Republic of the Philippines

Department of Health

Baguio General Hospital and Medical Center

BAGUIO CITY

(074) 442-4216 iNc, 223,444-3165: tELEFAX: (074) 8342

TECHNCAL SPECIFICATIONS

SPECIFICATIONS

PLEASE CHECK

COMPLY

DID NOT COMPLY

I. MANAGEMENT

The dialysis unit shall be under the direct supervision of the Baguio General Hospital and Medical Center management, designating a unit head, thus all rules and regulations with regards to administrative and financial arrangements shall be in accordance with the memorandum of agreement with the hospital.

II. FACILITIES

A. Central water treatment and distribution system (CWTS)

There should be new separate water treatment systems, two for the main hemodialysis unit (main building), and portable RO for 4 machines for medical intensive care unit (Flavier Bldg.), and single portable RO for IDB. (Infectious Disease Building).

1. Quality of water

-most satisfy AAMI Quality Guideline on quality of water (chemical/bacteriologic)

2. Construction quality

-The reverse osmosis unit and associated components shall be well designed and constructed. it shall be compact and designed to protect internal components and to facilitate ease of maintenance.

-The design shall provide protection for personnel against both moving and electrically energized parts.

-Mechanical, electrical and pneumatic termination, connectors, sockets, switches knobs and other controls must be designed to prevent fluid, penetration and incorrect connection of fittings and couplings. Electrical wiring should be nearly arranged and handled as appropriate and must at all times comply with wiring standards.

3. Ergonomic Design

The design must address the following:

a. Double pass stage Reverse osmosis system

b. Controls shall be logically arranged and clearly identify their function

c. Switches and controls must be protected against accidental contact, resulting in inadvertent setting and monitors.

d. Visual displays and indicators shall be easily read and interpreted

e. Monitors and alarms that are operator adjustable shall not allow illogical set points.

4. System Design

a. The PRE-TREATMENT phase of the CWTS shall consist of the following components:

1. The Raw Water Storage – Tank and Float Assembly,

This float assembly activates a shut-off valve to the main raw water supply. A pump is incorporated to pressurize the raw water from the break tank through the pre-treatment components to the reverse osmosis (RO) unit and should operate in conjunction with the RO unit system to enable filter backwash and similar functions at the times when the RO is not in service. Total capacity of the raw water tanks shall not be less than 25,000 liters and must be stored in stainless steel tanks. The raw water volume stored must be sufficient to finish a complete treatment for the total number of machines in the unit.

2. Multi-media Filter, Media to be a mixture of anthracite, sand, garnet and gravel, to ensure the removal of particulate matter down into the media for finer filtration and low differential pressure. The filter must incorporate a timer for backward cycles and a valve suitable for water sampling.

3. Softener and Brine Tank. The size of the tank must be enough to ensure exchange capacity. The flow rate should be adequate for the process to flow between regeneration cycles. The softener must incorporate a timer for regeneration cycles and a valve suitable for water sampling.

4. Granulated Activated Carbon. Two carbon tanks are required for all installation. The empty Bed Contact Time (EBCT) of each tank must be ten (10) minutes. With GAC iodine #1000. This ensures the effective removal of chloramines. Both tanks must incorporate timers for backwash cycles. Each tank must have sample valves suitable for water sampling between tanks and after the second tank.

5. Sediment Filtration Cartridge. Filters of 5 and 1micron rating must be installed for RO membrane protection against fine sediment and carbon fines.

6. Ultra violet sterilizer, these components should be included as a part of the pre-treatment. The removal of biological foulants extends RO membranes lifetime also assisting membrane biological rejection efficiency.

b. Reverse Osmosis Unit should incorporate the following features:

1. Automatic Control System. The tendered system must operate via microprocessor programmable logic control (PLC) based control system to provide fully automatic operation of unit functions.

2. Status Indication. A currently available water treatment system that has the following:

I. Permeate distribution loop

II. Percentage recovery

III. RO pump pressure

IV. Permeate loop pressure

V. System Alarm. Other system operational alarms should be displayed. It should not be possible to reset any alarm indication until the cause has been rectified. An audible signal and visual display must accompany any system operational alarm. The audible signal may be muted for a set period but may not be cancelled until the cause of the alarm has been rectified.

VI. Nurse Station. A basic indication of the CWTS operational status must be available at the nurse station within the treatment area (e.g. storage RO level alarm)

VII. System Methodology. A “demand and supply” indirect feed reverse osmosis system. Permeate and quality rejection characteristics are optimized when no backpressure is exerted to the RO membranes. Permeate should be allowed to flow to a break tank and then be pressurized to the distribution loop. The break-tank should include a level switch for permeate flow control and incorporate an air vent filter. Design and finish of the break tank is vital to lessen the possibility of bacterial contamination. The permeate return from the distribution loop must be via a stream that is sprayed into the interior of the tank.

VIII. Available power on-site: 220 volts, 3 phase, 60 hertz (BGHMC power on-site 220, 1 phase but 3 phase is possible upon request from the engineering department)

IX. Acid granules supply with replaceable , non rusting 2 mixer tanks plus 2 back up (200 liters) equipment rooms and hemodialysis treatment area will be supplied with RO water

c. Water quality

1. RO Membranes, Thin film Composite (TFC) Spiral Wounds Membranes, are required for this installation. The preferred configuration is double stage (RO/RO) where permeate from the first set of membranes provides the feed water for the second set of membranes. This configuration will produce permeate of ultra-pure quality. The required permeate feed rate is <>. The water recovery must be> 50% on the first stage and 90% on the second stage in order to minimize water wastage.

2. Permeate Quality. The rejections characteristics of TFC membranes, with pre-treatment and operating parameters conforming to manufacturer recommendations are preferred for water for dialysis use. It is therefore anticipated that the quality of permeate within the distribution loop will at all times, as a minimum requirement, conform to or exceed the current AAMI standards for the quality of water for dialysis use.

3. Permeate Distribution Loop. To assure continuance of the quality of permeate within the distribution loop, particular attention must be given to the loop material, the method of the installation and connections of dialysis machines to the loop.

1. Material chosen must be of medical grade

2. It should be heat resistant to >100C

3. Have low friction allowing high velocities with lowP

iv. Have a smooth interior surface offering minimal possibilities of bacterial proliferation

v. Be installed as a continuous, free looping loop, of minimal length with no dead ends

vi. No glues or adhesives are to be used

vii. Connection to the loop for dialysis machines and ancillary equipment (e.g. reuse machines, must be via stainless steel, quick connecting, self- sealing couplings (Swagelock or similar)

4. Pressurization pump. The requirement that a minimum pressure of 60 PSI be maintained within the loop under all normal operating condition, at a minimum from rate of one meter per second that the reticulation pump be accurately sized, with relation to loop piping diameter and loop length.

5. Ultra-filter. The inclusion of an ultra-filter within the permeate distribution loop is optional, Normally, this is not a requirement if all other quality assurance requirements are met. Should an ultra-filter be included, that it must be of a type that is heat resistant to a minimum of 100C.

6. Drainage, Drainage of effluent from the dialysis machines must allow for a minimum 30mm air gap between each machine drain outlet and the drainage piping. Piping material should be a minimum 90mm diameter PVC and have a minimum 3slope to the main drainage point. Up to five machine drain outlets may converge to a common tundish.

d. Disinfecting-Heat disinfecting

1. The method of disinfecting the permeate distribution loop is by heat. Water distribution should preferably be performed daily, at a temperature of 85C sustained for a minimum duration of (2) hours. The frequency duration and actual heat attained must be programmable. A failure of the heat program must be indicated as an alarm; however, failure must not inhibit the continuation of treatments.

2. During heat disinfecting, there must be a lockout to prevent treatment being performed. However, should acute treatment be required during the lockout period, then the disinfecting cycle must have the capability temperatures, within a 30-minute time period.

e. Portable Dialysis Water Treatment for 4 machines for MICU and single portable RO for IDB use must comply with equivalent quality of water in the main hemodialysis unit (minimum portable RO specs/ or equivalent)

· Entire device conforms to IEC UL Standard 60601-1

· Recirculation feature REUSES excess product water reducing water usage up to 45% or more

· RO is fed with cleaner water improving the quality and performance of the unit

· Plug and play controller provides easier access to program changes and disinfect mode

· Controller keeps you informed of operating conditions by displaying water quality readings and alarms

· System prevents product water flow to the patient if an alarm signals

· Quick and easy onboard disinfection with the push of the keyboard

· Dial membranes in stainless steel housings provide higher flow rate than other single patient systems

· Dual chloramine removal carbon cartridges are a special blended carbon block design that satisfies AAMI and CMS requirements

· Dual stage ultra-filter blocks microbiological contaminates down to 0.005 microns

· Test ports to simplify sample taking

f. Chlorine And Chloramine Test Apparatus

· 2 units Chlorine and Chloramine Test Apparatus with unlimited supply of chloramine test tablets

g. SUPPORT

1. In case of equipment malfunction, proponent must state availability of technically qualified personnel, qualification, component parts and consumable items and minimum inventory requirement (at least 1 assigned for BGHMC, response time, Turnaround time of service)

*** they will be informed within 1 hour

*** proponent replies within 1 hour,

*** repaired within 24-36 hours to avoid service disruption and avoid downtime of 24 hours)

i. At proximity to the location

ii. In Baguio City, Philippines

f. NOISE

1. The noise level from the installed system shall not exceed 60Db measured at a 1-meter distance from the point of entry to the systems location area.

g. UPGRADES

1. The system design should incorporate components that are within industry standard allowing local availability to prevent prolonged downtime in the event of equipment malfunction. The design must also facilitate future software and/or hardware upgrades, extending equipment lifetime and reducing the possibility of technical obsolescence.

h. MANUALS

Four copies, in original format of both operator and Technical manuals must be made available to BGHMC

i. ACCEPTANCE TESTING

1. Final acceptance testing of the complete installation is the ultimate responsibility of the BGHMC. Cost of testing should be shouldered by the Proponent.

2. At the time of final acceptance, all relevant parties involved must be present.

3. Prior to ANY hemodialysis treatment being performed, BGHMC must satisfy themselves as to the performance standards, and must sign off on the suitability and conformity of the installed system, together with the Proponent Representative, Issuance of a Certificate of Acceptance should coincide with the start of cooperation period.

III. EQUIPMENT MATERIAL/SUPPLIES

A. HEMODIALYSIS MACHINE: Minimum Technical Specifications

1. For the Main HD Unit

a. 4 shifts, Monday to Saturdays

b. 30 machines with 2 back up capable of HEMODIAFILTRATION

i. 26 negative machines (brand new)

ii. 3 Hep B positive (brand new)

iii. 1 Hep C positive (refurbished)

2. For the MICU

a. 2 units capable of HEMODIAFILTRATION, brand new

-Capable of Dialysate Flow Range of 50-600 ml/min.

b. 1 hep B (refurbished)

c. 1 hep C (refurbished)

D . 1 CRRT WITH REPLACEMENT FLUIDS (5000 ML)

3. For the IDB

a. 1 negative refurb,

b. 1 hep B refurb

c. 1 hep C refurb

4. Technical Specifications of HD Machines

a. Model – brand new, latest model, state of the art hemodialysis machines (unless specified above as refurbished)

b. Body and Parts

1. Rust proof and corrosion resistant

c. Required operational features

i. Large color LCD Display

ii. User friendly, graphical presentation of treatment parameters (ease of lining and printing connection and disconnection of treatment, ease of reading alarm parameters)

iii. Auto printing and rinsing capabilities

iv. Decalcification program

v. Environmental friendly/compatibility

vi. Electrical safety features

vii. Available power on site:220 volts, single phase

AVR

d. Essentials Standard (built-in) Features of HD Machine

i. Automatic self-test of the machine, hydraulic, sensors, limits software and screen function (functional test)

ii. Safety alarms/parameters includesfor proper functioning and safety of the patient)

a. Air detector-with alarm

b. Blood leak detector-RED SENSITIVE 50 ul micro foam with cannulated volume

c. Conductivity safety/Dialysate Circuit Monitoring

· Transmembrane pressure monitoring

· Display range (- 60 mmHg to + 520 mmHg), Resolution (20 mmHg)

· Bicarbonate (Dialysate Delivery)

· Adjustable range (24 to 40 mmol/L)

· Sodium therapy, Std range (125-150 mmol/L)

· Ultrafiltration pace, 0-4 l/hr

d. Temperature-dialysis fluid temperature(33degrees to 43 degrees C

e. Arterial and venous line clamp

f. First alarm indicator - allows diagnosis for the cause of the alarm

g. Close volumetric balancing chamber - for accurate volumetric UF control with no minimal rate UF requirement (valuable tool for management of Dry weight in clinically stable patients)

h. Setting of pressure (venous; arterial: TMP) limits automatically when blood flow is adjusted

i. Integrated disinfection system – heat and chemical

j. Battery back –30 mins to 1 hour for emergency power failure alarm (e.g. provide memory back-up of program)

k. Programmable heparinization with heparin pump alarm

l. Blood volume and blood temperature management system

m. Dialysate flow alarm

iii. On line dialysate filter for regular dialysis

iv. On line dialysate filter for production of substitution fluid for HDF

v. Use of bicarbonate solution

vi. Recirculation monitor

vii. Variable dialysate flow range

viii. Programmable mixing ratio of the concentrate can be programmed (K, free, 2K, 3K)

ix. Self-adjustable blood pump segment diameter (e.g. 6 mm, 8mm)

x. Adjustment parameters for ultrafiltration-100 to 6000 ml uf volume

xi. Variable sodium modelling

xii. Variable ultrafiltration (UF) profiling

xiii. Priming-bucket machine – attached (infection control issue)

xiv. Automatic priming and rinse back (e.g. auto prime plus)

xv. Blood Pressure Monitor

xvi. On-line Kt/V Measurement

xvii. Hemodiafiltration capable with online production of substitution fluid

xviii. Closed system of bicarbonate production

xix. Blood circuit monitoring

· Arterial pressure monitoring

Operating range (- 400 mmHg to + 400 mmHg) and Resolution (20 mmHg)

· Venous pressure monitoring

Operating range (- 20 mmHg to + 390 mmHg) and Resolution (20 mmHg)

· Arterial blood pump

xx. Heparin pump flow- Syringe pump for 10 – 30 ml syringes

Pumping rate of 0.1 – 10 ml/h in steps of 0.5 ml/h or 0.1 ml/h,

Can be turned off, bolus: 600 ml/h

With profiling capability

xx. Database software program compatible with BGHMC – HD unit’s computer network system (HOMIS)

5. Technical Specifications for CRRT

a. The machine should have the following pumps:

a.1. Syringe or Anticoagulation pump

a.2. Citrate pump

a.3. Effluent Pump

a.4. Substitution pump

a.5. Dialysate pump

b. It should have the following pre – assembled kit inclusions

b.1. Arterial Line

b.2. Venous Line

b.3. Effluent Line

b.4. Substitution or Replacement Line

b.5. Heparin Line

b.6. Calcium Line

b.7. Citrate Line

c. It should be capable of monitoring the following pressures:

c.1. Arterial Pressure

c.2. Venous Pressure

c.3. Effluent Pressure

c.4. Fluid Pressure

c.5. Filter Pressure

d. A Bar Code Scanner is available

e. It should have the following

e.1. a stop key or button to stop the treatment in case of emergency.

e.2. a status indicator light

e.3. an emergency battery backup capable for at least 30 minutes

e.4. a touch screen monitor and operator with access of all parameters but not limited to AP-VP-TMP

e. 5. level detector for arterial chamber-venous chamber-fluid chamber

e.6. an optional rinsing and recirculation mode

e.7. must be capable of unlimited recirculation and has an effluent sampling port

e.8. must be capable of temporary disconnection

e.9. can show the Patient ID time-date-blood flow

e.10. must have an on-screen numeric keypad and keyboard

e.11. must have a step by step user guide.

e.12. the menu bar should give the following information to the operator at all times

1. flow rate of heparin

2. filtration fraction

3. volume and time remaining in the bag

4. flow rate of substitution fluid

5. flow rate of net fluid removal

6. real renal dose

7. Flow rate of dialysate.

f. The maximum weight of the bag on citrate load cell should be at most 3 Kg

g. The Maximum weight of the bag on dialysate and substitution should be at most 15 KG each

h. The Maximum weight of the bag for effluent should be 15KG

i. The machine should be capable of the following flow rates:

i.1. Blood Flow 10 – 450 ml/min

i.2. Replacement / Substitution flow 0 – 8000 ml/h

i.3. Dialysate flow 50 – 7000 ml/h

i.4 Effluent Flow Range 0 – 11,000 ml/h

i.5. Heparin Pump range 0.5 – 20 ml/h

i.6. Citrate Pump flow rate 15 – 700 ml/h

i.7. PE Flow Range 50 – 3,000 mL/h

i.8. Calcium Flow Range 0.5 – 300mL/H

j. It should show the Graphs illustration of all the pressure and can be accessed any time during the therapy

k. It should give the history of the treatment during the entire treatment and gives the following information:

k.1. Volumes

k.2. Graph

k.3. Event Log

k.4. Report

l. The machine should have an event log screen that can be accessed any time during the therapy and should record all the alarms and events and actions that the operator has taken.

m. The machine can be primed for about 10 minutes.

m.1. can have a high Renal dose achievement (Up to 96%)

m.2. should have an automatic blood & fluid regulation.

m.3. should be mobile in the ICU during treatment

m.4. is able to detect artifacts movement and has a built in Integrated Ceramic warmer

m.5. is capable of more than 1 bags on each scale and less bag change is required.

n. Scale Calibration is performed during PPM service by certified personnel and engineer

o. With Replacement Fluids-5 liter bag

Service Maintenance

i. Should be maintained throughout the duration of the contract and extension periods as applicable (monthly schedule of maintenance by identified / dedicated engineer for BGHMC)

ii. Availability of spare parts and other accessories locally

iii. Availability of service personnel (dedicated technician, engineer to BGHMC)

iv. Accessibility to address any machine malfunction, failure and technical problems.

v. Maintenance program for all machines:

a. classified as Emergency (TAT 24 hours),

b. ROUTINE MAINTENANCE/CALIBRATION WORKS (monthly).

Qty.

Main hemodialysis unit

Qty.

MICU

1. Hemodialysis Chair

32

Inclusive of 2 back-up chairs for observation

a. Must have a comfortable, wide and movable armrest that permits optimal placement of the arms and side-collapsible working table.

a. Adjustable to horizontal and Trendelenburg position

b. Flexible for patient comfort

b. Must be mobile yet stable

c. Cushions must be comfortable and removable

c. Durable upholstery and made of leather

d. Adjustable footrest to fit leg length of the patient

d. Must have simultaneous single pedal caster lock

e. Total length is 5-6 feet

2. Reprocessing Machines

3

7 Fully Automated reprocessing machine with the following features, but not limited to, for non-reactive Hepatitis B patients.

2

a. Dedicated machine for Hepatitis B patients and Hepatitis C

b. Must have drip trap to catch spills and keep reprocessing room clean

c. Can accommodate conventional, high efficiency and high flux dialyzers.

d. Maximum number of re-use for dialyzers is programmable to 20≥ 80% and able to relay remaining efficiency of the dialyzer after reprocessing.

e. Must be automated, with data management system.

f. Can detect blood leak

3. Dialyzer (8 reuse)

1pc

a. Indicated for reuse 8x on all patients (except upon doctor’s orders or patient’s request)

1pc

a. Indicated for reuse on all patients (except upon doctor’s orders or patient’s request)

b. Biocompatible High flux, high efficiency dialyzers,

c. Low flux dialyzers as needed

I. KơA> urea 450 ml/min

II. Urea Clearance > 200ml/min

III. Kuf>15ml/min

IV. B2-microglobulin clearance>20ml/min

V. Surface area>1.5 (reduced risks of specific cardiac-related events)

d. High flux, high efficiency dialyzers,

VI.

4. Bloodlines(per treatment)

1pc

a. Single use bloodlines, 6 mm or 8mm diameter, with transducers protector: arterial pillow or chamber

1pc

a. Single use bloodlines, 6 mm or 8mm diameter, with transducers protector: arterial pillow or chamber

5. Hemodialysis Solution

Per treatment

a. Sodium bicarbonate bag at least 500 gms/ treatment (powder granules are acceptable)

Per treatment

a. Sodium bicarbonate bag at least 500 gms/treatment

b. Acid solution 5 L (premix)

b. Acid solution 5 L (premix)

2L

c. Normal saline-plastic bags: additional 1L for heparin – free prescriptions

c. Normal saline-plastic bags: additional 1L for heparin – free prescriptions

d. Sterilant solution for dialyzers (hydrogen peroxide with peracetic acid)

d. Sterilant solution for dialyzers (hydrogen peroxide with peracetic acid)

1. Anticoagulant

1 vial

a. Heparin, regular stock of 1000u/ml/ 10cc vial or 1000u/ml 5cc(2) vials

1 vial

a. Heparin, regular stock of 1000u/ml/ 10cc vial or 1000u/ml 5cc(2) vials

2. Access Dressing kit

1pr

AVF needles: sizes must be available G 15-17, with and without back-eye:

1pr

AVF needles: sizes must be available G 15-17, with and without back-eye:

4pcs

2x2 gauze pad: sterile: pre-packed

4pcs

2x2 gauze pad: sterile: pre-packed

2pcs

Alcohol prep pad and Chlorhexidine pad: with 2 extra pad for cleaning excessively dirty access

2pcs

Alcohol prep pad and Chlorhexidine pad: with 2 extra pad for cleaning excessively dirty access

2pcs

Povidone iodine prep pad

2pcs

Povidone iodine prep pad

1 roll

Plaster (hypoallergenic) 75’80’long;individual use

1 roll

Plaster (hypoallergenic) 75’80’long;individual use

4 pairs

Clean gloves; powderless; minimum( various sizes)

4 pairs

Clean gloves; powderless; minimum ( various sizes)

1pc

Under pad; small for access arm (8.5x11”L)

1pc

Under pad; small for access arm (8.5x11”L)

Take-off kit

Take-off kit

4pcs

Pressure dots: plus extra 2 for bleeders.

4pcs

Pressure dots: plus extra 2 for bleeders.

2pcs

Band aid (big wide and thick) approximately 2”Wx4”L

2pcs

Band aid (big wide and thick) approximately 2”Wx4”L

4 pairs

Clean gloves (various sizes)

4 pairs

Clean gloves: (various sizes)

2 pcs

Pillow Gauze

2 pcs

Pillow Gauze

Other supplies needed for fistula kit (separate from the kit)

Other supplies needed for fistula kit (separate from the kit)

2pcs

3 cc syringe: luer lock

2pcs

3 cc syringe: luer lock

2pcs

10cc syringe: luer lock

2pcs

10cc syringe: luer lock

Catheter dressing kit (Pat-on)

Catheter dressing kit (Pat-on)

1pr

Sterile gloves: powderless

1pr

Sterile gloves: powderless

1pr

Clean glove: powderless

1pr

Clean glove: powderless

4pcs

Sterile 4x4 gauze pad

4pcs

Sterile 4x4 gauze pad

2pcs

Alcohol swab stick

2pcs

Alcohol swab stick

2pcs

Povidone Iodine swab stick

2pcs

Povidone Iodine swab stick

1 roll

Plaster 85”L≥(individual use)

1 roll

Plaster 85”L≥(individual use)

2pcs

Surgical loop mask

2pcs

Surgical loop mask

Other supplies for catheter prep (separate from the kit)

Other supplies for catheter prep (separate from the kit)

2pcs

3cc syringe

2pcs

3cc syringe

2pcs

2pcs 10cc syringe

2pcs

2pcs 10cc syringe

1pc

Transparent dressing (10cmx12cm(; hypoallergenic)

1pc

Transparent dressing (10cmx12cm(; hypoallergenic)

1 pc

Under pad or absorbable pad (8.5x11”L)

1 pc

Under pad or absorbable pad (8.5x11”L)

Take-off kit

Take-off kit

6 pcs

4x4 gauze pad (pre-packed) for termination purposes

6 pcs

4x4 gauze pad (pre-packed) for termination purposes

1 pr

Sterile gloves; powderless

1 pr

Sterile gloves; powderless

1 pr

Clean gloves; powderless; unlimited supply

1 pr

Clean gloves; powderless; unlimited supply

3. Miscellaneous Supplies

1 pc

Intravenous line with regulator (not for gravity) infusion)

1 pc

Test strip for presence of sterilant (post reprocessed dialyzers)

1 pc

Test strip for sterilant residuals before use of dialyzer

2 pc

Blue plastic clamps for each station

4 pc

Plastic buckets for mixing low level disinfectant for cleaning surfaces of machines chairs; plus 2 buckets for in-patient unit.

Unlimited supply of disposal rags or disposable towels for machine; surfaces and chair cleaning with disinfectant safe for their machine, non-irritating to patients

1 set per treatment, for reprocessing area, 1 set per shift

Personnel protective equipment (PPE) face shields, water-repellant long sleeve gowns for staff at the treatment area; PPE’s for reprocessing room (goggles/face shields and gown; non-porous synthetic or plastic slip-on shoes.

2

Emergency box for supplies and materials in case of disaster or emergency (fire, earthquake, power-outage, etc.) PLASTIC, NON-POROUS MATERIAL.

2

MSD’s (for out and in-patient unit) all chemicals should be provided with MSDs to include lists of hazardous materials used in the unit with symbols (provided in binders) all chemicals must be BFAD approved and registered.

Each machine

Unlimited supply Sharps disposal container (red bucket) 15 liters, box type with lid ( wide opening )

Each machine

Hand sanitizer

Unlimited supply of Alcohol 70%, household bleach (hypochlorite solution); hand or disinfectant sanitizer (Institute approval for staff and current’s use.

3 units replaceable

Tape sealer with refillable TAPE for transparent bagged dialyzer (red/ blue )

3 units replaceable

Dialyzer barcode scanner or reader with unlimited supply of label rolls and label printer

Unlimited supply of transparent colored plastic bags for dialyzers (red and blue size 18.5 inches x 5.5 inches

Unlimited supply yellow, black, green and red plastic bags for wastes segregation size medium and XL

13 pcs replaceable

Infectious yellow waste containers with cover; rolling bin type 120 L with wheel, plus 3 pcs for inpatient unit.

15 pcs replaceable

Infectious yellow bin with cover 20L with pedal

Unlimited supply of Industrial salt

Reagent strip 14 in 1 for RO system

Unlimited gallons 5 Liters for acid bath

25 replaceable

Pail 8 gallons 5 red pail and 20 blue pail

3 Dialyzer stainless reprocessing sink replaceable

Acid gallon stainless Racks 3 levels ( 10 gallons per level)

Dialyzer rack

4. Others Equipment/Accessories

Main HD UNIT

MICU

I unit

Emergency cart with cardiac board, and accessories

· Lightweight and easy to maneuver

· Threaded stem 3” twin casters with break or lock

· Dimentions: 29-32”Wx24.5-28”Dx46.5-50”H

· Pre-threaded holes on sides and back easily mount accessories

· New dual push handles

· ABS plastic molded top with handrails on both sides to prevent stuff from falling out for protection and easy clean up stainless steel frame durable 5” easy roll casters with lock mount to non-marking material with 5 drawers at 3”, 3”, 6”, 6”, 9”

· High impact stabilizer base includes:

· -cardiac board and brackets

· -IV pole and bracket

· -oxygen tank bracelets

· -collapsible side shelf

· -utility hooks

· -railing supports

· -2”cut and clip divider system

· -100 plastic seals

· Parts are available locally

1 unit

Cardiac monitor with defibrillator or AED, ECG machine

· Power Supply Input: 220 VAC, 6-Hz with built in rechargeable battery pack

· Output Energy: Mode select knob from 2 to 360 joules biphasic

ECG

•Lead: 12 leads

•Color display

•Built-in memory of at least 100 patients in auto mode

•Patient data can be stored on USB flash drive

•Power supply: 220V-6-Hz with battery pack

•Print name/ID label, HR, axis, interval, voltage measurement, averages and interpretation

•Minimum printing width of 90mm

•Defibrillator and Electro Magnetic Interference protected

•HL7 compatible for data transfer

· Replaceable chest leads

Accessories

· Patient cable

· Reusable patient Electrodes (limb and chest)

· Power cord

· Ground wire

· Carrying case

· Include cart/trolley with drawer and 2 or 4 lockable casters

Consumables

· ECG recording paper unlimited

· ECG gel unlimited

Parameters

· HHHR, P-R interval, P duration, QRS duration, T axis, R (V5), S (V1), R (V5) + S(V1)

2 unit

Bag-valve device (adult and pedia)

Endotracheal Tube (size 7.5-8)

2 unit

Bag-valve device

2 sets

Laryngoscope with straight and curve blades (adult and pedia)

· Fiber optic (LED) bulbless curve blades

· Surgical Stainless steel blades (2,3,4)

· Stainless handle

·

Steam Autoclavable

20 units

Oxygen gauge with flow meter

1 unit

Free Body composition Monitor (BCM) – free for patient’s use

· Measure body composition

· Able to determine nutritional status of patients

With memory function to store patient’s data

NONE

6 units

Glucometer (Institute-approval device for non-reactive Hep patients; Inclusive of 1 unit for hepatitis B-C patients with compatible strips (refillable)

2 units

Glucometer (Institute-approval device for non-reactive Hep patients; Inclusive of 1 unit for hepatitis B-C patients

5 units

Suction machines

· Portable/electric

· Lightweight; plastic mould

· unbreakable plastic jar (1-2L)

· Low-noise level .55dB

· Dimension (will fit into the top shelf of E-cart)

· 220V

· Disposable bacteria filter (with replacement stocks)

· with CE mark/ ISO Standard

1 units

Suction machines

30 units

Blood pressure apparatus (rolling-type); non-mercurial as back-up or alternative use for BPM

· with stand and casters

· with basket

· Dial face at least 6” x 6”

· Bandage cuff (adult)-Velcro type

· Inflation bag (adult) latex-free

· Rubber valve with airflow control (latex-free)

1 unit

Blood pressure apparatus (rolling-type); non-mercurial as back-up or alternative use for BPM

10 pcs

Stethoscopes (specs) ( replaceable )

· two-sided chest piece

· Stainless Steel chest piece

· combination diaphragm and bell type

· rubberized ear tips

one pair spare ear tips

spare diaphragm

10 units

Thermoscan thermometers

· Power supply Input: Battery-operated

· Range of measurement: 32-40 degrees Centigrade (minimum)

· LCD display

· memory display

1

ROOM THERMOMETER

1 unit

Transport stretcher

· heavy duty, made of quantity PE materials, aluminum alloy and stainless steel

· Weight: not more than 68 kg

· At least 200 kg load capacity

· 6 “high quality ball caster wheels with individual lock

· Adjustable height

· Easy to manipulate/ steer

· 4” mattress-with side rails

· IV hook

· oxygen tank 10lbs with gauge humidifier

oxygen tank holder suitable to 10 lbs.

NONE

5 units

Drop light

1 unit

Drop light

1

Biomedical refrigerator

· Power supply: 220-240v VAC, 60Hz

· Capacity: 100 liters

· AVR compatible with equipment

· With Thermometer

30 units

Pulse oximeter

· portable

· lightweight

· range: Spo2 0-100%; +/ -%

· Pulse 25-255 BPM; +/-2BPM

· Continuous battery condition indicator

· Beep sound land and alarm should have separate volume control

· Audio and visual alarms for both upper and lower saturation and heart rate

· reusable adult finger probe

LED display of heart rate and oxygen saturation

10 units

Heating pad, replaceable

2

Heating pad

3 pcs

Screen divider

1 pc

Screen divider

2 unit

Heavy duty pushcart for solutions/gallons transport (in/out patients unit use)

2 unit

Heavy duty pushcart for transporting dialyzers (from reprocessing room to treatment room)

NONE

2 pcs

Dialyzer container; (e.g. plastic-cooler-type or igloo-type) 1 smaller for hep C patients

1 unit

Utility cart\, transport cart for office supplies

6 pcs

Plastic cabinets (transparent white) with 4-drawers for supplies and materials at center station, private room area and isolation room.

1 units

Standard stand weighing scale (detecto type or equivalent) with provision of tests weight, e.g. (5kg)

1 unit

Standard stand weighing scale (detects type or equivalent) with provision of tests weight, e.g. (5kg)

1 unit

Electronic weighing scale, capable of accommodating wheelchair and stretcher or bed (with provision of test weight; e.g. 5kg.

1 unit

Dialyzer storage rack (plastic mold with capacity of 400 plus, separate rack for Hep C patients.

6 units

Independent meter for testing conductivity, Ph and temp of machine

1 unit

Chloramines/chlorine reading device

5

SMART TV-LCD (flat); digital with free cable subscription

1 Unit

Ready floor or ceiling-mounted swivel arm

42’’for mainstation, column-mounted TV-LCD

Office Equipment/furniture fixtures

Office Equipment/furniture fixtures

2 unit

Water dispenser (hot and cold)

2

Standby rechargeable light

1 unit

LCD projector and laptop for training purposes

NONE

30 pcs

Watcher’s chair: single seater (plastic heavy duty) w/o back rest inclusive of 5 unit cushioned chair with back rest

2

Watcher’s chair; single seater (plastic-heavy duty) w/o back rest

10 units

· Desktop computer

· Display. Size. 15.60-inch-21-inch

· Processor. Processor. Intel Core i3 6th Gen 6006U. ...

· Memory. RAM. 8GB-16GB

· Graphics. Graphics Processor. Intel Integrated HD Graphics 520. ...

· Storage. Hard disk. 256GB-500GB

· Connectivity. Wi-Fi standards supported. 802.11

· Inputs. Pointer Device. Touchpad.

(with AVR, UPS) and printer

· Printing Method. On-demand inkjet

· Nozzle Configuration. 180 Nozzles Black, 59 Nozzles per Color.

· Minimum Droplet Size. 3 pl, With Variable-Sized Droplet Technology.

· Ink Technology. Dye Ink.

· Printing Resolution. 5,760 x 1,440 DPI.

· Category. Home, Office Desktop.

· All-in-One Functions. Print, Scan, Copy.

for database management with corresponding computer tables and chairs

50 pcs

Initial and replaceable supply of plastic clipboard for each station and log sheets

300 pcs

Initial and monthly replaceable supply of patient folder/binder chart; 3’” thick, 3-hole punch with 1 pc 3-hole puncher

10 units

Posture chair for nurse station

4 units

Small office side table for nurse station 32”x24’’W

2 units

Receptionist chair

NONE

6sets

Gang chair (for patients and visitors)

NONE

Chair set/1pc-2 chair-set

4

IV STAND POLE

· Material: Stainless steel

· Height Adjustment range:

· 152-213cm (60-84 inches)

2 to 4 hooks (2HOOKS

2

Mayo Table and Tray

Mobile Type

Height Adjustment range: 152-213 cm (60-64 inches

3

MINOR SURGICAL SET

· Components:

· Curved Mayo Scissor 8”

· Kelly Forceps curve, 6”

· Knife handle with blades

· metal tray cover

· Metzembaum scissor, 8”

· Mosquito Forcep, curve

· needle Holder, 8”

· Skin retractors

· Straight mayo scissors

· Tissue forceps with teeth

· Tissue forceps without teeth

· Thumb Forcep

2 units

Intercom connecting all areas (reception area, treatment area, reprocessing room)

NONE

1 set

Conference table/chairs 12 persons

NONE

2 units

Small table at center station 32’’x24’’

1 unit

Small table at center station 32’’x24’’

UNLIMITED Office supplies (coupon bond, batteries, )

4 units

Fire extinguisher

4

Adequate number of air conditioning units for treatment area

5. Database Management

a. Software program that will:

1. Allow encoding of patients, staff and facility data

2. Generation of routine monthly, quarterly, and annual reports such as:

· Cost/expenses/ income and financial reports.

· Patients compliance to treatment (attendance monitoring:

· Risk management (medication error, incidence of fall, etc.)

· QA/QI/CQI

· Daily patient census per shift, per day, per month, quarterly, semi-annually and annually:

3. Generation of special reports as needed for both individual patients and the facility as a whole.

4. Generation of the Dialysis Treatment Flowsheet.

5. Allow expansion should additional database be identified.

b. Facility report- (per day/monthly/quarterly/semi-annual/annually and as required.

1. Number of patients dialyzed with breakdown according to:

· Old/New/age/sex

· Diagnosis

· Service/pay

· Emergency/elective

· Out-patient/inpatient by priority (A-C)

· Source of funding/payment

· No, of performed HD/CRRT per day/month

· Mortality and morbidity report

2. Dialyzers used, issued and inventory

· Type

· Re-use rate; type of failure

3. Incidence in dialysis unit

· CP arrest

· Conversions Hepatitis B non-reactive to reactive

· Conversions Hepatitis B to C or both Hep B and C

· Conversion Hepatitis C to negative to positive or vice versa

· Pulled out fistula needles

· Infections control reports; Access infections

· Admissions from out-patient to in-patient ward or other hospitalization

4. Transfer to other facility endorsement information for transfer to other facility.

5. Provide interface with hospital information management system.

c. Individual patient reports

· Anemia

· Calcium phosphorus

· Albumin/weight/nutrition

· Access history

· Blood flow/recirculation

· Medications

· Admissions

· Co-morbidities

· Outcomes: Transplant/death/transfer

d. Staff Reports

· IV Therapy accreditation

· BLS/ACLS certification

· Employment history

· PRC licenses update/renewal

· Hepatitis profile

· Transfer/resignation/replacement

12. PERSONNEL

· As per compliance to Administrative Order 2012-0001, for licensing requirements.

· Agreement with BGHMC Management Committee for additional personnel as needed.

IV. Service and Maintenance program for the FACILITY and EQUIPMENT

· All HD machines, chairs, blood pressure apparatus, weighing scales, glucometers, digital thermometers, cardiac monitors, colorimeter, reprocessing machines, and the R.O. system, should always be maintained in good working condition by ensuring regular calibration on a monthly basis.

· Upon the award of the contract, the proponents in requested to outline in detail the different processes for the service and the maintenance program carefully identifying the emergency and routine jobs necessary for the equipment units to be in full service.

· The service and maintenance program shall also include other works required in order to address restoration of equipment to full service if unforeseen events may prevent equipment from being used.

V. Changes in treatment protocol including changes in medical management influenced by local and international requirements as recommended by nephrologists on quality healthcare standards, shall be grounds for review of the contract including possible change in the contract rate.

VI. The proponent shall have an emergency preparedness program specifically design to address the following like water supply interruption, earthquake and fire, which might lead to interruption of treatment sessions. The program shall be made up of contingency measures to equip both staff and patients alike through education and training eventually minimize damages to both property and human lives us well as an assurance of the continuity of care.

VII. There will be a 3month transition period from the current contract to the winning bidder. The prospective bidder shall submit a detailed plan and schedule to ensure no disruption of services for the dialysis patients during the said transition period. (This includes changing of the facility machines, reverse osmosis water systems, chairs, etc.)

VIII. Physical Plant Facilities requirements

1. The supplier and his project engineer must have close coordination with the hospital engineering department from planning to implementation. Only the plans which are duly approved by the Medical Center Chief and the DOH National Center for Health Facilities Development (NCHFD) shall be adopted for implementation.

2. The supplier must conduct detailed engineering investigation, surveys, and site and space planning needed. In the preparation design development and detailed drawing. Site and space planning shall be governed by the standards, rules and regulations on the designs of tertiary general hospitals as prescribed by the DOH and other government agencies.

3. The winning supplier, upon issuance of Notice of Award, will be required to submit within 15 calendar days, to the Hospital Engineering Department the floor plans, including complete space allocation depicting all the required functional areas, for the evaluation and approval of the Medical Center Chief or his Authorized representative, (Please see attachment for estimated cost and scope of work)

4. The following provisions must be included in the expansion and renovation of the physical plant and facilities:

4.1. Reception Area

4.1.1. Improvement of the business area

4.1.2. Provision of gang chairs for watchers and patients good for 20 seats

4.2. Nurses station/pantry

4.2.1. Rehabilitation of present nurse’s station, an arrangement that would ensure centralized monitoring of patients in the whole treatment area.

4.2.2. Rehabilitation of present pantry to enable more staff friendly atmosphere, with provision for 20 lockers for staff.

4.2.3. Improve storage space in and around the nurse station and pantry.

4.3. Improvement of the water treatment area, supply and installation of various plumbing pipes for connection from main water treatment system.

4.4. Supply and installation of various stainless steel tanks with total capacity of at least 25,000 liters.

4.5. Provision for a reprocessing area and installation of dialyzer rack.

4.6. Must have 2holes seamless sink stainless steel x 1.5 mm thick.

4.7. Installation of various plumbing pipes for connection from RO source to each treatment area/station.

4.8. Supply and installation of power cable for each station, including that from the generator (please coordinate with engineering)

4.9. Panel board

4.10. Enough circuit breakers for hemodialysis machines, reprocessing machines, others

4.11. Painting works

4.12. Independent Internet connection Cable wires and cable TV connections/ subscription

4.13. Supply and installation of air conditioning units in designated treatment area

4.14. Improvements of existing comfort rooms

4.15. PWD/ Gender sensitive comfort rooms

4.16. Gender sensitive staff comfort room with hot shower

4.17. Miscellaneous (specs), washing machine

4.18. OFF SITE WAREHOUSE

4.19. A waste disposal area away from sterile areas, and treatment area

4.20. Linen room

The supplier may submit offers which provide for superior specifications and/or better terms at no extra cost to BGHMC.

IX. ANY CHANGES IN THE PROVISIONS AFTER CONTRACT SIGNING SHALL BE DISCUSSED WITH THE TWO BEFORE IMPLEMENTATION.

CORRECTIONS/Addendum:

Personnel of the hemodialysis Center Project shall be provided by Baguio General Hospital and Medical Center: Said personnel shall be trained by the provider (winning bidder) for six (6) months.

The following personnel shall be provided by winning bidder (in house/dedicated trained renal technicians, engineer, in-house custodian)

The minimum use of reuse factor on the dialyzer will depend on the DECISION of the nephrologist. The first 8 reuse of dialyzers (FREE) shall be included in the cost of the dialysis package. The cost shall be shouldered by the patient in case the nephrologist requires the use of a new set.

There shall be thirty-four (34) BRAND NEW Hemodialysis Machines, 1 CRRT, 6 REFURBISHED machines, including the backups,

The costs needed for the facilities/waste disposal shall be shouldered by the provider (winning bidder),

Blankets and white linens for patients shall be provided by winning bidder.

Monthly Water analysis and Physical (analysis) shall be shouldered by provider.

After completion of the One (1) year contract by the provider (winning bidder), hemodialysis machines will be retrieved from the hospital. It is however understood that during the term of the contract management over the facilities shall be with BGHMC.

Additional Responsibilities of the provider (winning bidder)

= Shall be responsible in the installation of electrical wirings and lightings, phone lines, internet connections, TV cable at the respective area

= Shall have their own maintenance personnel to maintain and repair their facilities

=Shall be in charge in the collection, disinfection, transporting and final disposal of all wastes generated.

BGHMC is capable of database management system, Further, the provider (winning bidder) shall adapt / rent (?) to the hospitals existing software.

BGHMC shall use closed system of bicarbonate production, however: in extremes of cases, premixed may be used after proper consultation with the management.

Provider (winning bidder) shall coordinate with the Hospital’s Engineering office regarding the AVR.

Provider shall shoulder water bills, electric bills, telephone/ internet bills, cellphone bills, space rental.

I hereby certify that the above data is/ are “correct”.

__________________________________ _____________________

Name of Authorized Representative Date

(Printed Name over Signature)

_________________________________

Name of Company & Complete Address