BS Tool For Compliance
BS Tool For Compliance
Name of Facility: Calumpit District Hospital Certificate of Inclusion No. DOH-NBVSP-DOH-CL-2021-0042 Exp. Jan-Dec. 31, 2021
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
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:
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
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++)
1.2.1.1 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
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
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
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
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.
1.3.2 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.
1.3.5.1 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 /
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
1.3.8.1 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
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 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)
.
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.
1.5.2 There is a program for calibration, preventive and repair of the quipment
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++)
1.6.2 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
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.
1.7.4 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.
1.7.5.2 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
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.
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.
1.9.1 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 /
7. Blood Collection
9. Centrifuge
11.1 Enzyme Immunoassay (EIA) equipment set with AVR 11.1.1 EIA reader
11.1.2 EIA washer microdiluter
13. Freezer
19. Pipettor
24. Refrigerator
/
26. Sphygmomanometer (Non-mercurial)
27. Stethoscope
31. Water bath/ dry bath set at 37'C for cross-matching and discrepant bloodtyping
/
Recommendations:
A. For Licensing
Process:
[]Issuance depends upon compliance to the recommendations given and submission of the following within days from the date of inspection:
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
RECOMMENDATIONS:
B. For Monitoring Process:
[] Issuance of Notice of Violation
Monitored by:
Printed Name Signature Position/Designation
Girlie C. Soriano LO III
Received by:
Signature
Printed Name Rowena Evangelista Position/Designation-------------
Date _