Interior Tenders
Interior Tenders
Wohn und Pflegezentrum Havelland GmbH Tender
Others
Germany
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
Closing Date28 Jan 2025
Tender AmountRefer Documents
Wohn und Pflegezentrum Havelland GmbH Tender
Others
Germany
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.
Closing Date28 Jan 2025
Tender AmountRefer Documents
Municipality of Lana Tender
Civil And Construction...+2Consultancy Services, Civil And Architectural Services
Czech Republic
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
Closing Date30 Jan 2025
Tender AmountRefer Documents
DEPT OF THE NAVY USA Tender
Others
Corrigendum : Closing Date Modified
United States
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.
;
Closing Date14 Jan 2025
Tender AmountRefer Documents
VETERANS AFFAIRS, DEPARTMENT OF USA Tender
Healthcare and Medicine
United States
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).
Closing Date30 Jan 2025
Tender AmountRefer Documents
Directorate Of Property Management And Social Activities Dussd Of The Ministry Of Internal Affairs Ministry Of The Interior Tender
Civil And Construction...+1Civil Works Others
Bulgaria
Purchaser Name: Property Management And Social Activities Dussd Of The Ministry Of Internal Affairs Ministry Of The Interior | Insurance of Motor Vehicles, Engineering and Watercraft, Including Additional Equipment Installed Thereon, Owned by the Ministry of Internal Affairs (MIA), and Such Received for Temporary Use by the MIA Under Separate Items
Closing Date18 Jan 2025
Tender AmountBGN 12.6 Million (USD 6.6 Million)
Directorate Of Property Management And Social Activities Dussd Of The Ministry Of Internal Affairs Ministry Of The Interior Tender
Civil And Construction...+1Construction Material
Bulgaria
Purchaser Name: Property Management And Social Activities Dussd Of The Ministry Of Internal Affairs Ministry Of The Interior | Removal and Disposal of Waste That Is Not Subject to Sale on a Commodity Exchange
Closing Date22 Jan 2025
Tender AmountBGN 99.9 K (USD 52.6 K)
Directorate Of Property Management And Social Activities Dussd Of The Ministry Of Internal Affairs Ministry Of The Interior Tender
Works
Electrical and Electronics...+1Electrical Works
Bulgaria
Purchaser Name: Property Management And Social Activities Dussd Of The Ministry Of Internal Affairs Ministry Of The Interior | Bulgaria – Construction Work – Изготвяне На Инвестиционен Проект, Упражняване На Авторски Надзор И Изграждане На Обект "външно Ел. Захранване За Увеличаване Предоставената Мощност В Съществуващ Тп "мвр Симеоново Iii" От 400 Kw На 1000 Kw"
Closing Date13 Jan 2025
Tender AmountBGN 239.9 K (USD 126.4 K)
1771-1780 of 1821 archived Tenders