Interior Tenders

Details: Construction work is being put out to tender for the conversion of a nursing home into a psychiatric-psychosomatic specialist clinic of Havelland Kliniken GmbH. A four-storey, partially basemented solid building with a flat roof is being converted for clinical use by three nursing stations, a day clinic and a psychiatric outpatient clinic Pia. The construction work affects the interior of the building, the outer shell remains unchanged. The subject of this tender is floor covering work on all floors, consisting of - 750 m² of subfloor preparation (cement screed) and filling - 65 m² of rubber floor covering - 500 m² of linoleum floor covering - 70 m² of vinyl chloride floor covering - 35 m² of carpet floor covering - 35 linear metres of PVC skirting board - 475 linear metres of wooden skirting board - 45 linear metres of stainless steel expansion joint profile

Details: Construction work is being put out to tender for the conversion of a nursing home into a psychiatric-psychosomatic specialist clinic of Havelland Kliniken GmbH. A four-storey, partially basemented solid building with a flat roof is being converted for clinical use by three nursing wards, a day clinic and a psychiatric outpatient clinic Pia. The construction work affects the interior of the building; the outer shell remains unchanged. The subject of this tender is the execution of tiling work including the delivery of required tiles. The following are to be carried out - 50 sq. m. floor tiles 10/10 cm - 120 sq. m. wall tiles 10/10 cm - 62 linear metres of tile frieze made of 5/5 cm tiles, in two rows - 9 shower areas with gradient made of 5/5 cm tiles, 100x100 to 150x150 cm in size as well as demolition and sealing work.

Details: The subject of the performance of the Public Contract is the Projection Work Follow-up to the Prepared Study of the Reconstruction of the Dubina V Láne Building, Including the Adjacent Public Space, Prepared by the Company Mackovič Architecture Sro, Ičo 24814334 (Annex No. 2 Zd). The subject of the work is the processing of project documentation in the scope of: • Project documentation for the construction permit, including the performance of related engineering activities and securing the construction permit • Project documentation for the implementation of construction, including the itemized budget and list of construction works, supplies and services • Project documentation for the interior of the building for the following parts Buildings – Entire 2np (common spaces, Hall + Accessories, Municipal Office, Rented Premises) And also Common Spaces In 1np (corridors, Social Facilities). • Cooperation and technical assistance in the procurement procedure for the selection of the contractor • Performance of the author's supervision during the implementation of the building until its approval

Description: Item Unique Identification And Valuation (jan 2023)|19|||||||||||||||||||| inspection Of Supplies--fixed-price (aug 1996)|2||| inspection And Acceptance - Short Version|8|x||x|||||| stop-work Order (aug 1989)|1|| wide Area Workflow Payment Instructions (jan 2023)|16|see Schedule|n/a|tbd|n00104|tbd|tbd|w25g1u|tbd|n/a|n/a|tbd|||||| monetary Limitation Repair Purchase Orders|1|7,235.00| navy Use Of Abilityone Support Contractor - Release Of Offeror Information (3-18))|1|wss| transportation Of Supplies By Sea (oct 2024)|2||| alternate A, Annual Representations And Certifications (oct 2024)|13|||||||||||||| annual Representations And Certifications (may 2024)|13|332710|500|||||||||||| notice Of Priority Rating For National Defense, Emergency Perpardeness, And Enrgy Progam Use (april 2008))|2|x|| 1.this Requirement Is Pursuant To Emergency Acquisition Flexibilities (eaf). 2.the Resultant Award Of This Solicitation Will Be Issued Bilaterally, Requiring The Contractor's Written Acceptance Prior To Execution. 3.all Contractual Documents (i.e. Contracts, Purchase Orders, Task Orders, Delivery Orders, And Modifications) Related To The Instant Procurement Are Considered To Be "issued" By The Government When Copies Are Either Deposited In The Mail, Transmitted By facsimile, Or Sent By Other Electronic Commerce Methods Such As Email. The Government's Acceptance Of The Contractor's Proposal Constitutes Bilateral Agreement To "issue" Contractual Documents As Detailed Herein. 4.if Requirement Will Be Packaged At A Location Different From The Offeror's Address, The Offeror Shall Provide The Name, Street Address, And Cage Of The Facility. 5.any Contract Awarded As A Result Of This Solicitation Will Be Do Certified For National Defense Under The Defense Priorities And Allocations System (dpas). Provision 52.211-14, Notice Of Priority Rating For National Defense, Emergency Preparedness, And Energy program Use, Shall Be Inserted In Solicitations When The Contract To Be Awarded Shall Be A Rated Order. 6.if Drawings Are Included In The Solicitation, Access Needs To Be Requested On The Individual Solicitation Page Under Contract Opportunities On Sam.gov Website. After Requesting Access, Send An Email To The Poc Listed On The Solicitation. 7.please Provide Repair Price As Estimated (est) For The Full Repair Effort Of The Requirement. 8.vendor Shall Have 90 Days After Receipt Of Carcass(es) To Complete A Teardown & Evaluation (td&e) Of The Carcass(es) And Submit A Firm-fixed Price (ffp) Quote For The Full Repair Effort Of The Carcass(es). 9.when Submitting A Quote, Please Include The Cost Of New (actual Or Estimated) For Evaluation Purposes. 10.quote Shall Specify Any Exceptions Including But Not Limited To Mil-std Packaging, Mil-std Labeling, Inspection & Acceptance Locations, Packaging House, Surplus Materials, Etc. If No Exceptions Are Indicated Or Received, Award Shall Be Based Upon Solicitation requirements. Changes Or Requests For Changes After Award Shall Be Subject To Consideration Costs Deducted From The Unit Price. 11.in Repair Price, Include All Costs Associated With Receipt And Complete Repair Of Material That May Be In Unwhole Condition, Missing Hardware, Damaged, Handling Damage, Missing Parts, Wear Damage, And Cav Reporting. Also Provide The Following Information: a.teardown & Evaluation Rate: b.repair Turn Around Time (rtat): c.throughput Constraint: d.induction Expiration Date: 12.price Reductions a.any Asset For Which The Contractor Does Not Meet The Required Rtat Will Incur A Price Reduction Of Xxxx Per Unit. This Adjustment Will Be Implemented Via A Reduction Modification At The End Of Contract Performance. Price Reductions Made Pursuant To This Section shall Not Limit Other Remedies Available To The Government For Failure To Meet Required Rtats, Including But Not Limited To The Government's Right To Terminate For Default. 13.the Contractor Must Obtain Final Inspection And Acceptance By The Government For All Assets Within The Rtat Established In The Resulting Contract. a.requested Rtat: 80 Days 14.quotes Shall Reference The Proposed Rtat And Any Capacity Constraints. \ this Requirement Has Been Updated From 3r To 2g. all Other Terms And Conditions Remain The Same. \ teardown And Evaluation Only Quotes Will Not Be Accepted. Induction Expirationdate: 120 Days After The Date Of Subsequent Award. Any Assets Recieved Afterthis Date In Days Is Not Authorized To Be Repaired Without Bi-lateralagreementbetween The Vendor And contracting Officer. If Firm-fixed Repairpricing Isprovided, Beyond Economical Repair (ber) Does Exist. With Dcma Concurrence,beyond Repair (br) Is Possible. If Unit Is Determined Br, The Unit Price Willbe Negotiated Downward From The Awarded Firm-fixed Repair price. unless Otherwise Specified, Pricing For This Quotation Is Valid For 90 Days After The Closing Date As Indicated On The Quotation. Please Specify (if Other Than 90 Days) _________ Days. if You Are Submitting Your Quote Via Email Or Neco, Please Specify The Number Of Days Pricing Is Valid. all Contractual Documents (i.e. Contracts, Purchase Orders, Task Orders,delivery Orders And Modifications) Related To The Instant Procurement Are Considered To Be "issued" By The Government When Copies Are Either Deposited In The Mail, Transmitted By Facsimile, Or Sent By Other Electronic Commerce Methods, 1. Scope 1.1 This Contract/purchase Order Contains The Requirements For Repair And The Contract Quality Requirements For The Stand,maintenance,a . 1.2 Government Furnished Material - Government Furnished Material Is Available. The Material And Quantities Are As Follows: ;prior To Delivery Of Any Unit, With Exception Of A Fa Unit, Thecontractor Must Perform A Manufacturer's Proof Test On Each Engine housing Maintenance Stand Assembly. The Manufacturer's Proof Test Requirement Isdefined In Drawing 53711-7052553 And Includes Use Of Government Furnished Material (gfm), Engine Housing Stand Test Weight (53711-8667274).the Gfm Test Weight For Proof testing Can Be Obtained From Naval Underseawarfare Center Division Newport, Newport, Ri 02841-1708. Requests Can Beemailed To Nwpt_nuwc_npt_8554_torpmtrlrqst@navy.mil. The Weight Test Plate,when Filled Out Completely As Described In note 3 Of Drawing 53711-7052553,serves As Objective Quality Evidence (oqe) For Completion Of This Test.; . 2. Applicable Documents 2.1 Applicable Documents - The Document(s) Listed Below Form A Part Of This Contract/purchase Order Including Modifications Or Exclusions. 2.1.1 "document References" Listed Below Must Be Obtained By The Contractor. Ordering Information Is Included As An Attachment To This Contract/purchase Order. drawing Data=6301669 |53711| A|fn |d|0001 | A|49998|0112700 drawing Data=6301669 |53711| A|pl |d|0001 | A|49998|0022283 drawing Data=6301669 |53711| A|pl |d|0002 | A|49998|0032676 drawing Data=7052526 |53711| B|fn |d|0001 | |49998|0022325 drawing Data=7052553 |53711| H|fn |d|0001 | |49998|0168695 drawing Data=7052553 |53711| H|pl |d|0001 | |49998|0012642 drawing Data=7052553 |53711| H|pl |d|0001.0002 | A|49998|0036978 drawing Data=7052554 |53711| A|fn |d|0001 | A|49998|0081004 drawing Data=7052554 |53711| A|fn |d|0002 | -|49998|0039263 drawing Data=7052574 |53711| C|fn |d|0001 | |49998|0720658 drawing Data=7052574 |53711| B|pl |d|0001 | |49998|0009092 drawing Data=7052574 |53711| B|pl |d|0001.0002 | A|49998|0027928 drawing Data=7052605 |53711| G|fn |d|0001 | |49998|0019343 drawing Data=7052674 |53711| B|fn |d|0001 | |49998|0028045 drawing Data=7052681 |53711| E|fn |d|0001 | |49998|0055962 drawing Data=7052682 |53711| C|fn |d|0001 | |49998|0023328 drawing Data=7052683 |53711| D|fn |d|0001 | |49998|0135611 drawing Data=8243462 |53711| D|fn |d|0001 | D|49998|0048512 drawing Data=8243463 |53711| D|fn |d|0001 | D|49998|0048452 drawing Data=8475682 |53711| -|fn |d|0001 | -|49998|0050234 drawing Data=8667456 |53711| | |d|0001 | |49998|0410681 drawing Data=8667457 |53711| A| |d|0001 | |49998|0111686 drawing Data=8667457 |53711| A|pl |d|0001 | |49998|0027661 drawing Data=8667540 |53711| | |d|0001 | |49998|0151055 document Ref Data=mil-std-129 | | |r |180524|a| |01| 3. Requirements 3.1 Cage Code/reference Number Items - The Stand,maintenance,a Repaired Under This Contract/purchase Order Shall Meet The Operational And Functional Requirements As Represented By The Cage Code(s) And Reference Number(s) Listed Below. All Repair Work Shall be Performed In Accordance With The Contractors Repair/overhaul Standard Practices, Manuals And Directives Including But Not Limited To Drawings, Technical Orders, Manufacturing Operations, Tooling Instructions, Approved Repair Standards And Any Other contractor Or Government Approved Documents Developed To Provide Technical Repair Procedures. cage___ref. No. ;53711 7052553; 3.2 Marking - This Item Shall Be Physically Identified In Accordance with ;mil-std-129; . 3.3 Changes In Design, Material Servicing, Or Part Number - Except For A Code 1 Change, Which Shall Be Processed As Provided In The Code Statement Shown Below, No Substitution Of Items Shall Be Made Until The Navicp-mech Contracting Officer Has Notified And approval Has Been Given By Issuance Of A Written Change Order. When Any Change In Design, Material, Servicing Or Part Number Is Made To Replace Or Substitute Any Item To Be Furnished On This Contract/purchase Order, The Contractor Shall Furnish, For The substituting/replacement Item, A Drawing And An Explanation Of The Reason For The Change, Explaining The Reason Therefor. If Finished Detail Drawings Are Not Available, Shop Drawings In The Form Used By The Manufacturer Will Be Acceptable For Government evaluation. When Notifying The Procurement Contracting Officer Of The Reasons For Making Substitutions, The Type Of Change Shall Be Indicated By Code Number In Accordance With One Of The Following Statements: code 1: Part Number Change Only - If The Manufacturer's Part Number Indicated Thereon Has Changed, But The Parts Are Identical In All Respects, Supply The Item And Advise Navicp-mech Immediately Of The New Part Number. code 2: Assembly (or Set Or Kit) Not Furnished - Used Following Detail Parts. code 3: Part Not Furnished Separately - Use Assembly. code 4: Part Redesigned - Old And New Parts Are Completely Interchangeable. code 5: Part Redesigned - New Part Replaces Old. Old Part Cannot Replace New. code 6: Part Redesigned - Parts Not Interchangeable. 3.4 Mercury Free - The Material Supplied Under This Contract/purchase Order Is Intended For Use On Submarines/surface Ships And Therefore Shall Contain No Metallic Mercury And Shall Be Free From Mercury Contamination. Mercury Contamination Of The Material will Be Cause For Rejection. If The Inclusion Of Metallic Mercury Is Required As A Functional Part Of The Material Furnished Under This Contract, The Contractor Shall Obtain Written Approval From The Procurement Contracting Officer Before Proceeding With Manufacture. The contractor's Request Shall Explain In Detail The Requirements For Mercury, Identify Specifically The Parts To Contain Mercury, And Explain The Method Of Protection Against Mercury Escape. Such A Request Will Be Forwarded Directly To The Procurement Contracting officer With A Copy To The Applicable Government Inspector. Upon Approval By The Contracting Officer, The Vendor Will Provide A "warning Plate" Stating That Metallic Mercury Is A Functional Part Of The Item And Will Include Name And Location Of That Part. The Use Of Mercury, Mercury Compounds, Or Mercury-bearing Instruments And/or Equipment In A Manner Which Might Cause Contamination In The Manufacture, Assembly, Or Test Of Material On This Contract Is Prohibited. The Most Probable Causes Of contamination Are Direct-connected Manometers, Mercury Vacuum Pumps, Mercury Seals, Or The Handling Of Mercury In The Immediate Vicinity. Mercury Switches, Mercury In Glass Thermometers, Standard Cells And Other Items Containing Mercury May Be Used If They Are located So As Not To Constitute A Contamination Hazard. If External Contamination By Metallic Mercury Occurs Or Is Suspected, The Following Test May Be Used To Determine Whether Contamination By Metallic Mercury Exists Or Whether Corrective Cleaning Measures Have Been Effective. Enclose The Equipment In A polyethylene Bag Or Close-fitting Airtight Container For Eight Hours At Room Temperature (70 Degrees F Minimum).sample The Trapped Air And If Mercury Vapor Concentration Is 0.01 Mg/cu Meter Or More, The Material Is Mercury Contaminated Insofar As The requirements Of This Contract Are Concerned. These Requirements Shall Be Included In Any Subcontract Or Purchase Order Hereunder And The Contractor Shall Insure Subcontractor Compliance With These Requirements. Technical Questions Pertaining To These Requirements Shall Be Referred To The Procurement Contracting Officer Via The Cognizant Administrative Contracting Officer. For Background, The Following Information Is Provided: Mercury Is Corrosive To Gold, Silver, Nickel, Stainless Steels, Aluminum And Copper Alloys. Stainless Steels, Nickel, And Copper Alloys Are Widely Used In Reactor Plants And Other Submarine/surface Ship Systems. Accidental Trapping Of Mercury In A component Could Cause Serious Damage To Vital Parts. Mercury Is Also Toxic If Inhaled, Ingested, Or Absorbed Through The Skin. It Is Evident That Grave Consequences Could Result From Small Amounts Of Mercury Vapor Present In An Unreplenished Submarine/surface ship Atmosphere. 3.5 First Article Approval (government Testing) - First Article Test (fat) And Approval Is Required. 3.6 Serialization - The Supplier Shall Mark A Serial Number On Each Stand,maintenance,a In Accordance With ;iaw Dwg 7052553 Rev "h" Note 13.; . Actual Serial Numbers Will Be Assigned ;apply A Goverment Serial Number To Each Unit Manufactured. Serial Number Shall Be Obtained From Commander, Naval Undersea Warfare Center Division Newport, Newport, Ri 02841-1708. Requests Can Be Made To nuwc_npt_serialnumbers@navy.mil.; . 3.7 Serialization - The Supplier Shall Mark A Serial Number On Each Stand,maintenance,a In Accordance With ;iaw Dwg 8667456 Rev "-" Note 9.; . Actual Serial Numbers Will Be Assigned ;apply A Goverment Serial Number To Each Unit Manufactured. Serial Number Shall Be Obtained From Commander, Naval Undersea Warfare Center Division Newport, Newport, Ri 02841-1708. Requests Can Be Made To nuwc_npt_serialnumbers@navy.mil.; . 3.8 ;a First Article (fa) Sample Is Required If The Contractor/supplier Has Not Manufactured This Item Before (or Has Not Done It In A Long Time).for Fa, One (1) Preproduction Sample, Here In After Referred To As The Fa, Shall Be Inspected And Tested By The government Prior To Proceeding With Production Of Any Additional Units. The Fa Shall Be Fully Representative Of Those Proposed For Production And Demonstrate The Adequacy And Suitabilityof The Contractor's Processes And Procedures In Complying With There quirements Set Forth By The Engine Housing Maintenance Stand Assembly Technical Documentation. Acceptance Of The Fa Is Required Prior Toproceeding With Production Of Additional Units. The Government Will Be Responsible For Performing Fa Inspection, Testing And acceptance. The Fa Shall Not Be Previously Load Tested. All Tests Will Be Performed Atan Ambient Temperature Of 77 � 18� Fahrenheit With Ambient Humidity. The Naval Undersea Warfare Center Division Newport Will Prepare A Written Test Report At The Conclusion Of fa Inspection And Testing. Once A Contractor Has An Accepted Fa, The First Article Submission Requirementmay Be Waived Thereafter.; 3.9 Marking - This Item Shall Be Physically Identified In Accordance With Mil-std-130. 3.10 ;packaging And Packing. unless Otherwise Specified In The Contract Or Purchase Order, Each Engine Housing Maintenance Stand Assembly Shall Be Prepared For Shipment Inaccordance With Mil-std-2073-1, Method 10. One Engine Housing Maintenance Stand Assembly Shall Be Packed By Pallet Or wooden Box. Blocking Andbracing Of The Box Shall Be Performed To Restrict The Engine Housingmaintenance Stand Assembly Movement Within The Wood Box. The Wood Box Shallbe Of Nailed And Locked Corner Construction (formerly Ppp-b-621, Class 1,style 4, Grade B). the Box Shall Have Full Cleated Ends And Butt Joints.the Thickness Of The Wood Members Shall (as A Minimum) Be In Accordancewith Table 1. table 1 - Wood Thickness:thickness Of Sides Inch Top And Bottom: 1/2 Inch; Ends: 5/8 Inch;thickness And Width Of Cleats: 5/8 X 3 Inches nails Shall Be Placed So As Not To Intrude On The Interior Space Ofthe Box. The Box Shall Accommodate One Complete Engine Housing Maintenancestand Assembly. The Box Shall Be Banded Using Two Straps Conforming Toastm D3953, Type 1 (flat Strapping Regular Duty), finish B, Grade 3(galvanized Commercial Coating). marking. in Addition To Any Special Marking Required By The Contract Or Purchase Order, The Wood Box Shall Be Marked In Accordance With Mil-std-129. As A Minimum,the Box Shall Contain The Following Information: example: The Below Information Is For Example Purposes Only. p/n 7516900 nomenclature: Beam, Lifting, Mk 99 Mod 0 nsn 1450-01-123-4567 1 Each n08861-08-c-1001 156 Lbs s/n 123 ; 3.11 ;item Unique Identification (iuid). defense Procurement And Acquisition Policy Requires Serial Number Registration For The Engine Housing Maintenance Test Stand Assembly. Data Submission And Policy Requirements Are Found In The Following Websites: https://www.acq.osd.mil/asda/dpc/ce/ds/unique-id.html And Https://piee.eb.mil/.; 4. Quality Assurance 4.1 Responsibility For Inspection - Unless Otherwise Specified In The Contract/purchase Order, The Contractor Is Responsible For The Performance Of All Inspection Requirements As Specified Herein. Except As Otherwise Specified In The Contract/purchase Order, the Contractor May Use His Own Or Any Other Facilities Suitable For The Performance Of The Inspection Requirements Specified Herein, Unless Disapproved By The Government. The Government Reserves The Right To Perform Any Of The Inspections Set Forth In The specification Where Such Inspections Are Deemed Necessary To Assure Supplies And Services Conform To Prescribed Requirements. 4.2 Inspection/testing Repaired Items - The Contractor Shall Perform All Inspection And Testing Requirements As Specified In The Original Manufacturer's Specifications And Drawings. 4.3 Records - Records Of All Inspection Work By The Contractor Shall Be Kept Complete And Available To The Government During The Performance Of Contract/purchase Order And For A Period Of 365 Calendar Days After Final Delivery Of Supplies. 4.4 First Article Test/inspection (government) - The Contractor Shall Deliver ;1 Unit; unit(s) To ;receiving Officer, Naval Station Newport47 Chandler St.newport, Ri 02841-1716 Mark For: Navunseawarcendiv Newport, Code 8524; for First Article Tests In Accordance With The ;iaw The Schedule Provided By The Contract. dwg 7052553 Rev "h" Note 4 "d". a First Article Sample Is Required When Specified In The Contract. Acceptance Will Be Based On Conformance To The Requirements Of This Drawing.; . 4.5 First Article Test/inspection Report - The Contractor Shall Prepare And Submit A Report In Accordance With The Contract Data Requirements List (dd Form 1423). The Report Shall Be Approved Prior To Production. 4.6 ;supplemental Quality Assurance Provisions: a. Due To The Critical Application Of This Part That Includes Personnel Safety,it Is Recommended That The Critical/major Characteristics And Key Features Of Thepart, Identified Below, Be Emphasized When Communicating With The Contractor/supplier b. Government Source Inspection: drawing 7052553 (engine Housing Maintenance Stand Assembly) Key Features: 1. Note 1 On Drawing Is A Critical Characteristic (c1) 2. Note 3 On Drawing Is A Major Characteristic (m101) 3. Note 7 On Drawing Is A Key Feature 4. Note 13 On Drawing Is A Key Feature 5. Note 14 On Drawing Is A Key Feature drawing 7052554 (base Assembly) Key Features: 1. Note 8 On Drawing Is A Key Feature drawing 8667456 (clamp Machining) Key Features: 1. Note 7 On Drawing Is A Key Feature 2. Note 8 On Drawing Is A Key Feature 3. Note 9 On Drawing Is A Key Feature 4. Note 10 On Drawing Is A Key Feature 5. Note 11 On Drawing Is A Critical Characteristic (c1) 6. Note 13 On Drawing Is A Major Characteristic (m101) drawing 8667540 (swivel Caster) Key Features: 1. This Is A Source Control Drawing With One Approved Source Of Supply Listed O drawing 7052681 (horizontal Stop) Key Features: 1. Note 7 On Drawing Is A Key Feature 2. Note 8 On Drawing Is A Key Feature drawing 7052682 (vertical Stop) Key Features: 1. Note 1 On Drawing Is A Key Feature drawing 7052526 (toggle Clamp Mounting Plate) Key Features: 1. Note 2 On Drawing Is A Key Feature drawing 7052683 (locator) Key Features: 1. Note 2 On Drawing Is A Key Feature drawing 7052605-7 (identification Plate) Key Features: 1. Note 3 On Drawing Is A Key Feature: drawing C49667 (hand Wheel) Key Features: 1. Note 2 On Drawing Is A Key Feature drawing B49671 (bearing Shaft) Key Features: 1. Note 3 On Drawing Is A Key Feature drawing C49672 (bearing Block) Key Features: 1. Note 3 On Drawing Is A Key Feature; 5. Packaging 5.1 Preservation, Packaging, Packing And Marking - Preservation, Packaging, Packing And Marking Shall Be In Accordance With The Contract/purchase Order Schedule And As Specified Below. mil-std 2073 Packaging Applies As Found Elsewhere In The Schedule 6. Notes 6.1 Ordering Information For Document References - The Department Of Defense Single Stock Point (dodssp), Website Http://www.dsp.dla.mil/, Provides Product Information For The Department Of Defense Index Of Specifications And Standards (dodiss) (i.e.military/federal Specifications And Standards), Data Item Descriptions (dids), And Other Dodssp Products. Most Specifications Can Obtained Directly From Http://quicksearch.dla.mil/ a. Availability Of Cancelled Documents - The Dodssp Offers Cancelled Documentsthat Are Required By Private Industry In Fulfillment Of Contractual Obligationsin Paper Format. Documents Can Be Requested By Phoning The Subscription Services Desk. b. Commercial Specifications, Standards, And Descriptions - These Specifications, Standards And Descriptions Are Not Available From Government Sources. Theymay Be Obtained From The Publishers Of The Applicable Societies. c. Ordnance Standards (os), Weapons Specifications (ws), And Navord Ostd 600 Pages - These Type Publications May Be Obtained By Submitting A Request To: commander, Indian Head Division, Naval Surface Warfare Center code 8410p, 101 Strauss Avenue indian Head, Md 20640-5035 d. On Post-award Actions, Requests For "official Use Only" And "noforn" (not Releasable To Foreign Nationals) Documents Must Identify The Government Contractnumber, And Must Be Submitted Via The Cognizant Defense Contract Management Command (dcmc) For certification Of Need For The Document. On Pre-award Actions Such Requests Must Be Submitted To The Pco For Certification Of Need For The Document. e. Noforn Military Specifications And Standards (including Amendments, Change Notices And Supplements, But Not Interim Changes) To Be Ordered From: contracting Officer navsup-wss code 87321 5450 Carlisle Pike p.o. Box 2020 mechanicsburg, Pa. 17055-0788 f. Nuclear Reactor Publications Assigned Navsea Documents And Identification Numbers (i.e. Navsea Welding Standard, Navsea 250-1500-1) Are To Be Ordered Enue: commanding Officer navsup-wss code 009 5450 Carlisle Pike p.o. Box 2020 mechanicsburg, Pa. 17055-0788 g. Technical Manuals Assigned Navsea Identification Numbers (i.e. Navsea Welding And Brazing Procedure, Navsea S9074-aq-gib-010/248) Are To Be Ordered From: commanding Officer navsup-wss code 1 Support Branch 700 Robbins Avenue philadelphia, Pa. 19111-5094 h. Interim Changes And Classified Specifications Must Be Obtained By Submitting A Request On Dd Form 1425 To Navsup-wss. 6.2 Notice To Distributors/offerors - Consideration For Award Of Contract Shall Be Given Only To Authorized Distributors Of The Original Manufacturer's Item Represented In This Solicitation. If You Desire To Be Considered As A Potential Source For Award Of this Contract, Proof Of Being An Authorized Distributor Shall Be Provided On Company Letterhead Signed By A Responsible Company Official And Sent With Your Offer To The Procurement Contracting Officer. 6.3 In Accordance With Opnavinst 5510.1 All Documents And Drawings Provided By The U.s. Navy To Perspective Contractors Must Include A "distribution Statement" To Inform The Contractor Of The Limits Of Distribution, And The Safeguarding Of The Information contained On Those Documents And Drawings. There Are 7 (seven) Seperate Distribution Statement Codes Used For Non-classified Documents And Drawings. The Definition For Each Is As Follows: a... Approved For Public Release; Distribution Is Unlimited. b... Distribution Authorized To Us Governments Agencies Only. c... Distribution Authorized To Us Government Agencies And Their Contractors. d... Distribution Authorized To Dod And Dod Contractors Only. e... Distribution Authorized To Dod Components Only. f... Further Distribution Only As Directed By Commander, Naval Sea Systems Command, Code 09t. x... Distribution Is Authorized To Us Government Agencies And Private Individuals Or Enterprises Eligible To Obtain Export Controlled Technical Data In Accordance With Opnavinst 5510.161. 6.4 ;for Contracting: quality Assurance Provisions (qaps) For Dwg 7052553 Can Be Found On S: mech navicp icpm wss General Shares n97 General Shares n9713 Technical torpedo (qaps) Quality Assurance Provisions; date Of First Submission=030 Dac ;certificate Of Quality Compliance (coqc). a Certificate Of Quality Compliance For Drawing 53711-7052553 Note 1 Manufacturer Proof Test Results For Each Unit Shall Be Delivered To The Government Via Contract Data Requirements List (cdrl). Note 1. Manufacturer's Proof Test: Using The Test Configurations Shown In Figures 1 And 2, Each Engine Housing Maintenance Stand Assembly Shall Withstand A Static Load Test Of 684 (+34/-0) Lbs For A Minimum Of Two Minutes In The Vertical Direction And Two Minutes In The Horizontal Direction. Failure Or Permanent Deformation Of Any Part Shall Be Cause For Rejection. Copies Of The Certificate Of Quality Compliance Cdrl Shall Be Delivered To the Engineering Support Activity, Nuwc Newport: nwpt.nuwc_8554_qapcdrl@navy.mil james.c.ferguson1.civ@us.navy.mil richard.d.penfold2.civ@us.navy.mil patrick.r.faerber.civ@us.navy.mil recommend A Post Award Conference Be Conducted With The Contractor/supplier To Review The Item Key Features. The Government Engineeringsupport Activity, Nuwc Newport, Would Like To Participate In Theconference If One Is Scheduled. ;

Details: Sources Sought Notice Medical Waste Sterilizing Autoclave disclaimer this Rfi Is Issued Solely For Information And Planning Purposes Only And Does Not Constitute A Solicitation. All Information Received In Response To This Rfi That Is Marked As Proprietary Will Be Handled Accordingly. In Accordance With Far 15.201(e), Responses To This Notice Are Not Offers And Cannot Be Accepted By The Government To Form A Binding Contract. Responders Are Solely Responsible For All Expenses Associated With Responding To This Rfi. response Instructions: do Not Provide More Than 8 Pages, Including Cover Letter Page. submit Your Response Via Email To: Barron.long@va.gov submit Your Response Nlt 14:00 (mst) On Friday February 7th mark Your Response As Proprietary Information If The Information Is Considered Business Sensitive. va Has Identified The Appropriate North American Industry Classification System (naics) Code 332420 - Autoclaves, Industrial-type, Heavy Gauge Metal, Manufacturing With A Small Business Size Of 750 Employees. Please Identify And Explain Any Naics Codes Your Company Believes Would Better Represent The Predominated Work Included In The Attached Statement Of Work Draft / Salient Characteristics List; information Requested From Industry: in Response To The Sources Sought, Interested Contractors Shall Submit The Following Information And Any Capabilities/qualifications Statement To Include But Not Limited To An Overview Of Proposed Solution(s) And A Description Of The Product Your Company Possesses Accordance With The Statement Of Work Draft / Salient Characteristics List. vendor Name: sam Uei #: name Of Manufacturer: manufacturer Address: estimated Delivery Time: sac Fss Contract Number vendor Point Of Contract (poc) Name poc Phone Number: poc Email Address: statement Of Work introduction: the Autoclave Shall Be Delivered Within 120 Calendar Days After The Effective Date Of The Contract. Delivery Dates Specified May Be Adjusted By The Co To Coincide With The Date The Tcpf Will Be Ready To Receive Installation. The Co Will Advise The Contractor Of The New Delivery Date At Least 45 Days Prior To The Original Or Adjusted Delivery Date(s). Deliveries, Cranes, Or Haulage Will Be Arranged With The Contracting Officer Representative (cor), As To Not Interfere With Day-to-day Ancillary Va Medical Services Such As Nutrition/food Service, Laundry Delivery, Maintenance Routes, Etc. the Autoclave Shall Be Delivered Within 120 Days After The Effective Award Date. Installation Of The Autoclave Shall Take Place No More Than 30 Days After The Delivery Date. The 2 Days Onsite Shakedown And 1-day Onsite Training Are Included In The Installation Timeframe. Training Shall Consist Of Both Operator And Maintenance Personnel At A Minimum.â trainingsâ shall Not To Be Conducted Concurrently. The Total Contract Duration Is 150 Days. note: Installation Shall Be Continuous, Without Interruption, Monday Through Friday, Excluding Federal Holidays, Until All Installation And Testing Work Has Been Completed. Installation May Take Place On The Weekends If Pre-approval Is Given By The Cor. site Specific Project Requirements the Contractor Shall Furnish The Supervision, Labor, Equipment, Tools, Safety, Rigging, Hoisting, Supplies And Installation Services Necessary To Meet The Terms And Conditions In Accordance With The Statement Of Work (sow). this Sow Includes Removal Of Trade-in Equipment, Delivery, Installation, And Training Of The New Laundry Equipment Installed. The Equipment And Installation Shall Be Conducted In Conformance With The Sow And Technical Specifications Provided Herein. All Items Provided By The Contractor Shall Be New. The Contractor Shall Not Utilize Any Refurbished Equipment, Machinery, Or Parts. the Autoclave Is To Be Located Within Building 154, Near The Waste Removal Area. within The New Design Layout Of The Autoclave Area, The Contractor Shall Relocate Existing Lighting Fixtures, And Provide New Energy-efficient, Light-emitting Diode (led) Lighting For Any New Workstation Or Storage Area. New Lighting Shall Comply With Va Lighting Design Guide, January 2022; And Shall Be 50 Foot-candles (minimum) Measured 30-inches Above Floor For Workstation Task Areas, And 35 Foot-candles (minimum) For Storage Areas. all Valves Within The Layout Of The Autoclave And Equipment Shall Be Ball Valves With The Appropriate Ratings And That Are Part Of The Scope Of Work Within This Rfq. all Old Piping, Drain Piping, Ductwork, Vents, Hangers, And Water Piping Associated With Equipment Shall Be Removed. all Piping, Water, Steam, Condensate, And Air Will Be New And Originate From The Nearest Header Within 35 Of The New Autoclave And Electrical For The New Equipment Will Originate From The Electrical Panel Identified By The Station. All Piping, Water, Conduit, Steam, Condensate, And Air Lines Within This Rfq Shall Be New. waste Material Sorting/recycling the Contractor Shall Divert Discarded Items And Other Wastes To Recycling Trash Disposal Scheduled Regularly. Items Which Need To Be Sent For Recycling Or Resale Unless Not Feasible Include Pallets, Metals (iron, Copper, Brass, Etc.) Cardboard, Mercury Items, Used Oil, Electronic, Rechargeable Batteries, Wood Products And Debris. the Contractor Shall Not Store Waste Materials And Items Held For Recycling. Waste Materials Shall Be Stored Prior To Pick Up In A Manner That Does Not Allow The Items To Become A Fire, Health, Environmental Or Safety Hazard Or Provide Harborage For Pests And Consistent With Federal, State And Va (listed In Order Of Preference) Laws And Regulations Governing Storage Of Waste Materials. Actions Include Using Drip Drains Pans, Storing Liquid Wastes Or Items That Rot In Closed Containers, Removing Freon From Junked Air Conditioning, Observing Occupational Safety And Health Administration (osha) And National Fire Protection Association (nfpa) Limits On Sizes Of Piles Of Lumber Or Wood Products. Dumpsters Larger Than One And One-half (1 ½) Cubic Yards In Size Must Be Located At Least Ten (10) Feet From Exterior Walls Of Buildings. painted Or Treated Lumber, Paint Chips, A Potential Asbestos Containing, Or Asbestos Contaminated Items Should Not Be Recycled But Shall Be Disposed Of Properly. No Waste Material Disposal Is Allowed On Government Property. the Cor Designated Contractor Staging Area (tbd After Award) Will Be Fully Enclosed Completely With Fencing And Fence Covering Provided By The Contractor. The Fencing Height Shall Be A Minimum Of Six (6) Feet High, With Covering, Signage And Sandbags Or Plastic Temporary Fence Weights. external Equipment/motor Protection Filters Are To Be Provided For All Air Intakes To Include But Not Limited To Washer Extractors, Electronic Boxes, Mechanical Equipment, Etc., Wherever Air Intakes Are Located. These Are Used As A Primary Pre-filtration Defense To Help Prevent Damage And Extensive Maintenance That Large Volumes Of Lint/debris Can Cause. They Are To Fit All Air Intakes, Motors Etc. And Be Made Of Three-dimensional Electrostatic Media And Encased In A 1/8"-3/8" Rigid Magnetic Galvanized Steel Frame And Contain 2 Layers Of Polypropylene Media. The Media Will Not Shed Fibers, Absorb Moisture, Or Promote Bacterial Growth; The Filter Should Be Designed For Uv Protected, And Stands Up To Extreme Outdoor Or Indoor Exposure, Corrosive Chemicals, High Velocity Air Flow, As Well As Industrial Cleaning And Maintenance Handling. the Contractor Shall Supply Lock-out/tag-out Devices For Each Piece Of Equipment. All Lock-out/tag-out And Confined Space (cs) Locations Shall Be Marked And Identified On The Machine With Instructions On Lock-out Or Cs Procedures For The Equipment. These Instructions/procedures Shall Be Permanently Mounted On Each Piece Of Equipment. Lock-out/tag-out Procedures Include All Sources Of Stored Energy, Including But Not Limited To: Electrical, Gas, Water, Air Lines, Hydraulic, Etc. Relief Valves Shall Be Installed For Lock-out/tag-out Locations To Relieve Residual Air Lines Etc. the Contractor Shall Supply One (1) Lock-out And Tag-out Kit With The Lock-out/tag-out Devices For Each Piece Of Equipment. The Kits Shall Turned Over To The Cor. All Lock-out / Tag-out And Permit Required Confined Space (prcs) Locations Shall Be Marked And Identified On The Machine With Instructions On Lock-out Or Prcs Procedures For The Equipment. These Instructions/procedures Shall Be Permanently Mounted On Each Piece Of Equipment. Lock-out/tag-out Procedures Include All Sources Of Stored Energy, Including But Not Limited To: Electrical, Gas, Water, Steam, Condensate, Air Lines, Hydraulic Etc. Relief Valves Shall Be Installed For Lock-out/tag-out Locations To Relieve Residual Air Etc. number And Nomenclature Will Separately Identify All Equipment With No Less Than Two (2) Inch Numbers And Letters. Each Piece Of Equipment Will Be Separately Identified And Labeled. Example: Hot Water Heater 1, Hot Water Storage Tank Etc. The Equipment Shall Be Made Compatible To Meet Production Requirements Specified In The Technical Specifications. contractor Bears All Responsibility For All New Utility Connections. All New Utility Piping That Has Been Added Shall Be Leak Tested (air, Water, Steam And Condensate). connections To Va Supplied Utilities Shall Be Within 35 Of New Equipment Supplied And Electrical Panel Identified. Penetrations In Floors, Walls And Ceilings Not Utilized Will Be Filled With Existing Floor, Wall, And Ceiling Like Material. All Braces, Pipes (air, Gas, Water, Steam, Condensate, Electrical), Conduit And Duct Work That Will Not Be Utilized Shall Be Removed Back To The Source That Pertains To The Equipment Directly Associated With This Rfq. the Contractor Shall Not Damage Equipment Frame, Door Panels, Cylinder, Cylinder Panels, Control Box On The Government Installation. If The Contractor Causes Damages To Any Government Property, The Contractor Shall Replace Or Repair The Damage At No Expense To The Government As The Co Directs. If The Contractor Fails Or Refuses To Make Such Repair(s) Or Replacement(s), The Contractor Shall Be Liable For The Cost, Which May Be Deducted From The Contract Price. existing Equipment That Will Be Re-used Shall Be Protected From Damage During Installation Up To And Including Removal And Replacement Where Necessary To Facilitate Installation Of New Equipment. utility Shutdowns And Hot Work Permits contractor Shall Provide Ten (10) Calendar Days Advance Notice For Any Planned Utility Shutdowns And Should Be Indicated On The Project Schedule. contractor Shall Follow Stations Protocol On Notice Of Any Hot Work Permits Needed. the Tcpf Will Be Open During The Project. The Contractor Will Have Access To The Tcpf Seven Days A Week From 7:00 Am Through 3:30pm. On The Weekends There Will Be A Staff Member On Station To Allow Entrance And Will Monitor The Contractor While They Are On Station. note: With Cor Approval The Contractor May Work Evenings And/or Weekends To Accomplish The Work Required. badge Requirements the Contractor S Personnel (including Subcontractors) Anticipated To Be On Site For More Than Two (2) Days Will Need To Obtain A Piv Badge Through The Va Cor. [note: Piv Badges Require At Least 30 Days To Secure So It Would Be Beneficial For The Contractor To Start This Process Immediately.] site Visit the Contractor Has The Responsibility Of Visiting The Site And Examine The The Installation Area. Failure On The Part Of The Contractor To Accomplish A Site Visit And Become Thoroughly Familiar With All Conditions That May Affect Their Quote Will Be At The Contractor S Risk. the Ft. Harrison Tcpf Will Accommodate Site Visits As They Are Requested. The Site Visits May Be On Different Dates Or All On The Same Date, Depending On If/when Requests Are Made By The Contractor. The Contractor Must Request A Scheduled Date To Visit The Ft. Harrison Tcpf And The Cor Will Determine If The Requested Date Is Available. Site Visit Requests Shall Be Made By Contacting. exemption Certificate the Cor Will Provide A Valid Certificate Of Exemption For The State Of Montana Sales And Use Tax To The Contractor. general Installation Requirements existing Utilities Shall Be Utilized To Meet The Performance Requirements Of The Technical Specifications. Connection Points For All Equipment Shall Be Within 35 Of New Equipment. When Existing Service Lines Require Demolition, They Shall Be Removed Back To The Source. the Contractor Shall Ensure Maximum Utilization Of Existing Equipment Space To Prevent Additional Plumbing, Electrical Or Other Utilities. should Additional Utilities Be Required For The Equipment, These Utilities Shall Be The Responsibility Of The Contractor. Utilities Are Electric, Water, Steam, Condensate And Air Lines. all Exposed Utility/ductwork/piping Systems, Control Boxes And Motors That Are Exposed To Floor Traffic Shall Be Appropriately Guarded And Protected. equipment And Materials Shall Be Suitable For Installation In Available Space, Arranged For Safe, Efficient, And Convenient Operation And Maintenance, And If Applicable With Referenced Specifications To Include A Summary Of Routine Preventative Maintenance For Each Piece Of Equipment. the Contractor Shall Furnish All Labor And Materials Necessary For Storage And Installation Of New Equipment. Installation Shall Include, But Is Not Limited To: all Mounting Holes Shall Be Utilized For Anchoring Equipment. Secure Mounts Shall Be Laid Out In Advance For Review And Approval By The Cor. any And All Penetrations Of Walls, Ceilings And Floors For The Installation Or Removal Of Electrical Conduit, Pipes, Ductwork, Liquid Supply Lines, Communication Wiring, Etc. Shall Be Sealed With An Approved Fire-retardant Material (not Foam) And Shall Match Existing Materials On Both Sides Of The Penetration. contractor Is To Supply New Utility Connections (i.e., Wall/ceiling Mounts, Junction Boxes, Raceways, And Conduits). the Contractor Shall Be Responsible For All Control Wiring Including Disconnects Interconnections, And Conduit. Interconnecting Consists Of All Control Wiring, All Ductwork, Interconnecting Pieces Of Equipment And Outside Vents, All Airlines, And All Connections From Va Supplied Utilities. all Installation And/or Modifications Of Utilities And Structures, Shall Match Existing Materials. No Wooden Platforms Allowed. all Pipes, Vents, Drains, Electrical Boxes, Ductwork, And Conduit Shall Be New. all Pipes And Ductwork Shall Be Insulated. All Conduits And Air Pipes Shall Not Be Painted. All Vents And Drains Shall Be Painted, (refer To The Table Below For Colors). All Insulation Shall Be Wrapped With White Pvc Plastic As Indicated Below. Pvc Covering Shall Be A Minimum .030 Thickness. Flow Markings And Identification Of All Pipes, Vents, Ductwork, And Airlines To Equipment Shall Be Appropriately Marked With A Minimum Of Two (2) Inch Letters. Pre-made Adhesives Are Acceptable, Spray-painting Stencils Are Not Acceptable. air Piping: (only Identification/flow Markings) air Intake Ductwork: safety White Pvc (identification And Flow Markings) large Dryer Air Exhaust Ductwork: safety White Pvc Textured Aluminum (identification & Flow Markings) small Dryer Air Exhaust Ductwork: safety White Pvc (identification & Flow Markings) vent Pipe: painted Flat Black (identification And Flow Markings) drain Line: painted Flat Black (identification And Flow Markings) domestic Water: safety White Pvc (identification And Flow Markings) fire Suppression Piping: painted Bright Red (identification And Flow Markings) outside Exposed Ductwork: sealed Watertight And Weather-proofed To Protect From The Environment all Conduits: not Painted installation Of Piping, Sleeves, Inserts, Hangers, And Equipment Shall Be In Accordance With The Installation Design Drawing And Shall Be Sealed By A Licensed Professional Architect And Engineer, Which Were Previously Approved By The Cor. In The Installation Design Drawings, The Contractor Shall Locate Drains, Piping, Sleeves, Inserts, Hangers, And Equipment Out Of The Way Of Windows, Doors, Openings, Light Outlets And Other Services And Utilities. All Piping Shall Be Installed To Comply With Accepted National And Local Plumbing Practices. Mechanical Or Grooved Fittings On Mechanical Piping Are Acceptable. if Necessary To Drill Through Structural Sections, The Contractor Shall Notify The Cor Immediately. The Cor Shall Work With A Structural Engineer To Determine Proper Location. The Cor Shall Instruct Contractor On Structural Location To Continue Work. install Gauges, Thermometers, Valves, And Other Mechanical And Electrical Devices For Ease Of Reading, Operating, And Maintaining. Servicing Shall Not Require Dismantling Of Adjacent Equipment, Electric Or Pipe Work. valve Tags - Furnish And Install Valve Tags On All Compressed Air, Gas, Steam, Condensate And Water Valves On Equipment And Connection Points. Tags Shall Be Engraved With Identification (gas, Air Etc.), Black Filled Identification, Numbers, And Letters Not Less Than ½ Inch High For Number Designation And Not Less Than ¼ Inch For Service Designation On 19 Gauge 1-1/2-inch Round Brass Disc; Tags Shall Be Attached With Brass Hooks Or Brass Chain. trap Tags: Furnish And Install All Steam Trap Tags On Equipment And Connection Points Of The Textile Care Processing Equipment. Tags Shall E Engraved, Black Filled Numbers And Letters Not Less Than ½ Inch High For Number Designation And Not Less Than ¼ Inch For Service Designation On 19 Gauge 1-1/2 Inch Round Brass Disc, Tags Shall Be Attached With Brass Hooks Or Brass Chain. the Contractor Shall Provide Two (2) Valve Lists And Two (2) Steam Trap Lists On Typed Plastic-coated Cards, Sized 8-1/2-inch X 11 Inch Showing Tag Number, Valve Type, Valve Function And Location Area Of Valve For Each Service Or System To The Cor. equipment, Motors, Piping, Ductwork And Any Other Components Or Materials Shall Be Protected Against Physical Damage From Carts With Guardrails Supplied By The Contractor. belts, Chains, Pulleys, Couplings, Motor Shafts, Gears Or Other Moving Parts Shall Be Fully Guarded In Accordance With Osha 1910.219. Guard Parts Shall Be Rigid And Suitably Secured And Be Readily Removable Without Disassembling The Guarded Unit. a Minimum Clearance Of 36 Inches Between Moving Parts And Fixed Objects And 24 Inches Between Non-moving Parts And Fixed Objects Is Required In Accordance With Osha 1910.219. All Conveyor Rollers Shall Have Roll Caps Installed And Guards Will Be Provided Under All Conveyors. plumbing Requirements plumbing grooved Or Mechanical Fittings Are Allowed On Piping. the Contractor Shall Not Use Cast Iron Fittings, And Components Or Malleable/ductile Fittings Anywhere In The High-pressure And Medium Pressure Steam System (15 Psi Or Above). The Contractor Shall Only Use Cast Steel Or Forged Steel Fittings And Components, In Accordance With Applicable Va Master Specifications Found At Https://www.cfm.va.gov/til/spec.asp traps the Contractor Shall Provide Traps On All Sanitary Branch Waste connections From Fixtures Or Equipment Not Provided With Traps. Exposed Brass Shall Be Polished Brass Chromium Plated With Nipple And Set Screw Escutcheons. Concealed Traps May Be Rough Cast Brass. Slip Joints Are Not Permitted On Sewer Side Of Trap. Traps Shall Correspond To Fittings On Cast Iron Soil Pipe Or Steel Pipe Respectively, And Size Shall Be As Required By Connected Service Or Fixture. plumbing Installation in Accordance With The National Standard Plumbing Code, 2021 Edition. pipe Saddles Shall Be Installed On The Outside Of All Insulation And Pvc Coverings. escutcheons Shall Be Installed At All Floors, Wall And Ceiling Locations That Pipe, Conduits, Vents And Ductwork Penetrate. pipe Shall Be Round And Straight. Cutting Shall Be Done With Proper Tools. Pipe, Except For Plastic And Glass, Shall Be Reamed To Full Size After Cutting. all Pipe Runs Shall Be Laid Out To Avoid Interference With Other Work. install Valves With Stem In Horizontal Position Whenever Possible. All Valves Shall Be Easily Accessible. piping Shall Conform To The Following: waste, Storm Water Drain And Vent: Drain To Main Stack As Follows: pipe Size Minimum Pitch 3 Inch And Smaller 1/4 Inch To The Foot 4 Inch And Larger 1/8 Inch To The Foot exhaust Vent extend Exhaust Vents Separately Through Roof. Sanitary Vents Shall Not Connect To Exhaust Vents. insulation Requirements unless Specified In Other Sections Of The Technical Specifications, Cellular Glass Insulation Is Required For Hot Water Piping. A Minimum 1.5 Inches Thick For Hot Water Is Required. All Insulation On Piping And Equipment Shall Be Terminated Square At Items Not To Be Insulated, Access Openings And Nameplates. Cover All Exposed Raw Insulation With Sealer Or Jacket Material That Does Match The Color Of The Insulation. water Piping interior Domestic Water Piping Shall Be Copper Tube, Type L Drawn Per Astm B88. Fittings For Copper Tube Must Be Wrought Copper Or Bronze Castings Conforming To Ansi B16.18 And B16.22. Unions Shall Be Bronze In Accordance With Federal Specification Ww-u-516 With Solder Or Braze Joints Including Adapters For Joining Screwed Pipe To Copper Tubing. air Piping interior To The Building And Outdoor External Air Piping Shall Be Copper Tube. all Piping Shall Be Installed Parallel To Walls And Column Centerlines. Pipe Shall Be Round And Straight. Cutting Shall Be Done With Proper Tools. Except For Plastic And Glass, Pipe Shall Be Reamed To Full Size After Cutting. Copper Piping Work Shall Be Performed In Accordance With Best Practices Requiring Accurately Cut Clean Joints And Soldering In Accordance With The Recommended Practices For The Material And Solder Employed. all Pipe Runs Shall Be Laid Out To Avoid Interference With Other Work. install Ball Valves In Horizontal Position. All Valves Shall Be Easily Accessible. pipe Saddles Shall Be On The Outside Of All Insulation And Pvc Coverings. pipe Escutcheons Will Be Used For All Pipe Penetrations Through Walls, Floors, And Ceilings. electrical Requirements electrical electrical Installation conduits, Fittings, And Electrical Wire all Electrical Installations Shall Conform To Requirements Of The National Electrical Code (nec). install A New Power Disconnect Box For Each Piece Of Equipment. all Electrical Wire Shall Be Copper, Heat Resistant Grade, Thermoplastic Insulated. Control Wiring Shall Be (stranded) Thermoplastic High Heat Nylon (thhn)/thermoplastic Heat And Water-resistant Nylon (thwn) Or Equal. Intermediate Wall Conduit Is Required. Provide Conduit Trapeze Hangers. all Power Wiring Shall Have A Minimum Conduit Size Of 3/4-inch In Diameter. Color Coding Of All Wiring Shall Be In Accordance With Established Nfpa 70. all Low Voltage Communication Wire Used For Data Management Systems, Liquid Supply Systems And Intercoms Shall Be Installed In Minimum 3/4-inch Diameter Protective Conduit. Wire Nuts Shall Not Be Used For Any Connections. electrical Wiring Installation in Accordance With Nfpa 79 Electrical Standard For Industrial Machinery 2021 Edition: wiring Shall Not Be Cut, Abraded, Nor Have Excessive Insulation Stripped, And Shall Be Properly And Tightly Joined At Terminals. wire Nuts Shall Not Be Used, And Solderless Connectors Shall Have Insulation Grip. Wiring Shall Have Adequate Slack To Provide Strain Relief. Wire Nuts Are Only Acceptable For Electrical Installation Of Motors And Terminal Boxes. wiring Shall Be Provided Between Motors, Controllers, Timers, Pushbuttons, Starters, And Limit Switches Installed On Or Within The Equipment And Shall Be Done With Materials As Applicable, Except Liquid Tight Flexible Conduit Shall Be Used Where Required For Belt Adjustment By Moving A Motor Or For Vibration Isolation. all Wiring Shall Terminate In Connection Boxes With Provisions For Connections Beyond The Machine; Each Conductor Shall Be Identified By A Different Color. the Line Voltage Side Of The Work Is A Single Point Demo And Termination To A Prewired Control Cabinet. electrical Identification Installation in Accordance With Nfpa 79 Electrical Standard For Industrial Machinery 2021 Edition: install Nameplates - Center On Device, Cover Plate, Or Enclosure. use Power Source Designations Defined In The Technical Specifications. Indicate Electrical Power Loads Served Using Designations From Electrical Schedules And Designations From The Appropriate Trade Furnishing The Equipment Served. lettering Shall Include Name Of Equipment, The Specific Unit Number, And Any Reference To On/off Or Other Instructions That Are Applicable. all Labeling Shall Be On Laminated Phenolic Nameplates And Shall Be Placed On Equipment. nameplates Shall Be Laminated Phenolic With A Blue Surface (480 Volts)/black Surface (208 Volts) And White Core. Use 1/16-inch Thick Material For Plates Up To 2 Inch X 4 Inch. For Larger Sizes, Use 1/8-inch Thick Material. the Contractor Shall Mark All 4-plex Outlets And Boxes With The Electrical Panel, Circuit, And Branch Identification. electrical Protection the Contractor Shall Provide Any Protective Methodology Or Devices Necessary To Protect The Equipment From: damage Due To Electrical Power Problems, Including Brownouts, Emergency Power Interruptions, Electrical Surges, Sags, And Electrical Storms. any Equipment Located Outside The Building Or On The Roof Shall Have Lightning Protection Installed. data Loss Due To Electrical Power Problems. All Equipment Electronics Shall Be Protected With A Power Monitor Hook-up Point And Power Monitor. existing Equipment That Will Be Re-used Shall Be Protected From Damage During Installation Up To And Including Removal And Replacement Where Necessary To Facilitate Installation Of New Equipment. uninterrupted Power Supply (ups) Shall Be Installed For All Equipment Supplied. (minimum 2-hour Back-up). electrical Receptacles And Outlets receptacles Shall Be Underwriters Laboratories Certified. mounting Screws, Mounting Strap And Terminal Screws Shall Be Brass Or A Copper Alloy Metal. receptacles Shall Have Provisions For Back Wiring From Four (minimum) Separate Wiring Holes And Side Wiring From Four Captivity Held Binding Screws. ground Fault Interrupter (gfi) Four-plex Receptacles Shall Be Single Phase, 20 Ampere, 120 Volts, 2-pole, 3-wire, Us National Electrical Manufacturers Association (nema) 5-2or. the Duplex Type Receptacles Shall Have Break-off Feature For Two Circuit Operation. The Ungrounded Pole Of Each Receptacle Shall Be Provided With A Separate Terminal. the Receptacle Bodies Shall Be White In Color. four-plex Receptacles With Gfi Shall Be An Integral Unit Suitable For Mounting In A Standard Outlet Box. gfi Shall Consist Of A Differential Current Transformer, Solid State Sensing Circuitry And A Circuit Interrupter Switch And Shall Be Rated For Operation On A 160 Hz, 120-volt, 20 Ampere Branch Circuit. The Device Shall Have Nominal Sensitivity To Ground Leakage Current Of Five (5) Milliamperes And Shall Function To Interrupt The Current Supply For Any Value Of Ground Leakage Current Above Five (5) Milliamperes On The Load Side Of The Device. The Device Shall Have A Minimum Nominal Tripping Time Of 1/30th Of A Second. receptacles 20, 30 And 50 Ampere, 250 Volt: Shall Be Complete With Appropriate Cord Grip Plug. weatherproof Receptacles shall Consist Of A Duplex Receptacle, Mounted In Box With Gasket, Weatherproof, Cast Metal Cover Plate And Cap Over Each Receptacle Opening. The Cap Shall Be Permanently Attached To The Cover Plate By A Spring Hinged Flap. The Weatherproof Integrity Shall Not Be Affected When Heavy Duty Specification Or Hospital Grade Attachment Plug Caps Are Inserted. Cover Plates On Outlet Boxes Mounted Flush In The Wall Shall Be Gasket To The Wall In A Watertight Manner. wall Plates wall Plates For Switches And Receptacles Shall Be As Specified By The Cor. Oversize Plates Will Not Be Acceptable. wall Plate Color Shall Be White. standard Nema Design, So That Products Of Different Manufacturers Must Be Interchangeable. for Receptacles Or Switches Mounted Adjacent To Each Other, Wall Plates Shall Be Common For Each Group Of Receptacles Or Switches. the Contractor Shall Provide 4-plex Receptacle At Each Equipment Location For Mechanic S Use. marking Pen Labeling use For All Junction And Outlet Boxes Or Portions Of Junction Boxes With Power Wiring, Communication Systems, Pull And Junction Boxes, And Conduit Installed For Future Use. For All Boxes With Power Wiring, Indicate Appropriate Panel And Circuit Number(s) Where Applicable, Etc. Label Inside Covers In Finished Areas And Outside Covers In Unfinished Areas. Labeling Shall Be Completed Using Permanent, Waterproof, Quick Drying Marking Pen. label Tapes label Each Conductor At Origin And Destination Points And At All Junction Boxes Where Two Or More Feeder Or Control Circuits Are Present. Identify With Branch Circuit Or Feeder Number For Power And Lighting Circuits, And With Control Conductors, Number As Indicated On Schematic And Interconnection Diagrams Or Equipment Manufacturer's Drawings For Control Wiring. Using Cloth, Plastic, Split Sleeve Or Tubing Type Wire And Cable Label Markers. dielectric Fittings provide Dielectric Couplings Or Unions Between Ferrous And Non-ferrous Pipe. In Addition, Provide Threaded Dielectric Unions For Pipe Sizes 2 Inches And Under. For 2-1/2 Inches And Above, Provide Copper And Steel Flanges Electrically Isolated At Gasket And By Sleeves At Bolts. Fittings On Cold Water And Soft Water Lines Shall Be Rated For 100 Psi, 80 Degrees F. Fittings On Other Services Shall Be Rated For The Maximum Pressure And Temperature Conditions Of The Service. Where Copper Piping Is Connected To Steel Piping, Provide Dielectric Connections. prefabricated Roof Curbs galvanized Steel Or Extruded Aluminum 12 Inches Overall Height, Continuous Welded Corner Seams, Treated Wood Nailer, 1-1/2 Inch Thick, 3-pound Density Rigid Mineral Fiberboard Insulation With Metal Liner, And Built-in Curved Cantilever Strip. Provide Raised Cantilever Strip (recessed Mounting Flange) To Start At The Upper Surface Of The Insulation. Curbs Shall Be Constructed For Pitched Roof Or Ridge Mounting As Required To Keep Top Of Curb Level. installation Requirements approval For The Contractor To Proceed With Installation Shall Be Contingent Upon The Acceptance Of The Design Submittals And Written Notification To Proceed With Installation From The Cor. the Contractor Shall Be Responsible For The Determination Of, And Compliance With, Federal, State, And Local Code Requirements, Design Data, And Other Factors Necessary To Design And Install The System. the Contractor Shall Verify The Location Of Extant Utilities. Contractor Shall Connect To Designated Utilities In A Manner Conforming To A Nationally Recognized Code And At A Time Satisfactory To Minimize Or Preclude Disruption To Existing Functions Or Clinical Services. the Contractor Shall Be Responsible For Installation, Which Consists Of Assembling, Positioning, And Mounting Of All Equipment And Connections Of All Cables. The Contractor Is Responsible For Furnishing And Pulling All Interconnecting Wiring And Cabling, Including Wiring, And Cabling To Be Pulled Through Conduit And Raceways. It Is The Responsibility Of The Contractor To Supply And Install Junction Boxes; Wall/ceiling Mounts And Support Structures. the Contractor Shall Provide Certified Field Engineers Or Technicians To Conduct All Necessary Tests During Installation. Contractor Shall Provide Copies Of The Certifications Upon Government Request. the Contractor Shall Inform The Co And Cor Of Any Problems As They Occur In Connection With Installation, Or Issues Which Will Affect Optimum Performance Shall Be Reported Prior To The Start Of Installation. Installation Shall Not Proceed Under Such Circumstances Until Authorized By The Co. availability Of Parts And Service the Quoter Shall Guarantee The Contractor Availability Of Servicing And Replacement Parts For A Period Of Ten (10) Years To The Government For The Laundry Equipment Being Procured Under This Rfq. incorporation Of Documents the Following Documents Are Hereby Incorporated By Reference And Made A Part Of This Rfq. the Equipment And Installation Supplies Shall Conform To The Following Standards: air Moving And Conditioning Association, Inc. (amca) Standards, 2009 Edition. american National Standards Institute (ansi), 2021 Edition. Z8.1-2006 Safety Requirements For Commercial Laundry And Dry Cleaning Operations. femp: Federal Energy Management Program (energy Efficient Product Rating). hvac Duct Construction Standards-metal & Flexible. national Electrical Manufacturers Association (nema), 2021 Edition. national Fire Protection Association (nfpa), 2021 Edition. All Nfpa Standards And Codes. National Electrical Code (nec), 2020 Edition. national Standard Plumbing Code, 2021 Edition. occupational Safety And Health Administration (osha) 29 Cfr 1910. sheet Metal And Air Conditioning Contractors National Association (smacna), 2021 Edition. sheet Metal Contractors National Association Inc. Publication, 2019 Edition. underwriters Laboratories Standards, 2022 Edition. city, County, State, Federal, Va And National Environmental, Fire And Safety Regulations/standards.

Details: The Department Of Veterans Affairs Network Contracting Office 2 Is Issuing This Source Sought Synopsis As A Means Of Conducting Market Research To Identify Parties Having An Interest In And The Resources Providing Testing Of Sterile Compounding Areas At The Northport Vamc, 79 Middleville Road , Northport, Ny 11768. the Result Of This Market Research Will Contribute To Determining The Method Of Procurement. The Applicable North American Industry Classification System (naics) Code Assigned To This Procurement Is 541380. the Va Requires A 12-month Base Year, Plus Four 12-month Options Contract. This Contract Will Be Inclusive Of All Labor, Materials, Equipment, And Travel (within 2 Hours) To Perform Initial And Recurring Certification Of The Facility S Sterile Compounding Areas. based On The Responses To This Sources Sought Notice/market Research, This Requirement May Be Set-aside For Small Businesses Or Procured Through Full And Open Competition. telephone Inquiries Will Not Be Accepted Or Acknowledged, And No Feedback Or Evaluations Will Be Provided To Companies Regarding Their Submissions. submission Instructions: Interested Parties Who Consider Themselves Qualified To Perform The Above Listed Services Are Invited To Submit A Response To This Sources Sought Notice By October 24, 2024, At 12:00pm Est. All Responses Under This Sources Sought Notice Must Be Emailed To Lee.kern@va.gov. please See The Below Statement Of Work (sow): statement Of Work testing Of Sterile Compounding Areas introduction United States Pharmacopeia (usp) Establishes Standards For Cleanroom Design, Environmental Monitoring, And Competencies For The Preparation, Handling, And Storage Of Compounded Sterile Preparations (csps). To Maintain Compliance With These Standards, Northport Vamc Requires A Base Plus Four (4) Year Contract Inclusive Of All Labor, Materials, Equipment, And Travel (within 2 Hours) To Perform Initial And Recurring Certification Of The Facility S Sterile Compounding Areas. Certification And Testing Will Consist Of: Testing All Primary Engineering Controls [(pecs) E.g., Biological Safety Cabinets (bscs), Laminar Airflow Workbenches (lafws), Compounding Aseptic Containment Isolators (caci), And Compounding Aseptic Isolators (cai)] testing All Secondary Engineering Controls (secs), Non-iso Rated Controlled Non-classified (cnc) Rooms, And High-efficiency Particulate Air (hepa) Filtration Devices. microbiological Laboratory Testing Of Collected Viables Samples. wipe Sampling For Environmental Hazardous Drug (hd) Residue testing And Certification Must Be Completed In Accordance With The Most Currently Published Versions Of Usp Chapter , Usp Chapter , Controlled Environment Testing Association (ceta) Application Guides For: Cag-003 Certification Of Sterile Compounding Facilities For Usp Compliance, Cag-002 Compounding Isolator Testing, Cag-008 Certification Matrix For sterile & Nonsterile Usp Compounding Facilities, Cag-009 Viable Environmental Monitoring For Sterile Compounding Facilities, Cag-014 Airflow Visualization Study, National Sanitation Foundation/american National Standards Institute (nsf/ansi) Standard 49 Biosafety Cabinetry, And Institute Of Flow Clean Air Devices, Iest-rp-cc-002.4. All Lab Analysis Of Viable Samples Must Be Performed By A Facility With Iso/iec 17025 Accreditation For Microbial Analysis. This Environmental Quality Testing May Not Be Performed Under The Laboratory S Clinical Laboratory Improvement Amendments (clia) License. The Lab Must Attain Iso/iec 17025 Certification From An External Accrediting Body (e.g., American Association For Laboratory Accreditation ) To Ensure Quality And Accuracy Of The Testing. background. northport Vamc Is Pursuing A Facility Contract For Certification Of All Pecs, Secs, Cnc Rooms, And Hepa Filters Must Be Performed Pursuant To The Most Current Version Of Usp Chapter And Usp Chapter Standards Following Ceta S Standardized Testing Procedures Which Include (but Is Not Limited To) Cag-003 Ceta Certification Guide For Sterile Compounding Facilities For Usp Compliance, Cag-002 Ceta Compounding Isolator Testing Guide, Cag-014 Airflow Visualization Study, And Cag-009 Viable Environmental Monitoring For Sterile Compounding Facilities. certification Must Be Performed Every 6 Months. Recertification Will Be Required After Any Servicing Of Facilities Or Equipment, Post Changes To The Area That Could Affect Airflow Or Air Quality ( E.g., Redesign, Construction, Replacement Or Relocation Of Any Pec, Or Alteration In The Configuration Of The Room), And/or In Response To Identified Problems Or Trends. certification Procedures Defined In Relevant Ceta Application Guides Must Be Performed No Less Than Every 6 Months By An Individual Who Has The Required Ceta Competencies And Training Related To The Certification Of Primary And Secondary Engineering Controls. Additionally, It Is Preferred That The On-site Certification Individual Have Received Nsf Accreditation For The Field Certification Of Class Ii Biosafety Cabinets And Are Accredited Through Cnbt As A Registered Certification Professional In The Sterile Compounding Facility (rcp-scf). Prior To Testing, The Contractor S Technician(s) Who Conduct On-site Certification Will Provide, To The Cor, Documentation Of Competency And Training Related To The Certification Of Pecs And Secs. procedures For Air And Surface Sampling And Evaluation Must Be Compliant As Per The Most Current Usp Chapter 797 Requirements For Environmental Air Sampling, Surface Sampling (cag-009), Gloved Fingertip Testing (cag-011), And Media Fill Testing (cag-013) Following The Appropriate Ceta Cag Application Guide. northport Vamc S Sterile Compounding Areas And Equipment Must Be Compliant To The Joint Commission (tjc) And Food And Drug Administration (fda) Requirements. Tjc Medication Compounding Requirements For Critical Access Hospitals And Hospitals, Effective January 1, 2024, Established New Medication Compounding (mc) Standards For Non-sterile And Sterile Compounded Preparations Which Are Based On Usp Standards. The Fda Has The Authority To Inspect Va Medical Facilities Under The Food, Drug And Cosmetic Act, And Evaluate Based Upon The Guidance Provided In The Insanitary Conditions At Compounding Facilities Guidance For Industry, November 2020 (or Most Current Version). scope testing Frequency. the Northport Vamc Has A Requirement For Onsite Initial And Reoccurring Ceta Certification And Viable Environmental Sampling Of The Facility S Pharmacy-specific And Non-pharmacy Specific Areas And Equipment As Detailed Within This Statement Of Work (sow). Testing And Certification Dates Contained Within This Sow Are Best Documented; Contractor Shall Be Responsible To Confirm And/or Adjust Certification/testing Requirements To Ensure No Lapse In Requirements And Thus No Undesirable Effect On The Mission Of The Northport Vamc. all Pharmacy-specific Equipment Will Minimally Obtain Ceta Certification Every Six (6) Calendar Months From The Date Of The Last Certification/testing Of Bscs, Lafws, Cai, Caci, Hepa Filters, And Room Spaces/environments In Accordance With Vha Directive 1108.12 (see Attachment A), And Usp 797 (attachment B) & 800 (attachment C). Recertification May Be Required Sooner If Equipment Is Relocated/altered, Or A Major Service Is Performed. testing Locations. The Following Location Shall Be Tested As Per Usp 797 And Where Applicable Usp 800 Standards As Per Respective Ceta Guide Applications. Locations May Be Amended As Per The Facility S Renovations And Construction. building 200, Unit 31 Cleanroom Suite(s) Primary Space(s) And Equipment iso-8 Anteroom(s): Two Ceiling Mounted Hepa Filters iso-7 Buffer Room(s) two Ceiling Mounted Hepa Filters one Iso-5 Lawf: Baker Edgegard 5252 Lawf building 200, Inpatient: One Iso-5 Compounding Aseptic Isolator (cai): Baker Ss-500 building 200, New Pavilion 2f, E2-49 hd Negative Pressure Storage Room: One Ceiling Mounted Hepa Filter cnc Hd Negative Pressure C-sca one Ceiling Mounted Hepa Filter one Iso-5 Hd Negative Pressure Compounding Aseptic Containment Isolator (caci): Baker Cs-500 germfree Trailer (adjacent To Building 11) - This Location Will Be Covered Under This Contract For Monthly Viable Sampling And Hazardous Drug Wipe Sampling. note: There Is A Separate Contract Which Covers The Semiannual Ceta Testing And Viable Sampling Of The Trailer. testing Requirements Of Pecs. biological Safety Cabinet (bsc): On-site Certifications Of The Bscs Shall Be Tested To Manufacturer Specifications In Accordance With The Most Recent Version Of Nsf/ansi Standard 49 Biosafety Cabinetry (as Per Ceta Cag-003:2022 Section 8.2. Through 8.2.5 Application Guide And Ceta Cag-005:2007 (or Most Current Versions) compounding Aseptic Isolator (cai) And Compounding Aseptic Containment Isolator (caci): The Contractor Shall Test And Certify All Cais And Cacis As Per Ceta Cag-003 Sections 8.3 Through 8.3.5 And In Accordance With Ceta Cag-002 Guide Application. laminar Air Flow Workbench (lafw): The Contractor Shall Test And Certify All Lafw As Per Ceta Cag-003:2022 Section 8.4. Through 8.4.6 Application Guide (or Most Current Version) the Contractor Shall Test And Certify All Pecs In Accordance With The Most Current Version Of The Institute Of Environmental Sciences And Technology (iest)-rp-cc002 (unidirectional Flow Clean-air Devices), Ceta Cag-003, And The Manufacturer's Specifications. the Contractor Shall Record Each Individual Face Velocity Reading And The Average Of Those Readings, The Downstream Concentration Reading Of The Hepa Filter Leak Test And The Results Of The Induction Leak Test And Back Streaming Test all Equipment Used To Certify Pecs Must Be Calibrated In Accordance With Iest-rp-cc013 Or Manufacturer's Recommendation And Be Nist Traceable Where Possible. where Applicable The List Of Tests For Pecs Includes, Where Applicable But Not Limited To The Following: air Flow Velocity Profile air Flow Visualization Profile: Dynamic Smoke Pattern Testing (video Recorded And Provided To Us On A Thumb Drive Or Made Available For Download On A Secure Website) For All Primary Engineering Controls. Tester Must Utilize Sufficient Smoke To Demonstrate Unidirectional Airflow At Critical Sites And Sweeping Action Over And Away From Preparations. prefilter Check hepa/ulpa Filter Leak Integrity Testing (must Be Performed Upon Installation And As Part Of Certification) induction Leak Integrity Test And Patching If Necessary electrical Leakage And Ground Circuit Resistance And Polarity Tests preparation Ingress And Egress Test Where Applicable chamber Pressure Test total Airborne Non-viable Particle Count Testing In All Classified Areas Performed Under Dynamic Operating Conditions for Each Pec Passing The Required Certification Tests, The Contractor Supplies Each Unit With A Certification Tag Or Sticker Displaying The Following Information: company Name And Contact Information. unit Make, Model And Serial Number. report Number location (e.g., Building, Room Number, Area Identification) certification Date recertification Date technician Name And Signature any Pec That Fails To Meet Ceta Specifications Shall Be Clearly Marked With Signage Which Alerts Compounding Personnel That The Unit Is Out Of Order Until Further Notice. testing Requirements Of Secs. the Contractor Will Provide Comprehensive Cleanroom Testing And Certification Services Every 6 Months, In The Event Of An Environmental Or Engineering Control Excursion/exceedance Or Sooner If There Are Changes To The Area Such As Redesign, Construction, Replacement Or Relocation Of Any Pec, Or Alteration In The Configuration Of The Room That Could Affect Airflow Or Air Quality Or If A Cleanroom(s) Did Not Meet Compliance. Certification Tests For Rooms Within A Cleanroom Suite Include, But Are Not Limited To: airflow Testing: Hepa Filter(s) Air Volumes And Velocities Will Be Measured And Documented As Per Ceta Cag-003:2022 Section 8.1.1 Application Guide (or Most Current Version) Airflow Testing Is Performed To Determine Acceptability Of The Air Velocity, The Room Air Exchange Rate, And The Room Pressure Differential In Doorways Between Adjacent Rooms To Ensure Consistent Airflow And That The Appropriate Quality Of Air Is Maintained Under Dynamic Operating Conditions. the Contractor Shall Calculate The Total Room Area And Volume For Each Buffer Room, Anteroom, Containment Segregated Compounding Area (c-sca), And Hazardous Drug Storage Room. The Iso Classification And A Sketch Of The Room With Dimensions, Exhaust/supply Diffuser Locations And Equipment Locations Shall Be Included In The Report. The Report Provided Will Specify Flow Rates Detailing Returns And Supply That Were Obtained During The Testing. The Contractor Shall Calculate Air Changes Per Hour (acph) For Each Buffer And Anteroom And Include Their Findings In The Report. Acph For Hvac, Acph Contributed From Pec, And The Total Acph. Comparison Of Acph Will Be Completed Both For Usp 797 Standards As Well As Those Referenced In The Vha Hvac Design Manual (attachment D Or Earlier Version If Available), Which Are Further Stringent Than Usp Chapter 797. iso Classified Turbulent Airflow Area Reporting And Documentation record All Airflow Measurements And Their Corresponding Filter Or Diffuser Locations Or Grid Identifications On A Diagram calculate And Report Room Volume calculate And Report The Average Total Room Airflow Volume calculate And Report The Total Air Changes Per Hour Of The Room (include Lafw And/or Non-ducted Bsc Hepa Exhaust To Room, Where Applicable) report Any Correction Factors Used Or Deviations From The Primary Method name Of Test (e.g., Room Airflow Analysis) report Acceptance Criteria provide A Pass Or Fail Statement Based On The Results Of The Test non-iso Classified Negative Pressure Turbulent Airflow Area Testing Procedure Including Acph Requirements For Containment Segregated Compounding Areas And Hazardous Drug Storage Areas, Must Be A Minimum Of 12 Exhaust Acph. Because These Rooms/areas Are Not Iso Classified Airflow Measurements Should Be Taken On The Exhaust Of Negative Pressure Differential Rooms. Non-iso Classified Negative Pressure Turbulent Airflow Reporting And Documentation Must Include: record All Airflow Measurements And Their Corresponding Exhaust Filter Or Exhaust Grill Locations calculate And Report Room Volume calculate And Report The Average Total Room Airflow Volume calculate And Report The Total Air Changes Per Hour Of The Room report Any Correction Factors Used Or Deviations From The Primary Method name Of Test (e.g., Unclassified Negative Pressure Room Airflow Analysis) report Acceptance Criteria provide A Pass Or Fail Statement Based On The Results Of The Test sec Hepa Filter Integrity Testing Performed As Per Ceta Cag-003:2022 Section 8.1.2 Application Guide (or Most Current Version) record Upstream Aerosol Challenge Concentration list Method Used To Report Concentration (measured Or Calculated) record Maximum Leak Penetration In Percent name Of Test (hepa Filter Leak Test) report Acceptance Criteria provide A Pass Or Fail Statement Based On The Results Of The Test sec Room Pressure Differential/room Pressurization As Per Ceta Cag-003:2022 Section 8.1.3 Application Guide (or Most Current Version) the Contractor Shall Include In Their Report Differential Pressure Readings From Each Buffer Room, Anteroom, C-sca, And Hazardous Drug (hd) Storage Rooms To All Surrounding Areas. the Report Shall Indicate Whether The Area Is Required To Be A Negative Or Positive Pressure Location As Per Usp 797 And/or Usp 800. All Readings And Acceptance Criteria Shall Be Documented To At Least One Thousandths Of An Inch Water Gauge Or Water Column (e.g., 0.020 W.g. And Not 0.02 W.g.) Or One Tenth Of A Pascal (e.g., 5.0 Pa). Pressure Differentials Will Be Reflected On A Report Showing The Sketch Of The Room(s). sec Room Pressure Reporting And Documentation report Room Pressure Differential Relative To An Adjacent Room/space report And Compare Performance Of Room Pressure Monitor report Whether Smoke Dispersed At Entry Doors Follows Correct Direction name Of Test (room Pressure Differential Test) report Acceptance Criteria provide A Pass Or Fail Statement Based On The Results Of The Test total Airborne Particle Count Testing (0.5 Micron And Larger) In All Classified Areas Performed Under Dynamic Operating Conditions As Per Ceta Cag-003:2022 Section 8.1.5 Application Guide (or Most Current Version). Reporting Shall Be Completed Following Iso 14644-01 [2015] Section 5.4 Test Report And Shall Include The Following: the Name And Address Of The Testing Organization, And The Date On Which The Test Was Performed the Number And Year Of Publication Of This Part Of Iso 14644 (i.e., Iso 14644 1:2015) a Clear Identification Of The Physical Location Of The Cleanroom Or Clean Zone Testing (including Reference To Adjacent Areas If Necessary), And Specific Designations For Coordinates Of All Sampling Locations (a Diagrammatic Representation Can Be Helpful) the Specified Designation Criteria For The Cleanroom Or Clean Zone, Including The Iso Class Number, The Relevant Occupancy State(s), And The Considered Particle Size(s) details Of The Test Method Used, With Any Special Conditions Relating To The Test, Or Departures From The Test Method, And Identification Of The Test Instrument And Its Current Calibration Certificate the Test Results, Including Particle Concentration Data For All Sampling Locations report Acceptance Criteria provide A Pass Or Fail Statement Based On The Results Of The Test sec Airflow Visualization Studies (avs) - Visual Smoke Studies Per Ceta Cag-014 Guide Application sec General Temperature And Moisture Tests To Verify Accuracy Of Monitoring Devices As Per Ceta Cag-003:2022 Section 8.1.7 Application Guide (or Most Current Version) sec Viable Sampling As Per Ceta Cag-003:2022 Section 8.1.6 And Cag-009:2020 Application Guides viable Sampling Testing All Viable Sampling Will Conform To Usp 797 Requirements And Performed As Per Ceta Cag-009 Application Guide Viable Environmental Monitoring For Sterile Compounding Facilities environmental Air Sampling. biannually (every Six Months) The Collection Of Environmental Air Samples Will Be Performed By The Contractor S Ceta Technician During Certification And During Negatively Impactful Incidents Which Require Repeat Air Sampling As Follows: whenever There Is A Change To The Placement Of Equipment In The Room Or Any Other Alteration Within The Cleanroom Suite That Affects The Quality Of The Air. in Response To Identified Problems And Trends. in Response To Changes That Could Impact The Sterile Environment (changes In Cleaning Agents). viable Air Sampling Will Be Performed Utilizing A Calibrated High-volume Impaction Sampler During Dynamic Operating Conditions Single Plate Tsa Media Which Supports Growth Of Both Bacteria And Fungi Will Be Used To Sample. A Sufficient Volume Of Air (1000 Liters) Shall Be Tested At Each Location To Maximize Sensitivity (samples Of Less Than 1000 Liters Will Not Be Acceptable) positive And Negative Control Plates Will Be Included With Sampled Plates Submitted By The Contractor For Analysis. environmental Surface Sampling. biannually (every Six Months) The Collection Of Environmental Surface Samples Will Be Performed By The Contractor S Ceta Technician And During Repeated Ceta Testing. Upon The Request Of The Facility, The Contractor Will Repeat Surface Sampling As Follows: whenever, There Is A Change To The Placement Of Equipment In The Room Or Any Other Alteration Within The Cleanroom Suite That Affects The Quality Of The Air. in Response To Identified Problems And Trends. in Response To Changes That Could Impact The Sterile Environment (changes In Cleaning Agents). surface Samples Will Be Collected In Each Room, The Interior Of Each Pec, Passthrough Chambers Connecting To Classified Areas, And Frequently Touched Surfaces (e.g., Door, Tables, Carts, Stools, Benches, Etc.) surface Sampling Will Be Performed At The End Of The Largest Csp Activity Of The Day But Before Area Has Been Cleaned And Disinfected. single Plate Tsa Media Supplemented With Neutralizing Additives (e.g., Lecithin And Polysorbate 80) To Neutralize The Effects Of Any Residual Disinfecting Agents Will Be Used. routine Monthly Surface Sampling Will Be Performed By An Appointed Trained Northport Vamc Personnel. The Collected Samples Will Be Shipped To The Laboratory Service Employed By The Contractor For Incubation And Microbiological Analysis. as Needed, Appointed Trained Northport Vamc Personnel Will Collect Surface Samples Within The Pec As A Part Of The Competency Assessment For Assigned Personnel. The Collected Samples Will Be Shipped To The Laboratory Service Employed By The Contractor For Incubation And Microbiological Analysis. personnel Viable Sampling. The Collection Of Personnel Viable Samples For Competency Testing Will Be Performed By An Appointed Trained Northport Vamc Personnel. The Samples Will Be Shipped To The Laboratory Service Employed By The Contractor For Incubation And Microbiological Analysis When It Is Required For Personnel Competency Assessment Sampling As Follows: gloved Fingertip And Thumb (gft) Testing upon Initial Assignment Compounding Staff Will Be Assessed, Post Hand Hygiene And Garbing, Utilizing Gft Samples In Triplicate (three Samples/hand) For Analysis. every Six (6) Months And Thereafter Compounding Staff Will Be Assessed, Post Hand Hygiene And Garbing, Utilizing Single Collection Of Gft Samples (one Sample/hand) Will Be Collected For Analysis Post Hand Hygiene And Garbing. initially And Every Six (6) Months Thereafter Compounding Staff Will Be Assessed For Gft During Aseptic Manipulations, Utilizing Single Collection Of Gft Samples (one Sample/hand) Post Media Fill Testing (mft). media Fill Test (mft) upon Initial Assignment And Every Six Months Thereafter, Compounding Staff Will Be Assessed For Aseptic Manipulations Utilizing Usp 797 Compliant Media Fill Testing Kits. other Viable Sampling Requirements. the Laboratory Service Employed By The Contractor Must Be Able To Provide The Following: microbial Growth Media Plates Which Are Usp 797 Compliant And include Certificates Of Analysis (coa) From The Manufacturer That Verify The Plates Meet The Expected Growth Promotion, Ph, And Sterilization Requirements Consistent With Usp Chapter 797 contain Tsa Supplemented With Neutralizing Additives (lecithin And Polysorbate 80) have A Raised Convex Surface support Both Bacterial And Fungal Growth On The Same Plate For Single Media Incubation media Fill Testing (mft) Kits Compliant To Usp 797 And Designed To Simulate Medium Complexity (category 2) Sterile Iv Compounding. simulate Low Complexity (category 1) Sterile Iv Compounding. a Chain Of Custody Documenting Each Sample Collected Must Be Created And Provided To The Northport Vamc . during Self-sampling, Which Is Performed By Northport Vamc, The Contracted Lab Is Responsible For Providing A Prepaid Mailer For Properly Sending Samples To The Laboratory For Testing. all Samples Shipped To The Laboratory Service Must Be Incubated In Accordance With Current Usp Chapter 797 Requirements For Duration And Temperature. additional Requirements For Pecs And/or Secs Testing any Pec Or Sec That Fails To Meet Ceta Specifications Shall Be Immediately Reported Directly To The Site-identified Point(s) Of Contact (poc) Or Appointed Ad Hoc. areas Where Hazardous Drug Handling Occurs Will Be Tested By Environmental Wipe Sampling For Hazardous Drug (hd) Residue: every 6 Months, Or More Frequently As Needed To Verify Contaminant, Environmental Wipe Sampling For Hd Residue Will Be Performed By An Appointed Trained Northport Vamc Personnel. The Collected Samples Will Be Shipped To The Contractor S Laboratory Service For Hd Residue Analysis. The Kits Used To Complete Hd Wipe Sampling Must Be Verified Prior To Use To Ensure The Sensitivity And Validity Of The Methods And Reagents Used To Recover A Specific Percentage Of Known Marker Drugs. the Hazardous Drugs (hds) To Be Tested Will Be Determined By The Facility And May Include, But Are Not Limited To: cyclophosphamide ifosfamide fluorouracil gemcitabine methotrexate platinum-containing Drugs taxane-based Drugs on Average 14 Surface Environmental Hd Wipe Samples Will Be Collected Per Testing Date. The Facility Can Elect To Adjust The Quantities Of Samples Submitted As Needed During Investigative Remediation. Routine Environmental Hd Wipe Sampling Will Include, At Minimum, The Following Areas: interior Of Containment Primary Engineering Control (c-pec) And Any Equipment Contained Inside The C-pec. pass-through Chambers. surfaces In Staging Or Work Areas Near C-pec. areas Adjacent To C-pecs (e.g., Floors Directly Under C-pec, Staging, And Dispensing Area). areas Immediately Outside The Hazardous Drug Buffer Room Or C-sca. areas Designated For Pharmacist End Product Verification (checking) / Workstations. hazardous Drug Storage Areas (including Refrigerators). hazardous Drug Receiving Areas. patient Administration Areas. competency Of Technician Performing Testing ceta Testing Must Be Performed By A Cnbt Individual/company Accredited To Perform This Work. The Technician/contractor Shall Provide A Copy Of The Individuals Ceta Credentials At Time Of Offer. If, During The Contract, A Different Individual(s) Is Designated By The Contractor, The Ceta Certification Credentials Of The Assigned Individual(s) Must Be Provided To The Poc, Co, And Cor Prior To The Start Of Work. to Ensure Accurate And Reproducible Sampling Results, Environmental Viable Sampling Should Be Performed By A Ceta Cnbt Technician Or A Trained Technician Competent In Air And Surface Sampling Procedures. Prior To Sampling The Contractor Must Provide The Facility Documentation Records For The Individuals Training And Competencies To Perform Sampling. additional Contracting Requirements certification Periodicities Shall Be Confirmed By Contractor, Post Award, And Adjusted As Necessary To Meet The Needs Of The Northport Vamc. certification And Testing Shall Conform To Usp And Osha Standards. technician Will Disinfect And Sanitize All Equipment Brought Into The Cleanroom Suite Or Segregated Compounding Area Prior To Entry (with Preemptâ® Or Peridoxâ® (or Facility Approved Disinfectant Cleaner), Followed By Sterile 70% Isopropyl Alcohol Or As Per Current Standard Operating Procedure For The Cleanroom Suite). contractor Will Follow Northport Vamc S Protocols For Use Of Ppe In The Classified Spaces And Understands The Risks Associated With Facilities And Equipment Designed For Storage And Preparation Of Hazardous Drugs. the Contractor Shall Comply With Federal, State, And Local Laws, Plus And Federal Regulations As Applicable To The Performance Of This Contract; To Include Usp Chapter 797 And Usp Chapter 800. Contractor Must Obtain All Necessary Licenses And/or Permits Required To Perform The Work Herein. reporting Results For Ceta Testing (including Viable Sampling) a General Report Documentation For All Ceta Test Results Must Be Provided Via Email Directly To The Cor (contracting Officer Representative), Chief Of Facility Management Services, Chief Of Pharmacy Service, And To The Designated Compounding Pharmacist No Later Than One Week After The Testing Is Performed. The Ceta Report Will Be A Comprehensive Informative Report Of The Certification Process Which Will Include A Statement Of Compliance Or Non-compliance Regarding The Requirements And Guidelines Outlined Respective To Ceta Application Guide. The Formal Report Will Include As A Minimum, But Not Limited To, The Following Items: name, Address, And Contact Information For The Certifying Organization Also Listing Key Personnel With Appropriate Accreditations Including The Name Of Ceta-certified Technician Performing The Testing. confirming Remark That Facility/equipment Was Tested In Accordance With Ceta Cag-003:2022 (or Most Current Version) And Any Other Applicable Performance Testing Standard Followed. The Most Current Version Of This Cag Must Be Referenced. Note: Usp 797 Is Not A Certification Specification. explanation Of Test Procedure Used For Data Collection And Justification For Any Deviations From Established Industry Practices Encountered During The Certification Process. a List Of Test Equipment Utilized In Data Collection. List Shall Include Make, Model, Serial Number, And Calibration Date. A Copy Of The Current Calibration Documentation For Each Piece Of Equipment Must Be Provided When Requested. required Reporting Values Listed In Each Test Section type, Make, Model And Serial Number For Each Pec Tested each Pec And Sec Nonviable Particulate Counts (including Sample Volume And Time) And Iso Classification measured Air Velocity Data For Pec, Including Air Flow In Cfm, Average And Standard Deviation Of Air Velocity Measurements And Acceptance Criteria pec Blower Setting And Pressure Gauge Reading (if Any) for Bscs: measured Downflow Air Velocity Data, Acceptance Criteria And Pass/fail Result measured Exhaust Damper Acceptance Criteria And Pass/fail Result inflow Velocity Test Method, Measurements, And Results documentation Of Results For The Video Of The Airflow Smoke Pattern Test Documenting Unidirectional Flow At Critical Sites In The Pec. total Air Changes Per Hour (acph) For Each Sec, With Indication Of Acph Supplied By The Pecs pressure Differentials Between Each Sec And The Anteroom/pharmacy results Of Hepa Leak Tests For All Filters Tested, As Well As The Results Of Any Patching That Was Performed if Leaks Were Detected And Sealed, Include A Diagram Showing Approximate Location Of Sealed Leaks prefilter Type, Size, And Condition For Each Pec sec Temperature And Relative Humidity video Recording Of All Smoke Pattern Testing (airflow And Dynamic) alarm Test Results (if Any) a Diagram Of The Areas Tested, Noting The Approximate Location Of Air And Surface Particle Counts any Recommendations For Hepa Replacement/hepa Lifespan microbiological Lab Analysis Reports Must Meet The Following: the Laboratory Performing Microbial Analysis Must Be An American Association For Laboratory Accreditation (a2la)-accredited Laboratory With Iso/iec 17025 Certification For Microbiological Testing. all Viable And Non-viable Analyzed Sampling Results Must Be Provided Via Email Directly To The Chief Of Facility Management Services, Chief Of Pharmacy Service, And To The Designated Compounding Pharmacist No Later Than 2 Weeks After Sampling Is Performed. At A Minimum, The Provided Lab Analysis Report Must Include: the Manufacturer, Lot Number, And Expiration Date For Each Media Lot Analyzed. date And Time Sampling Was Performed. comments Indicating Sampling Under Dynamic Conditions. sampling Location(s), With A Site Map Sketch Identifying Location Of Each Sample Obtained. sampling Type And Incubation Dates, Temperature, And Duration Intervals. quantitative Number Of Discrete Colonies Of Microorganisms On Each Media Device As Colony Forming Units (cfus) Of Bacterial/fungal Isolates. Results Equal To Or Greater Than The Action Level Will Require Immediate Notification To The Facility S The Poc(s). recovered Organisms Identified To The Genus Level (the Pharmacy Must Be Notified Of Any Microbial Growth Immediately After It Is Identified (no Later Than 48 Hours After The Report Is Received By The Contractor From The Laboratory). determination Of Whether Lab Findings Are Actionable (e.g., Acceptable/unacceptable As Per Usp 797). response-travel- Expense Considerations response Time- The Contractor Shall Use Commercially Reasonable Efforts To: provide Technical Support Via Telephone To Northport Vamc On A 24/7, 365 Days A Year Schedule. respond By Telephone To Any Report Of A Malfunction Requiring Repair Within One Hour Of Notification. provide On-site Support Within 2 Hours Of Notification Unless Prevented By Unforeseen Circumstances. travel Time due To The Time Sensitive Nature Of Testing, The Contractor Must Guarantee A Maximum Two-hour Time Travel And Arrival At Facility On Scheduled Testing Dates For Any Required Testing Personnel And Equipment. travel Expenses- contractor Shall Be Responsible For All Service-related Equipment Shipping And Tester S Trip Expenses, Including But Not Limited To Round Trip Travel, Mileage, Meals, And Overnight Living Expenses. title To Equipment- Contractor Shall Not Assume Possession Or Control Of Any Part Of The Equipment. The Government Retains Ownership To Title Thereof. utilities- Contractor May Use Government Utilities, (e.g., Electrical Power, Compressed Air, And Water) Which Are Available And Required For Any Service Performed Under This Contract. access To Equipment- Contractor Shall Be Provided Reasonable Access To All Equipment That Is To Be Serviced And Utility Outlets Required To Do The Service. The Contractor Shall Be Free To Start And Stop All Primary Equipment Incidentals To The Operation Of The Maintained Equipment After Permission Is Received From On Duty Personnel Responsible For Such Equipment. parts And Materials- All Compensation For Parts And Materials Is Included In Contract Price. parts/supplies Quality- Parts And Supplies Provided Under This Contract Shall Be New Oem (original Equipment Manufacturer) Parts. field Service Reports- Contractor Shall Furnish A Written Or Electronic Vendor Supplied Field Service Report (fsr). place Of Performance. northport Vamc 79 Middleville Road northport, N.y. 11768 period Of Performance. base Plus Four (4) Option Years information Security/privacy/ Records Management this Contract Does Not Involve Access To Va Patient/employee Information And Does Not Involve Access And/or Connection To The Va Information System. va Privacy Training For Personnel Without Access To Va Computer Systems Or Direct Access To Or The Use Of Va Sensitive Information the Department Of Veterans Affairs, Va Must Comply With All Applicable Privacy And Confidentiality Statutes And Regulations. One Of The Requirements In Va Is To Have All Personnel Trained Annually On Privacy Requirements. Privacy Represents What Must Be Protected By Va In The Collection, Use, And Disclosure Of Personal Information Whether The Medium Is Electronic, Paper Or Verbal. this Document (20939 Training) Satisfies The Basic Privacy Training Requirement For A Contractor, Volunteer, Or Other Personnel Only If The Individual Does Not Use Va Sensitive Information Or Protected Health Information (phi) In Any Form Such As Electronic Or Paper Or Have Access To Any Va Computer System. the Contracting Officer Representative (cor/ Cotr/ Project Manager) Is Responsible To Obtain This Training From The Contractor And To Maintain According To The Records Control Schedule (rcs 10-1).

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