Delaware Health and Social Services Division of Public Health Office of Health Facilities and Licensing Certification 2055 Limestone Road, Suite 200 Wilmington, DE 19808 Phone (302) 995-8521 Blueprint Plan Review & Approvals Process The Office of Health Facilities Licensing & Certification (OHFLC) utilizes the 2006 Guidelines for Design and Construction of Health Care Facilities developed by The Facility Guidelines Institute, the American Institute of Architects Academy of Architecture for Health with assistance from the U.S. Department of Health and Human Services as the standard for new construction, additions and alterations (including change of usage) of Health Care Facilities in Delaware. OHFLC plan review and approval governs construction that impacts upon or dictates the quality of service provided by healthcare facilities. The Office defers to the local government in matters of zoning, parking, environmental issues (such as drainage) and access. In addition, this Office recognizes the authority of the Fire Marshal to determine compliance with the State Fire Prevention Regulations and the Life Safety Code. 1. How do I get a copy of the Guidelines? OHFLC cannot provide you with copies of the Guidelines. You may purchase copies by calling 202.626.7541 or 1.800.242.3837 or you can go to the following websites: http://www.fgiguidelines.org/guidelines.html, or http://www.aia.org/books. 2. How do I submit plans to OHFLC? There is no fee required for submission at this time. There is a 3 step procedural process. OHFLC Project Code: - Someone who owns or manages the business must contact this Office (302.995.8521) to discuss the intended construction or renovation with the primary contact for that facility type. During that contact, the owner/manager will be given a project code. - The architect, engineer or project manager must have this project code when (s)he contacts this Office about blueprints and construction. Application - Upon receipt of the project code, complete the “Application for Blueprint Review” and submit to the Office of Health Facilities Licensing & Certification. This may be done by email (to the primary contact or Barbara.Bowser@state.de.us, fax (302.995.8529) or mail. - Upon receipt, OHFLC will review the application and provide further instructions. OHFLC Blueprint presentation: - OHFLC does not accept blueprints dropped off or mailed for review. - You are required to prepare a presentation in accordance with the directions provided. - Please contact Barbara Bowser to set up an appointment for the blueprint presentation. If a meeting presents a hardship to the facility/project, it may be possible to arrange for a conference call. - You will be required to leave your presentation material and a floor plan. OHFLC does not accept full sets of drawings. The floor plan must include dimensions and/or floor area but does not need to be to scale. It may be on any size paper greater than 8.5 x 11. 3. What do I need to do to prepare for the presentation? You will be expected to utilize the appropriate sections of the 2006 Guidelines for Design and Construction of Health Care Facilities to develop a presentation document that addresses each guideline and refers to the blueprint by section, room number or page. During the meeting you and a representative from OHFLC will use this information to determine compliance. 4. How do I know which sections of the Guidelines apply? OHFLC uses the classifications within the table of contents to determine what standards to use when reviewing the plans. The following sections are mandatory for every project. Please be concise and use outlining when appropriate. - The Seal or registration number of the Delaware licensed architect or engineer involved in the blueprint design. - Chapter 1.2.2: Functional Program (pages 15-18). - Chapter 1.4.3: Equipment Requirements (page 25). - An Infection Control Risk Assessment (ICRA), see Chapter 1.5: Planning, Design and Construction. (pages 26-28) - The section (common elements and type) that applies to your project. If you are unable to find any specialty section that applies, please contact this Office to discuss your concern. Finally, you will need to utilize equipment manufacturer specifications as well as comply with ventilation requirements and the number of station outlets for oxygen, vacuum and medical air. 5. Do I have to document the information repeatedly? There are sections of the Guidelines that overlap. No, you may cross reference. If your project has unique criteria, you may cross reference any of the common elements, service areas, administration, construction standards, etc that are redundant. 6. What if the project is only a renovation of existing space? OHFLC does not allow construction to be performed to a lesser standard because it is a renovation. All construction must meet current Guideline standards. 7. What if the project is only cosmetic? Changes that are repainting, changing carpeting or other cosmetic changes do not require blueprint approval. Changing the function of an area, moving walls or entrance ways is never considered cosmetic. Removing or adding cabinetry, alterations to plumbing and/or alterations to HVAC require authorization from this Office to be classified as cosmetic. 8. Do all projects require a blueprint presentation? No. Some projects may be “registered” with the office and not require a blueprint presentation. OHFLC must authorize a project to be “registered” in order to avoid the blueprint submission and approval process. 9. What is registration? Areas that do not impact patient care or have very little criteria to meet in the Guidelines may not require a blueprint presentation. These projects are registered with this office with accompanying compliance documentation (see questions #3 & #4 above), given a project code and will be closed when you notify OHFLC that the project is complete. These projects may or may not require additional paperwork submission. 10. What do I do if I cannot meet the building and construction requirements or I feel that my design is more practical? This Office will entertain waiver requests. The process must be addressed prior to the blueprint approval meeting. Waiver of a standard requires Director (of OHFLC and possibly others) approval and could be a lengthy process. Waiver requests must be made in writing, include the full justification behind the request and address issues of safety and infection control. They are an exception to established standards and will only be approved for compelling reasons. Cost alone will never be sufficient. 11. How soon will I have my plan approval? If your presentation is complete and there are no outstanding issues, you will walk away from the meeting with a letter of approval. You will be required to submit various reports depending on the type of construction being performed but that will not delay the construction of your project. 12. Do I have to do anything else? One final thing…after construction is complete but before occupancy, you will need to arrange for a post construction site visit. 13. What is a post construction walk-thru? OHFLC must complete an onsite inspection after your project is completed and before use. Please note that building and renovating of healthcare facilities requires compliance with many special codes such as NFPA 99 and NFPA 101, and you will be expected to produce the following reports and certifications at the time of the walk-thru: - HVAC Balancing, - Fire Marshal approval, - Certificate of Occupancy - Medical Gas Certification (when using med gases) - Evidence of inspection and approval of the Delaware Radiation Control office. 14. Who else do I have to contact? You will need to contact the municipality where you are doing the construction. Each municipality has its own requirements for the construction, building codes, zoning, plumbing and electrical. You will need approval from one or more fire marshal’s office(s). If you are a licensed facility, you will need to work with the municipality fire marshal. If the facility is certified, you will need authorization from the State Fire Marshal designee. Be very clear when you contact the State Fire Marshal, for many areas the State Fire Marshal is both the municipality and reviewing for certification and will require 2 separate reviews. You may also be required to obtain approval from other offices within public health for evaluation of compliance with other regulations. (i.e.: the Food Code or Radiation Control) Thanks for your attention and we look forward to meeting with you. Office of Health Facilities Licensing and Certification Help & Hints All facilities: - There are no exceptions to guidelines based upon specialty. Licensure and certification classifications are not limiting therefore all facilities carrying that designation must meet the specified standards. - Clean storage and sterile storage are not the same things. - Equipment storage is not clean unless is it new and unused, therefore it cannot co- mingle with clean supplies. Please keep separate through design or procedure. - Use of carts for linen and supplies will not negate the need for designated space. With appropriate procedures, alcoves may be used but they cannot decrease the width of the passageway below the standard. - Trash and hazardous waste must be maintained in a manner that minimizes the possibility of hazardous waste being disposed of in regular trash. This can be accomplished by using separate areas, use of dividers or other environmental cues. - When a “clearance” is required by the Guidelines, that space may not be “shared”. - Electronics must be maintained at the infection control level required by the designated area. This can be minimal in support areas (dusting, wiping with a damp cloth, keeping free from gross contamination), moderate (able to withstand routine cleaning through regular or specialized cleaning supplies) or high (scrubbable and able to withstand chemical cleaning). You are permitted to purchase the appropriate electronics or use cabinetry to minimize exposure. - When the Guidelines require a “handwashing” sink, it is limited to that purpose. If the area you are constructing requires a sink for food, mixing chemicals or cleaning agents, disposal of body fluids or other hazardous waste, preparation of lab specimens, etc., you must install an additional sink. - The number of janitorial closets must be dictated by the adjacent area cleaning needs. Clinical area carts should not be available for use in administrative areas. - HVAC criteria is located on page 130-132 (table 2.1-2). - Hot water standards are located on page 133 (table 2.1-4) - Medical Gas standards are located on page 134 (table 2.1-5) for inpatient facilities. - Medical Gas standards are located on page 207 (table 3.1-2) for outpatient facilities. - Intercom systems are inadequate to be used for emergency communication systems. Emergency call systems must connect to a control station and possess at least an auditory alert. - Skip any section entitled “Applicability”, “Site” Hospitals: - On Nursing Units, exam rooms may only be omitted if the all rooms are single – bed. - Trash and linen must be maintained in a manner that minimizes the possibility of trash being disposed of in linen containers. This can be accomplished by using separate areas, use of dividers or other environmental cues. - The number of janitorial supplies/closets must be dictated by the adjacent area cleaning needs. Areas requiring higher levels of sanitation such as a bone marrow unit, unit must have dedicated housekeeping supplies/closets. Areas requiring higher levels of sanitation due to the hazardous activity such as dialysis units must have dedicated housekeeping closets. Sterile corridors/areas much have dedicated janitorial supplies/closets. Outpatient Services: - Wheelchair storage is dedicated space for storing wheelchair transportation owned and utilized by the Outpatient facility. This space may be within the equipment storage area when it does not compromise infection control or patient rights. The amount of storage required will be based upon the number of wheelchairs the facility owns. - Wheelchair parking is dedicated space for storing wheelchairs that belong to patients. This space may NOT be within the equipment storage area. If a limited amount of space is available (ie: holds one parked wheelchair) a policy and procedure must be developed to address how the facility will accommodate their patients (ie: screen during intake and arrange patient be transported in a fashion that patient accesses the services without use of personal wheelchair – ie: transfers to facility wheelchair or uses medical transportation service. Surgical Centers: - There are no exceptions to guidelines based upon specialty. Licensure and certification classifications are not limiting therefore all facilities carrying that designation must meet the specified standards. There are no exemptions for Pain Centers, Endoscopy or Uroscopy Facilities. - The fact that “assessments” are done prior to scheduled procedures will not negate the need for an exam room. Plans for Outpatient facilities must include a room that meets the criteria of 2.1.1 or 2.1.2 or 2.1.3. This room may also serve as private interview space for the physician when discussing issues related to the health care of the patient. - When a clearance is required by the Guidelines, that space may not be “shared”. Specifically, the use of a curtain will not allow you to share space. If the criterion is ‘three feet clear’, then stretchers must be at least six feet apart. - You must provide a communication system. The type of facility and services provided will dictate the type of system required. - You must have designated pre-operative space despite the lack of design space criteria in the guidelines. It must be equal to the number of OR/Procedure rooms you have. If you do not use a solid wall design cubicle, you must have a distinct pre-op and post-op area. If you use a solid separation of at least three quarters the length (to increase the level of visual and acoustical privacy) of the stretcher/chair you may use the cubicle as both pre-op and post-op for that particular patient. - Guideline 2.4.2 mandates Phase II recovery. Delaware does not require Phase II recovery. If a Phase II recovery area is provided it cannot be “instead” of PACU. Patients must not go directly to a Phase II recovery area. A patient must go to PACU for at least a minimal assessment by Nursing before moved to a Phase II area. - Endoscopy suites are considered surgical areas. The Endoscopy room must meet the comparable standards of an Operating Room and the equipment, cabinetry, fixtures and furniture maintained accordingly (scrubbable and able to withstand chemical cleaning). - Electronics in operating rooms must meet the same criteria as the routine equipment and walls. They must be scrubbable and able to withstand chemical cleaning. You are encouraged to purchase the appropriate electronics or use cabinetry to minimize exposure. - Hazardous waste and soiled linen must be separate. This can be accomplished by using separate areas, use of dividers or other environmental cues. - Trash and hazardous waste must be maintained in a manner that minimizes the possibility of hazardous waste being disposed of in regular trash. This can be accomplished by using separate areas, use of dividers or other environmental cues. - The number of janitorial supplies/closets must be dictated by the adjacent area cleaning needs. Areas requiring higher levels of sanitation such as a sterile corridor and operating rooms must have dedicated housekeeping supplies/closets. The optimal setup for a surgery center is three (3) separate closets, but minimally three (3) dedicated carts in two (2) closets. - Patient’s clothing must be kept in a secure manner in a designated design space. Street clothes are not permitted to be placed in a bag and put on the stretcher that goes into the operating room. - CLARIFICATION APPENDIX A1.5.2: Please use the terminology within the Appendix on page 222. The “sterile corridor”, also known as the “restricted corridor”, are by appendix language SEMI-RESTRICTED. Attempting to use the terminology of the table and the language in the criteria creates a conflict within the design. Adult Day Care: - Failure to provide a dedicated staff bathroom will result in your staff complement being counted in your patient census for design purposes. Efforts will be made to expand this section on an ongoing basis. Please feel free to offer suggestions, additions or clarifications. Your feedback is appreciated. Blueprint Submission Memo - EXAMPLE TO: Office of Health Facilities Licensing & Certification Delaware Health and Social Services, Division of Public Health 2055 Limestone Road, Suite 200 Wilmington, DE 19808 RE: OHFLC project # 00-Type-000 Delaware Example Surgery Center (DESC) Some road Some city, DE DATE: 00/00/0000 Submitted by: Representative Relationship Architect of record is, Architect #1, Delaware identification number: 000000000000. The following design is based upon 2006 Guidelines for Design and Construction of Health Care Facilities. This project was submitted under the name of Example Surgery Center. It is now known as OHFLC Surgical Services LLC, dba Delaware Example Surgery Center. 1.2.2 FUNCTIONAL PROGRAM Purpose: DEF will be a XXXX square foot surgery center. It will be freestanding. It will licensed as a free standing surgical center and certified as an ambulatory surgical center. It will be deemed to meet Medicare guidelines by AAAHC. It is not a phased project. The anticipated date to begin construction is 00/00/0000 and the target date is 00/00/0000. Required Services: Outpatient surgery Nursing evaluation and support of patient Anesthesia services: local, conscious sedation and general Anticipated Vendors/subcontractors: medical supplies, biohazardous waste removal, pharmacy, trash removal, medical records destruction, medical gas supplier, security, alarm monitoring, office supplies, linens, landscaping, building maintenance, HVAC/generator maintenance, computer & phone maintenance. Environment: 2 Class C ORs with 1 scrub sink Pre-op area with 3 bays 9 bed PACU 2 nurses stations Exam Room On-site sterilizing Storage [sterile, clean, equipment, trash, biohazardous waste] Linen will be off-site and picked up daily. On-site management will be dirty linen carts with a designated holding area at the loading dock Business office Office space for Administrator, Nurse Manager and Medical Director Reception area Waiting room Housekeeping closets [1 for administration, 1 for clinical area & 1 for Operating suite] Lockers/changing area for staff 2 staff bathrooms 1 unisex handicap accessible bathroom in clinical area 2 public bathrooms Off site laboratory and x-ray services Anesthesia work room Functional Requirements: The size of each space is included in the descriptions that follow. DESC be staffed by 3 MDs, 5 nurses, 1 administrator and 3 clerical support staff when it is at full capacity. The anticipated maximum occupancy is XXX. Each OR is expected to support a maximum of X procedures per day. Hours of operation: 7:30 a.m.– 4:30 a.m. Monday through Friday. All vendors delivering supplies enter through rear entrance with no disruption of patient care. It is free standing and does not require separation by fire wall from any other occupancy. The lighting shall require manufacturer recommended safety reinforcement. The HVAC access panels and lighting panels in the OR shall all have gaskets. Computer equipment, monitors and panels are all scrub-able and/or enclosed in a container that is scrub-able. There is one-way pattern of access of patients from entry of the building to the patient exit off of the PACU. See design details for staff circulation. See design details for sterilization path. See design details for soiled/hazardous waste/trash route. The main entrance and discharge exits are open during business hours and then locked. The service entrance is locked and subcontractors must be allowed in by staff after the doorbell/buzzer is utilized. Community Utilities shall be used for: water, electricity, sewer and gas. Emergency generator [indicate size] is located XX feet from building. 1.4.3 EQUIPMENT REQUIREMENTS The following equipment requires special structural design OR lighting – ceiling reinforcement and ventilation Neptune waste disposal - plumbing 1.5.2 PLANNING AND DESIGN: Infection Control Risk Assessment (ICRA) [Please consider using the ICRA guidelines published by JCAHO] - As a free standing, new building – there is no patient involvement. Industry based standards shall be used for the protection of workers, integrity of the finishes and maintenance of equipment. - Impact of disruption on patients: none - Patient placement or relocations: none - Placement of effective barriers to protect susceptible patients from airborne contaminants such as Aspergillus sp: not required - Determination of additional numbers of: - Airborne infection isolation - none - Protective environment rooms - none - Patient protection from movement of debris: N/A - Traffic flow: N/A - Clean up: In addition to the construction clean up by the contractor, a cleaning service shall be utilized to clean the building and sanitize the clinical areas. 3.1 OUTPATIENT FACILITIES [INSERT COMMON ELEMENTS OF 3.1 STARTING AT 3.1.1.5 Skip 3.1.1.7 Site You are not required to document the information twice. Document x 1 in either section and cross refer]. 3.1.1.5 Shared/Purchased Services 3.1.1.6.1 DESC is freestanding, with no shared services 3.1.1.6.2 Entrance and patient exit are at grade level. 3.1.1.6.3 Traffic pattern shall be illustrated during presentation. 3.1.2.0 Diagnostic and treatment locations. 3.1.2.1.1(1) - Rm # 111, 80 square feet, 3.1.2.1.1(2) - A recliner lounger will be utilized allowing 3 feet clearance all around when placed in center of room. 3.1.2.1.2 - One (1) - handwashing sink 12x14x12 2.1.1.2.3 – A counter 4 feet long, enclosed sink leaving 2.5 feet clear writing space. 3.1.2.1.2 – N/A 3.1.2.1.3 – N/A 3.1.2.1.4 – N/A 3.1.2.1.5 – See ICRA 3.1.2.1.6 – See ICRA 3.1.2.1.7 – See section 3.7 3.1.2.1.8 – See section 3.7 3.1.2.2 – See functional program and section 3.7 3.1.2.3 – See functional program and section 3.7 3.1.3.0 Service Areas Address each item. 3.1.4.0 Adminstrative and Public Areas Address each item. 3.1.5.0 Construction Standards Address each item. 3.1.6.0 Special Systems Address each item. 3.1.7.0 Special Systems Address each item. 3.7 OUTPATIENT SURGICAL FACILITIES 3.7.2 Diagnostic and Treatment Locations 3.7.2.1 Diagnostic Facilities - DESC will not be offering any pre-admission testing. Any specimens requiring lab analysis shall be package per vendor requirements and delivered or picked up daily. 3.7.2.2 Examination rooms - See 3.1.2.1.1 3.7.2.3 ORS 3.7.2.3.1.1 Class A – none 3.7.2.3.1.2 Class B – none 3.7.2.3.1.3(1) Three (3) Class C ORs #111: 20 x 20 = 400 sq ft, greater than 4ft clearances around OR table #112: 25 x 18 = 450 sq ft, at least 4 ft clearances around OR table, designated area for additional storage carts for orthopedic supplies (which will be rotated) #113: 20 x 20 = 400 sq ft, greater than 4ft clearances around OR table 3.7.2.3.1.3(2) All the ORs have at least 4 ft clearances around the designated area for the OR stretcher. 3.7.2.3.1.3(2) All the ORs, all are accessible from the sterile corridor (semi-restricted space). 3.7.2.3.2 Emergency call system is accessible from each OR and the control panel is at the nurses station within PACU. Continue to complete each item. Doc. # 35-05-20/07/06/13 BP submission directions 2007