C--AE - USP 800 Pharmacy Compliance - Alvin C. York

Department of Veterans Affairs Requirements for A/E Design Services Project 626-308 USP 800 Pharmacy Compliance ACY Tennessee Valley Healthcare System, Murfreesboro Campus I. GENERAL SCOPE OF WORK The Architect / Engineering firm shall plan and design upgrades to comply with USP 800 and USP 797 at the Murfreesboro Campus, renovating approximately 2500 square feet. The design consultant shall provide all necessary architectural and engineering (A/E) services to completely evaluate the pharmacy Compounding Sterile Preparations (CSP) operations, processes and infrastructure in existing and adjacent affected spaces in order to develop concepts and provide a complete design. The A/E shall provide space planning, testing, technical reports, layouts, calculations, sizing, narratives, estimates, schedules and phasing plans to present concepts and fully discuss options. After the optimal solution is selected, the A/E shall develop a complete design and produce construction bid documents. Professional disciplines include, but are not limited to, USP design specialist(s), architectural, life safety, mechanical, plumbing, electrical, communications, security, access controls, industrial hygiene and commissioning. II. STATEMENT OF PROJECT OBJECTIVES AND CONCEPT It is the intent of the VA TVHS to be USP 800 compliant by December 2019, while also increasing the quality of USP 797 facilities and operations. In the current facility planning concept for the project, the pharmacy and the building footprint will expand, enabling USP improvements while the existing compounding rooms remain operational during the new construction. The new USP 800 and USP 797 space will be added onto the building, connecting to the adjacent pharmacy. The existing USP 797 space will remain operational until the new USP 800 and USP 797 space is commissioned and in service, then the existing USP 797 containment rooms will be converted for pharmacy operations. The A/E will fully investigate, survey, test, analyze, interview key personnel, document existing conditions, infrastructure, systems, equipment and processes, to gain the knowledge and insight necessary to prepare a quality design to meet the following objectives: Upgrade USP 797 operations and containment rooms Provide USP 800 compliant containment rooms and operations Increase capacity, productivity and functionality of the Pharmacy Improve flow and alleviate congestion Improve processes and staff efficiency Reduce downtime and improve reliability Promote uniformity between the TVHS campus pharmacy operations at the Nashville and Murfreesboro Campuses Ensure that USP operations can evolve and grow. Currently, the facility has two hoods (1 positive and 1 negative). However, the current design and construction shall accommodate the future projected program growth to 2 IV prep hoods and 1 chemo hoods with minimal alterations. Plan and design secondary CSP provisions to be used during planned and unplanned outages. Commission the project by implementing a process throughout design, construction, inspecting and testing. The focus shall be on providing a complete, working product that complies with all codes/standards/guidelines. III. STATEMENT OF A/E TASKS Perform a complete assessment (functional, infrastructure, operational, etc.) at both facilities developing a minimum of three, unique concepts to comply with both USP 800 and USP 797. Each concept shall be a specific solution that is independent and unique. A variance or modification of a concept theme is not unique and shall not be considered as another concept or alternative solution. Substituting a constructed, built solution in lieu of a modular solution shall not be considered as another unique concept or solution (and vice versa). Evaluate all components, materials, supplies and equipment associated with the CSP. Present alternative options and propose best practices. Design shall also weigh the benefits and risks of modular systems (manufactured offsite and assembled onsite) verses solutions that are totally built at the site. On-site interviews and discussions shall occur during schematic development and a narrative included in the schematic submission. This topic shall be fully discussed during the schematic submission review meeting and resolved prior to DD1. Pricing and lead times shall be broken down with submission for each choice (modular and stick built). Provide dimensioned layouts of the space with flow diagrams, furniture placement, and equipment selection, incorporate utility tie-in locations, and address any impact moves or construction during the schematic phase. This should be done to prove the validity of concepts, as well as the final solution(s). Provided complete concepts and designs that include impact moves, phasing, and staging plans for upgrading the USP 797 pharmacy facilities, while adding USP 800 compliance. Planning and design shall include any medical center spaces and operations impacted by the pharmacy upgrade. The TVHS Space Planner will not develop the plans or provide space planning, but will work with the consultant to determine the availability of space and evaluation the overall effects to services / spaces / functions. A/E s space planner shall interface with the VA space planner as part of schematic development and follow-up during DD s to ensure proper space allocation and planning. These meetings will be separate from scheduled submission reviews. Once the design team comes to a consensus, selecting the best concept, the A/E shall fully develop the selected concept and provide complete construction bid documents. The A/E shall furnish all services for planning and a complete Schematic Design (SD) through Construction Documents 2 (CD2), and then produce construction bid documents. 1. Necessary site survey work and evaluation during the SD phase, such as verifying existing conditions, observing and verifying operational processes, verifying record drawings, and verifying and analyzing utility systems shall be accomplished for the preparation of accurate Design Development submissions. A/E shall furnish documentation and drawings of these findings, and address deficiencies in the design process. 2. The complete site survey work shall include a thorough investigation of existing conditions to accurately document and convey space dimensions for measured drawings, all utilities for affected areas, and utilities that traverse through affected areas, typical construction type and variations, and finishes. This information provides the necessary base drawings for the Schematic Development phase and Design Development. 3. Utility system verification shall include, but not be limited to, the necessary testing, adjusting, and/or balancing (TAB), temperature testing/surveillance, visual inspection, Direct Digital Controls frontend trending and other innovative measuring and testing methods of affected systems to ascertain the existing operating and performance conditions that will impact the design and construction process. Systems that are insufficient in capacity or are no longer supported by OEM parts shall be considered for expansion and/or replacement. Document existing conditions, proposed alternatives, and corrective actions. Design shall meet VA needs, VA space criteria, VA design alerts, and VA design guidelines / standards and other applicable regulations (USP, CETA, etc.). The A/E shall incorporate Energy efficiency and cost savings shall be considered in all design decisions. Design to applicable sections of the TVHS Energy Requirements and Design Guide for specific energy guidance. Design shall incorporate, but not be limited to: All components of the supply, ventilation, and exhaust systems will be evaluated and upgraded to meet hospital standards, increase functionality, energy efficiency and building envelope maintenance. Include Direct Digital Controls (DDC) and optimization controls. Whenever possible, exhaust systems shall be converted to return. Optimize reliability, stability, monitoring, and control. Integrate native BACnet DDC controls with existing DDC frontend systems. Provide strict control of processing environment (temperature, pressure relationships, and humidity, etc.). When observed, include design for replacement or repair of duct work/duct access doors/access panels that are leaking air. Duct work leakage objective is to obtain ASHRAE Standard 90.1, Seal Class A on major supply lines and Seal Class B on return and exhaust lines. The A/E shall form a design team consisting of key designers and key VA personnel, including affected users and services, and conduct meetings to accomplish a cohesive design that addresses facility issues and concerns. Design team meetings shall be held on site in conjunction with each phase of design and each submission. Additional meetings with individual user groups will be necessary to gather information and produce an effective design. The A/E shall provide 3design concepts as part of the Schematic Design phase. The A/E shall provide narratives and present the concepts to the VA Design Team and fully discuss the merits (pros and cons) of each. The A/E shall, document team/staff feedback and facilitating discussions used to arrive at a consensus. The design team will select the concept that the A/E will be fully developing during Design Development and Construction Documents. The required stamp of the licensed architect and/or engineer of record will be considered as certification of compliance with the contract requirements for that document. The registered individuals who will stamp the final construction bid documents shall be the same lead designers that accomplish the assessments, surveys, interviews and design work. Design shall ensure proper life safety, including egress, proper fire/smoke compartmentation, fire alarm, sprinkler system, etc. The A/E shall provide a separate stamped Life Safety Sheet for the areas in question within the submitted drawings. In accordance with VHA Directive 7712 the final Fire Protection code review will be vetted by a VA provided 3rd party. Any comments by the 3rd party will be addressed and revisions made accordingly by the A/E. A/E shall submit a stamped Life Safety sheet(s) as part of the CD1 package and final construction bid documents. The AE shall provide commissioning agent(s) to perform complete project commissioning throughout the design and construction, covering all trades/disciplines and all codes/standards/guidelines. Commissioning will also be an integral part of the QA process. VA is assigning the 3rd party commissioning responsibilities to the A/E s commissioning agent(s) to provide unbiased oversight. Commissioning tracking sheet shall relate design issues and responsible party with decisions, code compliance and resolutions. The Commissioning Agent shall maintain a tracking sheet, mapping all code compliance issues from inception, review and resolutions. Commissioning tracking sheet line item activities shall include, date, issue, review and decision, responsible A/E designer and satisfactory resolution. The Commissioning Agent s updated comments will be included with each submission. Since the A/E is solely responsible for the design, VA Directed shall not be an acceptable explanation of compliance or resolution. The commissioning agent shall simultaneously copy the VA COR and Contracting Officer when producing/conveying any commissioning work product, (correspondence, reports, observation lists, tracking, etc). The commissioning agent shall submit a stamped final commissioning report to the VA COR, Contracting Officer, contractor and vendor. Any issues shall be discussed in group meetings and resolved to the satisfaction of the commissioning agent, then incorporated into the final revised, stamped commissioning report. A/E shall provide stamped as-built drawings. A/E shall develop and execute a Quality Assurance (QA) plan that demonstrates a team approach and methodology throughout all aspects of the entire design. Commissioning shall be integral to the QA process. The QA process shall drive design review, improvement and code compliance, including fully documented comments / issues and resolutions / corrections. The QA plan shall be submitted to the VA along with the design schedule and shall describe the QA tasks that will be performed through various phases of the design, including review of submissions. The design QA effort shall be led by the commissioning agent and a senior design engineer. In addition to the design engineers performing project design work, the QA team shall include another USP 797 and USP 800 specialist(s) (that meets the qualifications for the primary USP 797 and USP 800 specialist(s)) and another senior engineer that is not performing actual design work on this project. VA COR shall be invited to all QA and commissioning meetings. Completion of each QA task shall be initialed and dated by the responsible QA team member. A 100% completed QA review shall be submitted with each A/E design submission, including the final construction bid document submission package. Cost review and control shall be part of each phase of the QA process and each design submission. The QA process shall produce deliverables included with each submission package; including redline mark-ups and commissioning tracking sheets. QA teams shall review issues with the design team so corrections can be made prior to submission of each package. Commissioning Agent shall be involved throughout design, construction, installation, inspection, trending, testing and certification. At the completion of the project, the Commissioning agent shall provide a stamped report indicating compliance with all applicable codes/standard/guidelines (refer to Construction Period Service Requirements below). A/E will coordinate with leading industry equipment manufacturers and vendors to ensure proper layout and support of equipment according to manufacturer s requirements. A/E shall interface with various equipment providers, including modular solutions, to find the best working solution for TVHS, including all components, options, arrangements, utilities, etc. All selections shall promote fair and open competition. Preliminary facility planning has yielded a construction budget with a magnitude of approximately $1,700,000 to $2,300,000. A/E shall provide an independent estimate, arriving at a specific, construction total for a complete, working project, including all equipment, phasing and temporary measures. Planning and design shall account future program growth with minimal alterations or upgrades. Design shall incorporate an appropriate safety factor. For systems, an appropriate safety factor would be 15%. Safety factor shall also be applied to future growth of 33%. Current design in Murfreesboro is 2 hoods (1 positive and 1 negative). Future design projections for Murfreesboro CSP are to add one (1) more hood for a total of three (3; two positive and 1 negative). Design to minimize disruptions to medical center and pharmacy operations during construction and after project completion. Design shall allow for easy access, replacement and modification of components, minimizing rework, repair, patch-back and upgrade durations. Individual room or component failures must be corrected and returned to services within 24 hours. Design shall limit system failures affecting multiple rooms. In the case of a multiple room outage/failure, corrections shall be made and a hazardous room and a non-hazardous room must be returned to services within 24 hours. Components and equipment shall be easily replaceable / swappable. Outages resulting from component failures shall be corrected and affected rooms returned to service within 24 hours. Work to perform moderate upgrades/improvements to the containment rooms, such as the addition of a containment hood or replacement of multiple doors and automatic operator assemblies, shall be possible within a 3-day weekend (Thursday night through Sunday, including testing). Other project constraints and considerations are as follows: Construction will add new building square footage at the Murfreesboro Campus, expanding the building footprint. Since immediate supervision of the CSP is required, solutions that do not create staffing inefficiencies are preferred. Solutions that minimize travel distances are preferred. The controlled area outside the containment rooms shall affectively limit traffic and cross contamination. Utilities shall not be surface mounted or exposed, especially on the exterior of the building. IV. BASIS FOR DESIGN Comply with Department of Veterans Affairs standards/guidelines, which may be obtained from the internet (http://www.cfm.va.gov/TIL/), including (but not limited to) the following: Department of Veterans Affairs Design Manuals. http://www.cfm.va.gov/til/dManual.asp Physical Security Design Manuals for VA Facilities. The facility shall be considered Mission Critical. http://www.cfm.va.gov/TIL/spclRqmts.asp. VA HVAC Design Guidelines at http://www.cfm.va.gov/til/dManual.asp. Indoor air quality requirements must be met / maintained, such as outside air percentages, air changes / CFM, and humidity. Design shall maintain building envelopes to prevent moisture infiltration and possible mold growth. VA TIL, PG-18-3, Design and Construction Procedures http://www.cfm.va.gov/TIL/cPro.asp Topic 1 - Codes, Standards and Executive Orders Topic 2 - Drawings Topic 15 - Energy efficient and sustainable design policy for new construction Topic 16 - Sustainable buildings policy for new and Renovation construction VA TIL, PG-18-15, A/E Design Submissions and Review. http://www.cfm.va.gov/til/aeDesSubReq.asp (Click Vol. C Minor and NRM Projects). Comply with VA TIL, PG-18-12 Design Guides, https://www.cfm.va.gov/til/dGuide.asp Any deviation from requirements, standards and guidelines (to any extent) shall be fully presented by the A/E and fully discussed with the design team. The A/E is responsible for documenting the issue, discussions and resolutions, including detailed reasons, contributing factors and justification for deviation. The A/E shall attribute a deviation to VA input or direction. The A/E shall retain all responsibility for a compliant design and shall stamp the design, certifying compliance without any exceptions. New rooms and partitions shall be designed tight to reduce sound and air transfer. The target sound transmission class is 40 STC. This includes in-wall components such as doors, frames, boxes and glazing. Comply with TVHS Energy Requirements and Design Guide (revision September 2014, attached). See ASHRAE 90.1-2010 for energy requirements. Ensure proper compliance with requirements, codes, guidelines, standards, etc. Code Analysis will be clearly defined on a tracking sheet, with QA review and corrections prior to DD1. There shall be a stamped Life Safety sheet(s) as part of the CD1 package and final construction bid documents. The A/E shall implement cost control measures / processes / reviews during every phase of planning and design. Comply with current federal codes and guidelines, as well as applicable state and local codes. Comply with requirements, standards, codes and guidelines from other recognized authoritative bodies, such as The Joint Commission, American Society of Hospital Engineers, AIA & IBC. Other recognized bodies include but are not limited to; Associated Air Balance Council (AABC), American Concrete Institute (ACI), Acoustical and Insulating Materials Association (AIMA), American Society of Heating, Refrigeration, and Air-Conditioning Engineers (ASHRAE), American Society of Mechanical Engineers (ASME), American Society for Testing and Materials (ASTM), Gypsum Association (GA), International Building Code (IBC), National Electric Code (NEC), NFPA, National Environmental Balancing Bureau (NEBB), International Plumbing Code (IPC), OSHA, Sheet Metal and Air Conditioning Contractors National Association (SMACNA), and American Disabilities Act (ADA), American Barriers Act (ABA), Controlled Environment Testing Association (CETA) and United States Pharmacopeia (USP). Design shall consider industry standards and best practices, as well as facility standards, incorporating them to arrive at optimal design solutions. The A/E and the A/E s Commissioning Agent(s) shall comply with commissioning requirements in this SOW and with the commissioning requirements associated with any individual referenced regulations, codes, standards (such as AIA, ASHE, ASHRAE, etc.), including commissioning of architectural work. Commissioning shall focus on providing a complete, working product that complies with all codes/standards/guidelines for all trades. Also, perform all applicable commissioning work as indicated in the VA TIL Specifications Sections for commissioning requirements (General 01 91 00 Commissioning Requirements, 21 08 00 Commissioning of Fire Suppression System, 22 08 00 Commissioning of Plumbing Systems, 23 08 00 Commissioning of HVAC Systems, 26 08 00 Commissioning of Electrical Systems, 27 08 00 Commissioning of Communications Systems, 28 08 00 Commissioning of Electronic Safety and Security Systems, etc.). V. DETAILED SUBMISSION REQUIREMENTS Program Guide PG-18-15, establishes the guidelines for the A/E submissions. Design shall be performed and submitted in accordance with VA A/E Submission Instructions for Minor and NRM Construction Program. Refer to (http://www.cfm.va.gov/til/aeDesSubReq.asp). These guidelines indicate a level for submission compliance, which may not be adequate for certain, types of design. In some instances in which critical decisions need to be made, sufficient and relevant information has to be provided timely in order for the design to progress to meet certain milestone dates. The level of applicability of the program guide depends upon the scope of work and the exclusions, which are herein specified. Questions in regards to the applicability of specific requirements shall be resolved with the COR prior to any submission deadline. Where days are stated, this refers to calendar not work days (unless stated otherwise). A. At each submission, all drawings and support material shall be dated and appropriately labeled above the title block: Work Element Copies Duration Notes Delivery Kick-off Meeting & Initial Interview/Survey 1 Day Initial Site Survey & Interviews 2 Days Initial Survey/Interviews and Exit Interview Meeting 1 Day Documented questions & answers/resolutions Schematic Design (SD) and Assessment 4 21 Days Plan on survey trips to site Drawings of Existing Conditions for each trade/discipline Follow-up Interviews and Surveys 1 Day Documented questions & answers/resolutions Conceptual and Schematic Submission Review Meeting 4 1 Day Electronic copies & hardcopy (2 Full Size & 2 Half Size + 1 spec) Gov t Review 7 Days Conceptual and Schematic Submission Review Conference Call 1 Day Approvals (signatures by key design team personnel and User) Design Development 1 (DD1) 28 Days DD1 Submission Review Meeting 4 1 Day Approvals (signatures by key design team personnel) Electronic copies & hardcopy (2 Full Size & 2 Half Size + 1 spec) Gov t Review 7 Days Design Development 2 (DD2) 21 Days DD2 Submission Review Meeting 4 1 Day Electronic copies & hardcopy (3 Full Size & 1 Half Size including set for VA Energy Review +1 spec) Gov t Review 7 Days Construction Development 1 (CD1) 21 Days CD1 Submission Review Meeting 4 1 Day Electronic copies & hardcopy (3 Full Size & 1 Half Size including stamped set for VA 3rd party Life Safety review +1 spec) Gov t Review 7 Days Construction Development 2 (CD2) 14 Days CD2 Submission Review Meeting 4 1 Day Approvals (signatures by key design team personnel) Electronic copies & hardcopy (2 Full Size & 2 Half Size + 1 spec) Gov t Review 7 Days Final Revision and Reproduction of Bid Documents 7 Days Final VA Check 4 1 Day Electronic copies & hardcopy (2 Full Size & 2 Half Size + 1 spec) Total 159 Days VA submission review comments may be verbal, noted directly on review sets, or written list. The A/E shall be responsible for compiling and addressing review comments. A/E shall produce and distribute meeting notes or minutes for VA review immediately after each submission review meeting. A/E shall track all design team comments/issues and the resolutions on an Excel tracking sheet with dates and points of coordination / contact. In addition to the deliverables identified in Section A of Detailed Submission Requirements above and in the Requirements for A/E Design Submissions in the VA Technical Information Library http://www.cfm.va.gov/til/aeDesSubReq.asp, A/E shall provide the following: Separate Life Safety sheet(s). A/E shall furnish with drawings separate stamped Life Safety sheet(s). CD1 Life Safety drawings will be stamped and ready for VA 3rd party review. The final drawing/submission set will reflect all comments and/or revisions in accordance with VA provided 3rd party life safety review. QA team red-line mark-ups. Corrections shall be made prior to submission to VA. Red-line mark-ups shall be submitted to the VA with each, corrected submission. A/E submission checklists filled out by the A/E and submitted with each submission (see Program Design Guide, PG-18-15, Vol. C, latest revision) With each submission, provide QA Commissioning Agent tracking sheet, documenting issues through discussions, implementation, resolution and corrections to ensure a clear path to code compliance. D. For each submission, furnish electronic files in the latest version of Microsoft Office and Microsoft Word and/or AutoCAD 2016, as well as PDFs. Submit 4 hardcopies of all drawings (see additional delivery notes in table above) and 1 hardcopy set of specifications. This includes a full size hard copy at DD2 for energy review/comments. This also includes a full size hard copy of CD1 submittal with Life Safety sheets stamped for VA contracted 3rd party Life Safety review/comments. E. The final construction bid documents will also include 2 full sets and 2 half sets plus 1 set of specifications, including all disciplines/packages and will be stamped (sealed and signed by the Architects and Engineers of Record). F. Incomplete submissions will not be accepted or reviewed. Partial submissions or piecemealed information is considered to be incomplete and will not be accepted. Submissions and final construction bid documents shall incorporate or address all VA supplied comments from the previous submission package review(s) or it will be considered to be incomplete. Submissions packages shall undergo QA review and designer corrections prior to each submission. Submissions that have not been corrected shall not be accepted. Submissions without the required designer redline mark-ups and up-to-date QA tracking sheet will not be accepted. G. If the submission documents are not complete, the A/E must resubmit the package in its entirety. Total time to accomplish Schematics through final reproduced construction bid documents shall be 159 calendar days from the issuance of the Notice to Proceed. Each submission will require maximum 7 calendar days for VA review the consultant s submission package. A/E shall prepare a submission schedule based upon the submission table above so that the timeframes are met. VI. CONSTRUCTION PERIOD SERVICE REQUIREMENTS Review of Submittals: A/E and A/E s Commissioning Agent shall review all material submittals, shop drawings, test reports, etc. Reviews shall be completed and submittals returned to the VA Project Engineer within 7 calendar days of the A/E's receipt of the submittal. Review Analysis of Requests for Information, Change Orders, and Costs: A/E shall provide prompt response when contacted by the Contracting Officer, or COR, to review and provide analysis of construction contractor requests for information; change orders; and resulting cost adjustments due to omissions, errors, ambiguities, etc. RFI response time shall be 5 calendar days. Mandatory Site Visits: The A/E shall have a full team (with all trades represented) attend the in-wall inspection, above ceiling inspection, equipment start-ups (2) and final inspection. The A/E must also participate in two Pre-Bid conferences (2), but a full team is not required. The Commissioning Agent s on-site activities shall be involved and driven by the requirements of their certification/report. However, at a minimum, the Commissioning Agent shall attend final inspection, TAB, controls/VFD testing, operational testing prior to final inspection, dynamic real-world operational testing, CETA testing/certification, and additional site visits (2 minimum) during construction visits. Additional Site Visits: A/E shall provide 48 site visits (1 person for 3 hours) during the construction period, in addition to the Mandatory Site Visits listed above. A site visit unit is defined as a visit to the site by one individual for any part of a day when requested by the Contracting Officer. On this job, a site visit should last 3 hours and may require the use of multiple units when more than one individual or an extended period of time is needed to inspect an area of work. Only registered architects, engineers and/or the commissioning agent that are familiar with the project may make these site visits. The Contracting Officer Representative has the prerogative to determine the professional discipline(s) required for each site visit. The A/E shall notify the COR of their presence on site, before any work is performed, to document the number of individuals who are making the site visit. The A/E shall observe the construction, advise the COR of any deviations or deficiencies, and recommend appropriate corrective actions. The A/E, when requested, shall assist the Contracting Officer and COR to interpret the construction documents and shall: (1) recommend any action(s) deemed suitable for the satisfactory prosecution of the construction work; (2) prepare any supplemental drawings, specifications or other documents that may be required to clarify or supplement the construction documents; and (3) assess the preparation of Construction Contract Modifications initiated by or through VA to be executed in accordance with the Construction Documents. "Record Drawings" Requirement: A/E shall revise the solicitation documents if necessary and provide a complete set of all drawings showing actual, completed construction and reflecting any changes incorporated in the work on hard (bond) copy and on electronic media. Electronic media drawings shall be in AutoCAD 2016 and always electronically stamped. A/E shall load and demonstrate full AutoCAD compatibility at VA site. Compatibility means that data can be accessed directly by target system without translation or processing of data files. Problems shall be corrected to satisfaction of VA. Final electronic media specifications shall be in Microsoft Word 2016 and Adobe PDF. Commissioning Report Requirement: Commissioning report (indicating full compliance with all applicable codes/standards/guidelines) shall include (but is not limited too) an overview/main narrative, a narrative for each discipline/trade, subcontractor certification letters of compliance, mechanical controls operational testing (72 hour minimum, repeated until passed/compliant), mechanical testing, test, adjust and balance (TAB) report, final inspection (with designers, COR, commission agent, contractor and subcontractors), training reports, statement and certification of compliance of all applicable codes, tests of multiple cycles and conditions, lists of issues with actions taken and resolution/correction dates, operational tests with observation report of the final, real-world, working system / environment and CETA inspection report indicating full compliance with USP 797 and 800. VII. MATERIALS TO BE FURNISHED TO THE SELECTED A/E ...