1. New SOW -Statement of Work _PS-Lw_RAE24SEP24.docx

STATEMENT OF WORK

PROJECT TITLE: National Institutes of Health (NIH), Clinical Center (CC), Contamination Control and Cleaning Services Project

1. INTRODUCTION

The mission of the NIH Clinical Center is to provide clinical research and cGMP servicing needs of the NIH Intramural Research Program by providing a safe, clean and effective environment for the care and treatment of patients participating in structured biomedical research protocols. This program (Cleaning and Disinfection Program or “Cleaning Program”) will also ensure environmental control and preventive measures against external and internal contaminants during production and operations within the facilities covered under this SOW.

2. BACKGROUND

The NIH Clinical Center is a 200-bed research hospital located on the main campus of the National Institutes of Health in Bethesda, MD. The NIH’s CC provides state-of-the-art clinical care for patients that are enrolled in NIH research study protocols. The CRC serves as a center of excellence in medical research, training, and the clinical care for patients with unique and rare conditions. The CRC plays a critical role in the discovery and application of novel therapeutic agents to assist in the treatment or cure of acute and chronic diseases. To achieve this, the CRC carries out specialized research and is involved in the discovery and development of pharmaceutical grade reagents, cell therapy products, Positron Emission Tomography (PET)/radioactive drugs, and vaccine products. Optimal aseptic processing of these human administered medical products produced by NIH facilities is of upmost importance to ensure best clinical care and patient safety outcomes.

The Food and Drug Administration (FDA) ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (cGMP) regulations especially those on sterile drug product produced by aseptic processing, require stringent cleaning and hygiene programs in pharmaceutical/biologics manufacturing areas. Regulations require that aseptically produced biologics be produced in a cleanroom environment. A critical component to contamination control is the cleaning program for the classified areas which must be well-defined, contain detailed cleaning processes that must be stringently followed by highly trained and competent cleaning staff, and use appropriate, in some cases sterile, and dedicated cleaning supplies and equipment. To effectively clean for aseptic processing and other controlled areas, personnel need to be both qualified and motivated.

3. SCOPE OF WORK

The NIH is seeking a qualified and experienced vendor to provide contamination control cleaning services per the attached Standard Operating Procedure (ORSC-APF-001) and minimum cleaning frequencies for the list of aseptic processing facilities (APFs) at the NIH Clinical Center on the Bethesda, MD campus. The vendor must be able to demonstrate that it has a significant presence and experience in the pharmaceutical industry or equivalent regulated by cGMP through past and current client lists.

(I-IVAU)

Center for Cellular Engineering (CCE)

Department of Laboratory Medicine (DLM)

Rooms 2C450 - 2C452

4. ADMINISTRATIVE

4.1 The Contracting Officer’s Representative (COR) will be the Contracting Officer’s (CO) authorized representative in administering the contract. A contractor representative shall be available to discuss any problems that the contractor personnel may be experiencing during the performance of this contract. Problems experienced by the Government with the contractor performance will be discussed and resolved. Unresolved problems will be referred to the CO for resolution. The COR is not authorized to make changes to the contract’s terms and conditions.

4.2 All contractor personnel shall receive passing background check results before they can be sponsored ORSC to work at NIH. All facilities within the scope of the contract shall be accessed via NIH-Issued Personal Identity Verification (PIV) ID badges. Contractor personnel shall satisfy all of the federally mandated requirements for obtaining ID badge and/or background investigation required by the U.S. Government. These requirements will need to be fulfilled by each contractor personnel within the allowed timeframe in order to continue work at the NIH. Adequate time and planning must be built in to ensure the badging process is completed in a timely manner. The contractor is responsible for obtaining full cooperation from the contractor staff to prevent delays in the badging process.

4.3 Government Furnished Property (Supplies and Equipment): The contractor shall be responsible for safeguarding all Government property provided or obtained in connection with this contract. NIH facilities, cleaning and disinfection tools, cleaning and disinfection consumables, forms, and other properties required for contract performance shall be maintained in good condition by the contractor. Contractor shall notify the Government whenever maintenance of equipment is required or whether equipment or items necessary for performance are missing or outdated and should be replaced.

4.3.1 Contractor shall abide by all NIH requirements for physical security of government property and equipment, including NIH-issued badges. NIH shall be supplying the following consumables used for cleaning:

Entry to offices and closet areas

4.4 The contractor under this contract shall have access to and/or process information requiring protection under the Privacy Act of 1974. These positions are considered “Automated Data Processing (ADP) Sensitive” positions. Contractor shall comply with Executive Order (EO) 10450 and OMB Memorandum M-05-24.

4.5 The contractor shall abide by federal and local NIH regulations and requirements concerning the nature of privileged communication between patients and the contractor as may be necessary for security and personnel reliability programs. They shall also abide by federal and local regulations concerning the confidentiality of patient records, to include but not limited to the Privacy Act of 1974. All regulations referenced are available for review from the COR, or the CO.

5. REQUIREMENTS

5.1 Contractor Qualifications:

· The contractor will be subjected to NIH Vendor Qualification, which shall include a paper audit or in-person audits.

· At minimum, the contractor must be ISO 9001:2008 certified.

· The contractor must have the proven track record of success and expertise, meeting stringent sanitation requirements including equipment-appropriate cleaning agents, methods and products, as well as suitable frequencies of cleaning for various surfaces under strict gowning requirement, necessary to assist the Clinical Center with designing an effective cleaning program.

· The contractor must provide experience in the pharmaceutical industry or equivalent regulated by cGMP through past and current client lists.

· The contractor should possess knowledge in the effect and impact of cleaning of the types (ISO classified and non-classified areas) of spaces they are cleaning with reference to the impact on microbiological tests and Environmental Monitoring.

· The contractor shall demonstrate how they provide a strong presence in management of the cleaning staff and quality assurance of the work done.

5.2 Contract Core Basis:

· The time and materials contract coverage will be based on four factors: number of facilities, cleaning levels, square footage and frequency that are set as baseline and outlined in SOP ORSC-APF-001 and Master Cleaning Schedule (Form ORSC-APF-001A). When any of the four factors change, the work will be considered out of scope, then the contractor shall refer to Section 5.3 for guidance.

· At the commencement of the contract, the contractor must provide the stated number of staff for the core basis of this contract. Any additional staff required for new spaces or areas that fall under the cleaning program, the contractor must provide a satisfactory number of staff and ensure coverage.

· The contractor is expected to increase staff by 1 FTE per increase of 2500 sq. ft. for 5 days of work; 2 FTEs per increase of 2500 sq. ft. for 7 days of work.

· The contractor shall provide a minimum of two (2) staff members to complete cleaning within the facilities.

· The contractor shall provide a day porter stock cleanroom apparels (gown, smock, lab coat, boot covers, and googles) within each APF and perform cleaning and disinfection when needed during the day.

· Contractor is responsible for managing cleaning chemical supplies and reporting to COR when supplies are needed.

· The contractor shall purchase and replace HEPA Filters in the NIH-owned HEPA Vacuum Cleaners on quarterly basis. The invoice of this purchase shall be submitted to NIH for payments. The filters must be replaced before they are due, otherwise the contractor shall be responsible for initiating an impact investigation.

· The contractor is to specify at the start of each month the number of staff provided based on the four factors stated above.

· The contractor is to provide full coverage of staff for 365 days a year including major holidays and holiday eves and during the closure/delays of the federal government per OPM due to inclement weather.

· Contractor will not negotiate the reduction of cleaning or cancellation of cleaning for staffing convenience.

· The contractor shall accept any ad hoc or out of scope work requests deemed necessary for continuous operations at the NIH with at least 12 hours’ notice.

· A cancellation charge of $100.00- and 8-hours labor time per person scheduled will be charged in addition to this contract for less than 12 hours’ notice of cancellation for scheduled out of scope and emergency cleanings. Cancellation of routine cleanings will not incur additional cost to the NIH.

· The contractor is financially responsible for damages incurred in facilities upon a thorough investigation determining the damage is due to negligence and/or not following the procedures as outlined in the Standard Operating Procedures. The restitution may include paying for the cost of repair service and replacement of equipment or parts.

5.3 Ad Hoc or Out of Scope Work:

· The time and materials contract consists of core work that is set by the Master Cleaning Schedule. There is additional cleaning work that cannot be set on a regular schedule due to its unexpected, infrequent or temporary nature, thus a section for ad hoc or out of scope work is created. The ad hoc or out of scope work that does not need to be assessed to be ad hoc or out of scope are specified below. Both lists are set in the SOW and cannot be altered without a discussion and approval from the NIH cleaning program lead(s) or a member of ORSC.

· Ad hoc or out of scope work:

· Lower level cleaning to higher level cleaning (L2 to L3)

· One Time Cleaning of an out-of-scope facility

· Emergency Cleaning (Facility Incidents: flood, power outages, HVAC issues, etc.)

· Production Change Over Clean

· Delay in cleaning due to Facilities/Production

· Performance of cleaning validation that is not part of regular cleaning schedule on behalf of NIH

· Special training not derived from contractor performance issues correction actions. Example, retraining as part of changes to NIH procedures or part of process improvement.

· NIH required annual training of cleaning staff (besides cleaning time)

· Temporary increase in cleaning levels (overall)

· Temporary increase in facilities

· Temporary increase in cleaning frequency

· Temporary increase in square footage to an area

· Additional step to the cleaning process after repairs

· NOTE: Contractor will not execute any cleaning or activity NIH considers ad hoc or out of scope listed above before receiving prior approval from the NIH cleaning program lead(s) or a member of ORSC.

· Not considered ad hoc or out of scope work:

· Higher level cleaning to lower level cleaning (L3 to L2).

· One for one (L3 cleaning moving from one day to another day or week to week) substitution of cleaning.

· Inadequate number of staff leading to overtime.

· Ad hoc cleaning or out of scope cleaning with 12 hour advance notification.

· Cover one-for-one cleaning substitution from moving L3 cleaning one day to another day or week to week.

· During major holidays when many staff are on holidays.

· Cover time frame of daily cleaning.

· Cover ad hoc or out of scope cleaning.

· Contract Modification

· Increase in occurrence for ad hoc or out of scope to a point of regular work should be discussed with the NIH cleaning program lead(s) or a member from ORSC, and the COR to consider for contract modification.

· A permanent increase of work (immediate or observation of trend) should be discussed with the NIH cleaning program lead(s) or a member from ORSC, and the COR to consider for contract modification.

5.4 Deliverables:

· Routine Call with COR and/or NIH cleaning program lead(s) or ORSC leadership to provide cleaning-related topics, contract updates and discuss any quality issues.

· Submission of Monthly Key Performance Indicators (KPI) report on a routine-basis and shall include, at minimum, safety, turnover reports, training compliance, complaints, and any ad hoc / out of scope work.

· Creation of Monthly Cleaning Schedule based on NIH template.

· Creation of Cleaning Change Requests.

· Complete deviations or investigations.

· Continuous improvement plans.

· Evaluate scope of work or adjustments.

· Provide documentation of completion of initial, annual and periodic of NIH and facility required trainings for all staff members.

· Provision of documentation referenced in applicable Standard Operating Procedures.

5.5 Personnel and Management:

· The contractor must have management that has a background consisting of education, training, and experience in microbiological contamination control and be fluent in terminology and understanding of the cleanroom environment.

· The contractor must provide adequate staffing to cover the needs the facilities within the scope of this contract.

· At minimum, the contractor shall maintain one supervisor or lead to oversee the cleaning and disinfection program.

· The contractor manage and supervisor must provide clear supervision and low worker turnover maximize for cleaning consistency and regulatory compliance.

· Staffing levels of the contractor must be periodically adjusted as more facilities gets added to the scope.

· The contractor must provide a sufficient number of employees to meet the requirements of the contract. It is the responsibility of the contractor to appropriately coordinate employees to show up facilities on a timely basis and provide sufficient coverage for sick or absent employees. The contractor is then responsible to inform the Clinical Center of any unexpected gaps or changes.

· For personnel safety, the contractor must ensure adequate staffing to ensure that there will be no less than 2 employees present in each facility at all times. In addition, the contractor must provide sufficient supervisors to ensure adequate quality control and review of documentation.

· Employees must be prompt and the service provided by the contractor must be continuously meeting Clinical Center operational needs.

· Employees should be designated and identified for each of the Clinical Center facilities in order to limit the number of different personnel who will be authorized entry to the facility.

· Employees must strictly adhere to approved methods and cleaning procedures and will be periodically observed by Clinical Center personnel for adherence to the procedure.

· If discrepancies are observed, the contractor must have mechanisms in place to take corrective and preventive action, including investigating the cause of the deviation from procedure, and provide staff retraining where appropriate.

· The contractor must also provide replacement-cleaning staff when requested by the Clinical Center if there are 3 consecutive incidents of non-compliance with any of the cleaning staff.

· It is the responsibility of the contractor to ensure that adequate staff is available at all times to meet contractual needs.

· Regardless of the nature of night shift work, items, including but not limited to firearms, explosives, archery equipment, dangerous weapons, knives with blades over 2.5 inches, narcotics, controlled substances, alcoholic beverages and/or open containers of alcohol are not permitted at the NIH, a federal facility.

· The contractor must report any immediate items such as injuries related to work, inability to perform tasks (personnel and/or materials), or any other applicable concern.

5.6 Adherence to Cleaning Program Standard Operating Procedures (SOPs):

· The contractor shall execute the cleaning and disinfection program per NIH approved procedure SOP ORSC-APF-001.

· The contractor shall execute all routine cleanings specified on the Master Cleaning Schedule and current Dashboard Cleaning Schedule per facility routine cleaning frequencies. The contractor shall not change, replace, or modify the cleaning schedule at any time during this contract. All changes to cleaning scope be authorized by NIH. The contractor shall accommodate any changes to the specified cleaning times upon minimum of a 12 hour notification.

· The facility will be under an environmental monitoring program for particulates as well as viable organisms. If any objectionable organism or an unacceptably high enumeration of organisms is detected, the contractor must be able to provide the Clinical Center with a corrective sanitization and decontamination of the facility to restore to operating condition and cooperate with a Clinical Center root cause investigation as it may pertain to cleaning supplies, methods or contractor personnel as a potential root cause. The contractor will work with the Clinical Center to provide corrective and preventive actions if an investigation definitively determines contractor supplied materials or personnel as the root cause to a contamination in the controlled facility.

5.7 Creation of Monthly Cleaning Schedule:

· The contractor shall create and disseminate Monthly Cleaning Schedules using NIH approved templates at minimum, a week, before the next month.

· The contractor shall communicate the Monthly Cleaning Schedules to the necessary POCs of the APFs prior to the start of the associated month.

5.8 Training Requirements:

· The contractor must provide cleaning technicians that are highly qualified in education, experience, and training of cleaning.

· The contractor shall train all personnel on the Cleaning and Disinfection program employed by NIH before sending them over for NIH gowning and cleaning qualification.

· The contractor shall perform (read and understand/on the job) any necessary trainings associated with the cleaning of facilities prior to entry and cleaning tasks. This may include, but is not limited to, gowning and gowning qualification, material and personnel flow, etc.

· All contract staff must attend NIH Clinical Center Orientation, within 30 days of working onsite.

· Annually and periodically, the contractor must perform training (read and understand) and abide by any NIH Clinical Center training modules or documents.

· The contractor must provide periodic refresher training to keep staff up-to-date on new methods and ensure that all personnel meet the highest standards of Quality Assurance and Environmental Health and Safety.

· All personnel shall be subjected to Cleaning and Disinfection Qualification by NIH on random basis.

· Contractor supervisors and leads shall be trained in cGMP investigations in order to follow proper techniques when resolving cleaning related events.

· Maintain cGMP trainings on a routine basis and have current GMP knowledge.

· Possess relevant experience cleaning in cGMP-controlled environments such as ISO 7 and 8.

· Possess a basic understanding of microbiological principles as they relate to contamination control including an understanding of the pathways for contamination and the principles of sanitization.

· Be able to read, comprehend, and perform cleaning in accordance to detailed instructions provided in Standard Operating Procedures (SOPs).

· Provide proper documentation including any observations upon the completion of the cleaning in accordance to the requirements stated in SOPs.

· Pass knowledge and performance assessments relating to cleaning tasks.

· Successfully pass a gowning certification program.

· Adhere to standard, accepted cleanroom practices, such as absence of jewelry, perfumes, or makeup.

· Complete additional training and requirements required by each facility for authorization to enter the facility.

· Quality Assurance (QA) oversight shall be provided by NIH as part of this contract. The cleaning technicians are to comply with any advice, observations, and corrective actions provided by the QA oversight.

5.9 Tour of Duty/Work Schedule:

· Seven days a week cleaning, and holidays. Refer to the Cleaning Schedule Dashboard for latest schedule.

· All cleaning related documents are found within teams page CC ORSC Cleaning Program

· Cleaning request, cleaning events, and Good Documentation Errors are reported to Cleaning Contractor and ORSC via shared email box: ORSC Cleaning Program ORSCCleaningEvents@cc.nih.gov

5.10 Responsibility Matrix Table

Point of Contact

Cleaning Event Management

-APF Leadership

-APF Leadership

-APF Leadership N/A

-APF Leadership CONTRACTOR Lead

Cleaning Schedule Management

-APF Leadership N/A

-APF Leadership N/A

-APF Leadership

-APF Leadership N/A

Permanent Changes

-CONTRACTOR Lead

APF

ORSC

Training

-APF Leadership N/A

-ORSC

Cleaning Waste Management

Cleaning Logbook Management

-CONTRACTOR Porter

Processing new logbook requests

· Accessing folder

· Updating information on cover sheet

· Printing

· Binding

· Routing for approval

-APF Leadership

ORSC

Cleaning Supplies Management

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