PGH

PHILIPPINE GENERAL HOSPITAL The National University Hospital

University of the Philippines Manila Taft Avenue, Manila

"PHIC-Accredited Health Care Provider”1809001:2008 Certified

INVITATION TO CONSIGN

VARIOUS MEDICAL DEVICES FO R THE DEPARTMENT OF ANESTHESIOLOGY

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2.

The PHILIPPINE GENERAL HOSPITAL (PGH) w ith its m an d ate to su s ta in the dem an d s of public h ea lth services an d e n su re th e co n tin u o u s availability of low cost b u t h igh quality essen tia l m edical dev ices/im p lan ts , d ru g s a n d m edicines, an d m edical supp lies, w ithou t en tailing additional cost or investm en t from the governm ent, h a s adopted th e “Consignm ent S y s te n f .

The C onsignm ent System is a m ethod w herein consignors place its goods a t the PGH (consignee), a n d th e form er is being paid by the la tte r for th e ac tu a l quan tity sold or consum ed only, u s in g the proceeds generated from th e sale of the consigned goods a s recognized by Section 7 .3 .2 , second a n d th ird p a rag rap h s , of th e 2016 Revised Im plem enting R ules an d R egulations of Republic Act 9184.

The PGH C onsignm ent Com m ittee (PGH-CC) now invites eligible C onsignors to su b m it consignm ent offers for th e consignm ent of V ario u s M edical D ev ices fo r th e D e p a r tm e n t o f A n esth e s io lo g y u n til th e en d of th e year sub jec t to renewal.

Eligibility requ irem en ts of th e C onsignor is con tained in th e C hecklist of R equirem ents (please se e attached). S ubm itted eligibility docum en ts an d evaluation of consignm ent o ffers/p roposals shall be u n d e rta k en by th e PGH-CC.

The com plete se t of consignm ent docum en ts m ay be acqu ired by the in te rested C onsignor or h is /h e r duly au thorized rep resen ta tive from th e PGH C onsignm ent Office from M onday to F rid ay , except holidays or suspension o f work, 8 :0 0 AM to 5 :0 0 PM upon p aym en t o f the participation fe e in the am ount o f Ten Thousand Pesos (P hP l0,000.00) a s p e r PGH M em orandum No. 2018-118.

It m ay also be dow nloaded free of charge from th e w ebsite of the Philippine G eneral H ospital, provided th a t C onsignors shall pay Hie applicable fee for the C onsignm ent D ocum ents n o t la te r th a n th e subm ission of th e ir consignm ent offer.

5. The PGH-CC will ho ld th e following consignm ent activities, w hich shall be open to prospective consignors who availed of th e consignm ent docum ents.

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4.

A c tiv ity (ies) S c h e d u le .

D eadline for Subm ission of 30 A ugust 2019 (Friday), 3;00PMC onsignm ent Offers C onsignm ent Office

6. Subm ission of consignm ent o ffers/p roposals beyond th e s ta ted tim e an d date shall no longer be accepted.

7. The PGH reserves th e righ t to accep t or re ject an y a n d all o ffers/p roposals, cancel or declare a failure of consignm ent, or n o t aw ard th e co n trac t a t an y tim e prior to con trac t aw ard, w ithou t incu rring an y liability to any C onsignor or Consignors.

8. For fu r th e r inform ation, p lease refer to:

MS. ANNA LEAH G. VINLUANOfficer-in-ChargePGH Consignment OfficePhilippine G eneral H ospitalE rm ita , Taft Avenue, M anilaTrunk Line: +63(2) 554-8400 local 3001

Approved by:

JU LIET O /m O AGUILAR, MD, MScPGH-CC d m itp e rso n

PGHI * > < > ‘X’

PHILIPPINE GENERAL HOSPITAL The National University Hospital

University of the Philippines Manila Taft Avenue, Manila

PHTC Accredited Health Care Provider ISO 9001:2008 Certified

TERMS OF REFERENCE

FOR CONSIGNMENT OF VARIOUS MEDICAL DEVICES FOR THE DEPARTMENT OF ANESTHESIOLOGY

PR O JEC T DESCRIPTION

PGH is in need o f a CONSIGNOR to consign a brand new medical devices for the different clinical department o f the Philippine General Hospital.

For this purpose, the project medical device shall be understood as “any instrument, apparatus, implement, machine, appliance, implant, in,vitro reagent or calibrator, software, material or other similar or related article:

a) Intended by the manufacturer to be used, alone or in combination, for human beings for one or more o f the specific purpose(s) of:• Diagnosis, prevention, monitoring, treatment or alleviation o f disease;• Diagnosis, monitoring, treatment, alleviation o f or compensation for an injury;• Investigation, replacement, modification, or support o f the anatomy or o f a

physiological process;• Support and sustenance o f life, control o f conception, or disinfection o f medical

devices;• Provision o f information for medical or diagnostic purposes by means o f in-vitro

examination of specimens derived from the human body

b) Which does not achieve its primary intended action in or on the human body by pharmacologic, immunologic, or metabolic means, but which may be assisted in its intended function by such means.

The number o f source/s for CONSIGNOR/s, whether single or multiple shall be determined by the PGH-Consignment Committee.

Multiple sources shall be allowed in instances when the responsive CONSIGNOR with the lowest price offer cannot adequately fill-up the quantity demanded by the Hospital within a given consignment period.

In case that the contract is awarded to multiple sources, the schedule shall be set on the sourcing of said item(s) from all the CONSIGNOR/s. However, identification o f specific

CONSIGNOR/s may be allowed for items considered highly specialized, or where small variations may significantly influence the safety, efficacy, and general outcome of the treatments or procedures where the item will be used, provided that it is supported with valid justification by the respective Department Head and approved by the PGH Director.

II. CONTRACT DURATION

The Consignment Agreement shall be valid until the end o f the year, renewable subject to satisfactory performance to be recommended by the Consignment Committee and approval by the Director.

III. F T I C r m i l T Y REQUIREM ENTS (Please refer to ANNEX A)

IV. SCOPE O F W O RK

Ensure high quality, brand-new, timely or immediate delivery, and stock availability o f the medical devices for operational use o f the said selected clinical departments at reasonable prices based on the Consignment List (Please refer to ANNEX B)

V. TERM S AND CONDITIONS

1. The CONSIGNOR shall be required to fulfill the following:

1.1. Deliver, as the need arises, brand-new medical devices indicated in the consignment orders;

1.2. Deliver variable items (as to size, models, quality) to be confirmed by the Doctor based on the actual need o f the patient/s in case the items to be used are not yet determined due to compatibility concerns, which will then be reflected in the Consignment Order;

1.3. Deliver/supply consigned items within 48 hours upon receipt o f order, with commitment to stock availability;

1.4. Deliver a ‘‘‘‘custom-made medical device” which refers to a medical device, other than a mass-produced medical device, that is.

(i) Assembled or adapted in the manner that is intended for individual patient; or

(ii) Specially fabricated or imported for the sole use o f a particular person, in accordance with the specifications o f a qualified practitioner,

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1.5. Open to inspection and/or testing o f all deliveries by the PGH to the extent practicable and necessary prior to acceptance;

1.6. Comply with the security, safety, and PGH house rules related to the issuance o f medicines and other pharmacy products to patients;

1.7. Is subject to the investigation and submission of report/s to PGH for any incident or medication safety issue related to the activities done by theCONSIGNOR;

1.8. Relieve the PGH from any responsibility for any loss o f consigned items arising from fortuitous events beyond the control o f the PGH; provided, however, that such loss is not due to negligence resulting to theft or pilferage, and in which case the PGH Pharmacist-on-Duty/Nurse-on- Duty/Administrative Officer-on-Duty, or those staff physically present within the immediate vicinity o f incident, including the security guards shall be held jointly and severely liable for the monetary value o f the goods pilfered/stolen;

1.9. Certify that all the documents submitted are complete and authentic copies o f the original, and that all statements and information provided therein are true and correct

2. The consigned items shall be delivered and accepted as follows:

2.1. Just-In-Time Inventory Item s' - the CONSIGNOR agent delivers item directly to Operating Room (OR)/Procedure Supply Center;

2.2. Non-General/Special Inventory Item/s1 2 3 — the CONSIGNOR delivers initial stock items to OR/Procedure Supply Center and the item shall be inspected immediately together with the representatives o f the Internal Audit Services Staff (LASS) assigned to do inspection; and

2.3. General Inventory Item/s (Property and Supply Division or PSD Floor Stocks)1, - the CONSIGNOR delivers initial stock items to PSD Warehouse and the items shall be inspected immediately together with the representatives o f the IASS assigned to do inspection.

1 I te m V . ( 1 1 ) o f t h e C o n s ig n m e n t G u id e l in e s , Just in Time Inventory - r e fe r s t o t h e in v e n to r y m a n a g e m e n t s y s te m w h e r e i t e m s a r e m a d e

a v a i la b le o n ly w h e n th e n e e d f o r t h e i t e m a r is e s a n d n o s to c k s a r e k e p t o n s ta n d b y .

2 I te m V . ( 1 7 ) o f t h e C o n s ig n m e n t G u id e l in e s , Special/Non-General Inventory Item/s - r e fe r s t o t h e in v e n to r y m a n a ^ e n t s y s te m w h e r e

s p e c ia l u s e s u p p l ie s a r e d i r e c t ly r e q u e s te d b y c o n c e r n e d d e p a r t m e n t /a r e a a n d m a d e a v a i la b le a s f lo o r s to c k s t o c a te r t h e n e e d s o f in d iv id u a

p a t ie n ts a n d u s a g e c h a r g e d d i r e c t ly b y t h e O R / P r o c e d u r e S u p p ly C e n t e r t o t h e i r p a t ie n ts a c c o u n ts .

3 l t e m V ( 1 0 ) O f t h e C o n s ig n m e n t G u id e l in e s . General Inventory Item/s (PSD Floor stocks) - r e fe r s t o t h e m v e r i to r y m a n a g e m e n t s y s te m

w h e r e i te r n s a r e m a d e a v a i la b le t o a ) w a r d s /a r e a s t h r o u g h t h e i r r e s p e c t iv e d e p a r t m e n t s ; r e g a r d e d a s f l r o r s t o ^ '*e r " s “ " ^ ^ re d t 0 b e p

o f th e (O p e ra t io n a l c o s ts a n d n o t c h a r g e d t o in d iv id u a l p a t ie n ts , a n d b ) s u p p ly o u t le t , c h a r g e d i t e m s u s e d t o in d iv id u a l p a t ie n ts .

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3. The CONSIGNORS are prohibited from the following acts:

3.1. Offer/Deliver "counterfeit medical device", that is, a medical device, the label or outer packing o f which is an imitation of, or resembles or so nearly resembles that o f another medical device, as calculated to deceive into believing that it is the label or outer packing o f a medical device o f another manufacturer;

3.2. Offer/Deliver ‘‘‘'misbranded medical device", that is, a medical device —

(a) Which is not labelled in the prescribed manner;

(b) Which has on the label or labelling, any word, statement, other matter or information required by these rules, to appear not prominently or with such conspicuousness as compared with other words, statements, designs, or devices on the label or labeling, and in such terms as may render it likely to be read and understood by the ordinary individual under customary conditions o f purchase and use;

(c) Which is not labeled with directions for use and such warnings against use in indications wherein its use may be dangerous to health, or against unsafe administration or application, in such manner and form as are necessary for the protection o f users, or as may be prescribed;

(d) With a label or container, or anything accompanying which, bearing any statement, design, or device which makes any false claim for the medical device or which is false or misleading in any particular; or

(e) Which is so colored, coated, polished, or treated that damage is coiicealed, or which is made to appear o f better or o f greater performance than it really is;

3.3. Offer/Deliver "substandard medical device", that is, a medical device that is not o f specifications;

3 4 Offer/Deliver “refurbished medical device ”, that is, a medical device that was previously owned and reconditioned for resale, even if it meet the safety and performance parameters set by the manufacturer

VI. TERM OF REM ITTANCE O F TH E SALES PROCEEDS

All payments shall be referred to the payment provision o f the Consignment Agreement that is “the consignee agrees to remit the sales proceeds to the CONSIGNOR m fourteen (14) days, after receipt o f any o f the following, whichever is applicable.

(a) Receipt by the consignee o f the funds from the funding agency/ies;(b) Receipt by the consignee o f the patien t’s payment."

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VII. PARTICIPATION FEE

A complete set o f Consignment Documents may be acquired by interested Consignors from the PGH Consignment Office upon payment o f the participation fee in the amount o f Ten Thousand Pesos (PhP10,000.00) as per Memorandum No. 2018-118.

It may also be downloaded free o f charge from the website o f the Philippine General Hospital, provided that Consignors shall pay the applicable fee for the Consignment Documents not later than the submission o f their consignment offer.

VIII. POINT O F CONTACT

The CONSIGNOR will liaise with only six (6) offices and will receive Job orders only from the following:

1. Office o f the Deputy Director for Health Operations - Represented by the Deputy Director, Dr. Ju lie t O. Sio-Aguilar;

2. Department o f Anesthesiology - Represented by the Chairperson, D r. G race Anne A. Banson-Herbosa;

3. PGH-Consignment Committee - Represented by the Chairperson, D r. Ju lietO. Sio-Aguilar; and

4. PGH-Consignment Office - Represented by the Officer-In-Charge, Ms. A nna Leah G. Vinluan

All communications and requests are to be directed to the above named individuals. The above named individuals may designate a point person-in-charge o f all requests and other communications regarding the CONSIGNOR.

JU L IE T O.Chair, PGH-

^ G U IL A R , MD, MSc

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ANNEX WA”

CHECKLIST OF REQUIREMENTS FOR CONSIGNMENT OF VARIOUS MEDICAL DEVICES FOR THE DEPARTMENT OF ANESTHESIOLOGY

ENVELOPE NO. 1

Eligibility Documents

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3.

1. Appropriate Registration Certificate from the:>- Securities and Exchange Commission (SEC), for corporation >- Department o f Trade and Industry (DTI), for sole proprietorship >- Cooperative Development Authority (CDA), for cooperatives;

Mayor’s permit issued by the city or municipality where the principal place o f business o f the prospective CONSIGNOR is located;

Company profile indicating the following3.1 Company background;3.2 That the company is a major distributor o f medical devices in the Philippines for at

least five (5) years; and3.3 Preferably, with supply chain presence in major areas o f the coimtry;

4. List o f completed and all its ongoing government and private contracts, including contracts awarded but not yet started, if any, whether similar in nature and complexity to the contract to be consigned using the attached prescribed form at regardless consignment or procurement contract;

5. Sworn and duly notarized statement that the prospective CONSIGNOR has not beenblacklisted" to participate in biddings by any government agency;

6. ISO 13485-Medical devices-quality management systems for manufacturer. In case the prospective CONSIGNOR is not a manufacturer, its principal manufacturer’s certified true copy of ISO 13485 and Good Distribution Practice for M edical Devices (GDPMDS) must be submitted. In case, the CGMP is in foreign language, it shall be officially translated to English language by an appropriate foreign entity.

7. List o f Consigned Items that is intended to be consigned using the attached prescribed form at with the corresponding duly certified copies o f Certificate o f Product Registration (CPR) issued by the Bureau o f Health Devices and Technology of the Department o f Health or in the absence o f CPR, a Certificate o f Compassionate Use issued by FDA for consigned item that requires FDA registration. In case a consigned item is non-registrable, a Certificate o f Exemption issued by the FDA shall be submitted indicating specific item num ber therein;

8. Tax Clearance per Executive Order No.398, s. 2005, as finally reviewed and approved by the Bureau o f Internal Revenue.

9. Valid License to Operate (LTO) issued by the Food and Drug Administration

10. Memorandum o f Agreement (MO A) between the distributor and manufacturer.

Other Requirement

11. Notarized Letter o f Conformity with the Terms of Reference to be printed in the c o n s i g n o r ’s letterhead using the attached prescribed form at.

ENVELOPE 2

Consignm ent Price O ffer shall contain:

1. Accomplished Consignm ent Form / List;

2. An electronic form at of the ir accomplished Consignm ent L ist / Form in USB Flash Drive (virus-free); and

3. Accomplished L ist of Consigned Items Intended for Consignm ent

4. An electronic form at of the accomplished List of Consigned Items Intended for Consignm ent in USB Flash Drive (virus-free)

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CONSIGNOR’s Letterhead

List of Completed and All Its Ongoing Governm ent and Private Contracts

Name of the Contract Consignee Contract Period

ON-GOING SIMILAR CONTRACTS/'/>7c/mc//« '̂ contracts awarded but not yet started)

COMPLETED SIMILAR CO>[TRACTS

(Signature over Printed Name o f the Authorized Representative)

Date Signed:

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CONSIGNOR’s Letterhead

List of Consigned Items Intended for Consignment

ItemNo.

Consigned Item(s) CPR Numbers Date of Issuance

..... • •

Date of Validity

(Signature over Printed Name of the Authorized Representative)

Date Signed:

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CONSIGNOR’s Letterhead

LETTER OF CONFORMITY

Title of the Project: CONSIGNMENT OF VARIOUS MEDICAL DEVICES FOR THE DEPARTMENT OF ANESTHESIOLOGY

To: JULIET O. SIO-AGUILAR, MD, MScChairpersonPGH C o n s ig n m e n t C o m m it t e e (PCC) Philippine General Hospital Ermita, Taft Avenue, Manila

This is to inform the PGH CONSIGNMENT COMMITTEE that our company,________________________________, located at __________________________ _ conformsto the Terms and Reference of this project: CONSIGNMENT OF VARIOUS MEDICAL DEVICES FOR THE DEPARTMENT OF ANESTHESIOLOGY, and in changes(s) to be issued.

(Signature over Printed Name o f the Authorized Representative)

Date Signed:

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Please be guided with the following illustration:

ALL envelopes shall be sealed and marked, which shall contain the following details:For the Main Envelope:LI Name of the Consignment Project in CAPITAL LETTERS□ Name and address of the prospective CONSIGNOR in CAPITAL LETTERS; n Be addressed to the PGH-Consignment Committee in CAPITAL LETTERS11 Bear a warning “DO NOT OPEN BEFORE.. the date and time for the Opening Of Consignment Offer as stated in the Invitation to Consign or as change through a Bid Bulletin.

For other Envelopes (Original and Copy 1):

For Envelope 1:i 1 Bear a marking “ORIGINAL” or “COPY 1” for photocopy in CAPITAL LETTERS [; Below it “ENVELOPE 1: ELIGIBILITY”

For Envelope 2:□ Bear a marking “ORIGINAL” or “COPY 2” for photocopy in CAPITAL LETTERS□ Below it “ENVELOPE 2: ACCOMPLISHED CONSIGNMENT FORM”

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A n n e x B

L ist o f Medical Devices / Implants o f the PGH

Definition o f Terms:Generic NameDistributorBrand NameEstimated QuantityConsigned Price to PGHMarket Price (Hosptial/ Drugstore)Suggested Retail Price per pc.

Chemical or non-proprietary nameCompany who was appointed by the manufacturer to distribute or deliver the products to the retailer Proprietary name quantity in piecesThe least and best price offered by the Consignor to PGHPrevailing price in the market i.e. leading drugstore (Mercury) or nearby hospitals (if product is not available in Mercury) Suggested retail price of PGH to the public (lower than the market price)

ItemNo.

i l l y W M U . . W l - i f-t. . .....................

Generic NameEstimatedQuantity

D istributor Brand NameConsigned Price

to PGH

Market Price to Other Hosptial/

Drugstore

Suggested Retaii Price per pc

1Sterilized, disposable pressure monitoring kit with transducer compatible with the existing equipment

1,200

2

Point of care blood gas analyzer cartridge for pH, pC02, p02, Hct, Na+, K+, iCa, HC03, base excess/deficit compatible with the existing equipment

2,400

3Radial artery catherization set, latex-free with sprinq-wire guide G22

480

4Straight, transparent Polyvinyl chloride pressure tubing with luer-lock male/female connection, 125cm

360

5Straight, transparent Polyvinyl chloride pressure tubing with luer-lock male/female connection, 20cm

360

6 Pressure infusion bag, 1000ml 240

7 Male-Male adapter 600

8

15mm Compact, paediatric extendable breathing system with luer elbow, 1 liter reservoir bag and 1.5m limb, 2.0m in length

180

91000ml 0.9% normal saline solution in sterilized, self-collapsible, bag

600

A n n e x B

Request

ItemNo.

ina Unit: DEPAKliVltNi u r MiNCoinc

Generic NameEstimatedQuantity

D istributor Brand NameConsigned Price

to PGH

Market Price to Other Hosptial/

Drugstore

Suggested Retail Price per pc

10 /\dult splint 720

11 :,ediatric splint 300

12 1-wav rotary lock stopcock 2,400

13

Vlultifuse, smallbore, female luer-lock, needle-free, non-DEHP extension set with side clamps

600

14

Fr 7-8 multiport CCO-capable Pulmonary artery catheters with percutaneous introducer sheath kit and anti-infection catheter guard

36

IS Portex Sacett, Size 6.0 60

16Portex Sacett, Size 7.0 60

17Endoquide adult size 100

18 Endoquide pediatric size 100

19 EZ blocker (pediatric and adult sizes) 100

20

Point-of-care testing cartridge for blood Na, K, iCa, Glucose, Hgb, Hct, pH, PC02, P02, TCO, HC03, Base Excess compatibale with iStat point-of-care device

2,500

21

Point-of-care testing cartridge for blood Na, K, iCa, Glucose, Hgb, Hct, pH, PC02, P02, TCO, HC03, Base Excess compatible with IRMA TruPoint point-of- care device

3,500

22 Male-male adaptor 250

23

Multiple hemodynamic sensor for stroke volume, stroke volume variation, venous oximetry compatible with EV1000 clinica platform

250

24

Normothermic IV fluid administration set with maximum flow rate of 950 m/min compatible with Level 1 H1200 fast flow fluid warmer

100

I 25 Pressure bag 1L 2,500

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A n n e x B

Requesting Unit: DEPARTMENT OF ANESTHESIOLOGY

ItemNo.

Generic NameEstimatedQuantity

D istributor Brand NameConsigned Price

to PGH

Market Price to Other Hosptial/

Drugstore

Suggested Retail Price per pc

26Single-use Circle Breathing Circuit pedia (1LRB)

600

27Swan Ganz Pulmonary Artery Catheter F r7 , 4-Lumen 100cm with Cath Guard

150

28 Single shot nerve block needles22Gx50mm21Gx100mm

29 Continuous catheters18Gx51mm18Gx83mm

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