Complying with USP 797 is a complex, challenging and lengthy process. The basic configurations are: i) Sufficient space shall be made available to accommodate all ready-to- dispense medicines and intravenous fluids and large volume solutions. The following measures can help to make a health facility consistent with USP 797: • Start planning now. 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. There is no exception for low-volume compounding. 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. 2. 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. 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. An advanced management degree (e.g., M.B.A., M.H.A., or M.S.) 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. 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. Manufacturing division of the hospital Layout Typical layout of hospital pharmacy 4. 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. director of pharmacy should be thoroughly knowledgeable about and have experience in hospital pharmacy practice and management. While it may seem daunting, health facility managers can achieve compliance with USP 797 with the appropriate investment in planning, time and funding. 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. 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. endstream endobj 77 0 obj <> endobj 78 0 obj <. 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. 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. This timing represents an opportunity to take action. Getting up to speed on current USP 797 requirements while preparing to meet the more stringent standards on the horizon will prove challenging. 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. 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. For 50 years it has been practitioner-focused and dedicated to the promotion of best practices and medication safety. Psychiatric Hospital 11.1 General Conditions 144 11.2 General Psychiatric Nursing Unit 144 Compliance can be logistically challenging, time-consuming and expensive. 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 firm has designed over twenty new pharmacies, pharmacy renovations, and pharmacy … Compounded Sterile Preparations. 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. Hospital Pharmacy is an independent, peer-reviewed journal. Like USP 797, the standards outlined in USP 800 are legally enforceable by the federal government and state boards of pharmacy. The implications of these requirements vary by hospital. Should that occur, the enforceable date of the new regulations may be no earlier than spring 2018. Destruction of Drugs Chapter 305. The opinions expressed by authors do not necessarily reflect the policy of the American Hospital Association. The innovative firm offers complete pharmacy design services and consultation throughout the entire process, delivering recommendations far beyond most Pharmacy Design Companies. Unlike other capital expenditures, investment in USP 797 compliance does not generate increased revenue for the hospital. Design Guide Index. Magazine article Health Facilities Management. • Antineoplastic hazardous drugs must be stored in a negative-pressure room. External organizations and pharmacy programs nationwide consider VA pharmacy practice to be the professional benchmark in many areas of care. The USP is a scientific, nonprofit organization that sets recognized national standards for identity, strength, quality and purity of drugs. A written record shall verify that: Cost has been one of the key barriers to compliance with USP 797. 0 Several ways exist to configure the pharmacy, equipment and the HVAC system to meet USP 797 requirements. 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. Complying with USP 797 can seem intimidating, particularly for older hospitals that face facility limitations. The variables involved are risk level, type of equipment used (LAFW, vs. barrier isolator), and the cleanliness classification of the pharmacy. 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. – $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. JQ�Շ)a�a`�� r/� Ӷ8 • Enlist professional expertise. Polytrauma Rehabilitation Center (PRC) ... Design Requirements Manual. 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. iii) Heavy duty plastic pallets and adjustable,modular,heavy duty open racks shall be provided. 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. • Get the C-suite on board. 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. Ambulatory Care (Hospital Based) Audiology and Speech Pathology Service - 2017-11 ... Pharmacy Service - 2018-04. • The buffer area or area inside the perimeter of a segregated compounding area cannot contain water sources or floor drains. Regulatory requirements for the review and approval of each completed phase must be evaluated and incorporated into the project schedule. 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. • All hazardous drugs must be stored in a 0.01-inch wc negative-pressure room. 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. ii) The space shall be sufficient for the utilisation of forklift. 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. Moving walls and constructing a closed architecture for the compounding area could prove problematic given the limitations of existing buildings. According to the Honest Apothecary website, a good design plan should also optimize the workflow by eliminating unnecessary steps. Read more in our blog! The hospital pharmacy is integrated with the dispensing section, manufacturing section, quality assurance section, and clinical pharmacy services. The following general requirements are to be obtained [2] I. New rules for handling hazardous drugs are more comprehensive and stringent. Each hospital is comprised of a wide range of services and functional units. 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. Understanding pharmaceutical cleanroom design. endstream endobj startxref 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. e) The pharmacy personnel shall make regular inspections of all drugs storage areas. 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. 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. 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. USP 797 is a set of guidelines, procedures and compliance requirements for compounding sterile preparations (CSPs). • The biological safety cabinet must be vented to the outside air, a recommendation under USP 797 that is now mandatory. Complying with current U.S. Pharmacopeial Convention (USP) 797 sterile compounding regulations can seem like a steep hill to climb for health facilities professionals. 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. This directive is intended to identify the basic institutional support requirements for VA Pharmacy Services to ensure both 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. The single most important thing in a pharmacy is the focus on cleanliness and safety. The Environmental Services & Infection Prevention software used in over 950 hospitals. Complying with current U.S. Pharmacopeial Convention (USP) 797 sterile compounding regulations can seem like a steep hill to climb for health facilities professionals. 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 requirement of hospital pharmacists in hospitals is based on workload and number of beds in hospital. 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 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. 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. 16 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. This website contains links to sites which are not owned or maintained by the American Hospital Association(AHA). 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. • 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. Cooperation between the pharmacy director and the hospital's architects in planning a modern hospital pharmacy is described. 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. Clinical and hospital pharmacy deals with the application of drug treatments to patients in a hospital or clinical setting. Manufacturer and direct sales of the BALL-IN-THE-WALL® room pressure monitor. Educational Requirements Chapter 309. Any leeway hospitals believed they had under USP 797 disappears with the new revisions. Hospital Pharmacy Regulations: Preparing for Updated USP 797 and USP 800 Design Requirements . 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. Engaging a pharmacy inspector to review design and floor plans is another expedient tactic. 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. The requirements for USP 797 focus on patient safety by keeping contaminants out of injections, drops, and other sterile compounding preparations; whereas, USP 800 … Chapter 295. 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. Many upgrades require a significant investment in planning, new construction or retrofitting of existing spaces, and financial resources. Viable air sampling must be done monthly and environmental surveillance for hazardous drug contamination is required. The single most important thing in a pharmacy is the focus on cleanliness and safety. This document is arranged by topic. There are a number of key aspects of regulation relevant to the delivery of hospital pharmacy services. 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