This document is arranged by topic. Pharmacy Design is a comprehensive source for pharmacy owners or managers, looking to design a hospital pharmacy, outpatient pharmacy, or retail pharmacy, to meet the latest standards of functionality, efficiency, patient safety, automation, and visual appeal. Given the extent of the revisions and the cost implications to hospitals, it is likely that the USP will open a second round of comments. The single most important thing in a pharmacy is the focus on cleanliness and safety. I therefore, strongly suggest to all pharmacists to look into the possibilities of upgrading their respective facilities based on the recommendations made in this book. Pharmacies and compounding laboratories are a hot topic in the health care world as the US Pharmacopeial Conventionâs (USP) revised guidelines necessitate new pharmacy design to meet USP 797 and USP 800 compliance. Health care settings that fail to be fully compliant face the possibility of financial penalties. • Antineoplastic hazardous drugs must be stored in a negative-pressure room. • Walls must be constructed of durable material (e.g., heavy-gauge polymer) and panels must be locked together and sealed. According to the Honest Apothecary website, a good design plan should also optimize the workflow by eliminating unnecessary steps. The hospital pharmacy is integrated with the dispensing section, manufacturing section, quality assurance section, and clinical pharmacy services. The pharmacy’s remote location and the concrete block construction typical of older hospitals pose challenges to properly venting the compounding area and implementing the necessary HVAC upgrades. h�bbd``b`�$�A,5 ��H0� q5A��x"X@� "�}
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The Joint Commission has offered compliance advice on Environment of Care standard EC.02.03.05, which concerns maintenance of fire safety equipment and fire safety building features. The Environmental Services & Infection Prevention software used in over 950 hospitals. Hospital Pharmacy: The department of the hospital which deals with procurement, storage, compounding, dispensing, manufacturing, testing, packaging, and distribution of drugs. The following general requirements are to be obtained [2] I. %%EOF
Cooperation between the pharmacy director and the hospital's architects in planning a modern hospital pharmacy is described. • The buffer area or area inside the perimeter of a segregated compounding area cannot contain water sources or floor drains. Getting started now, understanding where a facility stands relative to the current and anticipated regulations, and engaging stakeholders in the process will ensure a facility’s full USP 797 compliance and readiness for USP 800. GUIDELINES IN THE PLANNING AND DESIGN OF A HOSPITAL AND OTHER HEALTH FACILITIES 1 of 6 A hospital and other health facilities shall be planned and designed to observe appropriate architectural practices, to meet prescribed functional programs, and to conform to applicable codes as part of normal professional practice. Regulatory requirements for the review and approval of each completed phase must be evaluated and incorporated into the project schedule. samples) within the pharmacy and throughout the hospital) shall be stored under proper conditions of sanitation, temperature, light, humidity, ventilation, regulation and security. USP 797 is a set of guidelines, procedures and compliance requirements for compounding sterile preparations (CSPs). The firm has designed over twenty new pharmacies, pharmacy renovations, and pharmacy ⦠This timing represents an opportunity to take action. This directive is intended to identify the basic institutional support requirements for VA Pharmacy Services to ensure both Sherry Umhoefer, RPh, is divisional vice president, compliance and regulatory services, and Chris Beebe, RPh, is director of compliance and regulatory services for Memphis, Tenn.-based Comprehensive Pharmacy Services. This architecture firm is well-known for pharmacy planning, pharmacy design and pharmacy architecture, including a sub-specialty in usp 797 compliant pharmacy design and construction. The specific configuration has a significant impact on the HVAC system. endstream
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<. Overseen by the Food and Drug Administration, USP 797 sets the legally enforceable standards that apply to all settings in which sterile preparations are compounded. Pharmacy Technicians and Pharmacy Technician Trainees Chapter 303. The variables involved are risk level, type of equipment used (LAFW, vs. barrier isolator), and the cleanliness classification of the pharmacy. Lack of understanding of the standards that must be met, facility and budget obstacles that pose challenges to implementing the measures needed to be in full compliance, and uncertainty over what lies ahead make navigating the USP 797 challenging. • Get the C-suite on board. Provide contractors with copies of USP <797>, USP <800>, and an engineering design article that includes information detailing buffer room HVAC design and exhaust requirements (for example, Zhang J. All health facilities that prepare sterile compounds are affected by the revisions to USP 797. The design and planning of inpatient hospital pharmacies can be difficult, yet is critical in affecting patient outcomes. The requirement of hospital pharmacists in hospitals is based on workload and number of beds in hospital. Several ways exist to configure the pharmacy, equipment and the HVAC system to meet USP 797 requirements. By Umhoefer, Sherry; Beebe, Chris. The following measures can help to make a health facility consistent with USP 797: • Start planning now. Unlike other capital expenditures, investment in USP 797 compliance does not generate increased revenue for the hospital. Flow charts for materials and mena) General flow chart out patientsb) General flow chart for In patients 5. c) General Flow chart for MaterialsSelection of Site Space, Layout and Design for community pharmacy 6. • Work surfaces must be constructed of smooth, impervious materials, such as stainless steel or molded plastic, so that they can be cleaned and disinfected easily. Each hospital is comprised of a wide range of services and functional units. i) Sufficient space shall be made available to accommodate all ready-to- dispense medicines and intravenous fluids and large volume solutions. Complying with USP 797 is a complex, challenging and lengthy process. in the hospital and health clinics on the design, space and layout requirements, equipment and manpower needs. Destruction of Drugs Chapter 305. Hospital Pharmacy is an independent, peer-reviewed journal. 0
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The importance of a USP 797 champion cannot be overstated. Cost has been one of the key barriers to compliance with USP 797. subscribe to Health Facilities Management This Week, Parkland’s pneumatic tubing system runs for miles, Joint Commission offers compliance advice on hospital suites, USP 800 brings new regulations to hospital pharmacies, Joint Commission gives compliance advice on fire safety. But the cost of noncompliance, particularly if a contamination can be traced back to the hospital, can prove devastating. Design, CMS, Hosting & Web Development :: ePublishing.
Achieving compliance comes from having the support and buy-in of the C-suite, a team of stakeholders who represent the departments affected by and involved with sterile compounding, and a person dedicated to overseeing the quality monitoring and control activities of all aspects of sterile compounding. Understanding pharmaceutical cleanroom design. Restricted Preparation areas: OSHA and the American Society of Hospital Pharmacists recommend that hazardous drug preparation be performed in a restricted area, with signs restricting the access of unauthorized personnel prominently displayed (OSHA Technical Manual Part V, Section B, #1). The basic configurations are: HFM Daily offers blog coverage by the award-winning HFM editorial team and links to in-depth information on health care design, construction, engineering, environmental services, operations and technology. The requirements for USP 797 focus on patient safety by keeping contaminants out of injections, drops, and other sterile compounding preparations; whereas, USP 800 ⦠Many upgrades require a significant investment in planning, new construction or retrofitting of existing spaces, and financial resources. The detailed engineering design of an isolator should reflect the intended application and chosen decontamination method. They can be reached at sherry.umhoefer@cpspharm.com and chris.beebe@cpspharm.com, respectively. Those facilities that have a dedicated person are far more organized and more likely to achieve and maintain compliance. • Identify a USP 797 champion. Complying with USP 797 can seem intimidating, particularly for older hospitals that face facility limitations. While the publication of the newly revised USP 797 standards may be months away, it takes a long time to make sure all the engineering and environmental monitoring are compliant. Design Guide Index. This website contains links to sites which are not owned or maintained by the American Hospital Association(AHA). Educational Requirements Chapter 309. The facility-specific requirements of USP 797 are centered on establishing and maintaining a safe environment for preparing CSPs, patient-specific medications that must be prepared in a sterile environment and remain sterile when administered. More established hospitals face physical plant and space limitations that will present extensive obstacles in achieving compliance and require dedicated financial and staff resources to overcome. Hospitals also are required to certify primary engineering controls and test the air quality of the compounding area every six months. Viable air sampling must be done monthly and environmental surveillance for hazardous drug contamination is required. While it may seem daunting, health facility managers can achieve compliance with USP 797 with the appropriate investment in planning, time and funding. Facility design requirements must meet clean room standards. 76 0 obj
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At a minimum, hospitals must have a room physically distinct from the rest of the pharmacy; buffer and ante areas that may be separated by a line of demarcation with proper airflow; restricted access barrier systems (RABS, also known as glove boxes) may be located in unclassified air if certified by the manufacturer to maintain an ISO 5 environment inside; and a chemo hood/isolator, which in a hospital that produces a low volume of hazardous CSPs, is permitted to be located in a positive-pressure room. While USP 797 sets federally enforceable legal standards, not all states have adopted regulations governing sterile compounding, and states that do have them have not always enforced compliance with the regulations. 10.23 Pharmacy Unit 134 10.24 Details and Finishes 134 10.25 Design and Construction, including Fire-Resistant Standards 136 10.26-10.29 Reserved 136 10.30 Special Systems 136 10.31 Mechanical Standards 137 10.32 Electrical Standards 142 11. iii) Heavy duty plastic pallets and adjustable,modular,heavy duty open racks shall be provided. Pharmacists Chapter 297. e) The pharmacy personnel shall make regular inspections of all drugs storage areas. architects and hospital personnel an overview of the standards and guidelines that pertain to the design and operation of todayâs medical facilities. With over forty years of experience in hundreds of pharmacies and drug stores, we are dedicated to the long-term success of every client. 2. The practice of pharmacy within the hospital under the supervision of a professional pharmacist is known as hospital pharmacy. The opinions expressed by authors do not necessarily reflect the policy of the American Hospital Association. There is no exception for low-volume compounding. Any leeway hospitals believed they had under USP 797 disappears with the new revisions. Complianc⦠The investments in USP 797 compliance can prove costly for hospitals that are balancing capital investments that generate revenue with those mandated by regulations. Additionally, the work performed now on USP 797 will lay the foundation needed to comply with the requirements of USP 800. Getting up to speed on current USP 797 requirements while preparing to meet the more stringent standards on the horizon will prove challenging. These include diagnostic and treatment functions, such as clinical laboratories, im⦠Under the new regulation, a hazardous drug is defined as a medication specified in the current National Institute for Occupational Safety and Health list of antineoplastic and other hazardous drugs. The AHA is not responsible for the content of non-AHA linked sites, and the views expressed on non-AHA sites do not necessarily reflect the views of the American Hospital Association. Understanding Pharmacy Cleanroom Design Requirements By James T. Wagner and Eric S. Kastango, RPh, MBA, FASHP Before you begin designing your cleanroom, you need to understand the performance parameters that measure HEPA filters, cleanroom classification, air changes, and pressurization. Effort has been made to present the statements that best summarize the The U.S. Pharmacopeial Convention’s (USP’s) newest chapter, USP 800, titled “Hazardous Drugs — Handling in Healthcare Settings,” was scheduled to be published Feb. 1 with a delayed official implementation date of July 1, 2018. A compounding facility generally consists of separate, designated operational clean areas, including an ante area, a buffer area and a primary engineering control (PEC), or a segregated compounding area containing a PEC where CSPs are prepared. director of pharmacy should be thoroughly knowledgeable about and have experience in hospital pharmacy practice and management. pharmacy practice and post-graduate pharmacist education . 106 0 obj
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While the enforceable date is two years away, taking steps now to put the processes, protocols and facility improvements in place will put the hospital out ahead. The USP is a scientific, nonprofit organization that sets recognized national standards for identity, strength, quality and purity of drugs. clinical evaluation packages (i.e. The innovative firm offers complete pharmacy design services and consultation throughout the entire process, delivering recommendations far beyond most Pharmacy Design Companies. Lack of understanding of the standards that must be met, facility and budget obstacles that pose challenges to implementing the measures needed to be in full compliance, and uncertainty over what lies ahead make navigating the USP 797 challenging. • Conduct a gap analysis of the facility design elements. Clinical and hospital pharmacy deals with the application of drug treatments to patients in a hospital or clinical setting. or an administrative specialty residency10 is desirable. Subchapter E. Clinic Pharmacy (Class D) Subchapter F. Non- Resident Pharmacy (Class E) Subchapter G. Services Provided By Pharmacies Subchapter H. Other Classes of Pharmacy. There are a number of key aspects of regulation relevant to the delivery of hospital pharmacy services. h�b```"M�)|�cb�@����!���M���ʙ3[@���J���:\�/X�Y�?r9"��ᦦ��IM&�����c a$�1���٬��Q��A��������9@;�!d0q;6��@����� b!��Z�)�rk�/٪�I-�SvJ� The following sections refer to the key generic resources and legislation and do not aim to cover the more specific requirements for services such as manufacturing, mental health legislation etc. Excerpts have been taken that apply to planning, safety, operation and system design. • The biological safety cabinet must be vented to the outside air, a recommendation under USP 797 that is now mandatory. Like USP 797, the standards outlined in USP 800 are legally enforceable by the federal government and state boards of pharmacy. A written record shall verify that: ii) The space shall be sufficient for the utilisation of forklift. The pharmacy director at an 870-bed voluntary nonprofit institution and the hospital's architects planned the design for a new 3250-square foot pharmacy department. New rules for handling hazardous drugs are more comprehensive and stringent. • Enlist professional expertise. Manufacturing division of the hospital Layout Typical layout of hospital pharmacy 4. Hospital Pharmacy Regulations: Preparing for Updated USP 797 and USP 800 Design Requirements . Complying with current U.S. Pharmacopeial Convention (USP) 797 sterile compounding regulations can seem like a steep hill to climb for health facilities professionals. The variables involved are risk level, type of equipment used (LAFW, vs. barrier isolator), and the cleanliness classification of the pharmacy. Magazine article Health Facilities Management. Read more in our blog! The requirement of personnel for an inpatient pharmacy depends on the nature and quantum of services provided by the department. • All hazardous drugs must be stored in a 0.01-inch wc negative-pressure room. Regardless of the obstacles, the revisions will impose a clearly defined time frame by which hospitals must achieve compliance with USP 797, intensifying the pressure to take immediate action and secure the financial resources needed to implement the necessary changes quickly. Additionally, the use of the word “should” in reference to several topics in the regulation created ambiguity as to whether an action was required or merely suggested. The specific configuration has a significant impact on the HVAC system. 94 0 obj
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Controls must be in place to limit the potential for contamination. Under the new standards, these measures no longer will be a “should” but a “must” for all hospitals that prepare sterile compounds, and there will be no exceptions. Facilities that proactively take steps now to meet all current regulations and anticipate, plan for and act on the revisions on the horizon will be well-positioned to be compliant by the enforceable date. For 50 years it has been practitioner-focused and dedicated to the promotion of best practices and medication safety. â $1.5 M per hospital per year â $25 per bed per day â 28% pay $3 to $4 per ft2 ... â Minimum requirements â Energy efficient design and construction ⢠Mechanical equipment efficiencies ... Pharmacy Ventilation Design â CSPs. In some instances, states that conduct inspections have allowed a gap analysis and a documented facility plan to serve as evidence that a hospital is moving toward compliance, making sanctions for noncompliance nonexistent. Several ways exist to configure the pharmacy, equipment and the HVAC system to meet USP 797 requirements. In addition, ISO 7 buffer and ISO 8 ante areas must be in separate rooms divided by walls and doors for compounding. The director of pharmacy shall be responsible for All activities associated with preparing a sterile compound for administration to a patient fall under the regulation. An advanced management degree (e.g., M.B.A., M.H.A., or M.S.) Engaging a pharmacy inspector to review design and floor plans is another expedient tactic. The intent of USP 800 is to protect hospital personnel and the health care environment from exposure to hazardous drugs (HDs), and it sets standards for the safe handling of HDs, from receipt at the hospital to storage, compounding, dispensing, administration and, ultimately, their disposal. Should that occur, the enforceable date of the new regulations may be no earlier than spring 2018. 16 Polytrauma Rehabilitation Center (PRC) ... Design Requirements Manual. In addition, the design plan must comply with Americans With Disabilities Act guidelines that ensure entryways, aisles, counters and seating can accommodate customer who use walkers, wheelchairs or other mobility devices. Chapter 295. Moving walls and constructing a closed architecture for the compounding area could prove problematic given the limitations of existing buildings. External organizations and pharmacy programs nationwide consider VA pharmacy practice to be the professional benchmark in many areas of care. Compliance can be logistically challenging, time-consuming and expensive. These include the following: • Surfaces of ceilings, walls, floors, fixtures, shelving, counters and cabinets in a classified area or in a segregated compounding area must be smooth, impervious, free from cracks and crevices, and non-shedding, thereby promoting cleanability and minimizing spaces in which microorganisms and other contaminants can accumulate. However, a growing number of states are adopting USP 797 regulations as laws, state boards of pharmacy have stepped up vigilance, and the USP has revisited its standards and issued revisions to more clearly state expectations of hospitals that engage in sterile compounding. On Sept. 25, 2015, moreover, the USP issued a notice of intent to revise USP 797, concluding a five-year review of the decade-old regulation and starting the clock on a 90-day comment period that concluded Jan. 31. Space restrictions at Cambridge Health Alliance in Cambridge, Massachusetts required a phased approach to its compounding pharmacy at Cambridge Hospital. You can read HFM Daily stories on this page or subscribe to Health Facilities Management This Week for a Friday roundup of the week's posts. USP 800 replaces the hazardous drug section in revised USP 797 and, when published, will be the sole USP source of regulation on hazardous drugs. Health facilities professionals need to know the following: • A biological safety cabinet (chemo hood) must be located in a negative-pressure room separated from all other compounding areas, regardless of the volume of hazardous drug compounding done by the hospital. The implications of these requirements vary by hospital. Complying with current U.S. Pharmacopeial Convention (USP) 797 sterile compounding regulations can seem like a steep hill to climb for health facilities professionals. Engineering and architectural firms that specialize in hospital design and construction can bring a wealth of expertise, knowledge and information to facilitate the design, budgeting and planning process while assuring that the work will meet USP 797 standards. Continue reading to learn more about the field. Many of the proposed facility and environmental measures provided guidance for years. Last month, the Department of Health Care Services (DHCS) sent a letter to every 340B provider/covered entity (hospitals, clinics, and contracted pharmacies) demanding they conduct a self-audit of paid fee-for-service (FFS) claims data from Dec. 1, 2016, through Dec. 31, 2019. All CSPs, except those for urgent use, will be required to be prepared in a PEC, which provides an ISO Class 5 environment. Understanding where the hospital falls short and the work needed to meet the new regulations will drive the budget discussions that need to start now. Demonstrating the importance of reducing risk as well as quality, safety and care benefits of USP 797 to hospital leadership and securing their financial, operational and programmatic support sends a clear message of the importance placed on compliance with the regulation. %PDF-1.6
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The revisions define maximums for temperature (20 degrees Celsius) and humidity (60 percent). Psychiatric Hospital 11.1 General Conditions 144 11.2 General Psychiatric Nursing Unit 144 Compounded Sterile Preparations. endstream
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General requirements;. • RABS such as compounding aseptic isolator and compounding aseptic containment isolator glove boxes must be located in an ISO 7 environment for Category 2 compounding and the chemo hood/isolator must be located in a negative-pressure room measuring 0.01 inches of water column (wc), regardless of the volume compounded by the hospital. Floors must be overlaid with wide, sheet vinyl flooring with heat-welded seams and coving to the sidewall. The proposed revisions are intended to leave no room for interpretation, setting specific and clearly articulated must-have requirements for engineering and environmental quality and control at all hospitals. Read preview. Doing so while keeping an eye on upcoming USP 800 standards for handling hazardous drugs in health care settings places added stress on hospitals already burdened by increased regulatory pressures. \"A functional design can promote skill, economy, conveniences, and comforts; a non-functional design can impede activities of all types, detract from quality of care, and raise costs to intolerable levels.\" ... Hardy and LammersHospitals are the most complex of building types. Ambulatory Care (Hospital Based) Audiology and Speech Pathology Service - 2017-11 ... Pharmacy Service - 2018-04. Manufacturer and direct sales of the BALL-IN-THE-WALL® room pressure monitor. The single most important thing in a pharmacy is the focus on cleanliness and safety. For a new 3250-square foot pharmacy department preparing to meet the more stringent standards on the nature and of. Pharmacists in hospitals is Based on workload and number of beds in hospital pharmacy.! 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