36C25018B0815-002.pdf

420 N. James Road Columbus, OH

Pharmacy IV Prep Room Project Number 757-19-201

Bid Set May 18, 2018

C o l l a b o r a t i v e D e s i g n, L t d

VAACC Columbus, OH

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04-01-18

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DEPARTMENT OF VETERANS AFFAIRS

VHA MASTER SPECIFICATIONS

TABLE OF CONTENTS

Section 00 01 10

DIVISION 00 - SPECIAL SECTIONS DATE

00 01 15 List of Drawing Sheets 07-15 00 11 21 Request for Proposal to Design Build 11-1 5

DIVISION 01 - GENERAL REQUIREMENTS

01 00 00 General Requirements 10-17 01 32 16.15 Project Schedules (Small Projects – Des ign/Bid/Build 04-13 01 33 23 Shop Drawings, Product Data, and Samples 05-17 01 35 26 Safety Requirements 02-17 01 42 19 Reference Standards 05-16 01 74 19 Construction Waste Management 09-13 01 81 13 Sustainable Construction Requirements 10-1 7 01 91 00 General Commissioning Requirements 10-15

DIVISION 02 – EXISTING CONDITIONS

02 41 00 Demolition 08-17

DIVISION 05 – METALS

05 50 00 Metal Fabrications 04-18

DIVISION 06 – WOOD, PLASTICS AND COMPOSITES

06 10 00 Rough Carpentry 10-17

DIVISION 07 - THERMAL AND MOISTURE PROTECTION

07 01 50.19 Preparation for Re-Roofing 02-16 07 21 13 Thermal Insulation 10-17 07 22 00 Roof and Deck Insulation 02-16 07 54 23 Thermoplastic Polyolefin (TPO) Roofing 08- 16 07 84 00 Firestopping 02-16 07 92 00 Joint Sealants 10-17

DIVISION 08 - OPENINGS

08 11 19 Stainless Steel Doors and Frames 08-16 08 31 13 Access Doors and Frames 02-16 08 71 00 Door Hardware 01-16

00 01 10-2

08 71 13.11 Low Energy Power Assist Door Operators 08-16 08 80 00 Glazing 10-15

DIVISION 09 – FINISHES

09 05 16 Subsurface Preparation for Floor Finishes 02-15 09 06 00 Schedule for Finishes 04-15 09 22 16 Non-Structural Metal Framing 05-16 09 29 00 Gypsum Board 11-14 09 65 16 Resilient Sheet Flooring 05-18 09 91 00 Painting 01-16

DIVISION 10 – SPECIALTIES

10 26 00 Wall and Door Protection 10-15

DIVISION 13 – SPECIAL CONSTRUCTION

13 03 70 Clean Room Pass-Through Chambers

DIVISION 21- FIRE SUPPRESSION

21 08 00 Commissioning of Fire Suppression System 1 1-16 21 13 13 Wet-Pipe Sprinkler Systems 06-15

DIVISION 22 – PLUMBING

22 05 11 Common Work Results for Plumbing 07-16 22 05 23 General-Duty Valves for Plumbing Piping 09 -15 22 07 11 Plumbing Insulation 09-15 22 08 00 Commissioning of Plumbing Systems 11-16 22 11 00 Facility Water Distribution 09-15 22 13 00 Facility Sanitary and Vent Piping 09-15 22 40 00 Plumbing Fixtures 09-15

DIVISION 23 – HEATING, VENTILATING, AND AIR

CONDITIONING (HVAC)

23 05 11 Common Work Results for HVAC 08-17 23 05 12 General Motor Requirements for HVAC and St eam

Generation Equipment 08-17

23 05 41 Noise and Vibration Control for HVAC Pipin g and Equipment

02-15

23 05 93 Testing, Adjusting, and Balancing for HVAC 02-15 23 07 11 HVAC and Boiler Plant Insulation 02-15 23 08 00 Commissioning of HVAC Systems 11-16 23 09 23 Direct-Digital Control System for HVAC 09- 11 23 21 13 Hydronic Piping 08-17 23 25 00 HVAC Water Treatment 02-15 23 31 00 HVAC Ducts and Casings 03-13 23 34 00 HVAC Fans 02-15 23 36 00 Air Terminal Units 02-15 23 37 00 Air Outlets and Inlets 02-15

00 01 10-3

DIVISION 26 – ELECTRICAL

26 05 11 Requirements for Electrical Installations 01-16 26 05 19 Low-Voltage Electrical Power Conductors an d Cables 01-17 26 05 26 Grounding and Bonding for Electrical Syste ms 01-17 26 05 33 Raceway and Boxes for Electrical Systems 0 1-18 26 08 00 Commissioning of Electrical Systems 11-16 26 09 23 Lighting Controls 01-18 26 22 00 Low-Voltage Transformers 01-18 26 27 26 Wiring Devices 01-18 26 29 11 Motor Controllers 01-18 26 29 21 Enclosed Switches and Circuit Breakers 01- 17 26 41 00 Facility Lightning Protection 01-17 26 51 00 Interior Lighting 01-18

DIVISION 27 – COMMUNICATIONS

27 05 11 Requirements for Communications Installati ons 06-15 27 05 26 Grounding and Bonding for Communications S ystems 06-15 27 05 33 Raceways and Boxes for Communications Syst ems 06-15 27 08 00 Commissioning of Communications Systems 11 -16 27 10 00 Control, Communication and Signal Wiring 0 6-15

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SECTION 00 01 15

LIST OF DRAWING SHEETS

The drawings listed below accompanying this specification form a part of the contract.

Drawing No. Title

G-001 Cover Sheet

G-002 General Information

G-003 Overall First Floor Plan

G-004 Overall Second Floor Plan

AS-100 Enlarged Demo & New Floor Plan

AS-101 Enlarged Equipment & Reflected Ceiling Plan

AS-102 Partial Roof Plan

AS-300 Schedules & Details

FP-100 Fire Protection Second Floor Plan

P-001 Plumbing Abbreviations / Symbols

P-100 Plumbing Floor Plans

P-200 Temporary Trailer Plumbing Plan

M-001 HVAC Abbreviations / Symbols

M-100 HVAC Second Floor Demolition Plan

M-101 HVAC Second Floor New Work Plan

M-102 HVAC Piping Second Floor Plan

M-103 HVAC Third Floor/Roof Plan

M-600 HVAC Schedules

E-001 Electrical Abbreviations / Symbols

E-100 Electrical Second Floor Demolition Plan

E-101 Electrical Second Floor Lighting & Power Plans

E-102 Electrical Third Floor/Roof Plan

E-200 Temporary Trailer Electrical Plan

E-500 Electrical Schedules and Details

- - - END - - -

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SECTION 01 00 00

GENERAL REQUIREMENTS

TABLE OF CONTENTS

1.1 SAFETY REQUIREMENTS

1.2 GENERAL INTENTION

1.3 STATEMENT OF BID ITEM(S)

1.4 SPECIFICATIONS AND DRAWINGS FOR CONTRACTOR

1.5 CONSTRUCTION SECURITY REQUIREMENTS

1.6 OPERATIONS AND STORAGE AREAS

1.7 ALTERATIONS

1.8 DISPOSAL AND RETENTION

1.9 PROTECTION OF EXISTING VEGETATION, STRUCTURES, EQUIPMENT,

UTILITIES, AND IMPROVEMENTS

1.10 RESTORATION

1.14 AS-BUILT DRAWINGS

1.15 USE OF ROADWAYS

1.18 TEMPORARY USE OF EXISTING ELEVATORS

1.21 AVAILABILITY AND USE OF UTILITY SERVICES

1.24 INSTRUCTIONS

1.30 PHOTOGRAPHIC DOCUMENTATION

1.31 TEMPORARY MOBILE COMPOUNDING CENTER ………………………………………………………………………15

CERTIFICATION APPENDIX

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SECTION 01 00 00

GENERAL REQUIREMENTS

1.1 SAFETY REQUIREMENTS

Refer to section 01 35 26, SAFETY REQUIREMENTS for safety and infection control requirements.

1.2 GENERAL INTENTION

A. Contractor shall completely prepare site for bui lding operations, including demolition and removal of existing struct ures, and furnish labor and materials and perform work for the Columb us VAACC Pharmacy IV preparation rooms renovations to comply with USP 79 7 & 800 requirements as required by drawings and specifications.

B. Visits to the site by Bidders may be made during the Pre-Bid conference on the date and times noted on the Solicitation for this project.

C. Offices of Collaborative Design, Ltd., as Archit ect-Engineers, will render certain technical services during constructi on. Such services shall be considered as advisory to the Government a nd shall not be construed as expressing or implying a contractual a ct of the Government without affirmations by Contracting Officer or his duly authorized representative.

D. Before placement and installation of work subjec t to tests by testing laboratory retained by Department of Veterans Affai rs, the Contractor shall notify the RCOR in sufficient time to enable testing laboratory personnel to be present at the site in time for pro per taking and testing of specimens and field inspection. Such pri or notice shall be not less than three work days unless otherwise desi gnated by the COR.

E. All employees of general contractor and subcontr actors shall comply with VA security management program and obtain perm ission of the VA police, be identified by project and employer, and restricted from unauthorized access.

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1.3 STATEMENT OF BID ITEM(S)

A. BID ITEM I (BASE BID), All work shown on the drawings and specifications. Work includes general, plumbing and electrical construction and removal of existing construction and certain other items.

B. BID ITEM II (DEDUCT ALTERNATE 1), All work in BID ITEM I except do not provide the temporary mobile compounding center, utility connections to the compounding center and certification of the compounding center.

1.4 SPECIFICATIONS AND DRAWINGS FOR CONTRACTOR

A. Drawings and contract documents may be obtained from the website where the solicitation is posted. Additional copies will be at Contractor's expense.

1.5 CONSTRUCTION SECURITY REQUIREMENTS

A. Security Plan:

1. The security plan defines both physical and administrative security procedures that will remain effective for the entire duration of the project.

2. The General Contractor is responsible for assuring that all sub-contractors working on the project and their employees also comply with these regulations.

B. Security Procedures:

1. General Contractor’s employees shall not enter the project site without appropriate badge. They may also be subject to inspection of their personal effects when entering or leaving the project site.

2. Before starting work the General Contractor shall give one week’s notice to the Contracting Officer so that security arrangements can be provided for the employees. This notice is separate from any notices required for utility shutdown described later in this section.

3. No photography of VA premises is allowed without written permission of the Contracting Officer.

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4. VA reserves the right to close down or shut down the project site and order General Contractor’s employees off the pr emises in the event of a national emergency. The General Contrac tor may return to the site only with the written approval of the Cont racting Officer.

C. Document Control:

1. Before starting any work, the General Contractor /Sub Contractors shall submit an electronic security memorandum desc ribing the approach to following goals and maintaining confide ntiality of

“sensitive information”.

2. The General Contractor is responsible for safeke eping of all drawings, project manual and other project informat ion. This information shall be shared only with those with a specific need to accomplish the project.

3. Certain documents, sketches, videos or photograp hs and drawings may be marked “Law Enforcement Sensitive” or “Sensitive Unclassified”.

Secure such information in separate containers and limit the access to only those who will need it for the project. Re turn the information to the Contracting Officer upon request .

4. These security documents shall not be removed or transmitted from the project site without the written approval of Co ntracting

Officer.

5. All paper waste or electronic media such as CD’s and diskettes shall be shredded and destroyed in a manner acceptable to the VA.

6. Notify Contracting Officer and Site Security Off icer immediately when there is a loss or compromise of “sensitive in formation”.

7. All electronic information shall be stored in sp ecified location following VA standards and procedures using an Engi neering Document

Management Software (EDMS).

a. Security, access and maintenance of all project drawings, both scanned and electronic shall be performed and track ed through the

EDMS system.

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b. “Sensitive information” including drawings and o ther documents may be attached to e-mail provided all VA encryptio n procedures are followed.

D. Motor Vehicle Restrictions

1. Vehicle authorization request shall be required for any vehicle entering the site and such request shall be submitt ed 24 hours before the date and time of access. Access shall be restricted to picking up and dropping off materials and supplies.

2. A limited number of (2 to 5) permits shall be is sued for General

Contractor and its employees for parking in designa ted areas only.

1.6 OPERATIONS AND STORAGE AREAS

A. The Contractor shall confine all operations (inc luding storage of materials) on Government premises to areas authoriz ed or approved by the Contracting Officer. The Contractor shall hold and save the

Government, its officers and agents, free and harml ess from liability of any nature occasioned by the Contractor's perfor mance.

B. Temporary buildings (e.g., storage sheds, shops, offices) and utilities may be erected by the Contractor only with the appr oval of the

Contracting Officer and shall be built with labor a nd materials furnished by the Contractor without expense to the Government. The temporary buildings and utilities shall remain the property of the

Contractor and shall be removed by the Contractor a t its expense upon completion of the work. With the written consent of the Contracting

Officer, the buildings and utilities may be abandon ed and need not be removed.

C. The Contractor shall, under regulations prescrib ed by the Contracting

Officer, use only established roadways, or use temp orary roadways constructed by the Contractor when and as authorize d by the Contracting

Officer. When materials are transported in prosecut ing the work, vehicles shall not be loaded beyond the loading cap acity recommended by the manufacturer of the vehicle or prescribed by an y Federal, State, or local law or regulation. When it is necessary to cr oss curbs or sidewalks, the Contractor shall protect them from d amage. The

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Contractor shall repair or pay for the repair of an y damaged curbs, sidewalks, or roads.

D. Working space and space available for storing ma terials shall be as directed by the COR.

E. Workmen are subject to rules of VAACC applicable to their conduct.

F. Execute work in such a manner as to interfer e as little as possible with work being done by others. Keep roads clear of construction materials, debris, standing construction equipment and vehicles at all times.

G. Execute work so as to interfere as little as pos sible with normal functioning of VAACC as a whole, including operati ons of utility services, fire protection systems and any existing equipment, and with work being done by others. Use of equipment and too ls that transmit vibrations and noises through the building structur e, are not permitted in buildings that are occupied, during construction , jointly by patients or medical personnel, and Contractor's per sonnel, except as permitted by the COR.

1. Do not store materials and equipment in other th an assigned areas.

2. Schedule delivery of materials and equipment to immediate construction working areas within buildings in use by Department of

Veterans Affairs in quantities sufficient for not m ore than two work days. Provide unobstructed access to the VAACC area s required to remain in operation.

H. Utilities Services: Where necessary to cut exi sting pipes, electrical wires, conduits, cables, etc., of utility services, or of fire protection systems or communications systems (excep t telephone), they shall be cut and capped at suitable places where sh own; or, in absence of such indication, where directed by COR. All such actions shall be coordinated with the COR.

I. Phasing:

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The VAACC must maintain its operation M-F 7:00 am to 7:00 pm and Sat &

Sun 7:00 am to 5:00 pm. Therefore, any interruptio n in service must be scheduled and coordinated with the COR to ensure th at no lapses in operation occur. It is the CONTRACTOR'S responsibi lity to develop a work plan and schedule detailing, at a minimum, the procedures to be employed, the equipment and materials to be used, t he interim life safety measure to be used during the work, and a sc hedule defining the duration of the work with milestone subtasks. The work to be outlined shall include, but not be limited to:

To insure such executions, Contractor shall furnis h the COR with a schedule of approximate phasing dates on which the Contractor intends to accomplish work in each specific area of site, b uilding or portion thereof. In addition, Contractor shall notify the C OR two weeks in advance of the proposed date of starting work in ea ch specific area ofthe building or portion thereof. Arrange such pha sing dates to insure accomplishment of this work in successive phases mu tually agreeable to

COR and Contractor.

J. Building will be occupied during performance o f work.

Contractor shall take all measures and provide all material necessary for protecting existing equipment and pro perty in affected areas of construction against dust and debris, so t hat equipment and affected areas to be used in the VAACC operations w ill not be hindered. Coordinate alteration work in areas occup ied by Department of Veterans Affairs so that VAACC operations will c ontinue during the construction period.

K. Utilities Services: Maintain existing utility se rvices for VAACC at all times. Provide temporary facilities, labor, materia ls, equipment, connections, and utilities to assure uninterrupted services. Where necessary to cut existing water, steam, gases, sewe r or air pipes, or conduits, wires, cables, etc. of utility services o r of fire protection systems and communications systems (including telep hone), they shall be cut and capped at suitable places where shown; or, in absence of such indication, where directed by COR.

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1. No utility service such as water, gas, steam, se wers or electricity, or fire protection systems and communications syste ms may be interrupted without prior approval of COR. Electric al work shall be accomplished with all affected circuits or equipmen t de-energized.

When an electrical outage cannot be accomplished, w ork on any energized circuits or equipment shall not commence without a detailed work plan, the VAACC Director’s prior know ledge and written approval.

2. Contractor shall submit a request to interrupt a ny such services to

COR, in writing, 14 days in advance of proposed int erruption.

Request shall state reason, date, exact time of, an d approximate duration of such interruption.

3. Contractor will be advised (in writing) of appro val of request, or of which other date and/or time such interruption w ill cause least inconvenience to operations of VAACC. Interruption time approved by

VAACC may occur at other than Contractor's normal w orking hours.

4. Major interruptions of any system must be reques ted, in writing, at least 21 calendar days prior to the desired time an d shall be performed as directed by the COR.

5. In case of a contract construction emergency, se rvice will be interrupted on approval of COR. Such approval will be confirmed in writing as soon as practical.

L. Abandoned Lines: All service lines such as wires , cables, conduits, ducts, pipes and the like, and their hangers or sup ports, which are to be abandoned but are not required to be entirely re moved, shall be sealed, capped or plugged at the main, branch or pa nel they originate from. The lines shall not be capped in finished are as, but shall be removed and sealed, capped or plugged in ceilings, within furred spaces, in unfinished areas, or within walls or par titions; so that they are completely behind the finished surfaces.

M. To minimize interference of construction activit ies with flow of VAACC traffic, comply with the following:

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1. Keep roads, walks and entrances to grounds, to p arking and to occupied areas of buildings clear of construction m aterials, debris and standing construction equipment and vehicles.

N. Coordinate the work for this contract with other construction operations as directed by COR. This includes the sc heduling of traffic and the use of roadways, as specified in Article, U SE OF ROADWAYS.

1.7 ALTERATIONS

A. Survey: Before any work is started, the Contract or shall make a thorough survey with the COR, of areas of buildings in which alterations occur and areas which are anticipated r outes of access, and furnish a report, signed by both, to the Contractin g Officer. This report shall list by rooms and spaces:

1. Existing condition and types of resilient floori ng, doors, windows, walls and other surfaces not required to be altered throughout affected areas of building.

2. Existence and conditions of items such as plumbi ng fixtures and accessories, electrical fixtures, equipment, veneti an blinds, shades, etc., required by drawings to be either reu sed or relocated, or both.

3. Shall note any discrepancies between drawings an d existing conditions at site.

4. Shall designate areas for working space, materia ls storage and routes of access to areas within buildings where al terations occur and which have been agreed upon by Contractor and C OR.

B. Any items required by drawings to be either reus ed or relocated or both, found during this survey to be nonexistent, o r in opinion of COR, to be in such condition that their use is impossibl e or impractical, shall be furnished and/or replaced by Contractor wi th new items in accordance with specifications which will be furnis hed by Government.

Provided the contract work is changed by reason of this subparagraph B, the contract will be modified accordingly, under pr ovisions of clause

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01 00 00 -9 entitled "DIFFERING SITE CONDITIONS" (FAR 52.236-2) and "CHANGES" (FAR

52.243-4 and VAAR 852.236-88).

C. Re-Survey: Thirty days before expected partial o r final inspection date, the Contractor and COR together shall make a thorough re-survey of the areas of buildings involved. They shall furn ish a report on conditions then existing, of resilient flooring, do ors, windows, walls and other surfaces as compared with conditions of s ame as noted in first condition survey report:

1. Re-survey report shall also list any damage caus ed by Contractor to such flooring and other surfaces, despite protectio n measures; and, will form basis for determining extent of repair wo rk required of

Contractor to restore damage caused by Contractor's workmen in executing work of this contract.

D. Protection: Provide the following protective mea sures:

1. Wherever existing roof surfaces are disturbed th ey shall be protected against water infiltration. In case of le aks, they shall be repaired immediately upon discovery.

2. Temporary protection against damage for portions of existing structures and grounds where work is to be done, ma terials handled and equipment moved and/or relocated.

3. Protection of interior of existing structures at all times, from damage, dust and weather inclemency. Wherever work is performed, floor surfaces that are to remain in place shall be adequately protected prior to starting work, and this protecti on shall be maintained intact until all work in the area is com pleted.

1.8 DISPOSAL AND RETENTION

A. Materials and equipment accruing from work remov ed and from demolition of buildings or structures, or parts thereof, shall be disposed of as follows:

1. Reserved items which are to remain property of t he Government are identified by attached tags or noted on drawings or in

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01 00 00 -10 specifications as items to be stored. Items that r emain property of the Government shall be removed or dislodged from p resent locations in such a manner as to prevent damage which would b e detrimental to re-installation and reuse. Store such items where d irected by COR.

2. Items not reserved shall become property of the Contractor and be removed by Contractor from VAACC.

3. Items of portable equipment and furnishings loca ted in rooms and spaces in which work is to be done under this contr act shall remain the property of the Government. When rooms and spac es are vacated by the Department of Veterans Affairs during the alter ation period, such items which are NOT required by drawings and s pecifications to be either relocated or reused will be removed by th e Government in advance of work to avoid interfering with Contracto r's operation.

1.9 PROTECTION OF EXISTING VEGETATION, STRUCTURES, EQUIPMENT, UTILITIES, AND

IMPROVEMENTS

A. The Contractor shall preserve and protect all st ructures, equipment, and vegetation (such as trees, shrubs, and grass) o n or adjacent to the work site, which are not to be removed and which do not unreasonably interfere with the work required under this contrac t. The Contractor shall only remove trees when specifically authorize d to do so, and shall avoid damaging vegetation that will remain in place. If any limbs or branches of trees are broken during contract per formance, or by the careless operation of equipment, or by workmen, the Contractor shall trim those limbs or branches with a clean cut and p aint the cut with a tree-pruning compound as directed by the Contractin g Officer.

B. The Contractor shall protect from damage all exi sting improvements and utilities at or near the work site and on adjacent property of a third party, the locations of which are made known to or should be known by the Contractor. The Contractor shall repair any dam age to those facilities, including those that are the property o f a third party, resulting from failure to comply with the requireme nts of this contract or failure to exercise reasonable care in performin g the work. If the

Contractor fails or refuses to repair the damage pr omptly, the

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Contracting Officer may have the necessary work per formed and charge the cost to the Contractor.

(FAR 52.236-9)

C. Refer to Section 01 57 19, TEMPORARY ENVIRONMENT AL CONTROLS, for additional requirements on protecting vegetation, s oils and the environment. Refer to Articles, "Alterations", "Res toration", and

"Operations and Storage Areas" for additional instr uctions concerning repair of damage to structures and site improvement s.

1.10 RESTORATION

A. Remove, cut, alter, replace, patch and repair ex isting work as necessary to install new work. Except as otherwise shown or specified, do not cut, alter or remove any structural work, an d do not disturb any ducts, plumbing, steam, gas, or electric work witho ut approval of the

COR. Existing work to be altered or extended and th at is found to be defective in any way, shall be reported to the COR before it is disturbed. Materials and workmanship used in restor ing work, shall conform in type and quality to that of original exi sting construction, except as otherwise shown or specified.

B. Upon completion of contract, deliver work comple te and undamaged.

Existing work (walls, ceilings, partitions, floors, mechanical and electrical work, lawns, paving, roads, walks, etc.) disturbed or removed as a result of performing required new work , shall be patched, repaired, reinstalled, or replaced with new work, a nd refinished and left in as good condition as existed before commenc ing work.

C. At Contractor's own expense, Contractor shall im mediately restore to service and repair any damage caused by Contractor' s workmen to existing piping and conduits, wires, cables, etc., of utility services or of fire protection systems and communications sy stems (including telephone) which are not scheduled for discontinuan ce or abandonment.

D. Expense of repairs to such utilities and systems not shown on drawings or locations of which are unknown will be covered b y adjustment to contract time and price in accordance with clause e ntitled "CHANGES"

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(FAR 52.243-4 and VAAR 852.236-88) and "DIFFERING S ITE CONDITIONS" (FAR

52.236-2).

1.14 AS-BUILT DRAWINGS

A. The contractor shall maintain two full size sets of as-built drawings which will be kept current during construction of t he project, to include all contract changes, modifications and cla rifications.

B. All variations shall be shown in the same genera l detail as used in the contract drawings. To insure compliance, as-built d rawings shall be made available for the COR review, as often as requ ested.

C. Contractor shall deliver two approved completed sets of as-built drawings in the electronic version (scanned PDF) to the COR within 15 calendar days after each completed phase and after the acceptance of the project by the COR.

D. Paragraphs A, B, & C shall also apply to all sho p drawings.

1.15 USE OF ROADWAYS

A. For hauling, use only established public roads a nd roads on VAACC property and, when authorized by the COR, such temp orary roads which are necessary in the performance of contract work. Temporary roads shall be constructed and restoration performed by t he Contractor at

Contractor's expense. When necessary to cross curbi ng, sidewalks, or similar construction, they must be protected by wel l-constructed bridges.

1.18 TEMPORARY USE OF EXISTING ELEVATORS

A. Use of existing elevators for handling building materials and

Contractor's personnel will be permitted subject to following provisions:

1. Contractor makes all arrangements with the COR f or use of elevators.

The COR will ascertain that elevators are in proper condition.

Contractor may use elevators Nos. S1 & S2 in Buildi ng Nos. 1Afor daily use and for special nonrecurring time interva ls when permission is granted. Personnel for operating elev ators will not be provided by the Department of Veterans Affairs.

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2. Contractor covers and provides maximum protectio n of following elevator components:

a. Entrance jambs, heads soffits and threshold plat es.

b. Entrance columns, canopy, return panels and insi de surfaces of car enclosure walls.

c. Finish flooring.

1.21 AVAILABILITY AND USE OF UTILITY SERVICES

A. The Government shall make all reasonably require d amounts of utilities available to the Contractor from existing outlets a nd supplies, as specified in the contract. The amount to be paid by the Contractor for chargeable electrical services shall be the prevail ing rates charged to the Government. The Contractor shall carefully cons erve any utilities furnished without charge.

1.24 INSTRUCTIONS

A. Contractor shall furnish Maintenance and Operati ng manuals (hard copies and electronic) and verbal instructions when requir ed by the various sections of the specifications and as hereinafter s pecified.

B. Manuals: Maintenance and operating manuals and o ne compact disc (four hard copies and one electronic copy each) for each separate piece of equipment shall be delivered to the COR coincidenta l with the delivery of the equipment to the job site. Manuals shall be complete, detailed guides for the maintenance and operation of equipme nt. They shall include complete information necessary for starting , adjusting, maintaining in continuous operation for long period s of time and dismantling and reassembling of the complete units and sub-assembly components. Manuals shall include an index covering all component parts clearly cross-referenced to diagrams and illustrati ons. Illustrations shall include "exploded" views showing and identify ing each separate item. Emphasis shall be placed on the use of specia l tools and instruments. The function of each piece of equipmen t, component, accessory and control shall be clearly and thorough ly explained. All necessary precautions for the operation of the equi pment and the reason

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01 00 00 -14 for each precaution shall be clearly set forth. Man uals must reference the exact model, style and size of the piece of equ ipment and system being furnished. Manuals referencing equipment simi lar to but of a different model, style, and size than that furnishe d will not be accepted.

C. Instructions: Contractor shall provide qualified , factory-trained manufacturers' representatives to give detailed tra ining to assigned

Department of Veterans Affairs personnel in the ope ration and complete maintenance for each piece of equipment. All such t raining will be at the job site. These requirements are more specifica lly detailed in the various technical sections. Instructions for differ ent items of equipment that are component parts of a complete sy stem, shall be given in an integrated, progressive manner. All instructo rs for every piece of component equipment in a system shall be availab le until instructions for all items included in the system h ave been completed.

This is to assure proper instruction in the operati on of inter-related systems. All instruction periods shall be at such t imes as scheduled by the COR and shall be considered concluded only when the COR is satisfied in regard to complete and thorough covera ge. The contractor shall submit a course outline with associated mater ial to the COR for review and approval prior to scheduling training to ensure the subject matter covers the expectations of the VA and the co ntractual requirements. The Department of Veterans Affairs r eserves the right to request the removal of, and substitution for, any i nstructor who, in the opinion of the COR, does not demonstrate suffic ient qualifications in accordance with requirements for instructors abo ve.

1.30 PHOTOGRAPHIC DOCUMENTATION

A. During the construction period through completio n, provide photographic documentation of construction progress and at selec ted milestones including electronic indexing, navigation, storage and remote access to the documentation, as per these specifications.

B. Photographic documentation elements:

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1. Each digital image shall be taken with a profess ional grade camera with minimum size of 6 megapixels (MP) capable of p roducing

200x250mm (8 x 10 inch) prints with a minimum of 22 72 x 1704 pixels and 400x500mm (16 x 20 inch) prints with a minimum 2592 x 1944 pixels.

2. Documentation where each photo has been taken on the construction documents and label each photo with the room number .

3. Before construction, document existing condition s at each area of work.

4. Construction progress at each location where wor k is completed when work commences and continuing until Project complet ion.

5. As-built finished conditions at each location of work.

6. Miscellaneous events that occur during any Cont ractor site visit, or events captured by the Department of Veterans Affai rs independently, shall be dated, labeled.

7. Regular interior progressions of the entire pro ject to begin at the start of the project or as directed by the COR thro ugh to completion.

1.31 TEMPORARY MOBILE COMPOUNDING CENTER

A. The contractor shall provide a temporary Mobile Compounding Center for the duration of the Pharmacy IV Prep Room project f or use by the

Ambulatory Care Center’s staff. The trailer must be in place, certified and operational prior to the start of any work insi de the current

Pharmacy IV Prep Rooms. Certification must be maint ained pre-occupancy and during the occupancy period.

B. The mobile compounding center will remain in pla ce, certified, and operational until the permanent facilities are cert ified, operational, and occupied.

C. Work includes the rental of the center, installa tion, leveling, setting the center on site, connecting utilities, certifica tions, removing the center, removal of the temporary utilities, removal of the enclosed

757-19-201

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01 00 00 -16 walk and canopy. See certification appendix attache d to this specification section for certification requirement s to be completed by the contractor’s certification subcontractor.

D. Related work included general requirements, site preparation, concrete, temporary covered canopy. Removal of temporary ramp , removal of existing temporary ramp and enclosure foundations a nd connector after use of trailer, removal of temporary utilities, and restoration of the site. The existing concrete pad will remain at the end of the project but foundations for the temporary ramp and enclosur e are to be removed with surrounding site put back to grass. Temporary utilities to be removed as noted on the drawings once the use of th e center is completed.

E. The center shall be provided by Life Sciences, I nc. The center is a premade mobile shipping container complete to opera te as a mobile compounding center.

F. Contact information:

Marybeth Eyer

Project Engineer

Life Scientific, Inc./ Aseptic Enclosures

c. 217-825-8110

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01 00 00 General Requirements Appendix A

Statement of Work

Certification of Sterile Compounding Facilities

The Columbus, Ohio Veterans Affairs Ambulatory Care Center (VAACC) has a requirement for certification of sterile compounding facilities including testing of rooms and equipment. Certification is to be performed at the completion of construction and installation, following terminal cleaning by VAACC staff. All testing is to be performed by personnel accredited by NSF or CNBT for certification of sterile compounding facilities. Contractor personnel will follow VAACC protocols for use of personal protective equipment in the hazardous and sterile compounding areas and understand the risks associated with facilities and equipment designed for storage and preparation of hazardous drugs.

Certification procedures shall be performed at the commissioning of new facilities. Following initial certification, recertification shall be performed no less than every six months, or sooner if equipment is relocated or altered or major service is performed.

A representative of the certifying company should meet with the Facility Program Manager for IV/Sterile

Preparations to perform a risk assessment and develop a robust written sampling plan and diagram for viable and non-viable sampling. This plan will designate the sample locations; method of collection, minimum air volume and sample time; time of day as related to the activities in the area; number of samples per location; time intervals between each sample; and action levels. Such a plan will be more detailed than this document and alterations agreed to by both parties will supersede to following plan.

Certification of facilities will be conducted from cleanest to dirtiest area – Containment Aseptic

Compounding Isolator (CACI), then buffer room, then anteroom. The contractor shall perform the designated testing and sampling in accordance with the most recent version of the identified standards and testing methods (or those referenced therein). Procedures described in this document are a general description; the designated methods shall be referenced for detailed guidance of testing and sampling procedures. All particle counts will measure particles of 0.5 microns and larger. Where instruments are used for testing, they shall be calibrated in accordance with current industry practice or as designated, no less frequently than every 12 months.

Inspection, testing, certification, and acceptance criteria shall be in accordance with the most recent version of the following recognized standards, as applicable:

i. United States Pharmacopeia, Chapter 797

ii. United States Pharmacopeia, Chapter 800

iii. United States Pharmacopeia, Chapter 1116

iv. CAG-002-2006

v. CAG-003-2006

vi. CAG-008-2010

vii. CAG-009-2011

viii. ISO 14644-1

ix. IEST RP CC-006

x. IEST RP CC-034

xi. Manufacturer Recommendations

Initial viable sampling of new construction will take place after facility certification. Upon recertification, viable sampling will occur prior to facility certification. Sampling will be conducted from cleanest to dirtiest area – inside CACI, then buffer room, then anteroom. Provided agar plates for viable samples will be double or triple wrapped and certificate of quality for each lot will be provided. Aseptic technique per

CAG-009-2011 will be followed and care will be taken by certification personnel to not contaminate agar plates. Agar plates will be stored and transported inverted and cool, but not frozen. All viable samples must be sent same day or overnight to an appropriately credentialed laboratory for analysis. In addition to samples, two unopened agar plates of each media type will be sent for negative and positive controls.

Chain of custody must be maintained. Reported results will include all data designated in CAG-009-2011, including colony counts and genus determination. Staphylococci will be designated as coagulase-positive or coagulase-negative.

Action levels for viable samples are based on USP <797> recommendations, as follows:

The results of each sampling and testing shall be recorded and submitted as a comprehensive report, along with a statement of compliance or non-compliance with the specified tests. A written report of certification for all primary engineering controls, with statement of Pass/Fail, will be furnished on the day of certification. Full report will be furnished timely upon completion of all analyses, including identification of viables, not to exceed 10 calendar days from certification date.

The report shall be informative and comprehensive, including the following at minimum:

• Name, address, and contact information of the testing organization;

• Written and signed names of certification personnel, with appropriate accreditations;

• Date on which the certification was performed;

• Reference to appropriate standards (CAG or other, most recent version) and testing/sampling method(s);

• Explanation of test procedures, or referral to SOP, and justification for any deviations from established industry practices;

• Clear identification of the physical location of the areas tested (in relation to the physical layout of the compounding facilities, including equipment) and specific designations for coordinates and nomenclature of all sampling locations, via diagram;

• All reported values designated in CAG-008-2010 for the specified tests;

• Specified designation criteria for the areas, including the ISO classification and considered particle size(s), relevant occupancy state(s), airflow volume or velocity, and pressure differential;

• Instruments and equipment used for data collection, including make, model, serial number, documentation of most recent calibration with date performed and date calibration due;

• Test results, including particle concentration data for all sampling location coordinates and aggregates, as applicable, and laboratory reports;

• A clear indication of Pass or Fail for each test or sample conducted, as indicated by the included criteria;

• An overall indication of Pass or Fail for each sterile compounding area and primary engineering control.

Locations:

Mobile Compounding Center General Workspace – Unclassified are for general pharmacy operations Anteroom, servicing hazardous buffer room Buffer Room, Hazardous

GLOSSARY

Anteroom: An ISO Class 8 or cleaner area where personnel hand hygiene and garbing procedures and other activities that generate high particulate levels are performed. When servicing a hazardous buffer room, the anteroom shall be ISO Class 7 or cleaner. The anteroom is the transition area between the unclassified area of the facility and the buffer area.

Buffer area: An ISO Class 7 or cleaner area where the PEC that generates and maintains an ISO Class 5 environment is physically located.

Classified space: A space that maintains an air cleanliness classification based on the International Organization for Standardization (see also definition for ISO Class).

Compounding Aseptic Containment Isolator (CACI): A type of RABS that uses HEPA filtration to provide an ISO Class 5 clean air environment designed for the compounding of sterile hazardous drugs. Located in a hazardous buffer area.

Compounding Aseptic Isolator (CAI): A type of RABS that uses HEPA filtration to provide an ISO Class 5 clean air environment designed for the compounding of sterile non-hazardous drugs. Located in a non-hazardous buffer area.

Direct compounding area (DCA): A critical area within the ISO Class 5 PEC where critical sites are exposed to unidirectional HEPA-filtered air, also known as first air.

Hazardous drug: Any drug identified by at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low dose in humans or animals, genotoxicity, or new drugs that mimic existing hazardous drugs in structure or toxicity.

ISO Class: An air quality classification from the International Organization for Standardization.

Primary engineering control (PEC): A device or zone that provides an ISO Class 5 environment for sterile compounding. Examples of PECs include CACI, CAI, and RABS

Restricted access barrier system (RABS): An enclosure that provides HEPA filtered ISO Class 5 unidirectional air that allows for the ingress and/or egress of materials through defined openings that have been designed and validated to preclude the transfer of contamination, and that generally are not to be opened during operations. Examples of RABS include CAIs and CACIs.

Unclassified space: A space not required to meet any air cleanliness classification based on the International Organization for Standardization (ISO).

Designated Testing and Sampling Anteroom and Buffer Rooms

1. Airflow Test

a. Citations: USP <797>, CAG-003-2006, CAG-008-2010

b. Method: IEST-RP-CC006.3 Section 6.1.2.a

c. Locations: Anteroom, buffer room

d. Procedure: Air Changes per Hour (ACPH) will be calculated using a validated method which will be kept on file. Measurements are to be taken of HEPA-filtered supply air by an airflow capture hood with backpressure compensation.

e. Pass/Fail Criteria (each room):

i. PASS – greater than or equal to 30 air changes per hour

ii. FAIL – less than 30 air changes per hour

2. Airflow Smoke Pattern Test

a. Citations: USP <797>, CAG-003-2006, CAG-008-2010

b. Method: Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current

Good Manufacturing Practice, U.S. Department of Health and Human Services Food and Drug

Administration, September 2004

c. Locations:

i. Doorways between buffer/ante rooms, ante room/general work space

ii. Other undesignated openings and penetrations

d. Procedure: Visual observation of airflow patterns to prove that air pressure and/or flow differential is in the correct direction and consistent across entire openings and penetrations.

Methods and locations tested will be kept on file. Delivery velocity of smoke generator shall not overcome room airflow patterns. Results to be diagramed and/or documented by photograph.

e. Pass/Fail Criteria (each room):

i. PASS – Airflow is in the appropriate direction and consistent across openings and penetrations.

ii. FAIL – Airflow does not meet direction or consistency across openings or penetrations

3. Room Pressurization

a. Citations: USP <797>, CAG-003-2006, CAG-008-2010

b. Method: IEST-RP-CC006.3 Section 6.4

c. Locations: Doorways between buffer/ante rooms, ante room/general work space

d. Procedure: Room pressurization will be measured in inches water column (wc) by an electronic manometer with resolution to the thousandths of an inch wc. The pressure differential will be determined at the doorway between each room. A validated method will be used and kept on file to measure pressure differential.

e. Pass/Fail Criteria (Anteroom):

i. PASS – Minimum differential pressure of 0.020 inches wc positive to general workspace and pressure differential 0.010 to 0.030 inches wc positive to buffer room

ii. FAIL – Pressure differential not meeting designated range or direction to either adjacent room

f. Pass/Fail Criteria (Buffer Room):

i. PASS – Differential pressure of 0.010 to 0.030 inches wc negative to anteroom

ii. FAIL – Pressure differential less than 0.010 inches wc negative, greater than 0.030 inches wc negative, or positive differential to anteroom

4. HEPA Filter Installation Leak Test

a. Citations: USP <797>, CAG-003-2006, CAG-008-2010

b. Method: IEST-RP-CC034.2 Section 6.2.1 for filters that can be scan tested

IEST-RP-CC034.2 Section 6.2.3 for filters that cannot be scan tested

c. Locations: Anteroom, buffer room

d. Procedure: HEPA filters will be leak tested using a validated method which will be kept on file.

An aerosol challenge of 10 micrograms per liter of Poly Alpha Olefin or equivalent will be introduced upstream and filter efficacy verified by aerosol photometer scan. Certifier shall have capability to patch and repair HEPA filter up to 3% of the face area per side and not to exceed

1.5 inches in width or provide replacement HEPA filter with filter of like size and construction

(Type C or K) on same day.

e. Pass/Fail Criteria (each room):

i. PASS – leakage of less than or equal to 0.01% of upstream concentration

ii. FAIL – leakage of greater than 0.01% or patch size exceeds IEST-RP-CC034 limit

5. Particle Count Survey

b. Method: ISO 14644-1

c. Locations: Anteroom, buffer room

i. CETA 9.7.4 recommendation of collecting the minimum number of samples no less than the square root of the clean space area in square meters will be followed

d. Procedure: Air particle counts will be measured under dynamic operating conditions using a validated method which will be kept on file. A discrete particle counter capable of detecting particles of 0.5 micron and larger shall be used. Sampling probe is to be oriented upward and a minimum sample of two liters of air over one minute will be taken for each testing location.

Individual readings will be reported. All particle counts will be averaged to determine the final room classification for each area.

e. Pass/Fail Criteria (each room):

i. PASS – ISO Class 7 or better: less than or equal to 352,000 particles (0.5 micron and larger) per cubic meter

ii. FAIL – greater than 352,000 particles (0.5 micron and larger) per cubic meter

6. Lighting Level and Uniformity Test

a. Citations: USP <797>, CAG-003-2006

b. Method: IEST-RP-CC006.3 Section 6.6

c. Locations: Anteroom, buffer room

d. Procedure: Background and operating light intensity to be recorded using a validated method and reported in foot-candles (FC), for baseline assessment. Not required for recertification.

e. Pass/Fail Criteria (each room):

i. PASS – Greater than or equal to 80 FC

ii. FAIL – Less than 80 FC

7. Noise Level Test

a. Citations: USP <797>, CAG-003-2006

b. Method: IEST-RP-CC006.3 Section 6.7

c. Locations: Anteroom, buffer room

d. Procedure: Background and operating noise levels to be recorded using a validated method and reported in decibels (dB), for baseline assessment. Not required for recertification.

e. Pass/Fail Criteria:

i. PASS – Less than 85 dB

ii. FAIL – Greater than or equal to 85dB

8. General Temperature and Moisture Uniformity Tests

b. Method: IEST-RP-CC006.3 Section 6.9

c. Locations: Anteroom, buffer room

d. Procedure: Temperature will be recorded with a sensor capable of measuring to 0.1°C or equivalent. Humidity will be recorded with a sensor capable of indicating a 1% change in relative humidity.

e. Pass/Fail Criteria:

i. PASS – Temperature 64-68°F; Relative Humidity 30-60%

ii. FAIL – Recordings outside of these ranges

9. Viable Air Sampling

a. Citations: USP <797>, USP <1116>, CAG-009-2011

b. Methods: CAG-009-2011

c. Locations:

i. Anteroom – staging area, gowning area,…