Attachment 6_SOO_SPD_BAMC_9 Apr 2024.pdf

BROOKE ARMY MEDICAL CENTER (BAMC)

(Final Version)

1 February 20, 2024

PROJECT NAME: Comprehensive Sterile Processing Distribution (SPD), Operating Rooms (ORs), and Outpatient Clinical Support Services

1. STATEMENT OF OBJECTIVE (SOO).

For End-to-End*(See Note Below) Management of Minimally Invasive Surgical (MIS) Cases, MIS Instrumentation and Equipment, and High-Level Disinfection (HLD) Clinical Scope Processing.

2. PURPOSE.

The purpose of this effort is for an experienced and certified SPD, High Level Disinfection (HLD), and Perioperative services contractor to independently manage instrument/equipment, workflow management, onsite operations, and administration from end-to-end with no direction, training, or management by the Medical Treatment Facility (MTF). To focus efforts on highly specialized equipment that exceeds the capacity and capability of current onsite staff. Removes the constraints of independent departments within the process continuum for MIS sets and HLD scopes, allowing for the end-to-end lifecycle management of equipment and processes.

3. SCOPE OR MISSION.

The Scope of this effort includes end-to-end independent management of perioperative services as it relates to equipment management from OR through SPD and various HLD outpatient clinics. Contractor support shall include certified personnel (as outlined herein), adhere to industry and regulatory requirements, manage onsite operations, oversee the alignment of equipment requirements against procedure/OR operations, manage onsite workflow, movement of equipment, cleaning/sterilization of equipment, HLD scope processing services, and provide necessary administration to perform services to the standards and acceptable quality levels identified in this SOO.

4. PLACE OF PERFORMANCE.

The work to be performed under this contract shall be performed at Brooke Army Medical Center (BAMC), a government facility located at Joint Base San Antonio, Fort Sam Houston, TX, and associated medical facilities located within a 40-mile radius.

5. BACKGROUND.

BAMC, an Academic Medical Center, is the DOD’s largest in-patient hospital and only Level I Trauma Center. BAMC is staffed by more than 8,000 Soldiers, Airmen, Sailors, Civilians, and contract personnel providing care to wounded Service Members and the San Antonio Community at-large. With an average of 1,500 cases per month, BAMC is the most robust and productive healthcare organization within the Military Health System (MHS).

BAMC consists of 28 Operating Rooms (ORs), whereas services under this contract shall also provide sterile processing and HLD support to the Sterilization/Processing/Distribution (SPD), Anesthesia, Interventional Radiology (IR) Clinic, Gastrointestinal (GI) Clinic, Genitourinary (GU) Clinic, Otolaryngology (ENT) Clinic, Pulmonary Clinic and General Surgery Clinic.

*NOTE End-to-End: A self-contained workflow encompassing the autonomous management of designated medical instruments, starting from decontamination, assembly, sterilization, utilization in the operating room or clinic, and concluding with the return through the decontamination phase. This process operates independently of external government intervention or direction, ensuring efficiency and quality control within the Sterile Processing workflow in a hospital setting.

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6. PERFORMANCE OBJECTIVES.

6.1. Provide end-to-end onsite Specialist and Management in support of Minimally Invasive Surgical (MIS) operative cases, and related MIS equipment such as cameras, scopes, flexible scopes, instrumentation, robotics, and other applicable devices as needed. Contract personnel shall possess all equipment licenses, registrations, permissions, and training necessary to perform these services.

6.1.1. The manufacturer and equipment currently on-site are as listed in the enclosed [Attachment 3_ Equipment List] that require experience, training, and/or certification; however, this equipment is subject to change or supplementation.

The contractor is obligated to maintain proficiency with any new equipment brought on-stie.

6.2. The Contractor shall be available to provide support 24 hours a day 7 days a week, determine the number of contract personnel required, establish its own schedule, and independently manage all personnel. This contract will not create an employer-employee relationship, partnership, or joint venture between the parties.

6.3. Rapid “Surge” Events. At the onset of this contract, the contractor will implement a “surge” event to clear all backlog MIS sets. The contractor will maintain the capability to surge throughout the term of this contract, no greater than 18 surge events per year. A surge event intended to clear instrument set backlogs of up to 250 sets. Surge events shall be coordinated and scheduled with the government within five (5) business days. A surge event shall clear all backlog sets within two (2) business days and shall not impede or delay normal operations or workload performed by this contractor.

6.4. Sterilization/Processing/Distribution (SPD) Support.

6.4.1. Independently executes the decontamination, assembly, prep and pack, and sterile storage of all MIS equipment (as noted in 6.1.1).

6.4.2. Testing, reprocessing, and transporting of all scopes and MIS instruments up to

Association of Perioperative Registered Nurses (AORN), Association for the Advancement of Medical Instrumentation (AAMI), and The Joint Commission (TJC) standards.

6.4.3. Workload is approximately 20 cases with approximately seven (7) sets/instruments per case per day. This contract may require increase volume and workload as additional ORs open (approximately 1 additional case per room per day).

6.5. Intraoperative Support Services.

6.5.1. The contractor will cover all MIS cases in the OR for the following:

6.5.1.1. Rapid turnover of required items.

6.5.1.2. Running required for instruments/supplies for covered cases.

6.5.1.3. Rapid Turnover of Adult and Pediatric Airway carts and inventory as required.

6.5.1.4. Non-affiliated or manufacturer specific camera, scope, and associated equipment trouble shooting.

6.5.1.5. Daily check and basic preventative maintenance of non-affiliated or manufacturer specific video equipment before a case begins and at the start of the day.

6.5.1.6. Conduct daily robotic arm inventory.

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6.5.1.7. Anticipate equipment and instrument turnover needs based on daily case volume.

6.5.1.8. Support the MIS OR case at the pre-operative (before), intra-operative (during), post-operative stages (after) of the surgery.

6.5.1.9. Pre-checks and plans accordingly based on the case schedules for the following days.

6.5.1.10. Communicates with OR leadership, physicians, and room circulators early and updates regularly when there are any issues with equipment or instrument inventory or functionality. Will immediately remove from circulation broken or inoperable equipment or instruments and replace with a suitable working replacement.

6.5.1.11. Supports the anesthesiologist with their scopes and equipment as needed.

6.6. Clinical Support Services.

6.6.1. Camera, scope, and associated equipment trouble shooting.

6.6.2. Scope High Level Disinfection (HLD), testing, and storage.

6.6.3. Supports at a minimum Interventional Radiology (IR) Clinic, Gastrointestinal (GI)

Clinic, Genitourinary (GU) Clinic, Otolaryngology (ENT) Clinic, Pulmonary Clinic, Anesthesia Services, and General Surgery Clinic.

6.6.4. Initiates work orders with BIOMED for all scopes, cameras, and tower components. Before submission to BIOMED, all instruments/scopes are fully tested to verify and determine the need for a repair. Communicates with the local equipment manager prior to submission.

6.6.5. Workload under the clinic areas is separate from the case workload performed under the Intraoperative Services (6.5) and SPD (6.4).

6.6.6. HLD Estimated Workload (Various Scopes and Probes).

6.6.6.1. Interventional Radiology: +/- 7 per week

6.6.6.2. Gastroenterology: +/- 280 per week

6.6.6.3. Genitourinary: +/- 23 per week

6.6.6.4. Otolaryngology (ENT): +/- 120 per week

6.6.6.5. Pulmonary: +/- 2 per week

6.6.6.6. Anesthesia: +/- 104 per week

6.6.6.7. General Surgery: +/- 15 per week

6.7. Personnel. The company shall employ, at Its own expense, all personnel required in performing onsite services. Personnel employed by the contractor shall not be employees of, nor have any contractual relationship with BAMC.

6.7.1. Key Personnel

i. Program Manager

1. Onsite Part-Time (Not Fully Remote):

a. Educa�on/Experience/Cer�fica�on

i. Bachelor’s degree (non-specific) from an accredited university, with a minimum of five (5) years of experience managing services in a general healthcare setting, or

ii. Project Management Professional (PMP) and 5 years of experience managing services in a general healthcare setting.

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6.8. Process evaluation and improvement. The contractor will conduct and propose to the to BAMC an evaluation of processes and inventory, designed to help transform workflow processes using comprehensive consultative solutions to drive efficiencies, cost containment and process optimization. Includes an evaluation of OR room and SPD optimization and workflow.

6.9. Acceptable Defect Rates. Defects are defined as Missing, damaged, or dysfunctional equipment and/or instruments, and positive hemo-checks. The Contractor shall have a defect rate of less than 2% for all scheduled MIS cases performed over a period of three (3) months.

6.10. Weekly Reports. The contractor shall provide a weekly report to the COR and Department Chief or his/her designee every Monday of each week, in representation of the work provided the previous work week, that identifies the following:

6.10.1. Dates of reporting period in reference.

6.10.2. Associated contract and/or task order number.

6.10.3. Discrepancy list detailing any instrument and/or equipment defects.

6.10.4. Detailed listing of all services rendered on each day of the reporting period.

6.10.5. Daily workload statistics.

7. OPERATING CONSTRAINTS.

7.1. All MIS and HLD services must be performed onsite, using the equipment and infrastructure contained within BAMC.

7.2. Physical locations of supported clinics, ORs, and SPD. This contract must cover multiple locations throughout BAMC. Due to how decentralized the areas are, the contractor may require more physical bodies and managers than other hospitals. The SPD is located centrally;

however, there are two separate OR’s and clinics spread between multiple floors and buildings.

7.3. Experience. Contract personnel shall have a minimum of one (1) year of experience within the last five (5) years providing services as a Central Sterile Supply (also known as SPD) Technicians.

While providing services under this contract, contract personnel shall also be required to comply with any applicable state laws concerning their profession.

7.4. Certification. In addition to Basic Life Support (BLS), a minimum of 50% of the contract personnel providing services shall have and maintain a current SPD certification as listed herein.

Any non-certified contract personnel shall acquire and maintain a certification within six (6) months of their start date.

7.5. Immunizations. Contract personnel shall meet all BAMC immunization and fit-testing requirements prior to the commencement of services.

8. APPLICABLE DOCUMENTS OR REFERENCES.

8.1. Certification. The Contract shall ensure that all required certifications in the SOO remain current during the life of the contract. Certifications required under these qualifications are the responsibility of the Contractor and shall be maintained at no cost to the Government. Prior to the commencement of services, all contract personnel must have and maintain a current Basic Life Support (BLS) certification from the American Heart Association (AHA). Contract personnel will obtain one (1) of the following certifications:

8.1.1. Certified Registered Central Service Technician (CRCST) or

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8.1.2. Certified Instrument Specialist (CIS) from the Healthcare Sterile Processing Association or

8.1.3. Certified Sterile Processing & Distribution Technician (CSPDT) from the Certification Board for Sterile Processing and Distribution

8.2. Contract Personnel Security Clearance Requirements. Contract personnel performing services under this contract must have an active T1 prior to the commencement of services and must maintain this level of security for the life of the contract. The Contractor shall coordinate and schedule all security requirements and appointments with the COR before contract personnel can provide services. The COR shall provide the Contractor with all required Security documentation, review all Security documentation submitted by the Contractor, and initiate the request for the contract personnel’s security action with the Security Manager. The Contractor is responsible for monitoring the coordination and completion of all Security requirements with the COR.

8.3. U.S. Citizen. U.S. Citizenship (copy of birth certificate or naturalization papers required).

Contract personnel performing under this contract must be U.S. citizens. In addition, if any contract personnel fail to meet the citizenship requirements stated herein the Contractor shall not hold the government liable for not allowing performance under this contract.

8.4. Installation Access. Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized. Failure to submit required information/data and obtain required documentation or clearances shall be grounds for denying access to U.S. installations, buildings, and controlled areas. The Contractor shall ensure that any subcontract personnel used in performance of this contract complies with these requirements and that all contract personnel, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements.

8.5. Decontamination Procedures. ANSI/AAMI ST79 and manufacturers written instructions and local policy and procedures.

8.6. BAMC SPD Policy. Reference for the 2% defect rate. Held locally and available upon request.