Microbiological testing with option years

Added: Feb 16, 2018 4:06 pm Modified: Feb 20, 2018 10:58 amTrack Changes Notice Type: Posted Date:

Combined Synopsis/Solicitation February 20, 2018



Original Set Aside: Response Date:

Open Market Small Business February 26, 2018 @ 4:30 PM EST



Classification Code: NAICS Code:

B510 Environmental Assessments 541620 Environmental Consulting Services



Synopsis:

The purpose of this solicitation amendment is to update language in the attached Statement of Work (SOW).

Statement of Work changes include:

On page 1 of the SOW, update business hours to read Monday Friday, 8:00 a.m. 4:00 p.m

On page 2 of the SOW, update testing location language to read:

Main Pharmacy, 1st Floor, IV Room 1A113A

Chemotherapy Pharmacy, 5th Floor / Chemo IV Room 5A132

On page 5 of the SOW, add the following additional certification requirement:

Controlled Environment Testing Association (CETA) Certification

Certificate of accreditation for laboratory from American Industrial Hygiene Association (AIHA).

The updated Statement of Work is also included below. The closing date for this requirement will remain unchanged, February 26, 2018 @ 4:30 p.m. EST.



Any contractor who believes it is capable of meeting the requirement may submit a bid to the contracting office no later than February 26, 2018 at 4:30 p.m. EST. Bid packages may be sent to Mark West at Jeffrey.west3@va.gov. No telephone responses will be accepted.







Statement of Work



Pharmacy Microbiological Monitoring

USP 797 Compliance



GENERAL

This requirement is to obtain a firm-fixed priced service contract for the William Jennings Bryan (WJB) Dorn VA Medical Center as the facility has an International Standards Organization (ISO) Class 7 Clean Room for compounding sterile preparations. To support the agency mission and regulations of sterile compounding, the government requires technical analysis services.



BACKGROUND

The WJB Dorn VA Medical Center is a 216-bed facility, encompassing acute medical, surgical, psychiatric, and long-term care. The hospital is located in Columbia, South Carolina and provides primary, secondary, and some tertiary care. Sterile preparations are used for, but not limited to, Operating Room, Inpatient, and emergency, compounds. Microbiological sampling and analysis shall be conducted at the WJB Dorn VA Medical Center s Pharmacy Intravenous (IV) Room, as well as the Chemotherapy Pharmacy Room, in compliance with United States Pharmacopeia, Chapter 797 (USP 797) standards.



PERIOD OF PERFORMANCE:

This procurement is for a Base Year with the possibility of four (4) one-year option periods.



Base Year:

March 3, 2017 December 3, 2018

1st Option Period

December 4, 2018 December 3, 2019

2nd Option Period

December 4, 2019 December 3, 2020

3rd Option Period

December 4, 2020 December 3, 2021

4th Option Period

December 4, 2021 December 3, 2022



Services are to be performed during normal business hours; Monday through Friday, 8:00 a.m. 4:00 p.m. Excluding weekends and holidays. No overtime is allowed at this time.



PLACE OF PERFORMANCE:

WJB Dorn VA Medical Center

6439 Garners Ferry Road

Columbia, SC 29209





PERFORMANCE REQUIREMENTS

A Contracting Officer Representative (COR) and/or Alternate Contracting Officer Representative (ACOR) shall be assigned to this procurement and written notification shall be provided to the Contractor after award.



Scheduling of work performance shall be arranged through the designated COR/ACOR assigned.



All work under this contract shall be monitored by the COR. Final inspection and acceptance of all work performed, reports and other deliverables shall be performed at the place of delivery by the COR.



The COR, with the assistance of the other affected Project Managers, is responsible for:

Setting task priorities, revising task priorities when necessary;

Communicating these priorities to the Contractor;

After consultation with the Contracting Officer when appropriate, modifying delivery dates and schedules, so that the revised priorities can be met, and

Formally assessing the level of Contractor performance and ascribing the extent to which quality assurance and acceptable performance levels have been met



The Contractor shall provide the following service having demonstrated experience and provide support staff, meeting the following requirements:

Knowledge and understanding of USP797 and USP1116; American Industrial Hygiene Association (AIHA); and American Conference of Government Industrial Hygiene (ACGIH).

Knowledge of the Industry Standards for Microbiological Sampling and Assessments.

Knowledge and Experience in managing and providing required clean room and Sterile Environment Microbiological Sampling and Assessment.

Provide at least one Certified Industrial Hygienist (CIH); certified by the American Board of Industrial Hygiene (ABIH).



The Contractor shall perform Sample Testing for Fungi and Bacteria using an Impaction Air Sampler (collecting sufficient air for testing per the manufacturers guidelines (normally 400-1000 liters)) and Agar Plates in the anteroom, near the clean room doorway, inside the clean room twelve inches from each laminar hood and biological safety cabinet and inside of each laminar hood and biological safety cabinet.

Test shall be conducted in the following rooms:

Main Pharmacy, 1st Floor / IV Room 1A113A

Chemotherapy Pharmacy 5th Floor / Chemo IV Room 5A132





The Contractor shall provide management and technical services to support the following tasks:



*Note: Microbiological sampling of clean rooms (ISO Class 7) and anterooms (ISO Class 8) is recommended by draft document USP 797. The sampling strategy recommended by USP 797 is to sample for fungi and bacteria using an impactor and agar plates in the anteroom, near the clean room doorway, inside the clean room twelve inches from each laminar flow hood and biological safety cabinet and inside of each laminar flow hood and biological safety cabinet.



*Note: USP 797 recommends baseline air sampling of clean rooms and anterooms prior to their initial use, and semi-annually thereafter for low to medium risk compounding sterile preparation areas, and after any facility construction or equipment servicing. USP 797 also recommends surface sampling and settling plate or air sampling inside ISO Class 5 laminar flow hoods and biological safety cabinets; identified contaminates and/or, air flow changes. According to USP 797, fungi and bacteria are not expected to be present in ISO Class 5 areas.



The scope of this effort includes services necessary to ensure USP 797 compliance.



Specifically, the scope of services to be conducted in the Intravenous (IV) room, as well as, the Oncology room, requirements include:

Bacteria air sample analysis

Fungi air sample analysis

Bacteria surface sample analysis

Fungi surface sample analysis

Bacteria glove dip sample analysis for IV and Oncology Pharmacists

Bacteria glove dip sample analysis as needed for other staff

Prepare and submit laboratory test



PROJECT MANAGEMENT



Work efforts performed in support of this service require managements expertise, oversight, control, and directing in: time management; quality assurance; and quality control. Using certified personnel and up-to-date equipment, the Contractor shall:

Utilize a CIH, monthly, to collect air and surface samples and conduct analysis

All samples shall be analyzed by a laboratory accredited by AIHA in Environmental Microbiology

Each session shall be scheduled at least five (5) working days in advance and is subject to the workload of the Pharmacy.

Each session is to be scheduled with the IV Pharmacist, with the approval of the Contracting Officer Representative (COR).

Any lab results, equal to or greater than, the action as outline within USP 797, shall require notification of the COR and IV Pharmacist, immediately upon receipt of the laboratory results. Results of these levels (or above), may also require re-sampling to be performed, after actions are taken to correct the microbiological growth, deemed appropriate by the Chief of Pharmacy (or the designee).

Resampling and analysis shall be performed within 24 hours of notification by the COR or designee.



Perform all Microbiological sampling for WJB Dorn VA Medical Center Pharmacy clean room and, the satellite Pharmacy clean room in compliance with USP 797 standard.









DOCUMENTATION



The Contractor shall develop a system to issue a report for each analysis, on a monthly basis to be submitted to the facility.



The Contractor shall provide the following documentation for each analysis:

Provide name, address, and proof of accreditation in environmental microbiology by AIHA for the laboratory to be utilized for microbiological sample analysis.

Each report shall include at a minimum:

Date

Time

Name of the Industrial Hygienist

Narrative of work practices used

Results of sampling

Location where samples were collected

Narrative interpretation of laboratory results

Comparison chart or table showing results of all monthly sampling by month and sample location

Laboratory results

Closed Chain of Custody.

A report shall be issued, for each sampling session, via electronic copy. Report shall be delivered via e-mail, to the: COR; IV and Chemotherapy Pharmacists; Inpatient Supervisor; and Chief of Pharmacy (or designee), within ten (10) business days of the receipt of laboratory results, but not later than fifteen (15) business days after completion of samples being collected.

All laboratory results shall be reported in Colony Forming Units (CFU s)



DELIVERABLES AND DELIVERY SCHEDULE



The delivery schedule of sample collection and written reports is outlined in a delivery schedule table below.



Contract Management Plan The Contractor shall prepare draft and final Contract Management Plan specifying the tasks, sub tasks, and approaches to be used to provide the services and products specified including the deliverable documents, analyses, and reports necessary to fulfill the requirements. This Plan shall be delivered in draft not later than seven (7) calendar days following the award of the Contract.



Quality Control Plan The Contractor shall prepare draft and final version of a Quality Control Plan specifying the tasks, sub tasks, and approaches to be used to ensure adequate quality and integrity of work developed. This Plan shall be delivered in draft not later than seven (7) calendar days following the approval of the Contract Management Plan.



Program and Project Plans The Contractor shall prepare draft and a final version of a Specific Program and Project Plans, as directed, that are appropriate for the size and scale of technical efforts being undertaken. These plans shall specify the tasks, sub tasks, dependencies, resource requirements, and schedules, required to complete specific technical programs or projects. When approved by the COR, these plans shall be used to monitor, control, and report progress, and issues. These plans shall be updated as required and approved by the COR as required to maintain currency with project objectives, activities, and direction.



Monthly Analysis Reports The Contractor shall prepare and submit a final monthly report. Report shall be all inclusive of certification documented and results of microbiological analysis . The report shall be submitted to the COR on or before the 10th calendar day of each month.



DELIVERY SCHEDULE



Certifications

One week (seven calendar days) after contract award

Draft Contract Management Plan

One week (seven calendar days) after contract award



Final Contract Management Plan

Five business days after receipt of Government comments upon reviewing of the draft version.



Draft Quality Control Plan

One week (seven calendar days) after final Contract Management Plan



Final Quality Control Plan

Five business days after receipt of Government comments upon reviewing of the draft version.

Monthly Analysis Reports

Within ten (10) business days of the receipt of laboratory results, but not later than fifteen (15) business days after completion of samples being collected.





NOTICE REGARDING LATE DELIVERY



The Contractor shall notify the COR, as soon as it becomes apparent to the Contractor, that a scheduled delivery shall be late. The Contractor shall include in the notification the rationale for late delivery, the expected date for the delivery and the project impact of the late delivery.



The COR shall review the new schedule and provide guidance to the Contractor.



The Contractor is responsible for providing personnel with the necessary level of expertise to support the task activities and service requirements.



CONTRACTOR QUALIFICATIONS/CERTIFICATION



The Contractor shall provide a single point of contact that shall serve as the project manager for the life of the Contract.



Certifications

Certified Industrial Hygienist (CIH), by the American Board of Industrial Hygiene (ABIH).

Controlled Environment Testing Association (CETA) Certification.

Certificate of accreditation for laboratory from American Industrial Hygiene Association (AIHA).

Key personnel shall be available on site for the majority of the time necessary to complete the tasks. For each proposed key person, a list of qualifications shall be submitted to the COR.



NOTE: Industrial Hygiene Technicians shall not be utilized on this project.



GENERAL ACCEPTANCE CRITERIA



General quality measures as set forth below shall be applied to each work product received from the Contractor.

Accuracy - Work Products shall be accurate in presentation, technical content, and adherence to accepted elements of style.

Clarity - Work Products shall be clear and concise. Any/All diagrams shall be easy to understand and be relevant to the supporting narrative.

Consistency to Requirements - All work products shall satisfy the requirements of this service.

File Editing - All text and diagrammatic files shall be editable by the Government.

Format - Work Products shall be submitted in hard copy and in media mutually agreed upon prior to submission.

Timeliness - Work Products shall be submitted on or before the due date specified, as described in assigned tasks or submitted in accordance with a later scheduled date determined by or approved by the COR.



QUALITY ASSURANCE



The COR shall review, for completeness, preliminary or draft documentation that the Contractor submits, and may return it to the Contractor for correction. Absence of any comments by the COR shall not relieve the Contractor of the responsibility for complying with the requirements. Final approval and acceptance of documentation required herein shall be by letter of approval and acceptance by COR.



The Contractor shall not construe any letter of acknowledgment of receipt material as a waiver of review, or as an acknowledgment that the material is in conformance. Any approval given during preparation of the documentation, or approval for shipment shall not guarantee the final acceptance of the completed documentation.



Contractor shall ensure all tools and equipment are secured at all times.

Tools and equipment must be removed from open areas or stored in secured location during breaks, lunch, and/or at the end of each work day.

All debris must be removed from the facility upon completion of service each day.



Contractor shall ensure proper signage and/or blockage of service area is provided and clearly visible to ensure patient/employee safety is adhered to.



Smoking is not permitted within the facilities at any time. All smoking will be conducted in designated smoking areas only.

6. INVOICES:

Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor and submitted through Tungsten Network (formerly known as OB10) http://www.tungsten-network.com/us/en/. A properly prepared invoice shall contain:

Invoice Number and Date

Contractor s Name and Address

Accurate Purchase Order Number

Supply or Service provided

Period Supply or Service Provided

Total Amount Due

Please begin submitting your electronic invoices through the Tungsten Network for payment processing, free of charge.

If you have questions about the e-invoicing program or Tungsten Network, contact information is as follows:       

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



RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS:

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

The Government Agency owns the rights to all data/records produced as part of this contract.

The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.