Type of Facility

There are numerous types of endoscopy facilities, including hospital endoscopy units, single-specialty or multispecialty ambulatory surgery centers (ASCs), and office endoscopy suites. Each model has a unique set of advantages, disadvantages, and regulatory issues. The hospital and ASC environments are highly regulated by state and federal agencies and by third-party accreditation bodies. In the United States, these include the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Accreditation Association for Ambulatory Healthcare (AAAHC), and the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF). Private payers sometimes impose their own specific requirements. Office endoscopy suites, previously less regulated, have been subjected to more controls by state and federal agencies in recent years.

The decision regarding which type of facility to establish is affected by the practice environment (solo practitioner, small or large group, single-specialty or multispecialty group, independent or hospital-based) and local economics and politics. Regardless of the service location, high quality must be maintained. The American Society for Gastrointestinal Endoscopy (ASGE) has stated that the “standards for out-of-hospital endoscopic practice should be identical to those recognized guidelines followed in the hospital.”¹ In an insurance-based environment, the hospital-based unit poses the fewest financial risks and demands for the endoscopist during the early phases of operation, and its use avoids alienating hospital administration by preserving hospital case volume. The hospital-based unit affords the endoscopist little control over operations, however, and offers him or her the lowest total financial return. Office endoscopy offers control and convenience with better financial return for the physician, but it poses some safety and liability concerns.^8,9 A single-specialty endoscopic ambulatory surgery center (EASC) provides the best of control, efficiency, convenience, and reimbursement for the physician owners and is extremely popular with patients, referring physicians, and payers.^10,11 At the time of this writing, a major ASC payment reform is being implemented by the Centers for Medicare and Medicaid Services (CMS), which is resulting in drastic cuts of facility payments for endoscopic services. How this reform will affect efforts to provide beneficial GI services to patients at a reasonable cost remains to be seen. More information about this payment reform is available elsewhere.¹² Regardless of the type of facility being developed, formulating a business plan and understanding various regulatory issues are usually the first steps in the process.

Business Plan

The decision to set up an endoscopy facility should be made only after detailed data gathering and the formulation of a business plan (e.g., market analysis, financial pro forma, implementation time line).^13–15 For a hospital-based unit or academic medical center, facility planners and accountants often perform these functions. For an office-based suite or an EASC, the tasks fall to the physician owners, aided by numerous consultants, contractors, or corporate partners. Even with skilled help, however, development of an accurate and reliable business plan and pro forma are highly dependent on physician estimates, insights, and work habits. Physician input into the business plan makes the difference between a perfunctory exercise and an accurate predictor of future performance. Endoscopy facilities represent small to medium-sized investments requiring substantial financial resources and staff. Procedure volume must be sufficient to produce adequate revenue to cover the costs of building and running the facility and to generate a profit on investment. Generally, three or four busy endoscopists performing 1200 to 1800 total procedures per year are required to offset the financial risk of the facility.¹⁶

Many factors influence the financial performance of an endoscopy facility, including initial investment, expected volumes of service, revenue per unit of service, fixed operating costs, and variable costs per unit of service. The initial investment includes the cost of construction, equipment, and working capital for the first few months of operation. Strategic planning is important to anticipate group growth and demand for services in the coming 5 to 10 years.^13,15 The impact of managed care plans or other major health plans on the practice must also be anticipated. In addition, competition, new technology, population changes, and demographics might affect case volume for the practice and the endoscopy facility.

A pro forma is a calculation examining the financial feasibility of a project based on anticipated investment and operating costs and revenues. The purpose of the pro forma is to predict reliably cash flows and profitability for the project. Initial investment costs have been defined previously. Also incorporated in the pro forma are estimated total costs per case based on estimated fixed and variable costs and expected case volume. Fixed costs are costs that remain constant regardless of the number of procedures performed and include rent, interest, depreciation, taxes, insurance, amortization, and management fees. Variable costs, which account for the largest component of the average cost per case, include salaries and benefits, medical supplies, medications, equipment, maintenance and repair, administrative supplies, utilities, and accounting and legal fees. Break-even volumes can be determined by subtracting the variable expense per procedure from the average payment per procedure to indicate the contribution available to be used for overhead and profit. Dividing fixed costs by the contribution margin per procedure indicates the number of procedures needed to pay the fixed costs, also known as the break-even point. Additional service units above that level constitute profit. Vicari and Garry¹³ provided a simple example of a pro forma. The business plan and pro forma are mandatory in assessing the financial feasibility of the proposed endoscopy unit before construction. They further aid discussions in obtaining financing and help the architect design the unit for anticipated volumes.

Regulatory and Certification Issues

Before planning and designing the facility, one must understand the relevant regulatory and certification issues. As with the business plan, units developed in a hospital or academic medical center usually benefit from administrators and planners familiar with these complex issues. Physician owners of an office endoscopy suite or EASC must gain their own understanding. Various agencies provide myriad rules and regulations concerning endoscopy facilities.^17–23 Legislation can come from federal, state, or local authorities. Regulations may come from federal agencies, state departments of health, and third-party accreditation organizations and private payers. Although these rules and regulations can seem excessive and needlessly costly, their intent is to ensure safe and successful outcomes for patients. Regulations and certification issues for endoscopy facilities can be divided into six main categories, as follows:¹⁷

General federal regulatory laws and rules

Facility state licensure

Medicare certification

Third-party accreditation

Physician credentialing

Private payer requirements

General Federal Health-Related Laws

Federal regulatory laws and rules include Fraud and Abuse Statutes (also known as antikickback laws), which are laws designed to prevent excessive or inappropriate payments. Endoscopy centers typically fall into a specific “safe harbor,” a designation that protects EASC investors or shareholders from allegations of fraud or abuse. The safe harbor applies if the physician participants are surgeons or specialists engaged in the same surgical or medical practice specialty, including gastroenterology. These physicians can refer patients directly to their center and perform procedures on them as an extension of and significant part of their practices.

Additional requirements of the safe harbor apply. Ownership of the facility, or remuneration from it, cannot be related to volume of referrals, services furnished, or the amount of business otherwise generated from that physician to the EASC. The amount of payment to physician owners from facility revenues must be directly proportional to the amount of each owner’s capital investment. There must be no requirement that a passive investor make referrals to the EASC, and the EASC or any investor cannot make loans or guarantee a loan for a physician, if these funds are used to purchase ownership in the EASC. Each physician must agree to treat Medicare and Medicaid patients. Finally, the physician owner must derive at least one-third of his or her medical practice income from the performance of procedures that require an EASC or hospital endoscopy unit setting.

Other general federal health-related laws and rules relevant to endoscopy facilities include the False Claims Act and copayment waivers, Stark provisions, Health Insurance Portability and Accountability Act (HIPAA) provisions, and labor and employment issues. The False Claims Act was designed to prevent false billings, claims that are medically unnecessary, and billings for inappropriately high payment. Copayment or deductible waivers may also be illegal if the government suspects such waivers are likely to induce referrals. Stark provisions stem from the Ethics in Patients Referrals Act. They are closely related to Fraud and Abuse Statutes but are civil rather than criminal laws. The regulatory body overseeing Medicare has ruled that a physician does not make an illegal referral for a procedure when he or she either personally performs the service or refers a patient to a partner to perform the service. HIPAA provisions are rules and regulations covering patient health information disclosed by any covered health care entity, provider, or facility. Regarding labor and employment issues, numerous rules and regulations cover discrimination, harassment, protection of the disabled, and workplace safety. The Occupational Health and Safety Act (OSHA) of 1970 seeks to protect employees from recognized work hazards that might cause death or serious harm. For endoscopy centers, OSHA requirements of major importance cover cleaning of endoscopic equipment, disinfection, and appropriate ventilation.

State Licensure

The state department of health licensing authority is interested in several features of a potential endoscopy facility. First, before any design and construction is undertaken, a careful review of the state’s certificate of need (CON) requirements is needed. Some states do not allow construction of new facilities unless need is demonstrated. This process can be difficult, and prospective physician owners of endoscopy facilities may encounter opposition from hospitals, fearing competition and seeking to maximize use of their own facilities. Regarding specific construction guidelines, state regulators are most often interested in the flow of the facility, cleanliness, and control of infection within the procedure areas. Many states have adopted specific room sizes, acoustic regulations, door and hall size requirements, handicapped access provisions, requirements for exhaust systems, and specific fire codes. The state fire marshal would be concerned with emergency exits. Building codes from the National Fire Protection Association generally apply to endoscopy facilities built as new centers or as centers built in existing buildings. Many states also follow guidelines from the American Institute of Architects and the U.S. Department of Health for design and construction of health care facilities.

Medicare Certification

Medicare certification is usually sought after obtaining state licensure and is required for any facility seeking reimbursement for Medicare and Medicaid work. Medicare regulations and requirements are usually more extensive than regulations of the state and address governance of the facility, transfer agreements with a nearby hospital, continuous quality improvement activities, Medicare architectural requirements, and medical records. Additional standards concern organization and staffing, administration of drugs, and procurement of laboratory and radiology services. Two other requirements warrant special attention as they relate to EASCs. First, the facility must be used exclusively for providing “surgical” services, a definition that includes GI endoscopies. This requirement mandates a separation from other health care activities, separate staffing, and maintenance of special medical and financial records. Finally, the facility must comply with state licensure laws,²⁰ which is potentially difficult in some states because of restrictive CON requirements.

Third-Party Accreditation

After state licensure and Medicare certification have been obtained, some states or specific payers may require a third-party accreditation before authorizing payments to an endoscopy facility. This accreditation can be provided by inspection from JCAHO, AAAHC, or AAAASF. Although these accreditations are typically achieved after state licensure, sometimes they can be pursued simultaneously with Medicare inspection. Under certain circumstances, Medicare accepts accreditation from one of the third-party accreditation authorities in lieu of its own survey; this is known as attaining “deemed status,” and it obviates an additional inspection. These third-party accreditations focus on patient-related and organizational functions and, in the case of an EASC, concentrate on the “environment of care” or “facilities and environment.”

Third-party inspection of a facility can be challenging and demands that the owners and operators fully understand the standards of each specific accrediting organization. A JCAHO survey scrutinizes five patient-focused functions and six organization-focused functions. Patient-related functions include patient rights and organization ethics, assessment of patients, care of patients, education of patients and family, and continuity of care. Organization functions include standards dealing with organization improvement; leadership; management of the environment of care; human resources; information; and surveillance, prevention, and control of infection. AAAHC and AAAASF inspections assess similar functions, although these may be grouped under different organizational headings.

Physician Credentialing

Credentialing and privileging of physicians using an EASC may be mandated by federal, state, local, or third-party organizations and include a formal application process, verification of licensure and drug enforcement administration status, malpractice history, admitting privileges, advanced cardiac life support (ACLS) status, and documentation of training.

Payer Requirements

Individual health plans or insurers may have their own requirements, and these may vary significantly from payer to payer. Careful attention to local payer mix and any special requirements is necessary before designing and building an endoscopy facility to ensure qualification for payment. As outlined previously, the regulatory and certification issues for endoscopy facilities are “complex, detailed, and broad.”¹⁷ Any physician wishing to develop an endoscopy facility must understand these rules of regulation and certification. Appropriate legal counsel should be considered essential.

Choosing a Site

For hospital-based endoscopy facilities, the location of the facility is usually determined by the hospital’s own planners. Although some hospitals have developed separate units for outpatient and inpatient endoscopies, most hospitals operate a single endoscopy unit. Choosing its location requires careful consideration of patient transport issues; the flow of inpatients and outpatients in and out of the unit; and the proximity to radiology, emergency department, intensive care units, and inpatient wards. With office-based endoscopy or EASCs, physician owners choose the site. The site size and location require careful consideration because most office-based facilities or ASCs later expand to accommodate more physicians and patients. Preliminary land requirements are determined from space estimates (discussed later), parking requirements, appropriate landscaping or “green areas,” and anticipated expansion. For an office endoscopy suite or EASC, proximity to a hospital is desirable to minimize travel for patients requiring hospital transfer and for physician convenience. The site should be near but perhaps not on a major street to ease patient parking. Many patients coming to an ASC or office-based facility are elderly or may be anxious about their upcoming procedures. Access should be easy. Locating the physician offices adjacent to the ASC should be strongly considered because it may be very efficient for staff and patients.

Facility Planning and Design

After forming a realistic business plan and acquiring an understanding of relevant regulatory and certification issues, attention turns to the planning and design of the facility. Although the remainder of this chapter includes some remarks about issues specifically related to hospital units, the main focus of the discussion is on the development of an outpatient endoscopy facility, details of which are equally applicable to hospital units. Objectives must be articulated to the design professionals to ensure that the facility meets the needs of patients, endoscopists, and staff. Some points to keep in mind are the following:²⁴

Allow adequate time for planning.

Set aside a regular block of time for discussion, review, and program development.

Choose experienced design professionals who communicate well.

Involve staff to ensure attention to their needs and wishes.

Prepare a statement of needs and goals to aid the architect in preparing a detailed program.

Prepare an inventory of equipment that will be used.

Visit other facilities to gather ideas worth incorporating.

Use flow studies to evaluate placement of functional elements.

Review preliminary drawings carefully.

If questions arise about the size or shape of a space, lay it out with tape on the floor and simulate work practices.

Planning and design of the facility is a team project. The team mainly involves a physician representing the endoscopists who will use the facility; two staff people, including the nurse responsible for patient care activities within the unit and the appropriate administrator; the architect; and the builder. The responsible physician must be given adequate time away from clinical duties to devote to planning, design, and oversight of the construction of the facility. Designated time must be set aside because the process is ongoing and cannot be relegated to lunch hours and brief sessions whenever time can be stolen from clinical activities. The architect is the primary professional involved in overseeing the entire project. It is wise to select an architect who specializes in medical buildings, particularly one who has experience in designing endoscopy facilities. Similarly, selection of a contractor who has experience in medical construction, particularly construction of endoscopy facilities, is important. Both the architect and the contractor must thoroughly understand the requirements of regulatory and certifying bodies and local and state building codes. Sometimes the design and contracting can be provided by one company with both design and building capabilities.

Although the physician representative, designated staff persons, architect, and contractor compose the major elements of the planning and design team, additional input may be needed from a mechanical engineer, electrical engineer, telephone contractor, information technology expert, and attorney.²⁵ Consideration might also be given to involving a layperson or “patient” to ensure sufficient attention to issues of patient comfort, dignity, and privacy.

Scope of Activities

The first consideration is which endoscopic procedures and other services will be performed in the facility.¹⁹ The type of facility will, to a great extent, answer this question. For a hospital unit that must provide a wide range of endoscopic services, one or more rooms must be large enough and appropriately equipped to accommodate the special equipment required for complex procedures (e.g., endoscopic retrograde cholangiopancreatography [ERCP], endoscopic ultrasound [EUS], balloon enteroscopy, laparoscopy, anesthesia cart). In some community hospitals, endoscopy units are shared with other specialties, such as cardiology or pulmonology, and have to accommodate procedures such as transesophageal echocardiography or bronchoscopy. If the hospital is part of an academic medical center, the unit may serve additional purposes, including teaching and research, requiring further modifications in space, equipment, and staffing.

For an office suite and EASC, services offered will be based on logistics and reimbursement ramifications. In these out-of-hospital facilities, procedures usually are limited to “routine” high-volume procedures having predictable turnaround times and minimal recovery times and requiring standard equipment and less expensive accessories. In an EASC, it is crucial that all procedures done be on the Medicare approved list to qualify for facility reimbursement. For both the office suite and the EASC, procedures usually are limited to upper GI endoscopy, esophageal dilation, and colonoscopy including polypectomy. Predictably, rapid turnaround time is crucial for an efficiently functioning EASC or office facility. Prolonged procedures or procedures that are unpredictable in duration, such as ERCP, are best done in the hospital. Procedures requiring prolonged recovery times, such as liver biopsy, are also best left for the hospital environment. Finally, procedures that require numerous and expensive accessories are best scheduled at the hospital because neither office suites nor EASCs can recover the costs of these accessories.

The question sometimes arises whether it is better to have a multispecialty or single-specialty ASC. From the standpoint of services offered and equipment, a single-specialty EASC has the advantage of being the “focus factory.”^27,28 In this environment, endoscopists, skilled GI nurses, and administrative staff maximally use equipment of relatively low cost, performing predictably timed procedures with a rapid turnaround. A single-specialty EASC avoids the problem of a multispecialty facility in which highly specialized equipment lies idle much of the time while physicians from differing specialties are performing their individual procedures.

Equipment

The greatest capital expense after the basic construction is equipment. Some tabulation of the equipment needed is necessary in the early planning stages and facility design. The basic equipment needed for an endoscopy unit is listed in Box 2.1.^1,26,29 A detailed discussion of individual items is not presented here, but a few points are useful in integrating the equipment needs into planning and design. Generally, examining or procedure tables have been replaced by height-adjustable, rolling procedural stretcher carts that allow patients, once properly gowned for endoscopy, to mount the movable cart and not leave it until ready to leave the facility. These useful carts allow patients to be shuttled from preparation areas to procedure rooms and back to recovery areas and serve as procedure tables. This capability is very important to overall system efficiency and adds to patient safety by avoiding transfer to and from a procedure table.

Another major determinant of overall system speed and efficiency is the availability of endoscopes. Adequate numbers of endoscopes, high-level disinfection systems (“scope washers”), and adequate storage for extra endoscopes are required. Adequate numbers of endoscopes must be available to prevent inefficient downtime in the unit. In most endoscopy suites, variable costs account for 80% or more of the total costs of providing endoscopic services, and 50% to 60% of this is attributable to staff salaries, wages, and benefits.¹⁴ It is inefficient and fiscally unwise to have highly paid physicians and staff waiting for endoscopes. One of the most efficient scenarios is for one endoscopist to work out of two rooms so that he or she can move from room to room without major downtime. This scenario typically requires that each unit have three colonoscopes and three upper endoscopes for every two rooms in the facility. This allows two rooms always to be equipped for either upper endoscopy or colonoscopy with one endoscope always available to restock the next room during turnaround.

The luxury of additional endoscopes per two rooms allows for the inevitable loss of an endoscope resulting from breakage and repair time. A high-volume, efficient endoscopy unit cannot afford to be penny wise and endoscope foolish when it comes to the number of endoscopes available. Regarding esophageal dilators, the decision of whether to use a Savary or American dilator system versus balloons can have major economic consequences. This is less of an issue in the hospital where some device costs can be separately billed. However, in an office suite or an EASC, use of balloons and other expensive accessories such as hemoclips may be problematic, particularly with Medicare or Medicaid patients, for whom the facility fee is set by regulation and extra costs for accessories cannot be passed on. Finally, with the growing use of propofol or anesthesia services for endoscopic procedures, additional medications and equipment are often required for this service.^30,31

Physical Environment

Before beginning specific planning and design, some issues affecting space efficiency should be considered. It is the goal for physicians and staff to work as quickly and efficiently as possible while giving the patient the assurance that he or she is receiving appropriate care. System speed in the endoscopy facility usually comes from the following three delivery components:

If the first two components operate properly, the number of procedure rooms available is not as important as the practice habits of the physician in performing procedures, talking to patients and their families, completing medical records, and returning to the procedure room.³⁰ In an efficient facility, physician discipline is needed because room turnover and equipment reprocessing time can be rapid. Scheduled times for one physician operating out of two rooms with adequate staff and equipment can be easily allotted at 30 minutes for colonoscopies and 20 minutes for upper GI endoscopies (Rockford Gastroenterology Associates, Ltd., Rockford, IL, unpublished data).

Flow

Architects use flow diagrams to plan movement patterns in arranging space before actual design plans. Physician and nurse input is crucial in arranging the flow relationships within the endoscopy facility to maximize efficiency, minimize travel distance, and achieve economy of movement. A basic flow diagram showing the components for a simple endoscopy unit is shown in Fig. 2.1. The patterns of movement in a more complicated facility are conceptualized in Fig. 2.2. Simple flow diagrams such as these can be elaborated into a functional relationship diagram as shown in Fig. 2.3. Although this diagram suggests a floor plan, it is not a true floor plan. The sizes of the areas within the diagram are not proportional to the actual relative sizes of the rooms they represent. This type of functional relationship diagram shows the way that patients, staff, physicians, and equipment move through the facility.

Fig. 2.1 Flow diagram for simple endoscopy unit.

(From Rich ME: Office layout and design. In Overholt BF, Chobanian SJ, editors: Office endoscopy, Baltimore, 1990, Williams & Wilkins.)

Fig. 2.2 Flow diagram for larger endoscopy unit.

(From Rich ME: Office layout and design. In Overholt BF, Chobanian SJ, editors: Office endoscopy, Baltimore, 1990, Williams & Wilkins.)

Fig. 2.3 Functional relationship diagram of ambulatory endoscopy center.

(From Marasco JA, Marasco RF: Designing the ambulatory endoscopy center. Gastrointest Endosc Clin N Am 12:193, 2002.)

For hospital-based units, specific patient flow issues must be considered. Separate entrances for sick, bedridden patients and ambulatory individuals should be considered. The monitoring and treatment requirements for sick inpatients must be taken into consideration. Separation of inpatients and outpatients in waiting or holding areas, preparation areas, and recovery areas may also be helpful. In the example of an ambulatory endoscopy center shown in Fig. 2.3, an endoscopy facility and an adjacent clinic facility are shown. The endoscopy facility on one side of the firewall can qualify as an ASC if the rules and regulations are followed and the endoscopy facility is separated from the clinic building by a required 1-hour fire rated wall-door construction system. This construction is usually achieved by using a wall with two layers of fire-rated gypsum board on either side of the structural wall supports and having the wall extend through the ceiling to the roof of the structure above.³²

A functional relationship diagram can be turned into a floor plan by assigning actual space requirements to the rooms that are represented. Fig. 2.4 shows a sample architectural space program worksheet that can be used to turn a functional relationship diagram into a floor plan. A 40% circulation allowance must be added at the end of the tabulation to account for wall thicknesses, corridors, and so forth.^32,33

Fig. 2.4 Architectural space program worksheet.

(From Marasco JA, Marasco RF: Designing the ambulatory endoscopy center. Gastrointest Endosc Clin N Am 12:194, 2002.)

Designing the Endoscopy Facility

The Guidelines for Design and Construction of Health Care Facilities (AIA Guideline), published by the American Institute of Architects (AIA) and the Academy of Architecture for Health, includes a section on the design and construction of GI endoscopy facilities. The document is updated on a 4- to 5-year revision cycle with the latest edition published in 2006 and a new version anticipated for 2010. The AIA Guideline, which is referenced by many federal and state jurisdictions, was originally conceived as minimum construction requirements for hospitals. Over time, the document has evolved to include engineering systems, infection control, and safety and architectural guidelines for design and construction of hospitals and other types of health care facilities. It provides an invaluable resource for the construction of a new ambulatory endoscopy center, the construction of a hospital-based endoscopy unit, or the renovation of existing units. The AIA Guideline can be purchased through the Facility Guidelines Institute (FGI) at http://www.fgiguidelines.org/about. For existing hospital facilities, many considerations are subject to limited space and resources and require a compromise between optimal choices and the realities of the existing building. Marasco and Marasco^32,33 suggested designing the endoscopy facility in modules. The modules to be designed include the following:

Waiting module

Business-reception module

Preparation-recovery module

Procedure room module

Utility module

Staff dressing module

Each of the above-listed modules is discussed separately because there are rules, regulations, and practical points to be kept in mind during design.

Waiting Module

There has been a marked shift toward outpatient-based endoscopy since the mid-1980s. This shift has major implications for the design and operation of the endoscopy facility. The patient’s experience of the endoscopy facility often begins outside of the building in the parking lot. Patients arriving for endoscopy are often anxious and sometimes frightened. Maps with careful driving instructions and signs posted in the vicinity of the endoscopy facility can minimize confusion and offer reassurance. An all-weather canopy and automatic opening doors are helpful to elderly, ill, or disabled patients. The reception and waiting room area provides an early impression of the endoscopy facility and should project efficiency and friendliness. Wheelchair storage should be available in this area, with wheelchairs stored out of sight. There must be adequate room for patients’ escorts because one or two people usually accompany each patient scheduled for endoscopy. It is good to have a sub-waiting room for the endoscopy facility if there is an adjacent clinic area. A separate waiting area might be required under rules and regulations; even if not required, it might prove useful because waiting times for the clinic may be quite different from waiting times for patients undergoing endoscopy. The waiting areas should be well appointed and equipped with a television set, DVD player, and reading material. A toilet should be available near, but not directly off of, the waiting room. A small refreshment station near the reception area is also appreciated by escorts. The number of seats required is generally 2.5 times the number of patients in the building at any given time. The general waiting area for Rockford Endoscopy Center, Rockford Gastroenterology Associates, Ltd., Rockford, Illinois, is shown in Fig. 2.5.

Fig. 2.5 General waiting area for Rockford Endoscopy Center, Rockford Gastroenterology Associates, Ltd., Rockford, Illinois.

(Photograph by David Friedrich, Media Production, OSF Saint Anthony Medical Center, Rockford, IL.)

Preparation-Recovery Module

The preparation-recovery area of the endoscopy facility requires constant patient surveillance from the nursing staff. This area usually contains a nursing control station (Fig. 2.6), which allows unobstructed viewing of patients during the preparation and recovery stages of their visit. The most efficient arrangement for preparation and recovery is to have them occur in the same place. Patient clothing can be stored in a locked cabinet in the preparation-recovery area or can accompany the patient during transport to the procedure room and back, stored underneath the rolling procedural stretcher cart. Patients can be rolled into procedure rooms on properly designed rolling carts that are also used as procedure tables. In this way, patients can move from preparation to procedure and back to recovery requiring no mounting or dismounting from wheelchairs or carts.

Fig. 2.6 Nursing control station for preparation-recovery area, Rockford Endoscopy Center, Rockford Gastroenterology Associates, Ltd., Rockford, Illinois.

(Photograph by David Friedrich, Media Production, OSF Saint Anthony Medical Center, Rockford, IL.)

Generally, at least two preparation-recovery rooms or curtained bays are required per procedure room. Some patients who need additional recovery time after they are able to dismount the procedure cart can recover in recliner chairs. A few curtained recliner chair areas can provide this extra recovery space. The number and type of recovery bays may vary depending on the type of sedation used. Corridors between procedure areas and preparation-recovery spaces should be wide enough to provide easy patient cart movement. Toilets should be close to both preparation-recovery and procedure areas.

Procedure Room Module

The number of procedure rooms is determined by the caseload of the endoscopy facility. This number is often overestimated. Much more important than the number of procedure rooms is the amount of recovery space available. In an efficient facility where turnaround time is quick, the number of procedure rooms can be minimized. It is most efficient for one endoscopist to have two rooms available so that turnaround between cases can be very rapid. Using procedure rooms for recovery compromises efficiency by tying up a specialized procedure room. Block scheduling of a single endoscopist with two rooms offers maximum efficiency. To determine the required number of procedure rooms, Marasco and Marasco³² recommended using a utilization chart, an example of which is shown in Fig. 2.7. By filling in the time of each of the time segments required in the endoscopy facility and adding the anticipated patient load, the number of procedure rooms needed can be estimated. Allowances should be made for growth in numbers of physicians and patients over the subsequent 5 years. Generally, annual caseloads increase 10% to 15% per year. By using the patient load anticipated 5 years hence and dividing this load by the number of procedures per room per year, the number of required rooms can be calculated. By examining vertically on the utilization chart, one can estimate the number of patients who will be in various stages within the endoscopy facility. This information can help predict the number of seats needed in the waiting room, the number of necessary procedure rooms, and the number of preparation-recovery bays and recliner chairs needed.

Fig. 2.7 Sample procedure room utilization analysis.

(From Marasco JA, Marasco RF: Designing the ambulatory endoscopy center. Gastrointest Endosc Clin N Am 12:199, 2002.)

The minimum size for an endoscopy room is probably 200 square feet,^1,24 but this is often inadequate to accommodate newer, larger videoendoscopy equipment, video monitors, and additional equipment for anesthesia services, if used. Approximately 300 square feet is more appropriate for the modern endoscopy room.^1,32 Sometimes state licensing departments or Medicare mandates a minimum size for an “operating room” that is inappropriately large for an endoscopy room. In that instance, a variance can be requested, but it is not automatically granted.

In an endoscopy procedure room layout, placement of the light source, videoprocessor, dual video monitors, and electrocautery must be considered carefully. Many variations are possible to fit the preferences of the endoscopists and nursing staff. Rooms should be planned with equipment and supplies integrated into the layout and positioned strategically around the site of the patient on the procedural stretcher cart. The floor should be free of cables and wiring; these can be arranged along the perimeter of the room or preferably above a dropped ceiling or in the walls. This arrangement allows physicians, staff, and equipment to move unfettered by cords and cables and avoids damaging these sensitive components. All endoscopic accessories, suction, oxygen, supplies, and all resuscitation equipment should be at hand. An emergency call button should be included in each procedure room, and an emergency (crash) cart should be stored nearby. A typical endoscopy procedure room (Rockford Endoscopy Center) is shown in Fig. 2.8. A more detailed discussion of basic clearances and human dimensional requirements is provided by Waye and Rich.³⁴

Fig. 2.8 Typical endoscopy procedure room, Rockford Endoscopy Center, Rockford Gastroenterology Associates, Ltd., Rockford, Illinois.

(Photograph by David Friedrich, Media Production, OSF Saint Anthony Medical Center, Rockford, IL.)

Utility Module

Efficient equipment turnover time can be achieved by having appropriate equipment for rapid cleaning and high-level disinfection. In this scenario, the speed of the endoscopy facility is determined by the efficiency of the physician between procedures rather than by the number of procedure rooms.³² Instrument cleaning and high-level disinfection can be accomplished by strategically placing the cleaning area between two procedure rooms or having an efficient large cleaning area within a short distance of several procedure rooms. Adequate numbers of endoscopes stored properly and reprocessed efficiently ensure that the most expensive cost elements of the endoscopy facility—the physicians and nursing staff—are not kept waiting for equipment.

Cleaning rooms should be large and adequately ventilated with ample plumbing and power provisions for future changes. Oversized sinks are required, and there should be a place for soiled instruments to hang while waiting to be cleaned. Automated endoscope washers with multiple scope compartments, such as that shown in Fig. 2.9, provide an efficient way of reprocessing endoscopes. Different instrument reprocessing units vary in their cleaning time, which has an impact on the number of scopes required by a busy unit. A “pass through” window from soiled to clean utility areas should be available to maintain separation of “clean” and “dirty” areas.

Fig. 2.9 High-level disinfection unit for multiple endoscopes, Rockford Endoscopy Center, Rockford Gastroenterology Associates, Ltd., Rockford, Illinois.

(Photograph by David Friedrich, Media Production, OSF Saint Anthony Medical Center, Rockford, IL.)

A closed cabinet for the storage of clean endoscopes is preferred to open storage to protect instruments and to prevent inadvertent sightings of instruments by anxious patients. Endoscope storage cabinets that circulate air through the endoscope channels provide added protection against moisture and bacterial growth within channels. A storage unit with channel air circulation is shown in Fig. 2.10. Exhaust fans in the cleaning area are a must, as are provisions for disposal of toxic chemicals. Also included in the utility module are storage areas. General storage for supplies must be readily accessible to the preparation-recovery areas and the procedure rooms. There must be locked cabinets for storage of drugs. Biohazardous waste and gases such as oxygen must also be stored. An alternative power source, such as a battery backup system or generator, is necessary to ensure uninterrupted power.

Fig. 2.10 Endoscopy storage cabinet providing air circulation through endoscopy channels, Rockford Endoscopy Center, Rockford Gastroenterology Associates, Ltd., Rockford, Illinois.

(Photograph by David Friedrich, Media Production, OSF Saint Anthony Medical Center, Rockford, IL.)

Summary of Planning and Design

The design of an efficient endoscopy facility is facilitated by a functional relationship diagram showing the flow of patients through the facility. An architectural space program is developed by tabulating the areas necessary and assigning space required. This architectural space program determines the size of the facility. A procedure room utilization calculation determines the number of procedure rooms and other areas necessary to handle the patient caseload, and provisions should be made for caseload growth. Careful attention to planning and design results in the construction of a pleasant, efficient endoscopy facility that meets the needs of patients, physicians, and staff.

Staffing

Decisions regarding staffing hinge on regulatory requirements, volumes of procedures, and case mix (disease acuity). Numerous federal and state regulations affect staffing decisions, and a thorough knowledge of these requirements is necessary to ensure compliance with state licensing requirements, Medicare certification regulations, and third-party accreditation standards.^35,36

Medicare guidelines stipulate that a registered nurse (RN) must be available on site during all hours of operation of a hospital or ASC endoscopy facility. The nurse practice act of each individual state also affects staffing decisions. A state nurse practice act defines the scope of practice for RNs, licensed practical nurses (LPNs), and other assistants or technicians. These nurse practice acts may limit who can start intravenous (IV) lines, administer IV medications, or provide other clinical services. To determine the number of full-time equivalents (FTEs) needed for staffing, one must quantify the time needed to care for a single patient, multiply this by the number of procedures scheduled daily, and divide by the work hours per day of a full-time employee. One current industry standard suggests an average time of 3 hours per procedure to admit, treat, and discharge a patient in an endoscopy facility (AMSURG Corporation, unpublished data).³⁵ Some factors that influence the decision to use RNs versus LPNs versus technicians include scope-of-practice regulations, salary costs, and availability. Regardless of the mix, care should always be directly supervised by an on-site RN.³⁷

A typical two-room endoscopy facility might be staffed as follows:³⁵

Procedure room number 1: one RN or LPN

Procedure room number 2: one RN or LPN

Cleaning room: one endoscope technician

Preparation-recovery area: two RNs and one LPN, or one RN and two LPNs or technician (the LPN or technician should also be used to float between procedure rooms)

Each endoscopy facility requires at least one receptionist and perhaps a second clerical person. The use of dedicated endoscope technicians to perform cleaning and high-level disinfection and instrument setup promotes strict adherence to endoscope reprocessing guidelines and endoscope durability.

Scheduling

Most facilities use block scheduling to maximize efficiency and convenience.^35,36 Block scheduling of one physician with two endoscopy rooms allows efficient movement of the endoscopist from one room to the next without delays caused by other endoscopists. It is possible for that individual to intermingle daily tasks such as telephone calls or chart review during any downtime. Block scheduling also allows for time allotments based on the performance characteristics of individual endoscopists. Examples of block scheduling and tools for use in block scheduling have been published by McMillan.³⁵ Equipment availability can affect scheduling. An ample number of endoscopes and rapid, efficient cleaning and high-level disinfection facilitate a more efficient schedule.

The first patient of the day can be prepared in the procedure room if an additional procedural stretcher cart is available for each procedure room at the beginning of the day. Time allotments for procedures vary from facility to facility. Reportedly, most facilities allow 45 minutes for colonoscopy and 30 minutes for upper GI endoscopy.³⁵ Other facilities schedule more tightly, allowing 30 minutes for colonoscopy and 20 minutes for upper GI endoscopy, including procedures with dilations (Rockford Gastroenterology Associates, Ltd., Rockford, IL, unpublished data). The tighter scheduling can be accommodated by efficient endoscopists, good staffing, adequate equipment, rapid turnaround time, and ample preparation-recovery space (two to three preparation-recovery bays per procedure room). Careful staffing and scheduling are imperative to ensure high-quality care, good patient outcomes, and optimal fiscal performance of the endoscopy facility.