Pharmacy. Graphic Standards Programming and Schematic Design. June 1999

Transcription

1 Graphic Standards Programming and Schematic Design June 1999

2 Table of Contents Table of Contents Function 3 Staff 5 Advantages of Movable Modular Casework 6 Functional Areas 7 Order Entry/Review 7 Unit Dose Picking/Dispensing 9 IV Admixture 11 Compounding/Packaging 12 Controlled Substance Storage 13 STAT Dispensing 14 Outpatient Picking/Dispensing 15 Technician s Workstation 16 Inventory Control 16 Bulk and Active Storage 17 Cart Holding 17 Pharmacist Office 18 Secretary/Reception 19 Break Room/Staff Lounge 20 Conference/Drug Information Center 21 Outpatient Consultation 22 Satellite Pharmacy 23 Functional Program 24 Bubble Diagram 25 Block Diagram 26 Preliminary Plan 27 Schematic Plan 28 Future Trends 29 Pharmacy 2

3 Function Function The primary function of the hospital pharmacy is the management of medications dispensed in the hospital, including the procurement, compounding, packaging, and distribution of those medications for both inpatients and outpatients. In addition and of equal importance, the pharmacy staff is responsible for the recordkeeping of information regarding medications, including the patient drug profile or history, drug usage and cost data, and drug inventory and security. The pharmacy is responsible for providing drug information to healthcare personnel, as well as being involved in drug educational programs. Pharmacists increasingly are becoming involved in patient care as members of the medical team. The hospital pharmacy function is monitored and regulated by national organizations, such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the American Society of Health System Pharmacists (ASHP), as well as state and local organizations, such as the State Board of Pharmacy. Methods of Medication Distribution The original medication order written by the physician is usually referred to as the first dose, first order, or STAT (immediate administration) order. This first dose is filled when received in the pharmacy, and sufficient dosage is supplied to cover the time until the next delivery of medications to the patient unit. The methods of continual repeat distribution of the medication by the hospital pharmacy usually fall into one of the following categories: Conventional Floor Stock System A given amount or par level of medications are stored in medication rooms at the nurses station and restocked by the pharmacy staff at a predetermined time. Measurement and administration of the medication and appropriate documentation are done by the nursing staff. Floor stock distribution alone is not widely used due to the lack of control, a high incidence of errors, and the waste of medications. Unit Dose Cassette Exchange System A unit dose (single dose) of packaged medication is prepared by the pharmacist. This unit dose is loaded into a small drawer designated for a specific patient, with all of that patient s medications for a given time frame (usually twenty-four hours) located in the drawer. Groups of these drawers, or cassettes, are loaded into a cart and transported to the patient units. Either the cassettes or the entire cart are exchanged for the existing cassettes or cart on the unit. Combination System A combination of a unit dose exchange system and conventional floor stock may be used. The floor stock is usually limited and consists of those generic medications of high usage such as aspirin, antacid, cough mixture, etc., while the majority of specific drugs are distributed by unit dose cassette exchange. Other Methods Medications are also administered in intravenous (IV) fluids. The addition of the medication to the sterile IV fluid is usually performed under a laminar flow hood by the pharmacist. Intravenous fluids of various types come in glass bottles, plastic bags, or syringes. Those IV fluids containing medications added by the pharmacist are then delivered to the patient units from the pharmacy. Pharmacy 3

4 Function Flow of Medication Orders and Medications Medication orders are always initiated by the physician in written form. The most common method of drug distribution used today is the unit dose system. The following chart shows the typical path or flow of the written drug order and the medication to, through, and from the pharmacy. PHYSICIAN WRITES ORDER FOR MEDICATION MEDICATION ORDER IS SENT TO PHARMACY VIA PNEUMATIC TUBE, FAX, COURIER, OR DUMBWAITER ORDER IS TIME/DATE STAMPED ORDER IS POSTED TO PATIENT PROFILE ORDER IS REVIEWED BY PHARMACIST NURSE ADMINISTERS MEDICATION TO PATIENT LABEL IS TYPED AND WORK ORDER PREPARED NURSE CHECKS MEDICATION ORDER AND IDENTITY OF PATIENT WORK ORDER IS REVIEWED BY PHARMACIST USED CASSETTES ARE RETURNED TO PHARMACY TECHNICIAN FILLS PATIENT DRAWER WITH ORDER CASSETTES ARE REPLENISHED OR EXCHANGED PHARMACIST CHECKS PATIENT DRAWER AGAINST ORDER CART IS DELIVERED TO PATIENT UNIT DRAWER CASSETTES ARE PLACED ON TRANSFER CART Pharmacy 4

5 Staff Staff Pharmacists Director of Pharmacy The director of the pharmacy is a registered pharmacist often holding an advanced education degree. The responsibility of this position is the total management of the direction and operation within the pharmacy including administrative, technical, functional, and policy issues. In addition, the director establishes relationships and interfaces with other hospital staff and committees as well as pharmaceutical representatives. It is the responsibility of the director to meet or exceed the standards of compliance of regulatory and accreditation organizations. Technicians Pharmacy Technicians Technicians may have various levels of education. It is their responsibility to perform tasks, such as packaging, picking, labeling, or inventory, as directed by the pharmacist. Support Staff Clerical Staff Clerical positions within the pharmacy may include receptionist, word processing, inventory, and/or procurement responsibilities. Pharmacist The pharmacist is licensed or registered to provide pharmaceutical services. The responsibility of the position is the management of the daily function of the department, primarily the accuracy of drug distribution. The pharmacist s accountability also includes the management and review of work done by technicians, interns, or residents and interfacing with patients, nursing, and medical staff. Pharmacy 5

6 Advantages of Movable Modular Casework Advantages of Movable Modular Casework Hospital pharmacies may differ somewhat in square footage, method of operation, and staffing based on the size of the hospital, type of hospital, and scope of outpatient services, but each hospital pharmacy has certain functional areas in common. The following pages describe the advantages of movable modular casework, give a brief description of the functional areas of hospital pharmacies, and provide typical plan views of movable modular casework applications. Movable Modular Casework In the past, hospital pharmacies were planned using fixed casework or millwork. However, fixed construction does not respond to the rapidly changing technology seen in healthcare facilities today. This fixed casework is often inaccurately described as modular. While these cabinets may be offered in many different widths for flexibility, they are attached to a custom-sized countertop to form an immovable, inflexible mass. By comparison with movable modular casework, fixed casework is difficult to install, reconfigure, and reuse. Movable modular casework offers the following major advantages and differences when compared with fixed casework or millwork: Movable modular casework components require less square footage within a pharmacy department. Movable modular casework components have been specifically designed to meet the functional requirements of the pharmacy department. Energy capabilities within the movable modular casework system allow the immediate addition or reconfiguration of all new and existing electrical equipment. Movable modular casework components have been designed to function as a movable system allowing the pharmacy to integrate with the patient units they serve, using the same components, for example, medication carts and satellite pharmacies using the same components. All movable modular casework components can be easily rearranged or reused by the end user, either minor or major reconfigurations, allowing ongoing changes with new technology. Additional components can be added at any time. Financial Advantages The initial cost of movable modular casework is competitive with fixed casework or millwork. However, the life cycle cost of movable modular casework is far less than fixed casework because of Longer product life. Minimal maintenance cost. Continual reuse of the components for new or different functions. Ability to install and reconfigure with little downtime. Accelerated depreciation rate, especially important to for-profit organizations. For preliminary budget purposes, movable modular casework for a pharmacy has an average price in the range of $177 to $265 per linear foot. This range will be affected by the density of overhead and undercounter storage components and the type of support structure used (wall-mounted versus panels). Pharmacy 6

7 Order Entry/Review Functional Areas Order Entry/Review This area of the pharmacy is the communications hub of the department and is often in a central or front location. A written medication order is received in order entry and reviewed by the pharmacist. Orders are compared with the patient s medication history or profile to prevent the administration of antagonistic or duplicated drugs. From this location, the order is assigned to a pharmacist or technician for selection and then rechecked by the pharmacist. All original written orders may be stored in this area. Work space must be provided for several people, as well as sufficient file and equipment space (telephone, fax machine, computers, copy machine, and printers). Movable Modular Casework and Furniture Systems Applications The entire order entry/review station can be planned using a freestanding panel or frame system with movable modular components to provide the following: Maximum utilization of space. Continual integration of computer technology. Electrical capabilities for continual integration of phones, fax, copiers, printers, etc. Movable modular components may include Corner work surfaces with keyboard trays or drawers to accommodate computers and printers. Cantilevered work surfaces. Overhead storage for manuals and technical reference materials. Above work surface counter or transactional work surface. Lateral and pedestal files. Task lighting under transactional counter. Pharmacy 7

8 Order Entry/Review Plan Views of Order Entry/Review Stations An order entry/review station will range in size from 50 to 150 square feet based on the size of the hospital and the amount of electronic equipment and staff requirements. Plan A 9' Plan A 18 linear feet work surface 40 filing inches 100 square feet 11' - 2" ORDER ENTRY/REVIEW Plan B 10 linear feet work surface 20 filing inches 50 square feet Plan B 7' - 2" 7' ORDER ENTRY/REVIEW Pharmacy 8

9 Unit Dose Picking/Dispensing Unit Dose Picking/Dispensing Hospital-dispensed medications are packaged in single doses for accuracy and efficiency of dosage administration. These single dose packages are referred to as unit dose and are usually the most frequently ordered or high-volume-use medications. The need for the retrieval of the most frequently used medications in an efficient, time-saving manner has led to the development of the unit dose picking station. The creation of a U-shaped workstation provides a space of limited dimensions containing a maximum quantity of drugs and allows the pharmacist to pick the appropriate drug. The pharmacist can fill drug orders with little wasted time and motion having high-volume or fastmoving drugs within arm s length. Multiple stations can be planned based on the number of drugs used and the number of hospital beds. A standard may be one picking station per 100 beds. The organization of these medications will vary among hospitals. Movable Modular Casework Applications The components for unit dose picking stations can be planned in many different configurations based on the space parameters, number of drugs to be dispensed, additional functions and equipment within the station, and the number of technicians using the station. The use of a freestanding panel system for the configuration of the stations provides the most efficient use of space as well as the capability of storing the maximum number of medications. Medication containers (subcontainers) can be arranged in a gravity-feed position or on flat shelves. Work surfaces for clerical and computer needs can be incorporated into the station at any time. Pharmacy 9

10 Unit Dose Picking/Dispensing Plan Views of Unit Dose Picking Stations Unit dose picking stations will vary in size and configuration. The number of stations and square footage depends on the size of the hospital and the number of drugs in the formulary. Drug Work Square Plan Bins Surface Feet Plan A 6' - 6 1/2" UNIT DOSE PICKING A 255 avg 6 LF 55 B 190 avg 6 LF 42 C 450 avg 8 LF 72 D 480 avg 10 LF 90 Plan B 8' - 6 1/2" 6' - 6 1/2" UNIT DOSE PICKING 6' - 6 1/2" Plan C 8' - 6 1/2" Plan D 8' - 6 1/2" 8' - 6 1/2" UNIT DOSE PICKING 10' - 6 1/2" UNIT DOSE PICKING Pharmacy 10

11 IV Admixture IV Admixture A specific area of the pharmacy is designated for the function of adding medications to intravenous (IV) fluids prior to administration to the patient. Although code requirements may differ, this area must be the cleanest part of the department. It is recommended that IV admixture be in a closed room with positive pressure for isolation and cleanliness in preventing contamination. Movable Modular Casework Applications Movable modular casework components are used for work areas and storage of fluids and medications and may include Cantilevered work surfaces for clerical and technical work areas. Mobile process tables and smaller mobile L carts for movable work areas adjacent to the flow hood. Lockers to store intravenous fluids and additives. Lockers on wheels (TR3 cart) moved to the storage area for restocking of fluids. The injection of the medication into the IV fluid is carried out under a laminar flow hood. The IV admixture room should provide space for a limited supply of intravenous fluids and medications, as well as sinks, refrigerators, computers, and work areas. The size of an IV admixture room will vary based on the size of the hospital, types of medications being added to fluids, and the number of hoods needed. REF IV ADMIXTURE HOOD Plan View of an IV Admixture Room An IV admixture room will range in size from 160 to 500 square feet. 46 linear feet work surface 92 linear feet overhead storage 2 lockers for IV storage 1 L cart 407 square feet HOOD 18' - 6" CHEMO HOOD 22' Pharmacy 11

12 Compounding/Packaging Compounding/Packaging The compounding area of the pharmacy is the section where liquid and topical medications are mixed and stored. There is a need for a sink, medication storage, computer, label printer, and sufficient work surface. In the packaging area, medications in both liquid and tablet form that are not manufactured as a single-dose unit can be divided and packaged as needed. In many smaller hospitals, compounding and packaging may be combined in the same location. Movable Modular Casework and Furniture Systems Applications A combination of both wall-mounted and freestanding modular components are appropriate for this area. The area is usually configured along an existing wall to access plumbing. All of the work surfaces, sink units, and overhead supply storage can be programmed with movable modular components. Plan Views of Compounding/Packaging Areas Compounding and packaging areas combined will range in size from 75 to 150 square feet. Compounding 10 linear feet work surface 16 linear feet overhead storage 50 square feet 10' - 1" COMPOUNDING 2' Additional storage and work space can be planned using freestanding panels. Large mobile tables for labeling and packaging equipment provide flexibility for the packaging function. Packaging 8 linear feet work surface 16 linear feet overhead storage 40 square feet 8' - 1" PACKAGING 2' Pharmacy 12

13 Controlled Substance Storage Controlled Substance Storage Narcotics and other governmentcontrolled drugs are stored in a vault or locked room in the pharmacy, usually located away from the primary entrance but in a highly visible location. Movable Modular Casework Applications Modular shelving is applicable for the controlled substance storage room within the pharmacy. Double-locking modular medication carts are used for transporting controlled substances to the patient units. 7' - 8" Plan View of a Controlled Substance Storage Room A controlled substance storage room will range in size from 45 to 120 square feet. 4 linear feet work surface 52 linear feet storage 80 square feet CONTROLLED SUBSTANCE STORAGE 10' - 8" Pharmacy 13

14 STAT Dispensing STAT Dispensing When a STAT or immediate drug order is issued by a physician, that order needs to be filled and delivered to the patient unit as soon as possible, rather than waiting for the next routine floor delivery. An area of the pharmacy is often set aside for STAT dispensing and contains smaller quantities of frequently ordered drugs. Hence, these STAT orders can be filled without disrupting the flow of normal order picking and filling. Movable Modular Casework Applications Similar to the unit dose picking station, this STAT picking area should be configured using freestanding panels, hanging drug containers, and cantilevered work surfaces. Plan View of a STAT Dispensing Station A STAT dispensing station will range in size from 60 to 120 square feet. 12 linear feet work surface 24 linear feet overhead storage 165 drug bins average 80 square feet 8' - 4" STAT DISPENSING 10' - 1 1/2" Pharmacy 14

15 Outpatient Picking/Dispensing Outpatient Picking/Dispensing The hospital pharmacy also may dispense medications to outpatients. To avoid direct competition with the retail pharmacy, the hospital pharmacy must purchase, discount, and maintain separate stock for outpatients. The outpatient dispensing area requires sufficient medication storage space, work surface, and space for equipment (computer, printer, label printer, refrigerator). The size of this space depends on the size of the hospital and the number of outpatient orders received. In some smaller hospitals, this may be an isolated aove, while in others, such as military, teaching, and veterans hospitals, this may be a major department. Picking and dispensing areas may be separated in larger hospitals. If the outpatient dispensing function of the pharmacy warrants, an area should be provided for patients to wait while their medication orders are filled. This can be provided as a seating area in an aove or small room at the primary entrance to the pharmacy. This area should be visible from the reception or order entry station and should be secure from the primary area of the pharmacy. Movable Modular Casework Applications The same movable modular casework components used in the primary pharmacy are applicable in the outpatient area and may include Cantilevered work surfaces. Regular and extra-deep modular shelving units. Drug bins. Cantilevered sink unit. 8' - 0 1/2" 8' - 4" OUTPATIENT PICKING 8' - 1 1/2" 8' - 7" OUTPATIENT DISPENSING Plan View of an Outpatient Picking Station An outpatient picking station will range in size from 60 to 100 square feet. 8 linear feet work surface 42 linear feet storage 165 drug bins average 70 square feet Plan View of an Outpatient Dispensing Station An outpatient dispensing station will range in size from 50 to 100 square feet. 10 linear feet work surface 12 linear feet overhead storage 64 square feet Pharmacy 15

16 Technician s Workstation, Inventory Control Technician s Workstation Technicians in the pharmacy need small workstations or office areas for completing paperwork, accessing computer programs, telephone conferencing, and reading medical manuals and reports. Movable Modular Casework and Furniture Systems Applications Components for these stations, either wall-mounted or panel-hung, offer the most flexibility for use of the space. Freestanding panels offer varying degrees of privacy and can be configured based on individual needs. 8' - 6 1/2" Plan View of a Technician s Workstation A technician s workstation will range in size from 45 to 90 square feet. 10 linear feet work surface 16 linear feet overhead storage 20 filing inches 55 square feet 6' - 6 1/2" TECH WORKSTATION Inventory Control A small workstation adjacent to bulk and active storage provides a space for maintaining information regarding the inventory of the pharmacy. From this area, the staff will log in drugs at arrival in the department, monitor supplies within the pharmacy, and procure medications as needed. Movable Modular Casework and Furniture Systems Applications Wall-mounted or panel-hung modular components can be used in this area providing work surface, storage, and filing capabilities. 8' - 1 1/2" Plan View of an Inventory Control Station 10 linear feet work surface 20 linear feet overhead storage 40 filing inches 40 square feet INVENTORY CONTROL STATION 4' - 1 1/4" Pharmacy 16

17 Storage, Cart Holding Bulk and Active Storage Bulk storage is the area of the pharmacy where medications and intravenous fluids are stored in bulk quantities. These bulk supplies are generally removed from the shipping boxes, prior to delivery to the pharmacy, or stored in an anteroom outside of the pharmacy because of the associated dust and dirt from the outer packaging. Bulk storage space can be conserved by using a movable aisle system. The active storage area contains readyto-use supplies in smaller quantities than bulk storage and is accessed to restock unit dose picking stations, compounding, and packaging and house the slowermoving medications not included in the picking station. Movable Modular Casework Applications Freestanding modular shelving and mobile carts are appropriate for the bulk and active storage areas. Shelving units can be configured with shelves of 24", 30", or 48" widths and can be arranged in many different combinations. 2' - 4 1/2" Plan View of Shelving for Bulk and Active Storage 40 linear feet per 4-foot section, shelving both sides 25 square feet per 4-foot section 10' - 6 1/2" BULK/ACTIVE STORAGE Cart Holding The cart holding area of the pharmacy should allow sufficient space for storing medication and/or transfer carts for the patient units awaiting delivery or exchange. The amount of space will depend on the method of cart replenishment or exchange. Movable Modular Casework Applications A modular medication cassette transfer cart will allow integration with the movable modular casework. 4' /4" 2' - 2 3/4" CASSETTE TRANSFER CART Pharmacy 17

18 Pharmacist Office Pharmacist Office The director of the pharmacy, as well as other pharmacists, may have private offices within the department. Small conferences and meetings with drug representatives and other hospital staff may require privacy and confidentiality. Movable Modular Casework and Furniture Systems Applications Either full-height fixed, demountable walls or freestanding modular panels are appropriate. 10' - 9 1/2" Consistency between systems used in administrative and clinical areas allows for compatibility and flexibility when dealing with future changes. PHARMACY DIRECTOR Plan View of a Pharmacy Director s Office 14 linear feet work surface 24 linear feet overhead storage 40 filing inches 150 square feet 13' - 6" ASSISTANT DIRECTOR 9' - 7 1/2" 10' - 9 1/2" Plan View of an Assistant Pharmacy Director s Office 8 linear feet work surface 20 linear feet overhead storage 136 filing inches 100 square feet Pharmacy 18

19 Secretary/Reception Secretary/Reception Most hospital pharmacies will have administrative areas for secretaries and clerks. These should be located toward the front of the pharmacy to discourage traffic into the clinical areas where medications are accessible. NOTE: Pharmacies are required to display all their various licenses. Movable Modular Casework and Furniture Systems Applications Modular furniture system components can be used to furnish these areas and may include Tool bars and accessories for paper handling. Corner work surfaces with keyboard tray or drawer to accommodate computers and printers. Flipper storage, display shelves, and open shelves for storing manuals and books. Tackboards or display shelves to display documents. Task lights and personal lights. Freestanding tables or peninsula work surfaces for conferencing. File storage in pedestal drawers, hanging drawers, and hanging or freestanding lateral files. 8' - 9 1/4" Plan View of a Secretary/Reception Area A secretary/reception area will range in size from 75 to 150 square feet. 8' - 7 3/4" 12 linear feet work surface 16 linear feet overhead storage 40 filing inches 75 square feet SECRETARY/ RECEPTION Pharmacy 19

20 Break Room/Staff Lounge Break Room/Staff Lounge Pharmacy departments generally provide a staff lounge for coffee breaks and meals. It is important to locate this break room close to or within the pharmacy department especially for staff working the second and third shifts. Since the number of staff working these shifts is small, it is preferred that they do not leave the area for breaks and be on hand for STAT orders or emergencies. Space should be provided for a refrigerator, microwave oven, coffee maker, and supplies. Movable Modular Casework and Furniture Systems Applications The break room/lounge area can be planned using modular components and may include Wall strips with cantilevered work surface and overhead storage or heavy-duty storage work surface with C frame storage units and drawers. Tables and seating. Tackboards to display information. BREAK ROOM/LOUNGE 11' - 7" Plan View of a Break Room/Staff Lounge A break room/staff lounge will range in size from 100 to 200 square feet. 8 linear feet work surface 12 linear feet overhead storage 125 square feet 10' - 9 1/2" Pharmacy 20

21 Conference/Drug Information Center Conference/Drug Information Center It is the responsibility of the pharmacy to provide current drug information and education for the medical staff, including the pharmacists, physicians, and nurses. A space is usually provided in larger hospital pharmacies that is accessible for this purpose. A large amount of shelving is provided to house current periodicals and other reference manuals. A conference type of table and seating are available for reading or studying, as well as a small copy machine and space for a computer. Movable Modular Casework and Furniture Systems Applications Movable modular casework components and modular furniture systems allow for future flexibility and change. The requirements of this area will be unique to each pharmacy but may include Extra-deep modular shelving units to hold large reference manuals. Tables or work surfaces for sitting and reading. Comfortable seating. Task lights to illuminate work surfaces for reading. Limited filing for articles and reports. 9' - 9" CONFERENCE/ DRUG INFORMATION CENTER Plan View of a Conference/Drug Information Center 40 linear feet storage 48 filing inches 150 square feet 15' - 6 1/2" Pharmacy 21

22 Outpatient Consultation Outpatient Consultation The pharmacist will often meet with patients and their families to discuss a medication program, instruction in administration, expected drug results, and possible drug complications. In larger hospitals, there is often a consultation room within the pharmacy which allows for the privacy of these meetings. Movable Modular Casework and Furniture Systems Applications Movable modular casework components and modular furniture systems allow for future flexibility and change. The requirements for this area may include Conference tables and seating. Wall strips with shelves, marker boards, and tackboards. 9' - 9" OUTPATIENT CONSULTATION Plan View of an Outpatient Consultation Room 32 linear feet storage 120 square feet 12' - 5" Pharmacy 22

23 Satellite Pharmacy Satellite Pharmacy Small satellite pharmacies may exist in any patient unit or service department but are more commonly placed in the more acute care units, such as critical care units, emergency departments, surgery, and chemotherapy units. This decentralization of the pharmacy function allows for more rapid response to the needs of the patient and allows the pharmacist more involvement in the clinical therapy of the patient. The space will vary in size but will usually contain a small drug picking area, sink, refrigerator, computer, printer, label printer, and controlled substance storage. Some satellite pharmacy areas may have a small laminar flow hood. The satellite pharmacy is staffed, stocked, and serviced by the primary pharmacy department. Modular carts are appropriate for the transfer of medications to the satellite pharmacy. Movable Modular Casework Applications The same movable modular casework components used in the main pharmacy are appropriate for the satellite pharmacy, allowing for continual flexibility and change in the space. Plan View of a Satellite Pharmacy A satellite pharmacy will range in size from 120 to 250 square feet. 18 linear feet work surface 28 linear feet overhead storage 80 drug bins average 1 locker 1 medication cart 140 square feet 12' - 3" SATELLITE PHARMACY HOOD 11' - 3" Pharmacy 23

24 Functional Program Functional Program Number Department Area Square Feet Movable Modular Casework Unit Dose Picking/Dispensing sq. ft. IV Admixture Room Compounding Area Packaging Area Controlled Substance Storage Room STAT Dispensing Station Outpatient Picking sq. ft. Outpatient Dispensing sq. ft. Bulk Storage Area Active Storage Area Cart Holding Area Staff sq. ft. Janitor s Closet Subtotal Modular Furniture Systems Order Entry/Review Station Technician s sq. ft. Inventory Control Station Pharmacist s sq. ft. Secretary/Reception Staff Lounge Conference Room Drug Information Center Outpatient Consultation Room Subtotal TOTAL NET SQUARE FEET Net-to-Gross Conversion Factor X TOTAL GROSS SQUARE FEET Pharmacy 24

25 Bubble Diagram Bubble Diagram The bubble diagram of the pharmacy department demonstrates typical departmental relationships and interaction between areas. Necessary adjacencies within the department become clear. ORDER ENTRY RECEIVING OUTPATIENT DISPENSING BULK STORAGE IV ADMIXTURE PICKING COMPOUNDING OUTPATIENT CONSULTING PACKAGING SECRETARY/ RECEPT CART HOLDING ACTIVE STORAGE NARCOTICS OFFICES Pharmacy 25

26 Block Diagram Block Diagram The block diagram demonstrates the adjacencies and relative sizes for the areas within a typical pharmacy. Evaluation of the work flow and materials flow from the bubble diagram has determined this initial general layout. The size of each area is determined by combining the typical movable modular casework plans for each identified function. Traffic patterns are developed, and an overview of the general work process can be evaluated. Pharmacy 26

27 Preliminary Plan Preliminary Plan The preliminary plan clarifies the pharmacy space requirements by showing the location of all the fixed walls and open areas and identifies entrances, exits, and exact traffic patterns. Pharmacy 27

28 Schematic Plan Schematic Plan The schematic plan shows all of the specific movable modular casework, modular furniture systems, and materials handling components appropriate for a typical pharmacy. 65' - 3" ASS'T DIR SECRETARY RECEPTION WAIT OUTPATIENT WAITING OUTPATIENT DISPENSING OUTPATIENT PICKING STAT DISPENSING DIRECTOR CONFERENCE DRUG INFO ORDER ENTRY/ REVIEW NIGHT CONSULTATION TOPICALS TECH WORK AREA TECH WORK AREA TECH WORK AREA LIQUIDS UNIT DOSE PICKING 70' - 10" STAFF LOCKER ROOM CART STORAGE CART STORAGE ACTIVE STORAGE BREAK ROOM/ LOUNGE IV ADMIXTURE IV STORAGE BULK STORAGE PACKAGING INVENTORY CONTROL RECEIVING/BREAKDOWN COMPOUNDING CONTROLLED SUBSTANCE STORAGE Pharmacy 28

29 Future Trends Future Trends Administration New pharmacy practices will continue to grow, with patient counseling and patient monitoring showing the most growth. Pharmaceutical care will concentrate on the prevention of drug-related problems. Medication Dispensing Most unit dose packs will be bar coded with operational and cost savings, and nurses will carry bar code wands to tabulate drug administration. The unit dose concept will continue to grow. There will be an increase in the number of STAT or first doses coming from the pharmacy or satellite pharmacy because very ill patients require more medication changes. New dosage forms, such as osmotic pumps, controlled release systems, and transdermal delivery, are appearing. IV admixture use is increasing with more complicated, expensive, and perishable drugs such as biotech drugs, hyperalimentation, and the mix of several drugs in one IV. First doses, PRN doses, and narcotics will be kept in cabinets in nurses stations, often dispensed by automated equipment. Layout The relative proportions of office, reference, storage, and drug distribution spaces will be constantly shifting and changing. Traffic congestion and traffic patterns are becoming more complex with patient consultations within the pharmacy growing at a rapid rate. Bulk storage will decrease as computers, prime vendors, and formulary practices increase. The size of IV admixture rooms will increase because of the increased volume of medications administered by this method. The pharmacists will more often be stationed in the satellite pharmacy on the patient unit with more patient contact, consulting, and evaluation of drug therapy. Automated drug dispensing machines will become more prevalent within the pharmacy. Pharmacy 29

30 For the location of the sales facility or dealer near you, visit or call (800) Herman Miller, Inc., Zeeland, Michigan Z, Y, Action Office, Aeron, Ambi, Arrio, Beirise Collection, Co/Struc, Custom Choices, Eames, Equa 2, Ergon 3, Ethospace, E-Wall, Frottage, Ground Cloth, Harmonics, Hollington, Intersite, Kinemat, Liaison, Meridian, Miare, Mosaic, Newhouse Group, Pellicle, Perspectives, Proper, Pulsar, Rapid Response, Relay, Response Plus, Scooter, Super Room, Systems Bridge, Timepiece, V-Wall, and Wild Card are among the registered trademarks of Herman Miller, Inc. SM Y, Aeron Chair Configuration, Ambassador, Burdick Group, Chadwick, CLT, CoActive, DIAMOND, Flex-Edge, Florence, ID, Iota, Milafin, Myriad, Passage, Potomac, Puzzle, Q, Raleigh, Rapunzel, and Traverse are among the trademarks of Herman Miller, Inc. OASIS is a service mark of Herman Miller, Inc.

31 Clean Room 1 Technical Bulletin June 1999

32 Clean Room Table of Contents Glossary 3 Traditional Preparation of Sterile Products and Associated Problems 5 Description of Clean Room and Activities 5 What is a Clean Room? 5 Clean Room Activities 5 Clean Room Standards and Guidelines 6 Federal Standard 209E 6 Technical Assistance Bulletin (TAB) Guidelines 6 Risk Levels Established by the Technical Bulletin 6 Enforcement of Guidelines 7 Anteroom Description and Activities 7 Material Transfer Between Anteroom and Clean Room 8 Considerations For Planning And Design 8 Clean Room Construction Methods 8 Allocated Space 8 Clean Room Size 8 Typical Installations 10 Plan View 1 11 Plan View 2 13 Plan View 3 15 List of Appropriate Herman Miller Product 16 Anteroom 16 Clean Room 16 Herman Miller Contact Information 16 Allied Suppliers of The Clean Room Package 16 V-Wall Modular Wall Systems 16 Gencorp 16 CRI (Clean Rooms International) 17 List of V-Wall Representatives 18 Supply Management 9 Operational Management 9 Allocation of Responsibilities 9 Design Requirements 9 1 Technical Bulletin 2

33 Clean Room Glossary Anteroom A support area adjacent to the clean room. Anteroom handles distribution and particle-producing activities which should be separated from the clean room. Aseptic Preparation The technique involving procedures designed to preclude contamination (of drugs, packaging, equipment, or supplies) by microorganisms during processing. ASHP American Society of Health System Pharmacists, Inc. Batch Preparation Compounding of multiple sterile-product units, in a single discrete process, by the same individual(s), carried out during one limited time period. Biological Safety Cabinet Also known as a bio-safety hood. Used for preparation of toxic, infectious, or sterile substances. This will always be a vertical flow hood. Clean Room A room in which the concentration of airborne particles is controlled and there are one or more clean zones. (A clean zone is defined as space in which the concentration of airborne particles is controlled to meet a specified airborneparticulate cleanliness class.) Clean rooms are classified based on the maximum number of allowable particles 0.5 micron and larger per cubic foot of air. For example, the air particle count in a Class 10,000 clean room may not exceed a total of 10,000 particles of 0.5 micron and larger per cubic foot of air. Clean Room Manufacturer A company which provides a variety of products and services for clean room environments. Closed-System Transfer The movement of sterile products from one container to another in which the container-closure system and transfer devices remain intact throughout the entire transfer process. The closure is compromised only by the penetration of a sterile, pyrogen-free needle, cannula, or equivalent needle-free system through a designated stopper or port to effect transfer, withdrawal, or delivery. Withdrawal of a sterile solution from an ampule in a Class 100 airflow hood would generally be considered acceptable; however, the use of a rubberstoppered vial, when available, would be preferable. Compounding The mixing of substances to prepare a medication for patient use. This activity would include dilution, admixture, repackaging, reconstitution, and other manipulations of sterile products. Controlled Area The area designated for preparing sterile products. CRI (Clean Rooms International) A co-operative supplier of clean room air pumps, filters, and lighting equipment. Critical Area Any area in the controlled area where products or containers are exposed to the environment. Critical Site An opening providing a direct pathway between a sterile product and the environment or any surface coming in contact with the product or environment. Critical Surface Any surface that comes into contact with previously sterilized products or containers. Expiration Date The date (and time, when applicable) beyond which a product should not be used (i.e., the product should be discarded beyond this date and time). NOTE: Circumstances may occur in which the expiration date and time arrive while an infusion is in progress. When this occurs, judgment should be applied in determining whether it is appropriate to discontinue that infusion and replace the product. Organizational policies on this should be clear. HEPA Filter A high-efficiency particulate air (HEPA) filter composed of pleats of filter medium separated by rigid sheets of corrugated paper or aluminum foil that direct the flow of air forced through the filter in a uniform parallel flow. HEPA filters remove 99.97% of all air particles 0.3 micron or larger. When HEPA filters are used as a component of a horizontalor vertical-laminar-airflow hood, an environment can be created consistent with standards for a Class 100 clean room. Horizontal Flow Hood Airflow hood used for preparation of nontoxic sterile products which pose no danger to the technician. Also known as a Laminar Flow Hood. Laminar Air Flow Hood Generic term for a vertical, horizontal or bio-safety hood. These terms may be used interchangeably. Micron A unit of measure equal to one-millionth of a meter ( meter). 1 Technical Bulletin 3

34 Clean Room Quality Assurance Activities used to ensure that the processes followed in the preparation of sterile drug products lead to products that meet predetermined standards of quality. Quality Control Testing activities used to determine that the ingredients, components (e.g. containers), and final sterile products prepared meet predetermined requirements with respect to identify purity, non-pyrogenicity, and sterility. Repackaging The subdivision or transfer from a container or device to a different container or device, such as a syringe or ophthalmic container. Sterilizing Filter A filter (of 0.2 micron or less) that will produce a sterile effluent when challenged with a solution containing the microorganism Pseudomonas diminuta, at a minimum concentration of 10 organisms per square centimeter of filter surface. Temperatures (USP) Frozen means temperatures between -20 and -10 C (-4 and 14 F). Refrigerated means temperatures between 2 and 8 C (36 and 46 F). Room temperature means temperatures between 15 and 30 C (59 and 86 F). USP Procedures and products that adhere to United States Pharmacopeial standards. USPC United States Pharmacopeial Convention, Inc. Generally referred to as USP. An agency which sets pharmaceutical standards. Authors of a pharmacy advisory document entitled Dispensing Practices for Sterile Products Intended for Home Use. V-Wall A modular wall system affiliated with Herman Miller, Inc. that can be used to create a certified Clean Room. V-Wall modular walls integrate with Herman Miller CO and AO components. Validation Documented evidence providing a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Vertical Flow Hood Airflow hood used for preparation of toxic sterile substances such as chemotherapeutic agents. The HEPA filtered air emerges from the top and passes downward through the work area to protect the technician when preparing toxic substances. 1 Technical Bulletin 4

35 Clean Room Traditional Preparation of Sterile Products and Associated Problems For many years, standard practice in many pharmacies has been to prepare sterile products within the microenvironment of an unidirectional airflow hood. Often the airflow hood was set up in an area adjacent to the main pharmacy. The airflow hood kept the immediate preparation area clean but surfaces surrounding the hood were subjected to airborne particles and contaminants. These contaminants could potentially compromise the quality and aseptic integrity of sterile products. Because documented cases of sterileproduct contamination have occurred, the pharmacy profession has now established recommendations to promote higher quality standards for prepared sterile products. Since 1993 there has been a significant upgrading of performance requirements for institutional pharmacies. This upgrading has been prompted by the Technical Assistance Bulletin (TAB) on Quality Assurance for Pharmacy- Prepared Sterile Products published in November 1993 by the American Society of Health System Pharmacists, Inc. (ASHP). Some pharmacists regard the TAB as a guideline only and choose not to follow all the recommendations. However, the TAB now makes clean room technology desirable for most pharmacies. The bulletin has also created more awareness among pharmacists concerning clean room procedures. The USPC has also distributed an advisory document entitled Dispensing Practices for Sterile Products Intended for Home Use. While this document is intended for home care, the USP intends to expand its scope and context to include the preparation of sterile products in pharmacies. Description of Clean Room and Activities What is a Clean Room? In essence, the ASHP s Technical Assistance Bulletin has formalized recommendations for creating a clean environment to surround the airflow hood microenvironment. Clean room technology has been used for many years in microelectronics assembly, biotech research, and pharmaceutical manufacturing. Recently clean rooms have been adapted for pharmacy. A clean room is a confined area in which the air must be so pure that even micron-sized particles are screened out. For example, the particle count in a Class 10,000 clean room may not exceed a total of 10,000 particles of 0.5 micron or larger per cubic foot of air. For size comparison, a micron is equal to onemillionth of a meter. The key issue in the clean room is to provide an area for IV preparation that is free of contamination and limited in the number of airborne particles. The reason for filtering these particles is to prevent microbes from migrating independently. Microbes are typically carried by airborne dust and organic particles. The clean room can effectively remove viable microbes by removing particles (less than or equal to 0.5 micron) from standing surfaces and incoming air. This air purity is achieved through the creation of a shell or secluded area that is sealed off from the rest of the environment. To compare this level of purity, conditioned air in an average office space is exchanged six times an hour. For example, in a common clean room, air is filtered and fully exchanged 60 or more times an hour. Because of this airflow rate and the number of filters and air pumps required to sustain it, a clean room can be a highnoise and high-heat environment. Clean Room Activities IVs, piggybacks, and syringes of medication are prepared in the clean room area of the pharmacy. The clean room may also be known as the clean area or critical area. The process of preparing IVs may also be known as sterile preparation of parenteral products or IV admixture. Many IVs arrive from the manufacturer already containing a solution and will not require additional preparation. Other types of IVs require a separate medication to be added to the solution in a process called IV admixture. This admixture process occurs under a horizontal or vertical airflow hood that is found inside a clean room or clean area in the pharmacy. Under a laminar airflow hood there is a constant pressure of twice-filtered clean air that flows in a laminar pattern across the work surface at approximately 90 linear feet per minute. This clean air physically sweeps the work area and prevents the intrusion of contaminated room air. The term laminar indicates that the final filter channels air into parallel streams to promote uniform air flow. There are two types of hoods used in admixture areas. In both types the air is drawn through a High-Efficiency Particulate Air ( HEPA ) filter which removes 99.9% of particles that are 0.3 micron or larger, thereby virtually eliminating airborne particles. In a vertical flow hood, HEPA-filtered air emerges from the top and passes downward through the work area. This directs vapors and splashes away from the technician. These hoods are used to protect the technician when preparing toxic substances such as chemotherapeutic agents. 1 Technical Bulletin 5

36 Pharmacy Clean Room A horizontal flow hood moves air Technical Assistance Bulletin Risk Levels Established by the toward the worker. Horizontal flow (TAB) Guidelines Technical Bulletin hoods are used for preparation of Pharmacists are responsible for the The Technical Bulletin groups sterile nontoxic parenterals (antibiotics, enteral aseptic preparation of sterile products. products into three levels of risk to the and parenteral nutrition) that are not a The Technical Assistance Bulletin patient, increasing from least potential threat to the technician. The horizontal (TAB) on Quality Assurance for Pharmacy-Prepared Sterile Products, (Level 3). Each risk level has different risk (Level 1) to greatest potential risk movement allows a more uniform, laminar flow of air. published by the ASHP in November quality assurance recommendations for 1993, describes appropriate practice product integrity, patient safety, and Clean Room Standards and procedures for preparation of sterile facility design. Level 1 preparation is the products matched with potential risks least demanding. Level 2 includes Guidelines posed to the patients. The recommendations apply to pharmacy services in and carries higher risk to the patient if products prepared for longer-term usage Federal Standard 209E The Federal Standards Bureau determines how clean a clean room must be. nursing homes, home health care more stringent requirements are appro- hospitals, community pharmacies, the product is contaminated; therefore, It has set up a classification system organizations, and other settings. priate. The quality assurance activities called (at time of publication) Federal for risk Level 3 are even more demanding in terms of process and facility Standard 209E. The standard states that The Technical Bulletin is organized by to achieve the goals of clean room several categories: requirements. operation, potentially damaging particles Policies and Procedures should be regulated. Personal Education Risk Level 1 Training and Evaluation Requires sterile products to be prepared Clean rooms are classified according to Storage and Handling inside a horizontal or vertical laminar the number and size of particles found in Facilities and Equipment airflow hood (Class 100 environment). a given cubic foot of space once the Aseptic Preparation Techniques The guidelines recommend that the room is operational. The number of Process Validation be placed in a limited access area particles determines the class of the Expiration Dating sufficiently separated from other room. For example, a Class 100,000 Labeling pharmacy operations to minimize the condition allows no more than 100,000 Product Evaluation and potential for contamination from outside particles 0.5 microns and larger per cubic Documentation sources, with drugs and supplies stored foot of air. A Class 10,000 room allows on shelving above the floor. no more than 10,000 sub-micron Although you should gain general particles per cubic foot and a Class 100 Risk Level 2 knowledge regarding the Technical room allows no more than 100 submicron particles per cubic foot. Calls for a Class 100,000 clean room Bulletin, the section most applicable to with positive air pressure relative to Herman Miller is Facilities And adjacent pharmacy areas. Other areas Equipment. (such as the anteroom) should be You will also need to become familiar separated from the controlled area by with the risk level of products as an air barrier. discussed in the Technical Bulletin. Risk Level 3 Sterile products should be prepared: In a Class 100 horizontal or vertical Class 100 Class 100,000 laminar airflow hood that is properly situated in a Class 10,000 clean room which has a positive pressure differential relative to other pharmacy areas; Or prepared in a properly maintained and monitored Class 100 clean room (without a hood). 1 Technical Bulletin 6