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BS Tool For Compliance

The document is an assessment tool for licensing blood service facilities in the Philippines, detailing the requirements and standards for management, human resources, physical facilities, and equipment. It includes instructions for completing the assessment, as well as specific criteria for evaluating compliance with regulatory standards. The tool aims to ensure that blood service facilities operate effectively and safely in accordance with Department of Health guidelines.
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© © All Rights Reserved
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0% found this document useful (0 votes)
50 views21 pages

BS Tool For Compliance

The document is an assessment tool for licensing blood service facilities in the Philippines, detailing the requirements and standards for management, human resources, physical facilities, and equipment. It includes instructions for completing the assessment, as well as specific criteria for evaluating compliance with regulatory standards. The tool aims to ensure that blood service facilities operate effectively and safely in accordance with Department of Health guidelines.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Republic of the Philippines Department of Health

HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

ASSESSMENT TOOL FOR LICENSING A BLOOD SERVICE FACILITY


INSTRUCTIONS:
1. Check to make sure that you have the complete tool with a total of-- pages with annex A--- that serve as reference for Equipment, Reagents & Supplies per Category.
2. If the corresponding items are present, available or adequate, place on of the appropriate spaces under the FINDINGS column or space provided alongside each corresponding item. If not, put an X instead.
3. The REMARKS column shall document relevant observations for Quality Improvement.
4. Make sure to fill-in the blanks with the needed information. Do not leave any items blank; write (N/A) not applicable or -if needed.
5. ■, (Shaded cell) means that specific items are not applicable to the BSF category. With (*) asterisk-policies incorporated in One Stop Shop facility are acceptable.
GENERAL INFORMATION:

Name of Facility: Calumpit District Hospital Certificate of Inclusion No. DOH-NBVSP-DOH-CL-2021-0042 Exp. Jan-Dec. 31, 2021

Address: Caniogan, Calumpit, Bulacan Region III

(Number & Street) (Barangay/District) (Municipality/City) (Province & Region)


Telephone/ Fax No. _ E-mail Address: ___________________

Initial: Renewal: / License to Operate No.: Authority to Operate No.: Date Issued: Expiry Date: _
Name of Owner or Governing Body (if corporation): Privincial Government of Bulacan _
Name of Head of Blood Service Facility: Angel Reyes Jr., MD

Classification According to: Ownership: / _Government _Private


Institutional Character: / _Institution-based (specify) HB _Free-Standing
Category: / _Blood Station _Blood Collection Unit _BCU/BS
_Blood Bank _Blood Bank with Additional Functions:

_Blood Center Collection _ Testing _ Processing

Blood Blood Blood Station I Hospital Hospital Blood Blood Center Remarks
Station CollectionUnit Blood Bank
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank With additional (BC)
(BCU) Collection Unit (HBB) function
(BS/BCU) (HBB++)
Appljcatjon Documents
• Documentary requirements complete (refer to application)
• Certificates valid and required forms duly accomplished (refer to aoolication)

1. MANAGEMENT REAQUIREMENTS:

1.1. MANAGEMENT RESPONSIBILITY

The Blood Service Facility (BSF) shall be managed effectively and efficiently and in
accordance with its vision, mission, and objectives.
1.1.1 Management shall formulate a vision, mission, objectives and values for
the BSF.
1.1.1.1 Mission, Vision, Objectives, Values
1.1.2 There shall be an Annual Operational Plan
1.1.2.1 Annual Operational Plan /
1.1.3 There shall be Management Review /
1.1.3.1 Management Review with Key Performance Indicators

1.2 MANAGEMENT OF BLOOD SERVICE FACILITY /


The BSF shall be managed by qualified physicians with proper training.

Blood Blood Blood Station/ Blood Bank Blood Bank Blood Center Remarks
Station Collection Unit
STANDARDS AND REQUIREMENTS (BS) (BCU) Blood (HBB) With additional (BC)
Collection Unit function
(BS/BCU) (HBB++)

1.2.1 The BSF is headed by a duly licensed physician who is:

For Hospital-based Blood Stations

1.2.1.1 Certified in Clinical Pathology by the Philippine Board of Pathology of the PSP,
1.2.1.1.1. Specialty Board Certificate
/
1.2.1.1.2. Resume /
1.2.1.1.3. Notarized Contract of Employment /
1.2.1.1.4. Job Description X
For Non Hospital based Blood Stations

1.2.2.1 Physician with at least three (3) months formal training in basic blood banking provided
by DOH recognized training provider.
N/A
1.2.2.1.1. PRC Board Certificate
1.2.2.1.2. Resume
1.2.2.1.3. Notarized Contract of Employment or Service Contract Agreement
1.2.2.1.4. Job Description
1.2.2.1.5. Training Certificate on Laboratory Management and Transfusion Medicine

For Non Hospital-based Blood Collection Unit

1.2.3.1. Physician with formal training in basic blood banking provided by the DOH
recognized training provider.
1.2.3.1.1. PRC Board Certificate
1.2.3.1.2. Resume
1.2.3.1.3. Notarized Contract of Employment or Service Contract Agreement
1.2.3.1.4. Job Description
1.2.3.1.5. Training Certificate on Laboratory Management
and Transfusion Medicine

For Non hospital-based Blood Station/ Blood Collection Unit

1.2.4.1. Physician with formal training in basic blood banking prov i ded by the DOH
recognized training provider.
1.2.4.1.1. PRC Board Certificate

Blood Blood Blood Station Hospital Hospital Blood Remarks


Station Collection / Blood Blood Bank Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank With additional (BC)
(BCU) Collection Unit (HBB) function
(BS/BCU) (HBB++)

1.2.4.1.2. Resume
1.2.4.1.3. Notarized Contract of Employment or Service Contract Agreement
1.2.4.1.4. Job Description
1.2.4.1.5. Training Certificate on Laboratory Management and Transfusion Medicine
For Blood Center, Hospital Blood Bank and Hospital Blood Bank with Additional
Functions

1.2.5.1 Certified in Clinical Pathology by Philippine Board of Pathology of the PSP, and
with experience in a blood service facility
1.2.5.1.1. Specialty Board Certificate
1.2.5.1.2. Resume
1.2.5.1.3. Notarized Contract of Employment
1.2.5.1.4. Job Description

1.3. MANAGEMENT OF HUMAN RESOURCES

The Blood Service Facility appoints and allocates personnel who are suitably
qualified, skilled and/ or trained to assume the responsibilities, authority,
accountability, and functions of the position.

1.3.1. There shall be an adequate number of qualified medical technologists


proportional to the workload as determined by the head of the Blood Service 7 RMTS
Facility.
1.3.1.1 Adequate number of personnel. As workload increases, the number of personnel
increases. (refer to Annex A)

1.3.2 There shall be a policy and procedure for hiring, orientation and promotion
for all levels of personnel.

Blood Blood Blood Station I Hospital Hospital Blood Blood Center Remarks
Station Collection Unit Blood Bank Bank
STANDARDS AND REQUIREMENTS (BS) (BCU) Blood (HBB) With additional (BC)
Collection Unit function
(BS/BCU) (HBB++)

1.3.2.1 Policy and procedure for hiring, orientation and promotion of personnel at all levels. X
1.3.2.2 Records of hiring, orientation and promotion of personnel. /
1.3.3 Duties and responsibilities shall be clearly spelled out.

1.3.3.1 Documented duties and responsibilities of all BSF personnel.


/
1.3.4 There shall be a program on staff development and training.

1.3.4.1 Program for staff development and training X


1.3.4.2 Certificates or Records of Training /
1.3.5 There shall be a policy and procedure for discipline, suspension, demotion and
termination of personnel at all levels.

1.3.5.1 Policy and procedure on discipline, suspension, demotion and termination of personnel X
at all levels none so far
1.3.5.2 Records of discipline, suspension, demotion and termination of personnel

1.3.6 The Blood Service Facility shall designate and train one (1) Registered Medical
Technologist as a Quality Assurance Officer. Such training shall be recognized by the
DOH
.
Rowena Evangelista
1.3.6.1 Designation of a Quality Assurance Officer / 2016 SBMA
1.3.6.2 Certificate of Training as Quality Assurance Officer /

Blood Blood Blood Station Hospital Hospital Blood Remarks


Station Collection Unit / Blood Bank Blood Bamnk Center
STANDARDS AND REQUIREMENTS (BS) (BCU) Blood (HBB) With additional (BC)
Collection Unit functions
(BS/BCU) (HBB++)

1.3.7. The Blood Service Facility shall designate one (1) qualified and trained full-
time Donor Recruitment Officer (DRO). Such training shall be recognized by the DOH
and shall include training on pre- and post donation counseling. As the workload
increases, the number of DROs increases. See Annex A

1.3.7.1 Designation as Donor Recruitment Officer


1.3.7.2 Certificate of training as Donor Recruitment Officer DRO from Philippine Blood /
Coordinating Council (PBCC) or Philippine Red Cross (PRC) /

1.3.8 There shall be a structured organizational chart

1.3.8.1 An Organizational chart* indicating the names with pictures and designation,
reflecting lines of authority, accountability and, communication, inter relationship, hierarchy
of functions and flow of referrals /
1.3.9 Each Staff member shall read and sign his Duties and responsibilities
/

1.3.9.1 Duties and responsibilities of each Staff member signed by Staff member.
/
1.4. PHYSICAL FACILITIES/ Work Environment

Services are provided in an environment that promotes


safety, has adequate space, meets the needs of clients, service providers and other
stakeholders, and conforms to the current Manual of Standards issued by the DOH.

1.4.1 The Blood Service Facility has adequate space for the conduct of its activities.

Blood Blood Collection Blood Station I Hospital Hospital Blood Blood Center Remarks
Station Unit Blood Bank Bank
STANDARDS AND REQUIREMENTS (BS) (BCU) Blood (HBB) With additional (BC)
Collection Unit function
(BS/BCU) (HBB++)

1.4.1.1 Ocular inspection demonstrates adequate space for the equipment, furniture, /
storage of glassware, reagents and supplies and the activities of the Blood Service
Facility staff
1.4.1.2 Work area accessible to Blood Service Facility personnel only /

Areas for Blood Station - Designated area in the Clinical Laboratory

• Storage blood bank refrigerator /


• Blood typing and Cross matching /
• Releasing of blood products /

Areas for BCU and BS/BCU

• Reception / waiting area - 1.0 m2 /person


• Donor Counseling - 5.02 m2
• Physical Exam area for donor - 5.02 m2
• Donor extraction - 6 m2 per bed or couch
• Provision of sink for hand washing
• Area for Refrigerator and supplies (at least 1.2 m2 per storage unit)
• Preparation Area - 5.02 m2
• Releasing of blood products
• Administrative Office

Area for Hospital Blood Bank - Area of at least 19 m2

• Areas for blood bank refrigerator, plasma freezer, platelet agitator, and supplies
(at least 1.2 m2 per storage unit)
• Blood typing and Cross matching Work Counter
• Releasing of blood products

NOTE: Location of HBB must be adjacent or easily accessible to the main laboratory
Blood Blood Blood Station I Hospital Hospital Blood Blood Center Remarks
Station Collection Blood Bank Bank
STANDARDS AND REQUIREMENTS (BS) Unit (BCU) Blood (HBB) (HBB++) (BC)
Collection Unit
((BS/BCU)
.

Areas for Hospital Blood Bank with Additional Function

**Reception / waiting area — 1.0 m2 /person Donor Counseling — 5.02 m2


Physical Exam area for donor — 5.02 m2 Donor extraction — 6 m2 per bed or couch Provision
of sink for hand washing
***Blood screening for TTls — 10 m2
Blood typing and Cross matching Work Counter Processing of blood into blood components 4.65
m* per equipment
Storage facility — 4.65 m2 per storage unit Releasing of blood products Administrative Office
equipment
• Storage facility- 4.65 m2 per storage unit
• Releasing of blood products
• Administrative Office
**Reception/Waiting area for HBB++ can be located outside or can be a common area for clinical
laboratory.
***May be carried out within the clinical laboratory if the HBB++ is adjacent to the main clinical
laboratory.

Areas for Blood Center

• Reception / waiting area - 1.0 m2 /person


• Donor Counseling - 5.02 m2
• Physical Exam area for donor - 5.02 m2
• Donor extraction - 6 m2 per bed or couch
• Blood screening for TTls - 10 m2
• Processing of blood into blood components - 4.65 m2 per equipment
• Storage facility- 4.65 m2 per storage unit
• Releasing of blood products
• Administrative Office

1.4.2 The Blood Service Facility shall be adequately, ventilated


well-lighted, clean, safe and functional based on the services provided.
Blood Blood Blood Station I Hospital Hospital Blood Blood Center Remarks
Station Collection Blood
STANDARDS AND REQUIREMENTS (BS) Unit (BCU) Blood Bank (HBB) Bank with (BC)
Collection Additional
Unit Function
lBS/BCU) (HBB++)

1.4.2.1 Ocular inspection demonstrates good ventilation, lighting, cleanliness with no risk of /
physical and chemical hazards.

1.4.3 There shall be a program of proper maintenance and monitoring of physical plant
and facilities.

1.4.3.1 Program for the proper maintenance and monitoring of physical plant and /
facilities
1.4.3.2 Records of the proper maintenance and monitoring of phvsical olant and facilities /

1.4.4 There shall be a policy and procedure on laboratory biosafety and biosecurity and
for the proper disposal of waste and hazardous/ infectious substances that shall
conform to the standards set by the DOH

1.4.4.1 Policy and procedure on laboratory biosafety and biosecurity and for the proper
disposal of waste and hazardous/ infectious substances.
X
1.4.4.2 Records on laboratory biosafety and biosecurity and for the proper disposal of waste
and hazardous/ infectious substances. /

1.5. EQUIPMENT

All equipment and instruments necessary for the safe and effective provision of
services are available and are properly maintained.

1.5.1 There is an adequate number of functional equipment to provide the procedures the
Blood Service Facility is authorized for.

1.5.1.1 Equipment listed in Standars available in the BSF


1.5.1.3 Personnel protec tive equipment available.
1.5.1.4 Records of monitoring of temperature of refrigerator and other cold storage equipment if /
any.Certificate of Product Rewgistration from Food and Drug Administration (FDA) /
/
/
Blood Blood Blood Station Hospital Hospital Blood Remarks
Station Collection / Blood Blood Bank Center
STANDARDS AND REQUIREMENTS (BS) Unit (BCU) Blood Bank (HBB) With additional (BC)
Collection Unit function
(BS/BCU) (HBB++)

1.5.2 There is a program for calibration, preventive and repair of the quipment

1.5.2.1 Program and schedule of calibration, preventive maintenance and repair of /


equipment calibrated weighing scale
1.5.2.2 Records of calibration, preventive maintenance and repair of equipment. /

1.5.3 There shall be a contingency plan in case of equipment breakdown,


especially of Blood Service Facility cold storage equipment.

1.5.3.1 Contingency plan in case of equipment breakdown / BMC


1.5.3.2 Record of actions taken in case of equipment breakdown
none so far

1.6. REAGENTS AND SUPPLIES

All reagents and glassware to be used by the Blood Service Facility shall be based
on the minimum requirement for sensitivity and specificity of testing reagents as
well as the testing procedures as recommended by the technical committee of
the NVBSP.

1.6.1 There is an adequate supply of properly stored and inventoried reagents and
supplies.

Blood Blood Collection Blood Station I Hospital Hospital Blood Blood Center Remarks
Station Unit Blood Bank Bank
STANDARDS AND REQUIREMENTS (BS) (BCU) Blood (HBB) With additional (BC)
Collection Unit function
(BS/BCU) (HBB++)

1.6.1.1 Records of inventory, usage/ consumption and disposal of reagents/ supplies. /


1.6.1.2 Materials Safety Data Sheet (MSDS) for all reagents/supplies accessible when /
needed

1.6.2 There are adequate storage facilities such as refrigerators for perishable reagents
and supplies.
/
/
/
1.6.2.1 Refrigerator for storage of perishable reagents and supplies /
1.6.2.2 Records of monitoring of temperature of refrigerator

1.6.3 There is appropriate storage area/system for flammable, combustible


and hazardous chemicals/ reagents.

1.6.3.1 Appropriate storage area for flammable, combustible, and hazardous /


chemicals/reagents.
1.6.3.2 Appropriate system of storage for flammable, combustible, and hazardous
chemicals/ reagents following safety (MSDS) requirements. /

1.7. REPORTING AND RECORDS MANAGEMENT

There shall be a system of reporting and recording of stored and issued blood and blood
products.

1.7.1 There shall be a policy and procedure for reporting of stored and issued blood and
blood products.
1.7.1.1 Policy and procedure for reporting of stored and issued blood and blood products. X

Blood Blood Blood Station I Hospital Hospital Blood Blood Center Remarks
Station Collection Blood Bank Bank
STANDARDS AND REQUIREMENTS (BS) Unit (BCU) Blood (HBB) With additional (BC)
Collection Unit function
(BS/BCU) (HBB++)

1.7.1.2 Monthly and annual reports on of stored and issued blood and blood products. /
1.7.2 There shall be a Policy and procedure for retention of records which shall follow
standards promulgated by the DOH and/or competent professional organizations.

1.7.2.1 Policy and procedure for retention of records.


X
1.7.2.2 File of retained records. /
1.7.2.3 Inventory of disposed records /

1.7.3 There shall be a designated area for storage of records.

1.7.3.1 Storage area adequate for records generated


/
For Blood Center and Blood Bank with Additional Functions

There shall be system of recording and reporting of results of immunohematology


examinations and testing for infectious diseases and collection, storage and issuance
of blood and blood products.

1.7.4 There shall be a policy and procedure for recording and reporting of results of
immunohematology examinations and testing for infectious diseases.

1.7.4.1 Policy and procedure for recording and reporting of results of immunohematology
examinations and testing for infectious diseases.
1.7.4.2 Records of results of immunohematology examinations and testing for
infectious diseases.

Blood Blood Blood Station I Hospital Hospital Blood Blood Center Remarks
Station Collection Blood
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Function
(BS/BCU) (HBB++)

1.7.4.3 Monthly and annual reports of immunohematology examinations and tests for infectious
diseases.
1.7.5 There shall be a policy and procedure for the recording and reporting of collection,
storage, issued, and shared blood and blood products from voluntary donors.

1.7.5.1 Policy and procedure for the recording and reporting


of collection, storage, issued, and shared blood and blood products.

1.7.5.2 Records of collection, storage, issued, and shared blood and blood products.

1.7.5.3 Monthly and annual reports of collection, storage, issued, and shared blood & blood
products.
1.7.6 There shall be a policy and procedure to ensure blood safety by screening and
testing for the five (5) TTls namely: HIV 1/2, HBsAg, HCV, Malaria, Syphilis and
other TTls mandated for screening by the Technical Committee of the NCBS.

1.7.6.1 Policy and procedure for testing for the five (5) TTls, i.e, HIV 1/2, HBsAg, HCV, Malaria
and Syphilis
1.7.6.2 Records of results of Testing for the five (5) TTls
1.7.6.3 Monthly and Annual Reports of no. of units of Negative and Reactive Blood.
1.7.6.4 Quarantine records for blood products that are reactive to any markers of TTI
1.7.7 There shall be a policy and procedure for confirmation of blood/blood products
intially reactive to any of the 5 TTI markers namely: HIV 1/2, HBsAg, HCV, Malaria & Syphilis

Blood Blood Blood Station I Hospital Hospital Blood Blood Center Remarks
Station Collection Unit Blood Bank Bank
STANDARDS AND REQUIREMENTS (BS) (BCU) Blood (HBB) With additional (BC)
Collection Unit function
(BS/BCU) (HBB++)

1.7.7.1 Policy and procedures for the referral to RITM TTI NRL for confirmation of blood/
blood products initially reactive to any of the 5 TTI markers
1.7.7.2 Records of referral for confirmation of blood/ blood products initially reactive to any
of the 5 TTI markers.
1.7.7.3 Records of receipt of results of confirmation testing of blood/ blood products initially
reactive to any of the 5 TTI markers referred.
1.7.7.4 Monthly and Annual Reports of results of confirmation testing of blood/ blood
products initially reactive to any of the 5 TTI markers referred.

1.7.8 There shall be a policy and procedure for the storage and distribution of whole
blood/ components.

1.7.8.1 Policy and procedure for the storage and distribution of whole
blood/components.
1.7.8.2 Records of storage and distribution of whole blood/ components.
1.7.8.3 Monthly and annual reports of no. of units of whole blood/components stored and
distributed.

1.7.9 There shall be a policy and procedure for the management of inventory of
blood products.
X
1.7.9.1 Policy and procedure for the management of inventory of blood products. /
1.7.9.2 Logbooks/records of management of inventory of blood products.

Blood Blood Blood Station I Hospital Hospital Blood Blood Center Remarks
Station Collection Unit Blood Bank Bank
STANDARDS AND REQUIREMENTS (BS) (BCU) Blood (HBB) With additional (BC)
Collection Unit) function
(BS/BCU) (HBB++)
FOR BLOOD STATION AND HOSPITAL BLOOD BANK

There shall be system of recording and reporting of results of immunohematology


examinations and collection, storage and issuance of blood and blood products.

1.7.10.1 Policy and procedure for recording and reporting of results of X


immunohematology examinations. /
1.7.10.2 Records of results of immunohematolgy examinations. /
1.7.10.3 Monthly annual reports of immunohematology examinations.

1.7.11 There shall be a policy and procedure for the storage and distribution of
whole blood /PRBC.
Note: For HBB, whole blood, PRBC and other blood components

1.7.11.1 Policy and procedure for the storage and distribution of whole blood /PRBC.
1.7.11.2 Records of storage and distribution of whole blood /PRBC X
1.7.11.3 Monthly and annual reports of the no. of units of whole blood/PRBC stored and /
distributed.

Blood Blood Blood Station Hospital Hospital Blood Blood Remarks


Station Collection / Blood Bank Bank Center
STANDARDS AND REQUIREMENTS (BS) Unit (BCU) Blood (HBB) With additional (BC)
Collection Unit function
(BS/BCU) (HBB++)

1.8 QUALITY ASSURANCE PROGRAM

The Blood Center shall put into practice a Quality Assurance Program.

1.8.1 There shall be policies and procedures on Quality Assurance Program and
Continuous Quality Improvement.

1.8.1.1. Policy and Procedure on Quality Assurance Program including Internal Quality Control
1.8.1.2 Records of Internal Quality Control and Quality Control of reagents X
1.8.1.3 Policy and Procedure for Internal Quality Audit /
1.8.1.4 Records of Internal Quality Audit. X
1.8.1.5 Analysis of results of Internal Quality Audit and recommendations to improve the services. /
1.8.1.6 Quality Improvement Studies for improvement of delivery of services. /
/
1.8.2 The Blood Service Facility shall participate in an External Quality
Assessment Program (EQAP) administered by the designated National
Reference Laboratories (NRL) or other External Quality Assessment Program
approved by the DOH.

1.8.2.1 Policy and Procedures in the participation in NEQAS administered by the


designated NRLs.
1.8.2.2 Certificate of participation of the Blood Center in the NEQAS administered by the
designated NRLs.

Blood Blood Blood Hospital Hospital Blood Remarks


Station Collection Station/ Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Function
(BS/BCU) (HBB++)
For Hospital Based Blood Station and Blood Bank

1.9 Hospital Blood Transfusion Committee:

1.9.1 There shall be a policy and procedure for the establishment and operation of a
Hospital Blood Transfusion Committee.

1.9.1.1 Policy and procedure for the establishment and operation of a Hospital Blood Transfusion
Committee. X
1.9.1.2 Letter, Memo or Order establishing the Hospital Blood Transfusion Committee providing for
its composition and duties and responsibilities. X duties & responsibilities for
each memeber with conforme
1.9.2 The Hospital Blood Transfusion Committee (HBTC) shall meet and perform its
duties and responsibilities.

1.9.2.1 Minutes of meetings of HBTC, including Monthly reports of Blood Bank procedures,
requests and issuance of blood and blood products. /
1.9.2.2 Memos or letters issued by HBTC to carry out recommended policies, procedures,
sanctions, etc. /
1.9.2.3 Records of blood utilization reviewed and performed including corrective actions
taken. /
1.9.2.4 Report on activities conducted in Blood Donors Month (July), if applicable
1.9.2.5 Annual reports of activities including review of policies, procedures, and blood utilization. /
1.9.3 The HBTC shall conduct seminars to promote voluntary blood donation and the
appropriate use of blood and blood products.
/

1.9.3.1 Calendar of seminars and other Training sessions on voluntary blood donation and the
appropriate use of blood and blood products.
1.9.3.2 Certificates or Records of Training on seminars and other training sessions on voluntary /
blood dobation and the appropriate use of blood and blood products conducted.
/
ANNEX B. EQUIPMENT
EQUIPMENT BS BCU BS/BCU HBB HBB++ BC Remarks

1. Agglutination viewer /
2. Air-conditioning Unit in work area /
3. Apheresis Machine with AVR, for BSF with component collection by Apheresis

4. Autoclave for sterilization before disposal of used blood bags if no outsourced waste
disposal provide OR Bio-waste processor or proof of waste collection (MOA with a tertiary
clinical laboratory for investigation of
sus ected contaminated blood units /

5. Automatic Emergency Light /


6. Balance

6.1 Analytical Balance


6.2 Rough balance, top loading

7. Blood Collection

7.1 Blood donor couch or bed


7.2 Spring scale for blood unit
7.3 Surgical forceps, scissors
7.4 Tube sealer
7.5 Blood mixer
7.6 Tube stripper
8. Blood Transport box with non-mercurial thermometer and adequate cold acks for
mobile blood donation

9. Centrifuge

9.1 Serological centrifuge (>3400 rpm with minimum timer of 30 seconds)


9.3 Clinical Centrifuge /
/
9.4 Refrigerated centrifuge with AVR- UPS
n/a
10. Computer with printer, UPS, AVR
/
11. Immunology Analyzer for TTIs:

11.1 Enzyme Immunoassay (EIA) equipment set with AVR 11.1.1 EIA reader
11.1.2 EIA washer microdiluter

11.1.3 Incubator or heating block or its equivalent


11.2 Chemiluminiscence (Optional)
11.3 NAT testin O tional for HBB++

12. Fire Extinguisher /

13. Freezer

13.1 Plasma freezer (-30°C) with AVR


13.2 Ultralow freezer (-70°C) with AVR
13.3 Blast freezer (Optional)

14. Generator with capacity of at least 40 KVA

15. Hematology Analyzer for QC of blood products

16. Hemoglobin determination, any one of the following:

16.1 Copper Sulfate for mobile blood donation


16.2 Hemoglobinometer, or Photometer or Spectrophotometer

17. Microscope, binocular, equipped with Oil Immersion Objective (010)

18. Needle destroyer


/
19. Pipettor

20. Plasma Extractor

21. Plasma Thawer or its equivalent, with regulated temperature

22. Platelet Rotator/ Agitator with incubator


17. Microscope, binocular, equipped with Oil Immersion Objective (010)

18. Needle destroyer

19. Pipettor

20. Plasma Extractor /

21. Plasma Thawer or its equivalent, with regulated temperature

22. Platelet Rotator/ Agitator with incubator

23. Red Cell Antibody Screening System and phenotyping

24. Refrigerator

24.1 Blood Bank Refrigerator controlled at 2-6 °c with temperature


recorder and alarm system, and AVR
24.2 Reagent refri gerator with laboratory thermometer and AVR

25.Rotator for RPR or VDRL /

/
26. Sphygmomanometer (Non-mercurial)

25. Rotator for RPR or VDRL


27. Stethoscope

26. Shygmomanometer ( Non Mercurial )

27. Stethoscope

28. Stopwatch or timer /


29. Tackle box/ Phlebotomy box /
30. Thermometer
30.1 Clinical Thermometer (non-mercurial)
n/a
30.2 Laboratory Thermometer /
30.3 Room Thermometer /

31. Water bath/ dry bath set at 37'C for cross-matching and discrepant bloodtyping
/

32. Clinical Weighing Scale


32.1 Calibrated up to 200 kilograms - for blood donors
32.2 Calibrated u to 500 rams - for blood units /
Name of Facility: Date of Inspection:

Recommendations:

A. For Licensing
Process:

[ ] For issuance of License as_____________-

VaIidity from_____________________ to _________________________.

[]Issuance depends upon compliance to the recommendations given and submission of the following within days from the date of inspection:

[ ] Non-Issuance: Specify reason/s.

Inspected by:
Printed Name Signature Position/Designation

Received by:
Signature Printed Name Position/Designation--------------
Date
Republic of the Philippines Department of
HealthHEALTH FACILITIES REULATIORY BUREAU

Name of Facility: Calumpit District Hospital _


Date od monitoring: August 10, 2021

RECOMMENDATIONS:
B. For Monitoring Process:
[] Issuance of Notice of Violation

[ ] Non-issuance of Notice of Violation

[/ ] Others (Specify) To comply noted deficiencies within 30 working days

Monitored by:
Printed Name Signature Position/Designation
Girlie C. Soriano LO III

Received by:
Signature
Printed Name Rowena Evangelista Position/Designation-------------
Date _

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