 Sinks Stainless Steel Hands free Wall mounted Eye Wash Unit Integrated or as shown Plumbing Ideally a pump shroud cover should be developed to streamline cleaning June 13, 2005 ASHP 2005 Summer Meeting 24 What about hand dryers? Encouraged by some Issues with hand driers: Additional equipment and installation cost Require frequent repair Takes too long to completely dry hands Staff end up taking lint free towels to finish drying so materials waste OR Staff put gloves on when hands not yet dry which increases risk of contamination Recommendation: use knee valve and lint free wipes June 13, 2005 ASHP 2005 Summer Meeting 25 Furniture Furniture Cleanroom grade Stainless Steel preferred Significant portion of budget; $8-16K Mobility Avoid placing against wall June 13, 2005 ASHP 2005 Summer Meeting 26 Furniture Should be constructed of smooth, impervious materials, such as stainless steel or molded plastic Cleanable (plastic not as easy to clean) Avoid dead air spaces for particulates to build up If carts used in a unidirectional space, consider wire shelving to reduce obstruction to airflow June 13, 2005 ASHP 2005 Summer Meeting 27 Electrical/Data Outlets are GCFI CAT 5 wiring Emergency backup Dedicated circuits: telephones, lights, outlets, hoods, filters, refrigerator, freezer, computer, printer, etc. June 13, 2005 ASHP 2005 Summer Meeting 28 Electrical/Data Generator Dedicated preferred Assess what hospital’s generator capacity is Load primarily from HVAC ATS (automatic transfer switch) UPS for short term outage: computers, compounders, printers June 13, 2005 ASHP 2005 Summer Meeting 29 Laminar Air Flow Work Benches and Hoods Laminar Airflow Work Benches Improved use of space Design critical Returns unobstructed 100% HEPA coverage preferred to get Class 5 under operating conditions Place 3-4” from wall Lexan shields with stainless steel brackets Smoke test validation? Lexan expensive June 13, 2005 ASHP 2005 Summer Meeting 30 LAF Work benches June 13, 2005 ASHP 2005 Summer Meeting 31 Traditional LAFH Traditional LAFH Reduces usable space Results in increased time and difficulty to properly perform weekly and monthly cleaning (walls and ceilings) Less custom design required June 13, 2005 ASHP 2005 Summer Meeting 32 BSC or Negative Pressure Barrier Isolator Required for NIOSH classified “Hazardous” drugs Antineoplastics, Ganciclovir, Oxytocin Venting to the outside ONLY required if drugs are volatile Volatility information on MSDS sheets June 13, 2005 ASHP 2005 Summer Meeting 33 Barrier Isolators Not a panacea; may be option for very small hospitals or hospitals with satellite pharmacies Unidirectional airflow model HEPA filtered transfer chamber Isotech, NuAire, Baker, and Germfree have unidirectional airflow and filtered transfer chambers Evidence is mounting that suggests placement needs to be in an ISO Class 8 or better unless manufacturer can demonstrate effectiveness of engineering controls in an unclassified environment June 13, 2005 ASHP 2005 Summer Meeting 34 Refrigerator/Freezer Refrigerator/freezer NIST certification annually Alarm? Temperature recording or temperature scribe Types: Walk in Vertical Pass Thru June 13, 2005 ASHP 2005 Summer Meeting 35 HVAC Dedicated unit preferred Tonnage determined by complex size Thermostat in cleanroom Temp preferred 68°F±4 Humidity controls Velocity: minimum at terminal height needs to average 90-100 fpm Smoke Testing validation? June 13, 2005 ASHP 2005 Summer Meeting 36 Temperature/Humidity Monitoring Can buy unit that comes with software so you can print out readings at specified intervals Allows you to look at room conditions at rest as well as during peak productions Decreases time to document Provides better data June 13, 2005 ASHP 2005 Summer Meeting 37 Temperature/Humidity Monitoring June 13, 2005 ASHP 2005 Summer Meeting 38 Communications Telephone system Minimize number of time persons come in and out of cleanroom Facilitate pharmacist supervision of technicians Phone needs to be cleaned per cleaning protocol Music/Speakers Institutional policy Recommend that music/speakers not be employed in clean room June 13, 2005 ASHP 2005 Summer Meeting 39 Practical Cleanroom Design Miscellaneous: Sprinkler system: local code Fatigue mats: not appropriate for ISO Class 7 room due to difficulty cleaning Stools, if allowed, need to be stainless steel Ergonomic considerations in setting bench and hood heights June 13, 2005 ASHP 2005 Summer Meeting 40 So what next? Develop CSP Risk Level Matrix Determine if modifications may be in order Look at existing plant What can be used (rooms, eqt, furniture) What is available space? What is current HVAC? What is current generator capacity? Develop Facility Design Requirements June 13, 2005 ASHP 2005 Summer Meeting 41 Strategies for Approval Prepare a “White Paper” on the project Know what you need; Facility Design Criteria Put on business / finance hat Explain it in terms others can understand Get multiple bids from cleanroom vendors Some have very good ideas They should come on site Will need to show multiple bids to finance Explain differences between vendors June 13, 2005 ASHP 2005 Summer Meeting 42 White Paper on Proposal Regulatory requirements: USP, BOPs Accreditation Considerations: JCAHO Quality/Patient Safety/Risk Management Insurance Underwriters have expressed concern Non compliance with USP puts hospital at risk May increase premiums or decline to cover if not in compliance with USP <797> and have defined CSP Risk Level Matrix June 13, 2005 ASHP 2005 Summer Meeting 43 White Paper on Proposal Business and Operational Requirements Define issues specific to your institution and how solution will assist Define positive impact to other internal stakeholders Strategic Competitive Advantage How will this provide an advantage to gain greater market share June 13, 2005 ASHP 2005 Summer Meeting 44 White Paper on Proposal Capital Expenditure/Cost Summary Summarize pertinent facts about the expenditure Provide vendor information Information on negotiated discounts (# dollars and %) Negotiated terms and projected $ outlay with dates so project can be fit into projected cash flow June 13, 2005 ASHP 2005 Summer Meeting 45 White Paper on Proposal Present alternatives considered Present different vendor proposals as attachments Present other scenarios considered (even if you don’t agree with them) as others will ask and it is important to present an objective picture Summary: relate back to essential rationale for the proposal and restate how it will create value for the organization June 13, 2005 ASHP 2005 Summer Meeting 46 Project Management and Coordination Assign ONE (1) person to oversee and orchestrate all vendors on behalf of the project plan steering committee Develop project plan that includes miscellaneous items not directly related to cleanroom vendor (ie; stainless steel) Clean room vendor will either hire own sub contractors or hospital can obtain contractors Establish firm dates for critical elements Suggest legally binding agreement that provides hospital with recourse for substandard work. June 13, 2005 ASHP 2005 Summer Meeting 47 Summary Securing organizational support for a clean room project requires understanding and communication of engineering, finance, marketing, operations, risk management and other facets beyond pharmacy practice. Design and development of adequate controlled compounding environments depends on: Pharmacist determination of CSP Risk Level Matrix Organization specific Facility Design Requirements Careful planning and coordination June 13, 2005 ASHP 2005 Summer Meeting 48