36C25924Q0012.docx
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- Q301--Pharmacy Lab Analysis Federal contract opportunity
- Solicitation number
- 36C25924Q0012
About this file
This is a solicitation for pharmacy lab analysis services. The Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 19 is seeking a contractor to provide microbiological surface samples, gloved fingertip and thumb samples, and media fill testing samples collected by the Oklahoma City VA Health Care System to an ISO/IEC 17025 accredited laboratory. Services include incubation, analysis, identification of microorganisms exceeding specified limits, and reporting of results. The base period of performance is the award date through October 2024 with four one-year option periods. The solicitation includes a performance work statement outlining sampling and reporting requirements according to USP standards, contractor qualifications, and a price schedule listing monthly rates for the base and option periods.
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| File | Type | Posted |
|---|---|---|
| 36C25924Q0012 0001.docx | DOCX document | |
| VHA Directive 1108.12 Pharmacy Lab Analysis.pdf |
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36C25924Q0012
PAGE 1 OF
1. REQUISITION NO.
2. CONTRACT NO.
3. AWARD/EFFECTIVE DATE
4. ORDER NO.
5. SOLICITATION NUMBER
6. SOLICITATION ISSUE DATE
a. NAME
b. TELEPHONE NO. (No Collect Calls)
8. OFFER DUE
DATE/LOCAL
TIME
9. ISSUED BY
CODE
10. THIS ACQUISITION IS
UNRESTRICTED OR
SET ASIDE:
% FOR:
SMALL BUSINESS
HUBZONE SMALL
BUSINESS
SERVICE-DISABLED
VETERAN-OWNED
SMALL BUSINESS
WOMEN-OWNED SMALL BUSINESS
(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED
SMALL BUSINESS PROGRAM
EDWOSB
8(A)
NAICS:
SIZE STANDARD:
11. DELIVERY FOR FOB DESTINA-
TION UNLESS BLOCK IS
MARKED
SEE SCHEDULE
12. DISCOUNT TERMS
13a. THIS CONTRACT IS A
RATED ORDER UNDER
DPAS (15 CFR 700)
13b. RATING
14. METHOD OF SOLICITATION
RFQ
IFB
RFP
15. DELIVER TO
CODE
16. ADMINISTERED BY
CODE
17a. CONTRACTOR/OFFEROR
CODE
FACILITY CODE
18a.
PAYMENT WILL BE MADE BY
CODE
TELEPHONE NO.
UEI:
EFT:
PHONE:
FAX:
17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED
SEE
ADDENDUM
19.
20.
21.
22.
23.
24.
ITEM NO.
SCHEDULE OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
(Use Reverse and/or Attach Additional Sheets as Necessary)
25. ACCOUNTING AND APPROPRIATION DATA
26.
TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA
ARE
ARE NOT ATTACHED.
27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212
-4. FAR 52.212-5 IS ATTACHED. ADDENDA
ARE
ARE NOT ATTACHED
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________
29. AWARD OF CONTRACT: REF. ___________________________________ OFFER
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND
DATED ________________________________. YOUR OFFER ON SOLICITATION
DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY
(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE
ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED
SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:
30a. SIGNAT
URE OF OFFEROR/CONTRACTOR
31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED
AUTHORIZED FOR LOCAL REPRODUCTION
(REV. NOV 2021)
PREVIOUS EDITION IS NOT USABLE
Prescribed by GSA - FAR (48 CFR) 53.212
7. FOR SOLICITATION
INFORMATION CALL:
STANDARD FORM 1449
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL
PRODUCTS AND COMMERCIAL SERVICES
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
36C25924Q0012 Frankie Basham 918.577.3923 10-26-2023 15:00
CDT
36C259 Department of Veterans Affairs Network Contracting Office
NCO 19
6162 South Willow Drive, Suite 300 Greenwood Village CO 80111 X X 541380 $19 Million N/A X Department of Veterans Affairs Oklahoma City VA Health Care System 921 N.E. 13th St.
Oklahoma City OK 73104 36C259 Department of Veterans Affairs Network Contracting Office
NCO 19
6162 South Willow Drive, Suite 300 Greenwood Village CO 80111
Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Pharmacy Lab Analysis at Oklahoma City VA Health Care System Email Solicitation: frances.basham@va.gov by date and time in block 8.
See CONTINUATION Page X X Mitch Purdom
VA-VHA-RPOW-2023-0050
Table of Contents
| SECTION A | 1 |
| A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES | 1 |
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 3 |
| B.1 CONTRACT ADMINISTRATION DATA | 3 |
| B.2 ESTIMATED QUANTITIES | 4 |
| B.3 PRICE/COST SCHEDULE – SERVICES PER THE PWS | 4 |
| B.4 PERFORMANCE WORK STATEMENT (PWS) | 4 |
| B.5 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) | 9 |
| B.6 PRICE/COST SCHEDULE | 14 |
| ITEM INFORMATION | 14 |
| B.7 CONTRACTOR PAYMENT REQUESTS | 20 |
| SECTION C - CONTRACT CLAUSES | 21 |
| C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022) | 21 |
| C.2 52.216-18 ORDERING (AUG 2020) | 27 |
| C.3 52.216-19 ORDER LIMITATIONS (OCT 1995) | 27 |
| C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995) | 28 |
| C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) | 28 |
| C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) | 28 |
| C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) | 30 |
| C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 30 |
| C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JUN 2023) | 30 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 39 |
| D.1 WAGE DETERMINATION (WD) | 39 |
| SECTION E - SOLICITATION PROVISIONS | 50 |
| E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAR 2023) | 50 |
| E.2 Addendum to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES | 54 |
| E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021) | 55 |
| E.4 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) | 57 |
| E.5 E. 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014) | 58 |
| E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022) | 59 |
SECTION B - CONTINUATION OF SF 1449 BLOCKS
B.1 CONTRACT ADMINISTRATION DATA
1. Contract Administration: All contract administration matters will be handled by the following individuals:
a. CONTRACTOR:
b. GOVERNMENT: Contracting Officer 36C259 Department of Veterans Affairs Network Contracting Office
NCO 19
6162 South Willow Drive, Suite 300 Greenwood Village CO 80111
2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:
| [X] |
| 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or |
| [] |
| 52.232-36, Payment by Third Party |
3. INVOICES: Invoices shall be submitted in arrears:
| a. Quarterly | [] |
| b. Semi-Annually | [] |
| c. Other | [X] Monthly, following satisfactory services. |
4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.
ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
| AMENDMENT NO |
| DATE |
B.2 ESTIMATED QUANTITIES
Oklahoma City VA Health Care System (OKCVAHCS) estimates that will require service sampling, employee MFT, GFT, direct compounding, CFU genus/species identification, incubation, analysis, report, monthly.
This is a five-year IDIQ (Indefinite Delivery Indefinite Quantity) Contract.
Minimum Guarantee for this five-year IDIQ is 64 test.
Maximum for this five-year IDIQ is 6000 total test.
B.3 PRICE/COST SCHEDULE – SERVICES PER THE PWS
The maximum aggregate ceiling value for this indefinite quantity contract is $______________ [To be inserted upon award]. (“Maximum Ceiling Value”).
Contract Period of Performance: contract award to October 2028.
B.4 PERFORMANCE WORK STATEMENT (PWS)
PHARMACY LAB ANALYSIS
Callout box text here. Drag on the yellow diamond to move the pointer on this box.
) PURPOSE: Oklahoma City VA Health Care System requires a contractor to provide microbiological surface samples, Gloved Fingertip and Thumb (GFT) samples and Media Fill Testing (MFT) samples conducted and submitted by OKCVAHCS, in accordance with this PWS, in an efficient and cost-effective manner, supporting the VA mission.
This is a non-personal services contract. The Contractor, its employees, agents and subcontractors shall not be considered VA employees for any purpose of fulfilling the PWS and shall be considered employees of the Contractor. Contractor shall furnish all labor, materials, parts, equipment, tools, shipping, transportation, insurances, licenses, certifications and supervision necessary to provide services in accordance with this Performance Work Statement (PWS).
GENERAL REQUIREMENTS:
· An ISO/IEC 17025:2017 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP) will process (incubate, analyze, record and report results) microbiological surface samples, Gloved Fingertip and Thumb (GFT) samples and Media Fill Testing (MFT) samples conducted and submitted by Oklahoma City VA Health Care System (OKCVAHCS). Samples will be processed by the laboratory immediately according to the general requirements outlined by ISO/IEC 17025:2017 and 2023 USP <797>.
· The contractor shall incubate and process personnel related assessment GFT samples according to 2023 USP <797> standards. GFT results will be reported for each plate, with the amount of colony forming units (cfu) present on each plate reported. No growth present shall be indicated on the report as 0 (zero) cfu or < 1 cfu.
· The contractor shall incubate and process personnel related assessment MFT samples according to 2023 USP <797> standards. MFT results will be reported as negative (pass) or positive (fail); failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container–closure unit(s) on or before 14 days.
· The contractor shall incubate and process viable surface samples according to 2023 USP <797> standards. Surface sample results will be reported in number of cfu. If cfu measured during viable sampling exceed USP <797> threshold levels, the report will at minimum identify genus and, when possible, species of any microorganism recovered on the report. No growth present shall be indicated on the report as 0 (zero) cfu or < 1 cfu.
· Pharmacy will de-identify any personal identifiable information (PII) such as the employees name prior to sending samples to the vendor. Pharmacy will be the only agent able link a random identification number to a VA staff member per OMB M-07-16.
SCOPE:
The contractor shall perform routine work detailed in this Statement of Work (SOW) on a regular schedule, mutually agreed upon by the Contractor and Contracting Officer Representave (COR).
Work items or services not already included in this SOW, but relevant to it, may be ordered by the CO without further competition. Only the CO has the right to obligate funding or order work not expressly detailed in this SOW. The Government shall not be held responsible for payment for any work performed by the Contractor that is outside the scope of this contract or without the prior approval of the CO.
TASKS:
a. Gloved fingertip and thumb sample incubation and sample analysis
b. Media-fill testing sample incubation and sample analysis
c. Bacteria and fungi surface sample incubation and sample analysis
d. Microbial identification to at least the genus level of viable surface samples exceeding the cfu limits listed in 2023 USP <797>.
OKCVAHCS Pharmacy IV personnel will conduct gloved fingertip and thumb testing, media-fill testing, and surface sampling according to 2023 USP <797> guidelines and pharmacy needs. The Facility Program Manager or their designee shall collect, label, and prepare all samples for shipping pursuant to instructions provided by the contractor ensuring viability of samples during shipping. Every effort will be made to ship samples the same day as sampled and will be shipped for next day delivery to the contractor according to instructions. If samples are not able to be shipped the same day as sampled, they will be shipped no later than the day after sampling takes place. Days of sampling will be coordinated so delivery occurs according to contractor’s normal hours.
Gloved Fingertip and Thumb Sampling:
Pharmacy compounding staff must be evaluated in Gloved Fingertip and Thumb (GFT) sampling to demonstrate competency in garbing and hand hygiene, as set forth in 2023 USP <797>. OKCVAHCS will perform GFT onsite, using one sampling device per hand (e.g., plates, paddles, or slides) containing general microbial growth agar {e.g., trypticase soy agar (TSA)} supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) as this agar supports both bacterial and fungal growth. Each media device will be labeled with a personnel identifier, right or left hand, and the date and time of sampling.
Contractor will incubate GFT sampling plates immediately upon receipt at a temperature of 30-35° C for no less than 48 hours and then at 20°–25° C for no less than 5 (five) additional days. Samples must be incubated in an incubator. Sampling plates will be stored during incubation to prevent condensate from dropping onto the agar and affecting the accuracy of the cfu reading (e.g., invert plates). Contractor will record and report the number of cfu per hand (left hand and right hand), as well as the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results. Contractor personnel who analyze sampling plates including reading of plates, counting cfu, and performing identification of recovered microorganisms will be a licensed and qualified environmental microbiologist or technician.
Failure is if total cfu for both hands is greater than the action level for the type of sampling (i.e., initial or biannual) listed in Table 1. The contractor will notify the Facility Program Manager, or if unavailable, the Inpatient Pharmacy Supervisor or Associate Chief Pharmacy Services, within 1 (one) business day of any failure.
All results will be transmitted to the facility within one business day of final analysis.
Table 1. Action Level for Gloved Fingertip Sampling and Thumb Sampling
| Gloved Fingertip & Thumb Sampling |
| Action Level* |
| Initial sampling after garbing |
| >0 |
| Subsequent sampling after media-fill testing (every 6 months) |
| >3 |
*Action levels are based on the total cfu count from both hands.
Media-Fill Testing Samples:
Media-fill tests will be designed and developed by the Facility Program Manager to reflect the most complicated manipulations performed at OKCVAHCS. The contractor will be provided with the final MFT sample (one sample is composed of 6 vials) per staff member tested.
Contractor will incubate MFT samples immediately upon receipt at a temperature of 20°–25°C for 7 (seven) days followed by 7 (seven) days at 30°–35°C to detect a broad spectrum of microorganisms.
Contractor will report pass/fail results, as well as the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results. Contractor personnel who analyze media fill including reading results are a licensed and qualified environmental microbiologist or technician.
Failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container closure unit(s) on or before 14 days. The contractor will notify the Facility Program Manager and the Inpatient Pharmacy Supervisor, within 1 (one) business day of any failure. All results will be transmitted the facility within one business day of final analysis.
Surface Sample Plates:
Microbiological surface sampling will be performed by OKCVAHCS monthly in each classified area, at minimum in each room, the interior of each ISO Class 5 Primary Engineering Control (PEC), and pass-through chambers connecting to classified areas. Surface sampling in the direct compounding area must also be conducted in conjunction with media-fill testing to assess aseptic manipulation competency.
Additional surface sampling may be performed during certification of new facilities and equipment, after servicing facilities or equipment, in response to identified problems, in response to identified trends, or in response to changes that could impact the sterile compounding environment.
One sample of TSA will be obtained per sample location. Contractor will incubate surface sampling plates immediately upon receipt at a temperature of 30-35° C for no less than 48 hours and then at 20°–25°C for no less than 5 additional days. Each media device will be labeled with the sample location, as well as personnel identifier if applicable.
Alternate Procedure:
Two surface sampling devices may be collected for each sample location and incubated concurrently. Both media devices could be TSA, or one TSA and one fungal media [e.g., malt extract agar (MEA) or Sabouraud dextrose agar (SDA)]. Contractor would incubate the surface sampling plates immediately upon receipt. Incubate each media device in a separate incubator. Incubate one media device at 30°–35° for no less than 48 hours and incubate the other media device at 20°–25° for no less than 5 (five) days. If fungal media are used, incubate the fungal media device at 20°–25° for no less than 5 (five) days.
Sampling plates will be stored during incubation to prevent condensate from dropping onto the agar and affecting the accuracy of the cfu reading (e.g., invert plates). Contractor will report the number of cfu per plate as well as the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results. Contractor personnel who analyze sampling plates including reading of plates, counting cfu, and performing identification of recovered microorganisms will be a licensed and qualified environmental microbiologist. If levels measured during surface sampling exceed the levels listed in Table 2, an attempt must be made to identify any microorganism recovered to the genus level, at minimum.
Failure is if cfu of any plate is greater than the action level for the classified area. The contractor will notify the Facility Program Manager, Inpatient Pharmacy Supervisor, and the Associate Chief of Pharmacy, within 1 (one) business day of any failure. All results will be transmitted the facility within one business day of final analysis.
Table 2. Action Levels for Surface Sampling
| ISO Class |
| Surface Sampling Action Levels |
(cfu/device or swab)
| 5 |
| >3 |
| 7 |
| >5 |
| 8 |
| >50 |
Qualifications:
An ISO/IEC 17025:2017 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP). Copies of pertinent certifications, licenses, and EMLAP accreditation will be required.
Performance Requirement Summary:
a. Monthly surface sampling analysis of viable samples taken from the Segregated Compounding Areas (SCA), Chemo Ante Room, Chemo Buffer Room, IV Ante Room, IV Buffer, and associated Primary Engineering Controls (PECs).
b. Personnel related sampling analysis of the following:
1. Gloved Fingertip and Thumb Sample incubation and sample analysis.
2. Media Fill Testing incubation and sample analysis.
3. Surface sample of the direct compounding area (DCA)
c. Identification of any surface sample to at least genus for any growth that exceed the levels in Table 2, and when possible, to species of the microorganism recovered.
Sampling Reports:
Results of viable samples and/or surface sampling must be submitted to the Facility Program Manager, Inpatient Pharmacy Supervisor, and the Associate Chief of Pharmacy within one (1) business days of the receipt of the results. Failure to follow these procedures may result in delay of payment or nonpayment. Pass/Fail notifications should be included where applicable.
FEDERAL HOLIDAYS:
| New Year’s Day | Memorial Day | Columbus Day | ||
| Thanksgiving Day | Martin Luther King Jr.’s Birthday | Christmas Day | ||
| Independence Day | Veterans Day | President’s Day | Labor Day | |
| President’s Day | Juneteenth |
When a federal holiday falls on a Sunday, the following Monday will be observed as the legal holiday. When a holiday falls on a Saturday, the preceding Friday is observed as the federal holiday for all U.S. Government agencies, including the VA.
CHECK IN/OUT PROCEDURES: Prior to commencement of and immediately after each service visit the Contractor must check in and out with the local VA POC.
B.5 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)
QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)
Pharmacy Lab Analysis
INTRODUCTION
This quality assurance surveillance plan (QASP) is pursuant to the requirements listed in the statement of work (SOW) entitled Pharmacy Lab Analysis SOW. This plan sets forth the procedures and guidelines the OKCVAMC will use in ensuring the required performance standards or services levels are achieved by the contractor.
Purpose
· The purpose of the QASP is to describe the systematic methods used to monitor performance and identify required documentation and resources to be employed. The QASP provides a means for evaluating whether the contractor is meeting the performance standards/quality levels identified in the PWS and the contractor’s quality control plan (QCP), and ensure the government pays only for the level of services received.
· This QASP defines the roles and responsibilities, identifies the performance objectives, defines the methodologies used to monitor and evaluate the contractor’s performance, describes quality assurance documentation requirements, and describes the analysis of quality assurance monitoring results.
Performance Management Approach
This QASP will define the performance management approach taken by Pharmacy Service to monitor the contractor’s performance to ensure outcomes communicated in the SOW are achieved.
Performance Management Strategy
The contractor is responsible for the quality of all work performed. The contractor will develop and implement a performance management system with processes to assess and report its performance to OKC VAMC Pharmacy. This QASP enables the government to take advantage of the contractor’s QC program.
The OKCVAMC Pharmacy will monitor performance of surface, GFT, and MFT lab analysis and reporting to determine how the contractor is performing. The contractor will be responsible for making required changes in processes and practices to ensure performance is managed effectively.
Roles and Responsibilities The Contracting Officer (CO) The CO is responsible for monitoring contract compliance, contract administration, and cost control, and resolving any differences between observations documented by the OKCVAMC Pharmacy contracting officer's representative (COR) and the contractor. The CO will designate one full-time COR as the government authority for performance management. The number of additional representatives serving as technical inspectors depends on the complexity of the services measured, as well as the contractor’s performance, and must be identified and designated by the CO.
COR
The COR is designated in writing by the CO to act as their authorized representative to assist in administering a contract. The COR is not empowered to make any contractual commitments or authorize any contractual changes on the government’s behalf. Any changes the contractor deems may affect contract price, terms, or conditions must be referred to the CO for action. The COR will have the responsibility for completing QA monitoring forms used to document the inspection and evaluation of the contractor’s work performance. Government surveillance may occur under the inspection of services clause for any service relating to the contract.
Identification of Required Performance Standards/Quality Levels The required performance standards and/or quality levels are included in the SOW and Attachment 1, Performance Requirements Summary.
Methodologies to Monitor Performance Surveillance Techniques To minimize the performance management burden, simplified surveillance methods shall be used by the government to evaluate contractor performance when appropriate. The primary methods of surveillance are:
· Timeliness of sample processing, report generation, and returned communication to the OKCVAMC Pharmacy.
· Microbial identification to genus level for samples exceeding CFU limits per USP 797 2023.
· Frequency of lab errors and requirement for additional samples to be sent from the VA to vendor.
Customer Feedback The contractor is expected to establish and maintain professional communication between its employees and customers. The primary objective of this communication is customer satisfaction. Customer satisfaction is the most significant external indicator of the success and effectiveness of all services provided and can be measured through customer complaints.
Performance management drives the contractor to be customer focused through initially and internally addressing customer complaints and investigating the issues and/or problems, but the customer always has the option to communicate complaints to the CO or COR, as opposed to the contractor.
Customer complaints, to be considered valid, must set forth clearly and in writing the detailed nature of the complaint, must be signed, and must be forwarded to the COR. The COR will accept those customer complaints and investigate.
Customer feedback may also be obtained either from the results of formal customer satisfaction surveys or from random customer complaints.
Quality Assurance Documentation Performance Management Feedback Loop The performance management feedback loop begins with the communication of expected outcomes. Performance standards are expressed in the SOW and assessed using the performance monitoring techniques shown in Attachment 1.
The COR will retain a copy of all completed QA surveillance forms.
Analysis of Quality Assurance Assessment Determining Performance The contractor may be asked to develop a corrective action plan to show how and by what date it intends to bring performance up to the required levels.
Reporting Reporting of each sampling by employees will be the frequency. The government staggers competency assessment with onboarding of new employees so workload will vary month to month and so will vendor reporting.
Reviews and Resolution The COR or designated alternate will meet with the contractor to discuss the performance evaluation as needed.
The COR must coordinate and communicate with the contractor to resolve issues and concerns regarding marginal or unacceptable performance.
The COR and contractor should jointly formulate tactical courses of action. Decisions regarding changes to metrics, thresholds, or service levels should be clearly documented. Changes to service levels, procedures, and metrics will be incorporated as a contract modification at the convenience of the procuring CO.
ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY
Required Services (Tasks) Performance Standards Acceptable Quality Levels Methods of Surveillance Incentive (Positive and/or Negative) (Impact on Contractor Payments)
Receive VA samples
Incubate samples, record, and report
Identification of genus and when possible, species of micro-organisms identified.
Prompt receipt and report of any damage to control plate or sample plates.
Follow USP 797/800 for sample processing as identified in SOW.
UPS 797/800 for sample processing also as identified in the SOW.
24 hours for communication.
Incubate, assess, and report sample results timely to VA
VA provided with report timely.
Assessment of Vendor communication.
Assessment of Vendor communication.
VA to f/u by report assessment.
ATTACHMENT 2: SAMPLE QUALITY ASSURANCE MONITORING FORM
SERVICE or STANDARD:
SURVEY PERIOD:
SURVEILLANCE METHOD (check):
Random Sampling 100% Inspection Periodic Inspection Customer Complaint LEVEL OF SURVEILLANCE (check):
| Monthly | Quarterly | As needed | |
| PERCENTAGE OF ITEMS SAMPLED DURING SURVEY PERIOD: | ______ % |
ANALYSIS OF RESULTS:
Observed Service Provider Performance Measurement Rate: ______%
| Service Provider’s Performance (check): | Meets Standards |
| Does Not Meet Standards |
Narrative of Performance During Survey Period:
PREPARED BY: ___________________________________ DATE: _________________
B.6 PRICE/COST SCHEDULE
ITEM INFORMATION
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 30.00 |
| MO |
| __________________ |
| __________________ |
Surface Sampling, in accordance with the PWS.
POP BEGIN: Date of Award
POP END: 10/31/2024
PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: Q301 - Medical - Laboratory Testing
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee MFT incubation, analysis, and report (I,A,R) in accordance with the PWS.
POP END: 10/31/2024
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee GFT incubation, analysis and report, in accordance with the PWS.
POP END: 10/31/2024
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee direct compounding surface sample, in accordance with the PWS.
POP END: 10/31/2024
| 4.00 |
| MO |
| __________________ |
| __________________ |
CRF Genus/Species Identification, in accordance with the PWS.
POP END: 10/31/2024
| 30.00 |
| MO |
| __________________ |
| __________________ |
Surface Sampling, in accordance with the PWS.
POP BEGIN: 11/01/2024
POP END: 10/31/2025
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee MFT incubation, analysis, and report (I,A,R) in accordance with the PWS.
POP END: 10/31/2025
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee GFT incubation, analysis and report, in accordance with the PWS.
POP END: 10/31/2025
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee direct compounding surface sample, in accordance with the PWS.
POP END: 10/31/2025
| 4.00 |
| MO |
| __________________ |
| __________________ |
CRF Genus/Species Identification, in accordance with the PWS.
POP END: 10/31/2025
| 30.00 |
| MO |
| __________________ |
| __________________ |
Surface Sampling, in accordance with the PWS.
POP BEGIN: 11/01/2025
POP END: 10/31/2026
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee MFT incubation, analysis, and report (I,A,R) in accordance with the PWS.
POP END: 10/31/2026
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee GFT incubation, analysis and report, in accordance with the PWS.
POP END: 10/31/2026
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee direct compounding surface sample, in accordance with the PWS.
POP END: 10/31/2026
| 4.00 |
| MO |
| __________________ |
| __________________ |
CRF Genus/Species Identification, in accordance with the PWS.
POP END: 10/31/2026
| 30.00 |
| MO |
| __________________ |
| __________________ |
Surface Sampling, in accordance with the PWS.
POP BEGIN: 11/01/2026
POP END: 10/31/2027
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee MFT incubation, analysis, and report (I,A,R) in accordance with the PWS.
POP END: 10/31/2027
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee GFT incubation, analysis and report, in accordance with the PWS.
POP END: 10/31/2027
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee direct compounding surface sample, in accordance with the PWS.
POP END: 10/31/2027
| 4.00 |
| MO |
| __________________ |
| __________________ |
CRF Genus/Species Identification, in accordance with the PWS.
POP END: 10/31/2027
| 30.00 |
| MO |
| __________________ |
| __________________ |
Surface Sampling, in accordance with the PWS.
POP BEGIN: 11/01/2027
POP END: 10/31/2028
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee MFT incubation, analysis, and report (I,A,R) in accordance with the PWS.
POP END: 10/31/2028
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee GFT incubation, analysis and report, in accordance with the PWS.
POP END: 10/31/2028
| 10.00 |
| MO |
| __________________ |
| __________________ |
Employee direct compounding surface sample, in accordance with the PWS.
POP END: 10/31/2028
| 4.00 |
| MO |
| __________________ |
| __________________ |
CRF Genus/Species Identification, in accordance with the PWS.
POP END: 10/31/2028
| GRAND TOTAL |
| __________________ |
B.7 CONTRACTOR PAYMENT REQUESTS
Contractor e-Invoice Set-Up Information: Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:
· Access the web site for more invoicing instructions: https://www.fsc.va.gov/einvoice.asp
· Tungsten e-Invoice Setup Information: 1-877-489-6135
· Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com
· FSC e-Invoice Contact Information: 1-877-353-9791
· FSC e-invoice email: vafsccshd@va.gov Payment requests may be impacted if contractor fails to maintain SAM registration, has legally changed its business name or "doing business as" name (whichever is shown on the contract), or has transferred the assets used in performing the contract. Refer to FAR clause 52.204-13.
**Vendor must remain "Active" in SAMs for entire contract term** 36C25924Q0012
SECTION C - CONTRACT CLAUSES
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)
(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—
(1) Within a reasonable time after the defect was discovered or should have been discovered; and
(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.
(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.
(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.
(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.
(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.
(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.
(g) Invoice.
(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—
(i) Name and address of the Contractor;
(ii) Invoice date and number;
(iii) Contract number, line item number and, if applicable, the order number;
(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;
(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;
(vi) Terms of any discount for prompt payment offered;
(vii) Name and address of official to whom payment is to be sent;
(viii) Name, title, and phone number of person to notify in event of defective invoice; and
(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.
(x) Electronic funds transfer (EFT) banking information.
(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.
(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.
(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.
(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.
(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.
(i) Payment.—
(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.
(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.
(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.
(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.
(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—
(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—
(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);
(B) Affected contract number and delivery order number, if applicable;
(C) Affected line item or subline item, if applicable; and
(D) Contractor point of contact.
(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.
(6) Interest.
(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.
(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.
(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—
(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;
(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or
(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).
(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.
(v) Amounts shall be due at the earliest of the following dates:
(A) The date fixed under this contract.
(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.
(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—
(A) The date on which the designated office receives payment from the Contractor;
(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or
(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.
(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.
(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:
(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or
(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.
(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.
(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.
(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.
(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.
(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.
(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.
(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.
(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 4701 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.
(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:
(1) The schedule of supplies/services.
(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;
(3) The clause at 52.212-5.
(4) Addenda to this solicitation or contract, including any license agreements for computer software.
(5) Solicitation provisions if this is a solicitation.
(6) Other paragraphs of this clause.
(7) The Standard Form 1449.
(8) Other documents, exhibits, and attachments
(9) The specification.
(t) [Reserved]
(u) Unauthorized Obligations.
(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:
(i) Any such clause is unenforceable against the Government.
(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.
(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.
(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.
(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.
(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
The following clauses are incorporated into 52.212-4 as an addendum to this contract:
C.2 52.216-18 ORDERING (AUG 2020)
(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from through .
(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.
(c) A delivery order or task order is considered "issued" when—
(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;
(2) If sent by fax, the Government transmits the order to the Contractor’s fax number; or
(3) If sent electronically, the Government either—
(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or
(ii) Distributes the delivery order or task order via email to the Contractor’s email address.
(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.
(End of Clause)
C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)
(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than , the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.
(b) Maximum order. The Contractor is not obligated to honor—
(1) Any order for a single item in excess of ;
(2) Any order for a combination of items in excess of ; or
(3) A series of orders from the same ordering office within days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.
(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.
(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.
(End of Clause)
C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)
(…
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