Attachment_1_-_Steris_SOW.pdf

SCOPE OF WORK

Norther Navajo Medical Center Sterile Processing Department

Sterilizer equipment removal/installation renovation

1. INTRODUCTION:

The Northern Navajo Medical Center (NNMC) is the largest geographical service-unit of Navajo Area Indian Health Service (NAIHS). NNMC’s population extends into New Mexico, Arizona, and Utah. NNMC was built from 1991 to 1994 and opened in 1995.

The scope of NNMC’s responsibility is extensive and includes administrative oversight of one hospital: NNMC and two health centers: Four Corners Regional Health Center and Dzilth-Na-O-Dith-Hle Health Center. NNMC is a 60-bed medical center and has one of the largest patient volumes in the NAIHS. NNMC provides the following primary and specialty care services in inpatient and outpatient care services: medical-surgical, pediatric inpatient, labor and delivery, intensive care units, internal medicine, family practice, urgent and emergency care, women's health, mental health, pharmacy, optometry, dental, radiology, public health nursing, medical social services, health promotion/disease prevention and traditional medicine. NNMC also provides Surgical Services for General Surgery, OB/Gyn, Endoscopy, Dental, Orthopedics, and Podiatry procedures.

2. BACKGROUND:

The Sterile Processing Department (SPD) has a requirement for the removal and installation of all new equipment. Currently the department has (2) AMSCO Washer/Disinfectors, (1) Steris cart washer, (2) AMSCO Steam Sterilizers, and one (1) each AMSCO 50 reprocessing sink. All of the equipment is used to sterilize surgical instrumentation and instrumentation used in all the above-mentioned services including FCRHC, and DZ clinics. NNMC operates sterilization equipment Monday through Friday. The washers and sterilizers are crucial to keep necessary surgical items sterilized for surgical cases, clinics, inpatient and outpatient services. The existing equipment is outdated and at the end of its lifecycle.

2.1 ADDRESS: Northern Navajo Medical Center, U.S. Highway 491 North, Shiprock, NM 87420.

3. SCOPE:

NNMC’s SPD has a requirement to remove and install all new equipment, configure space as needed, and add a new reverse osmosis system for clean water to be used for sterilizing. SPD is seeking a contractor who can design and build the current space for renovations to existing drains, piping, electrical, and hookups for the new equipment. The contractor shall provide all new equipment and accessories (installation kits, manifold racks, transfer carts, container rack, loading cart, transfer carriage, mounts, etc.) to upgrade the department with updated technologically advanced machines and configure required areas (i.e. drains/piping).

3.1 The contractor shall provide the following Steris equipment: two (2) each new washer disinfector units, one (1) each cart washer, two (2) each autoclave electric steam generators, and one (1) 3-bay reprocessing sink. In order to efficiently sterilize instruments, a closed loop filtration system is also needed.

3.2 Due to the critically of this requirement, NNMC requires a company that can handle the complexity of the requirement and must have experience working in a healthcare/hospital setting. NNMC recommends a pre-solicitation walkthrough and detailed proposal for contract award. After award, a post award orientation will be scheduled to aid both the government and contractor to achieve a clear understanding of requirements.

3.3 The contractor shall provide all supervision, labor, parts, materials, tools, supplies, equipment, maintenance, ground transportation, waste removal, and service upon removal and installation for this requirement.

3.4 Contractor shall warrant all services performed on units and shall remain defect free per manufacturer’s 1-year warranty.

4. EXISTING EQUIPMENT

The contractor shall remove and dispose of equipment. The list of existing equipment is as follows:

No. Equipment List Serial # Equipment # Department

1 STERIS Reliance Synergy Washer/Disinfector 3630809014 30-13365 SPD 2 STERIS Reliance Synergy Washer/Disinfector 363090906 30-13366 SPD 3 MDT Castle Cart Washer N/A 30-12718 SPD

4 STERIS Amsco Century V-148 Prevac Steam Sterilizer/Autoclave 0327409-04 30-13452 SPD

5 STERIS Amsco Century V-120 Prevac Steam Sterilizer/Autoclave 0326809-06 30-13453 SPD

6 Reprocessing Sink 3 Bay N/A N/A SPD

5. NEW EQUIPMENT REQUIREMENTS

Vendor shall replace existing equipment with new upgraded Steris equipment that meets the following characteristics below, including accessories:

No. Equipment List Qty Dimensions

5.1 STERIS AMSCO 5052 Washer/Disinfector 480V, 60HZ, DD, STEAM 2 (External) 42 x 80 x 31”

5.2 STERIS AMSCO 600 Prevac Steam Sterilizer, Electric

Steam Generator 2 (Chamber size) 26.5 x 26.5 x

39"

5.3 STERIS VISION 1321 Cart and Utensils

Washer/Disinfector, Electric 1 (Overall) 120 x 112.75 x 106"

5.4 STERIS AMSCO 50 Reprocessing Sink, height adjustable, 3 bay, 120” 1 (Overall) 120”x28”x 44-9/16 to 52-9/26”

5.5 Closed loop filtration water system 1 N/A

5.1 Two (2) Steris AMSCO 5052 Single-Chamber Washer/Disinfectors, steam generator.

NNMC SPD intends to use this equipment for cleaning and intermediate-level disinfection of surgical instruments. This equipment must work by combining impingement, water temperature and detergent to clean heat-resistant and heat-sensitive devices. SPD requires an equipment with low processing times, 25 minutes or equal per cycle. Equipment shall also come with the following:

• (2) Installation kit, flex hoses for utilities

• (2) 3 Level manifold racks

• (2) Transfer cart

5.2 Two (2) AMSCO 600 Steam Sterilizers, with integrated electric steam generator. The SPD intends to use this equipment to help kill harmful bacteria, viruses, fungi and spores on items that are placed inside this sterilizer. Medical devices such as surgical instruments and implanted medical devices that meet sterile body tissues or fluids are considered critical devices and must be sterilized. This equipment must sterilize using steam under pressure. SPD requires equipment shall also come with the following:

• (2) Sterilizer chamber rail

• (4) Steam filter assembly

• (2) Loading cars with shelves

• (2) Transfer carriage

5.3 One (1) Vision 1300 Series Cart and Utensil Washer/Disinfector, electric. The SPD requires a cart washer to provide efficient cleaning, disinfecting and drying of surgical instrument case carts, containers, utensils and other reusable items. This equipment must be a high capacity cart washer with multiple chamber lengths, to provide SPD maximum output for the department in an 8-hour day. Cycle time must be 10 minutes and produce high capacity washing and provide thermal disinfection with low water consumption per cycle. Equipment shall also come with the following:

• (1) Cart washer container rack

• (1) Installation kit (if required)

5.4 One (1) AMSCO 50 Reprocessing Sink. The SPD intends to utilize this sink for the manual cleaning and rinsing of certain instruments, devices and or items. This sink must be 120 inches, height adjustable, and of triple bay configuration. The sink shall also include:

• (2) Flex plates

• (1) Chemistry mount

• (1) Backsplash bracket

5.5 Closed loop filtration system. Water is the most important part of sterilization; the entire decontamination process uses water. Most U.S. public water systems contain substances like chlorine, dissolved salts, minerals, organic contaminants, bacteria and endotoxins. This contaminated water results in the formation of scale. Which leads to stained instruments and inactivate disinfectants. SPD intends to utilize a new water system for sterilization of instruments for each of the above-mentioned equipment.

6. INFECTION CONTROL

6.1 An Infection Prevention Risk Assessment shall be created and followed as specified by the Infection Control department.

6.2 Contractor shall provide all protective barriers/infection walls in a manner that will not interfere with daily operations.

6.3 Contractor shall be responsible for the cleaning of all containment area after work is done each work day.

7. WORK REQUIREMENTS

Contractor shall complete all steps below to fulfill tasks in this requirement. This is not in any particular order. Upon inspections, the below are a list of needs of this requirement.

7.1 Provide project schedule for work including milestones

7.1.1 The contactor shall provide a detailed schedule to the COR indicating the date that each phase of work will occur. The contractor shall propose the schedule, and the Contracting Officer/COR and Facility will confirm the schedule to ensure coordination with Contract and Facility requirements.

The first construction schedule shall be provided at the post-award meeting, with subsequent revisions provided with each invoice/payment request, or as necessary.

7.1.2 Weekly progress meetings shall take place to ensure project is on schedule or make necessary adjustments to put project back on schedule.

7.2 Ensure protective barriers/infection walls are in place for infection control and according to ICRA

7.3 Notify and coordinate with the COR for removal of existing equipment

7.4 Disconnect utilities

7.5 Remove existing cart washer and sterilizers

7.6 Reconfigure floor drains/sink and piping to meet new equipment requirements

7.7 All new equipment will need new shut off valves

7.7.1 Demo existing drains to meet Steris equipment standards

7.7.2 Pipe sizes need to be increased for equipment

7.7.3 Upgrade existing exhaust duct

7.7.3.1 Current are 8 in and new duct requires 10 in ducts

7.7.3.2 Corrosion-proof and watertight duct rated at 210 degree

7.8 Notify and coordinate with COR for pre-installation work

7.9 Frame in new sterilizer bays according to drawings from Designer of Record

7.10 Removal of existing reprocessing sink

7.10.1 Renovate sink location

7.10.2 Demo to install floor drain for new reprocessing sink closer to room entryway per Joint Commission requirement

7.10.3 Electrical GFCI will need to be relocated

7.10.4 Ultra Sonic electrical disconnect to be relocated

7.10.5 SEISMIC Anchors to be added

7.11 Drywall and finish walls as needed

7.11.1 Moisture-rated drywall and stainless steel

7.11.2 Coat new dirty side with epoxy paint

7.11.3 Paint needs to be microbicidal

7.12 Demo of new cart washer

7.12.1 Existing pit to be increased, existing is too shallow. Alternate solutions recommended. Upon inspection, it has been found the height clearance of the new equipment is not met. Current clearance is 96” and needs to be 102”.

7.12.2 Floor drain to be replaced with an 8 in by 6 in deep floor sink

7.12.3 Disconnect to be relocated

7.12.4 Add custom stainless-steel enclosure and trim panels

7.12.4.1 If necessary remove existing sheet rock wall

7.13 Design and build a closed loop filtration system or equal into unsterile equipment room

7.13.1 Water system to be connected to all equipment that will be used for sterilization

7.13.2 Proper floor drain needed for RO system (water system)

8. ELECTRICAL

8.1. Load calculation of all equipment

8.2 Existing electrical system is 3 phase 208V and 3 phase 480V

8.3 Run conduit and set new panel in electrical room from main to accommodate new 3 phase 480 for new cart washer

8.4 New 3 phase 208 as required for new equipment

8.5 Pull new home runs for new equipment

8.6 Run new conduit for installation of new disconnects and conductors

8.7 Electrical Lock Out Tag Out (LOTO), apply a Warning Tag on the physical restraint device

8.8 Upgrade new conduit for existing 3 phase 208V and 3 phase 480V

8.9 Test all electrical systems prior to and after connecting new equipment

9. UTILITY REQUIREMENTS

Contractor shall follow and meet utility requirements as outlined by Manufacturer drawings.

10. CODES AND STANDARDS

The contractor shall adhere to and meet the following standards upon completion.

10.1 Association of the PeriOperative Registered Nurses (AORN).

10.2 Association for Advancement of Medical Instrumentation (AAMI)

10.3 The Joint Commission

10.4 NFPA 70 electrical codes

10.5 UBC building codes

10.6 Plumbing codes

10.7 Manufacturing requirements

11. UPGRADES AND ADDITIONAL SOFTWARE

The Vendor shall complete these items when the system requires it as it applied to the contract.

12. PERIOD OF PERFORMANCE

Tasks required under this SOW shall be completed one year from receipt of award.

13. TRAVEL

All travel shall be the responsibility of the Contractor. Contractor shall park in designated areas near General Services receiving.

14. ESCORTS

The facilities department shall furnish escorts during contractor’s work in order to access work space as needed. The SPD shall furnish their own escorts because of sterile processing requirements.

15. OPERATING HOURS

The contractor shall perform work during normal business operating hours Monday through Friday from 8:00 a.m. to 5:00 p.m. excluding federal holidays. After hours are acceptable depending on project schedule needs.

16. WASTE REMOVAL

Contractor shall keep the premises clean on a continual basis, and no trash or debris will be permitted to accumulate in work areas. Contractor shall be responsible for removal and disposal of all debris and waste materials associated with this Contract. COR will coordinate with Project Manager on construction staging area for trash and metal.

17. CUSTOMER FURNISHED EQUIPMENT AND WORKSPACE

Depending on the nature of task, NNMC facilities will furnish up to 2 HEPA filter carts if requested in advance.

18. POCs The Point of Contacts will provide access on-site in accordance with established hospital policies, standards, regulations, and rules of conduct. The Point of Contact will provide access to the appropriate personnel (management, technical, subject matter expertise, etc.)

necessary to fulfill the contract requirements.

19.1 The Department Point of Contact, is Vickie Morez-Walser. Contact information:

phone (505) 368-6955 and email vickie.morez-walser@ihs.gov.

19.2 The Facility Point of Contact is Chris Begay. Contact information: phone (505) 368

– 6152 and email christopher.begay@ihs.gov.

19. INSPECTION AND ACCEPTANCE CRITERIA

20.1 The COR will monitor the vendor’s activities and accomplishments according to the

SOW. The COR will indicate acceptance or non-acceptance of deliverables. The deliverables identified above will be inspected and either approved or, if they are not acceptable, rejected by the COR. COR contact: Gabriella Clitso (505) 493- 6871 gabriella.clitso@ihs.gov.

mailto:vickie.morez-walser@ihs.gov mailto:christopher.begay@ihs.gov mailto:gabriella.clitso@ihs.gov

20.2 The vendor shall maintain a history file on all installations, testing, programming, upgrades, and inspections conducted throughout the life of the contract. The history file shall be the property of the Government and shall be maintained by the vendor and turned over to the COR upon completion of the contract.

20.3 The government reserves the right to inspect all aspects of the work performed and the contractor shall provide an inspection by someone other than equipment installer and verify proper installation.

20.4 Final acceptance will be based on an acceptable final inspection, including final verification of all material and workmanship and correcting any deficiencies and completing any remaining punch list items.

20. CONTRACTING OFFICER

Contracting Officer (CO): is the only individual to authorize modifications to the purchase order and/or terms and conditions.

19. INSPECTION AND ACCEPTANCE CRITERIA