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. 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. Polytrauma Rehabilitation Center (PRC) ... Design Requirements Manual. 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. 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. The hospital pharmacy is integrated with the dispensing section, manufacturing section, quality assurance section, and clinical pharmacy services. 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. 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. 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. The detailed engineering design of an isolator should reflect the intended application and chosen decontamination method. Complying with current U.S. Pharmacopeial Convention (USP) 797 sterile compounding regulations can seem like a steep hill to climb for health facilities professionals. pharmacy practice and post-graduate pharmacist education . 76 0 obj <> endobj 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. In addition, ISO 7 buffer and ISO 8 ante areas must be in separate rooms divided by walls and doors for compounding. • 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. The director of pharmacy shall be responsible for 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. While it may seem daunting, health facility managers can achieve compliance with USP 797 with the appropriate investment in planning, time and funding. 94 0 obj <>/Filter/FlateDecode/ID[<43601A4B8BDE424B8C81087DF2AA897E><71C26258E5755849B0678AC90033FF97>]/Index[76 31]/Info 75 0 R/Length 87/Prev 73766/Root 77 0 R/Size 107/Type/XRef/W[1 2 1]>>stream Excerpts have been taken that apply to planning, safety, operation and system design. 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. 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. Floors must be overlaid with wide, sheet vinyl flooring with heat-welded seams and coving to the sidewall. 0 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. This document is arranged by topic. Many of the proposed facility and environmental measures provided guidance for years. 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. Facility design requirements must meet clean room standards. 2. %PDF-1.6 %���� Engaging a pharmacy inspector to review design and floor plans is another expedient tactic. The firm has designed over twenty new pharmacies, pharmacy renovations, and pharmacy … • All hazardous drugs must be stored in a 0.01-inch wc negative-pressure room. iii) Heavy duty plastic pallets and adjustable,modular,heavy duty open racks shall be provided. All health facilities that prepare sterile compounds are affected by the revisions to USP 797. 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. Read preview. 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. 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. i) Sufficient space shall be made available to accommodate all ready-to- dispense medicines and intravenous fluids and large volume solutions. 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. 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. The investments in USP 797 compliance can prove costly for hospitals that are balancing capital investments that generate revenue with those mandated by regulations. 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. 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. 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. %%EOF The practice of pharmacy within the hospital under the supervision of a professional pharmacist is known as hospital pharmacy. Hospital Pharmacy Regulations: Preparing for Updated USP 797 and USP 800 Design Requirements . The USP is a scientific, nonprofit organization that sets recognized national standards for identity, strength, quality and purity of drugs. 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. Several ways exist to configure the pharmacy, equipment and the HVAC system to meet USP 797 requirements. 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. – $1.5 M per hospital per year – $25 per bed per day – 28% pay $3 to $4 per ft2 ... – Minimum requirements – Energy efficient design and construction • Mechanical equipment efficiencies ... Pharmacy Ventilation Design – CSPs. 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. Pharmacies and compounding laboratories are a hot topic in the health care world as the US Pharmacopeial Convention’s (USP) revised guidelines necessitate new pharmacy design to meet USP 797 and USP 800 compliance. 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. Like USP 797, the standards outlined in USP 800 are legally enforceable by the federal government and state boards of pharmacy. Complying with current U.S. Pharmacopeial Convention (USP) 797 sterile compounding regulations can seem like a steep hill to climb for health facilities professionals. • Enlist professional expertise. 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. Moving walls and constructing a closed architecture for the compounding area could prove problematic given the limitations of existing buildings. Complying with USP 797 is a complex, challenging and lengthy process. New rules for handling hazardous drugs are more comprehensive and stringent. 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. The implications of these requirements vary by hospital. They can be reached at sherry.umhoefer@cpspharm.com and chris.beebe@cpspharm.com, respectively. Manufacturing division of the hospital Layout Typical layout of hospital pharmacy 4. The revisions define maximums for temperature (20 degrees Celsius) and humidity (60 percent). With over forty years of experience in hundreds of pharmacies and drug stores, we are dedicated to the long-term success of every client. Any leeway hospitals believed they had under USP 797 disappears with the new revisions. • Antineoplastic hazardous drugs must be stored in a negative-pressure room. Space restrictions at Cambridge Health Alliance in Cambridge, Massachusetts required a phased approach to its compounding pharmacy at Cambridge Hospital. Controls must be in place to limit the potential for contamination. The requirement of personnel for an inpatient pharmacy depends on the nature and quantum of services provided by the department. But the cost of noncompliance, particularly if a contamination can be traced back to the hospital, can prove devastating. USP 797 is a set of guidelines, procedures and compliance requirements for compounding sterile preparations (CSPs). 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. JQ�Շ)a�a`�� r/� Ӷ8 clinical evaluation packages (i.e. There are a number of key aspects of regulation relevant to the delivery of hospital pharmacy services. The basic configurations are: The following measures can help to make a health facility consistent with USP 797: • Start planning now. Clinical and hospital pharmacy deals with the application of drug treatments to patients in a hospital or clinical setting. \"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. 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. 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. 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. Hospital Pharmacy: The department of the hospital which deals with procurement, storage, compounding, dispensing, manufacturing, testing, packaging, and distribution of drugs. The variables involved are risk level, type of equipment used (LAFW, vs. barrier isolator), and the cleanliness classification of the pharmacy. Destruction of Drugs Chapter 305. 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. Regulatory requirements for the review and approval of each completed phase must be evaluated and incorporated into the project schedule. Complying with USP 797 can seem intimidating, particularly for older hospitals that face facility limitations. Hospital Pharmacy is an independent, peer-reviewed journal. Getting up to speed on current USP 797 requirements while preparing to meet the more stringent standards on the horizon will prove challenging. Several ways exist to configure the pharmacy, equipment and the HVAC system to meet USP 797 requirements. By Umhoefer, Sherry; Beebe, Chris. The single most important thing in a pharmacy is the focus on cleanliness and safety. endstream endobj 77 0 obj <> endobj 78 0 obj <. Unlike other capital expenditures, investment in USP 797 compliance does not generate increased revenue for the hospital. Pharmacists Chapter 297. ii) The space shall be sufficient for the utilisation of forklift. All activities associated with preparing a sterile compound for administration to a patient fall under the regulation. Design, CMS, Hosting & Web Development :: ePublishing. This website contains links to sites which are not owned or maintained by the American Hospital Association(AHA). Additionally, the work performed now on USP 797 will lay the foundation needed to comply with the requirements of USP 800. Understanding pharmaceutical cleanroom design. This timing represents an opportunity to take action. 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. 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. The variables involved are risk level, type of equipment used (LAFW, vs. barrier isolator), and the cleanliness classification of the pharmacy. 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. director of pharmacy should be thoroughly knowledgeable about and have experience in hospital pharmacy practice and management. Health care settings that fail to be fully compliant face the possibility of financial penalties. The importance of a USP 797 champion cannot be overstated. in the hospital and health clinics on the design, space and layout requirements, equipment and manpower needs. 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. This directive is intended to identify the basic institutional support requirements for VA Pharmacy Services to ensure both The following general requirements are to be obtained [2] I. h�bbd``b`�$�A,5 ��H0� q5A��x"X@� "�} "�!�X�`�� �K{�n�Lf`$���8�@� � + 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. samples) within the pharmacy and throughout the hospital) shall be stored under proper conditions of sanitation, temperature, light, humidity, ventilation, regulation and security. Compliance can be logistically challenging, time-consuming and expensive. Should that occur, the enforceable date of the new regulations may be no earlier than spring 2018. 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 buffer area or area inside the perimeter of a segregated compounding area cannot contain water sources or floor drains. 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. Many upgrades require a significant investment in planning, new construction or retrofitting of existing spaces, and financial resources. 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. An advanced management degree (e.g., M.B.A., M.H.A., or M.S.) For 50 years it has been practitioner-focused and dedicated to the promotion of best practices and medication safety. 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. Each hospital is comprised of a wide range of services and functional units. • Walls must be constructed of durable material (e.g., heavy-gauge polymer) and panels must be locked together and sealed. 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. Viable air sampling must be done monthly and environmental surveillance for hazardous drug contamination is required. Compounded Sterile Preparations. A written record shall verify that: or an administrative specialty residency10 is desirable. • The biological safety cabinet must be vented to the outside air, a recommendation under USP 797 that is now mandatory. 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. 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. Continue reading to learn more about the field. Chapter 295. The Environmental Services & Infection Prevention software used in over 950 hospitals. endstream endobj startxref There is no exception for low-volume compounding. The innovative firm offers complete pharmacy design services and consultation throughout the entire process, delivering recommendations far beyond most Pharmacy Design Companies. Magazine article Health Facilities Management. The requirement of hospital pharmacists in hospitals is based on workload and number of beds in hospital. Psychiatric Hospital 11.1 General Conditions 144 11.2 General Psychiatric Nursing Unit 144 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. The specific configuration has a significant impact on the HVAC system. architects and hospital personnel an overview of the standards and guidelines that pertain to the design and operation of today’s medical facilities. 106 0 obj <>stream • 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. These include diagnostic and treatment functions, such as clinical laboratories, im… • Get the C-suite on board. 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� • Identify a USP 797 champion. Those facilities that have a dedicated person are far more organized and more likely to achieve and maintain compliance. All CSPs, except those for urgent use, will be required to be prepared in a PEC, which provides an ISO Class 5 environment. Hospitals also are required to certify primary engineering controls and test the air quality of the compounding area every six months. 16 Pharmacy Technicians and Pharmacy Technician Trainees Chapter 303. 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. 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. 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 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. 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. External organizations and pharmacy programs nationwide consider VA pharmacy practice to be the professional benchmark in many areas of care. 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