Manual of Standards for Blood Service Facilities (NVBSP)

In this document:

•Section 2: Quality System Requirements 2.1 2.2 Section 2 Quality System Requirements Quality Policies, Guidelines and Objectives 2.4.1 2.1.2 2.1.3 Policies and Guidelines There shall be a series of related or tiered documents, consistent with each other, describing the systems in each BSF, each tier becoming progressively more detailed. These documents shall cover essential policies, guidelines, procedures and specific work instructions, forms and records. Defining Organizational Objectives The management of each BSF shall define organizational objectives pertaining to good manufacturing practices, quality services and blood products and legal requirements. These shall indicate how the Standards herein can be complied with. Administrative Procedures A Quality System Manual which puts together the policies, job delineation, task delegation and coordination including the flow of authority and responsibility shall be required at each BSF.
•Section 6 : Blood Collection, Testing, Processing, Storage, issuance and Transport 6.3.5.4 _components not collected.
•Section 6 ; Blood Collection, Testing, Processing, Storage, issuance and Transport Cold chain shall be followed during transport and distribution of the blood products (Teble 3.1, page 9). Components ordinarily stored at room temperature (+ 20°C to +24°C) shall be transported also at +20°C to +24°C Blood products stored at +2°C to +6°C shall be transported at +2°C to +10°C. Frozen components shall be transported with dry ice to maintain their frozen state. Blood units shall be packed and distributed using blood transport boxes. 6.4.9 Reissue and Re-designation Blood units which have been returned to the issuing or releasing BSF within 30 minutes may be reissued provided that the following conditions are met and documented in the appropriate logbooks and records by the personnel-in-charge: . The sterility of the blood product is maintained + The product has been stored in the proper temperature At least two sealed segments of the integral donor tubing remained intact
•Section 9: Documents and Records 9.2.2 9.2.3 9.2.4 9.2.5 9.2.1.1 Copies of Records Before the destruction of the original records, the BSF shall have a process to ensure that copies of records are identified as such. Copies of records shall be verified as containing the original content and shall be legible, complete, and accessible. A system designed to prevent unauthorized access and ensure confidentiality of records shall be established and followed. The record system shail make it possible to trace any unit of blood, and blood products from iis source to final disposition; to review the records applying to the specific component, and to investigate adverse events manifested by the recipient. 9.2.3.1 The system shall ensure that the donor number and donation identification number are unique and shall match with each other. The actual result of each test observed shall be recorded immediately and the final interpretation shall be recorded upon completion of testing.

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Section 3: The Blood Products 3.3 Special Blood Product 3.3.1 Irradiated Blood Producis Irradiation utilizes gamma radiation to inactivate all potentially proliferative cells (T lymphocytes) in WB, PRBC and PC in order to prevent Transfusion-Associated Graft versus Host Disease (TA- GVHD). These are subjected to Cobalt 60 or Cesium 137 isotopes using a licensed blood irradiator. Dosage of irradiation 25gy. Manual of Standards for Blaod Service Facilities 25 oA

Section 4: Physical Plant, Equipment and Materials Section 4 The Physical Plant, Equipment and Materials Building and Facilities Buildings and facilities shall be located, designed, constructed and utilized so as to ensure both quality and safety of blood products and services as well as the safety and comfort of VNRBD and personnel. 4.1 4.2 4.3 4.4 Building Design and Maintenance Buildings shall be designed, constructed and maintained so as to protect against the effects of weather, ground seepage, flooding, fire, and the entry of vermin, insects, pests and stray animals. Restriction of Entry of Unautherized Person Selected rooms shall be secured against entry of unauthorized persons. Construction Materials and Werk Surfaces Construction materials shall be sturdy and resistant to strong and abrasive cleaning agents. Concrete materials shall be used for construction and support, Building materials in the processing areas shall be free from cracks or open joints and shall be non-porous. Floors shall be non-slip and easy to clean. Work areas shall have coated surfaces resistant to chipping. Clear Demarcation and Smooth Flow of Werk and Activities The physical arrangement shall atlow for the smooth and orderly flow of activities and movement of people and supplies. Work areas for blood donor selection and screening, collection, testing, processing, validation, packaging, issuance or transport and special procedures like apheresis when applicable, shall be separated and well- demarcated. Manual of Standards for Blood Service Facilities 29 oA

Section 4: Physical Plant, Equipment and Materials 4.5 Adequacy of Space The BSF shall provide adequate space for the different activities applicable to the services provided: 4.5.1 VNRBD Reception and Refreshment Areas This shall be equipped with comfortable waiting facilities as well as clean and convenient hand washing and toilet facilities with adequate water supply. Educational and promotional materials on blood donation and other interesting health issues shall be available. Audio-visual facilities are encouraged. 4.5.2 VNRBD Assessment Area The assessment area shall provide auditory and visual privacy to assure confidentiality of VNRBD -related information. This will also promote accuracy of medical and social history. 4.5.3 Hemoglobin Determination Area The area for hemoglobin determination shall be clean and organized to avoid errors and mislabeling. 4.5.4 Blood Collection, Testing and Processing Areas _These areas shall be suitable, adequate and appropriately equipped ‘and organized to ensure minimal risk of contamination and errors. 4.5.5 Areas for Packaging, Validation, Labeling and Other Documentation Operations There shall be a space for counterchecking, validating, packaging, computer work, and other documentation operations. 4.6 Storage Storage areas shall provide adequate space, suitable lighting, easy access and organized to allow dry, clean and orderly placement of stored material under controlled temperature conditions. 4.6.1 Blood Products There shall be clear demarcation of stored blood products under controlled temperature required for each type of products. Cold rooms shall be encouraged in large blood centers. 4.6.2 Reagents and Other Supplies and Materials There shall be temperature-controlled storage areas for reagents and adequate dry areas for other materials and supplies. 4.6.3 Records, SOP Manuals and References Records, manuals and references shall be orderly arranged in a readily accessible area. AH 30 = Manual of Standards for Blood Service Faciiltles

Section 4; Physical Plant, Equipment and Materials 4.7 4.8 Lighting and Ventilation There shall be adequate lighting and ventilation in all work areas. Safety and Cleanliness 4.8.1 4.8.2 4.8.3 4.8.4 4.8.5 4.8.6 Eating, Drinking and Smoking Eating, drinking and smoking shall not be permitted in any area where activities might adversely influence product quality or where staff may be exposed to potentially harmful agents, There shall be areas designated for eating, drinking and rest of personnel. Toilet and Washing Facilities and Lockers for Personnel There shall be adequate, clean and convenient handwashing and toilet facilities with adequate water for personnel. Secure lockers Shall also be provided. Doors and Fire Exits Access to temperature-controlled rooms and areas shall be from corridors and other processing areas. Where internal doors are a barrier to avoid contamination, they shall be kept closed when Linnotin.use. There shallbe accessible and clearly demarcated Fire Exits. Doors that lead from processing areas directly to the outside, e.g. fire exits, shall be secured in such a way that they may be used only as emergency exits. Daily Cleaning Maintenance Floors shall be cleaned daily with appropriate cleansing agent. When grossly contaminated, walls shall be cleaned and decomtaminated regularly. Work areas shall be neat and tidy at all times. Drains Drains shall be of adequate size and, where connected directly to a sewer, shall be equipped with traps to prevent back-siphoning. Pest Control Where pest control is needed, as in the case of storage of papers and records, it shall be carried out in such a way as to ensure that the chemicals used do not contaminate BSF materials. Manual of Standards for Blood Service Facilities

Section 4: Physical Plant, Equipment and Materials 4.9 Equipment Equipment which is technically suitable, properly located, easy to clean, and well maintained is essential for accurate testing, prevention of contamination and ensuring the quality of the blood products. 4.9.1 Appropriate and Adequate Equipment 4.9.1.1 4.9.1.2 4.9.1.3 4.9.1.4 4.9.1.5 Recommended Equipment, Furniture and Instruments Each BSF shall have appropriate and adequate equipment, furniture and instruments for blood bank and transfusion service. The quantity of equipment needed depends on the number of blood units collected and processed, the methods used, and the existing infrastructure. In situations where there are no back-up equipment, a contingency plan shall be in place. Procurement Plan and Specifications of Basic Equipment A comprehensive equipment procurement plan shall be prepared by each BSF with consideration as to specifications and quality of equipment to be procured. There shall be provisions for training of staff on new equipment and service maintenance agreements shall be required when procuring equipment. Quality of Equipment and Instruments Equipment shall meet the approved requirement set by the Food and Drugs Administration (FDA) - Bureau of Heaith Devices and Technology (BHDT) or Department of Trade and Industry (DTI). New equipment shall be capable of achieving the performance required and comply with specifications relevant to the examinations and procedures concerned. Proper Use of Equipment Equipment Operational Manual shall be available to all staff at all times. Equipment shall be operated only by authorized and properly trained personnel. Equipment Maintenance and Calibration All equipment shall be regularly monitored, calibrated and properly maintained with proper documentation. Please refer te table 4.9.1.5. OC] || 32 Manual of Standards for Blood Service Facilities

Table 4.9.1.5 Calibration and Preventive Maintenance of Equipment L I. Refrigirators/ Freezers/ Platelate Incubators A. Refrigirators 1, Recorder 2. Manual temperature 3. Alarm system board (if applicable} 4. Temperature charts {rewiew daily} 5. Alarm activation Freezers 1. Recorder 2. Manual Temperature 3. Alarm system board (if applicable) 4, Temperature charts (rewiew daily} 5. Alarm activation C. Platelate Incubatars 1. Recorder 2. Manual Temperature 3. Temperature charts (rewiew daily} 4. Alarm activation Ambient platelate storage area Dz Laboratory Equipment A, Centrifuges/cell washers 1. Speed 2. Timer 3. Funtion 4. Tube fill level {serologic} 5. Saline fill volume {serologic} 6. Volume of antihuman globulin dispensed (if applicable} 7. Temperature check (refrigirated centrifuge) 6. Temperature verification (refrigirated centrifuge) B. Heating blocks/ Waterbaths/ View boxes 1. Temperature 2. Quadrant/area checks Dose delivery check (with indicator Dose verification system a. Cesium-137 b. Cobalt-60 c. Other source C. Component thawing devices D. pH meters E. Biood indicators 1. Calibration 2. Turntable (visual each time of use} 3. Timer 4. Source of decay 5. Leak test 6. 7. Daily Daily Daily Weekly Quarterly Daily Daily Daily Weekly Quarterly Daily Daily Weekly Quarterly Every 4 hours Quarterly Quarterly Yearly Day of use Weekly Monthly Day of use Monthly Day of use Periodically Day of use Day of use Yearly Yearly Monthiy/ Quarterly Dependent on source type Twice yearly Each indicator use Yearly Twice yearly As specified by manufacturer | of Standards for Blood Service Facilities

Section 4: Physical Plant, Equipment and Materials Each item of equipment shall be labeled with the following details:

Identity of the equipment Serial Number Manufacturer’s name Dates of acquisition and installation Location of the equipment Inventory number (optional) Company service engineer contact number ~I N W B W h 4.9.1.6 Temperature Monitoring and Alarm Systems All blood storage equipment and room temperature shall be monitored and recorded every four (4) hours or at least every eight (8) hours. Temperature monitoring charts shall be posted strategically. Monitoring chart shall be reviewed and validated every end of the month by the Quality Officer or the Blood Bank Head. All blood storage equipment shall be equipped with a system for continuous temperature monitoring and an audible alarm in the event that storage temperature goes out-of-range. The alarm shall be set at temperature that will allow proper action to be taken before the blood” product reaches undesirable temperatures. Authorized personnel shall reset the alarm. 4.9.1.7 Thrawer for Frozen Components Warming devices such as plasma thawers shall be equipped with a temperature sensing device and a warning system to detect malfunctions. Depending on the frequency of use, the plasma thawer shall be tested for bacterial contamination at least once a month. 4.9.1.8 Equipment Malfunction Equipment found to be defective shall be taken out of service, properly labeled and appropriately stored until it has been repaired and re-calibrated to meet specified acceptance criteria, BSF shall follow prescribed protocols in case of equipment malfunction. ae 34 Manual of Standards for Bload Service Facilities

Section 4: Physical Plant, Equipment and Materials 4.9.1.9 4.9.1.10 Computer System a. All BSF shall subscribe to the integrated blood bank information system (National Blood Bank Network System or NBBNetS) to manage data on VNRBD, collection, processing, testing, storage, dispensing and generating reports. If the information system is unavailable in the area, the process flow shall be consistent with that of the NBBNetsS. b. Data security and integrity shall be ensured at all times. c. Data backup mechanism and co-location of database shall be in place. d. Computer hardware and peripherals shall conform to the prescribed specification set by the information system provider. e. Computer software, including that bundled with the hardware shall have valid and updated license. Record Keeping Each BSF shall maintain a Master list of Equipment and Calibration schedule for each unit. Preventive Maintenance and Service reports shall also. be maintained. Refer te Table under 6.5.1.5 — Documented reports of corrective maintenance done in defective equipment shall be kept. These records shall be maintained and shall be readily available for the equipment’s lifespan or as required by DOH local or international accrediting body. 4.10 Reagents and Supplies All BSFs shall ensure the provision of adequate and suitable reagents and supplies for the preparation and testing of blood. All BSFs shall have enough reagents and supplies for testing. 4.10.1 4.10.1.1 Quality of Reagents and Supplies BSF shall only procure reagents, blood bags and other supplies registered with FDA- Philippines and evaluated by the NRL. Manual of Standards for Blood Service Facilities

Section 4: Physical Plant, Equipment and Materials 4.11 4.12 4.10.2 4.10.3 4.10.4 4.10.5 4.10.6 4.10.1.2 Any product such as reagents, blood bags and other supplies found to be defective and sub-standard shall be properly documented and reported to the National Voluntary Blood Services Program (NVBSP). 4.10.1.3 The Quality Manual shall contain quality control process on the proper transport and storage of reagents and supplies to ensure potency and integrity. Glassware Glassware shall be inspected for breakages or scratches prior to use. Disposables (e.g. test tube) shall not be reused. Inventory of Reagents and Supplies BSF shall maintain a stock card or its equivalent to ensure proper monitoring of reagents and supplies. Strict Inventory management principles shall be observed. Manufacturer’s Instructions Operational manual of equipment and Product inserts of supplies and reagents shall be strictly followed and kept for reference. Suppliers The BSF shall have policies, processes and procedures to evaluate the capability and track record of suppliers of materials, equipment and services to consistently meet standard requirements. 4,10.5.1 Suppliers shall be accredited by the FDA, BHDT and DTI. There shall be procedures and criteria for acceptance and rejection of suppliers. Duty-Free Importation Only BSF actively participating in the NVBSP may be recommended for duty-free importation. Personnel 4.12.1 The BSF shall have an organizational chart, with job descriptions that define qualifications and duties for all personnel CIC] 36 Manual of Standards for Blood Service Facilities Ot

Section 4: Physical Plant, Equipment and Materials 4.12.2 4.12.3 4.12.4 The BSF shall have records of the relevant educational and professional qualifications, training and experience, and competence of ail personnel. This information shall be readily available to relevant personnel, and may include the following: a. Professional license relevant to the position references from previous employment; job description; records of continuing education and certifications; achievements and awards; competency evaluations mhoaocs Other records relating to personnel health may include records of exposure to occupational hazards and records of immunization status. The BSF shall be headed by duly certified pathologist or hematologist having management or administrative skills and the competence to assume responsibility for the services provided. Non-hospital based BCU shall be headed by a duly licensed physician with at least three (3) months formal training in blood banking recognized by DOH-NVBSP or with one(1) year experience in a Blood Bank/ Center that performs blood collection activities recognized by DOH-NVBSP. The responsibilities of the BSF head or his/her deputies shall include professional, scientific, consultative or advisory organizational, administrative and educational matters. These shall be relevant to the services offered by the laboratory. The BSF head or his/her deputies for each task should have the appropriate training and background to be able to discharge the following responsibilities: a. Relate and function effectively (including contractual arrangement, if necessary), with i. Application accrediting and regulatory agencies, ii. Appropriate administrative officials, iii. The healthcare community, iv. The patient population served; b. Define, implement and monitor standards of performance and quality improvement of the medical laboratory service or services; Manual of Standards for Blood Service Facilities

Section 4: Physical Plant, Equipment and Materials c. Implement the quality management system (the laboratory head and professional laboratory personne! should participate as members of the various quality improvement committees of the institution, if applicable); d. Monitor all work performed in the BSF to determine that reliable data are being generated; e, Ensure that there are sufficient qualified personnel with adequate documented training and experience to meet the needs of the BSP; f. Plan, set goals develop and allocate resources appropriate to the medical environment; g. Provide effective and efficient administration of the medical laboratory services, including budget planning and control with responsible financial management, in accordance with institutional assignment of such responsibilities; h. Provide educational programs for the medical and laboratory staff and participate in educational programs of the institution. i. Implement a safe laboratory environment in compliance with good practice and applicable regulations; j. Address any complaint, request or suggestion from users of BSF; k. Ensure good staff morale. The BSF Head need not perform all responsibilities personally. However, it is the BSF Head who remains responsible for the overall operation and administration of the BSP, for ensuring that quality services are provided for donors, patients and staff. 4.12.5 There shall be staff resources adequate to the undertaking of the work required and the carrying out of the functions of the quality management system. 4.12.6 Personnel shall have training specific to quality assurance and quality management for services offered. 4.12.7 BSF management shall authorize personnel to perform particular tasks such as sampling, examination and operation of particular AH 38 Manual of Standards for Blood Service Facilities

Section 4: Physical Plant, Equipment and Materials 4.13 4.12.8 4.12.9 4.12.10 4.12.11 4.12.12 EN .12.13 types of equipment, including use of computers in the laboratory information system. Policies shall be established which define who may access the information system, There shall be a continuing education program and updates available to staff at all levels. Employees shall be trained to prevent, manage and contain the effects of adverse incidents. The competency of each person to perform tasks shall be assigned following training and periodically thereafter. Retraining and reassessment shall occur when necessary. The personnel making professional judgment with reference to examinations shall have the applicable theoretical and practical background as well as recent experience. Confidentiality of information regarding donors and patients shall be maintained by all personnel at all times. Manpower Requirement 4.13.1 4.13.2 Qualification and Minimum Number Requirements The establishment, implementation and maintenance of a quality assurance system in the BSF including the correct preparation of blood components rely upon competent people. For this reason, personnel shall have the education, training, experience and skills to ensure that they can perform assigned duties. In addition, there shall be a sufficient number of qualified and experienced personnel with at least six (6) months on-the-job training in blood banking to carry out the required services and provide the necessary blood products. Job Descriptions and Functions Each position in a BSF shall have a written job description which shall contain the following: duties, functions and responsibilities, measurable standards of performance for the tasks, hours of work, qualifications, immediate supervisor with whom the employee frequently works and communicates. Staff shall be required to sign their specific job description forms which shall be filed in their individual personnel records. OO Manual of Standards for Blood Service Facilltles 39 oc

Section 4: Physical Plant, Equipment and Materials 4.13.3 4.13.4 4.13.5 Personne! shall likewise be required to document the fact that they have read the required manual that apply to their tasks. Levels of Responsibility and Delegation The levels of responsibility, delegation and limitations shall be formally defined for each group or individual members of the staff. The degree of authority, especially to evaluate problems and recommend, initiate or provide corrective actions shall be determined. Functional organizational charts shall be used to define the flow of work and responsibilities. There shall be adequate overall supervision by the blood center over BCU, BS, BCU/BS regarding the quality of services. Evaluation of Staff Competency The competency level of each staff shall be periodically evaluated. Validation can be done through external certification, formal evaluation or regular internal assessment at various levels. This shall be defined in the BSF manual. Program for Continuing Education and Consultation There shall be a program for continuing education of staff and a system of consultation and communication with the personnel. — The program shall be prepared in consultation with the concerned staff. A yearly staff development plan shall be prepared at the beginning of each year. CE) AQ Manual of Standards for Blood Service Facilities OO

Section 5 : The Voluntary Non-Renumerated Blood Donors Section 5 The Voluntary Non-Remunerated Blood Donors (VNRBD) BSFs. Sil 3.2 The VNRBDs are the foundation for an adequate and safe blood supply. The quality and safety of the blood products shall be the responsibility of the Types of Blood Donation S.L.1 5.1.2 5.1.3. 5.1.4 Whole Blood Donation The VNRBD can give about 450 ml of blood every three (3) months provided he/she meets the eligibility criteria. (Refer to Manual on Blood Donor Selection and Counseling) Apheresis Donation Platelets, leucocytes, red blood cells or plasma are selectively collected using the apheresis machine. (Refer to Manual on Blood Donor Selection and Counseling for the eligibility criteria) Autologous Donation in A patient donates his/her own blood at a pre-defined period prior to the elective surgery. (Refer to the Manual on Blood Donor Selection and Counseling for the eligibility criteria) Directed Donation, includes Dedicated Donation Under special circumstances, it may be important to use blood or blood components from a specific VNRBD for transfusion to a specific patient (e.g. patients with rare blood types or atypical red cell antibodies}. The repeated use of a single VNRBD to supply components needed for a single patient is allowed provided it is requested by the patient’s physician and approved by the BC/ BCU physician, Target Groups for Bloed Denation Healthy men and women with the qualification presented below shall be considered as potential “Voluntary Non-Remunerated Blood Donors”. They shall be encouraged to donate blood regularly in licensed/ authorized BSFs. 5.2.1 VNRBD Qualification 5.2.1.1 Allogeneic VNRBD Qualification The potential VNRBD shall meet the VNRBD qualification requirements contained in the Blood Donor Selection and Counseling Manual. | | Manual of Standards fer Bisod Service Facilities

Section 5; The Voluntary Non-Renumerated Blood Donors 5.2.1.2 Autologous VNRBD Qualification Autologous blood transfusion may not require the rigid criteria for VNRBD selection. The alternate requirements shall be defined (refer to Blood Donor Selection and Counseling Manual) and documented by the BC physician. 5.2.1.3 Apheresis VNRBD Qualification With the exception of the donation interval, the standards that apply to allogeneic VNRBD qualification shall apply to the selection of apheresis VNRBDs (refer to Blood Denor Selection and Counseling Manual). VNRBD s who do not meet allogeneic VNRBD requirements shall undergo apheresis only when the blood components are expected to be of particular value to an intended recipient and only when approved by the BC or Apheresis facility physician 5.3 WNRBD Temporary and Permanent Deferral 5.3.1 For the protection of VNRBDS and recipients, VNRBDs with any of the conditions in the Deferral Lists (see A-Z Guide to Medical Assessment of Blood Doners, Blood Donor Selection and Counseling Manual, Appendix C) shall not be allowed to donate for the stated duration. VNRBDs whose blood has been implicated in Transfusion Related Acute Lung Injury (TRALI) shall be evaluated regarding their continued eligibility to donate. Hach potential VNRBD shall be evaluated and examined immediately prior to phlebotomy. 5.4 Pre-Donation Education, Netification and Counseling 5.4.1 Objectives 5.4.1.1 To maintain safety of blood supply and quality of blood products S.4.1.1.1 Enable high-risk persons to defer themselves 5.4.1.1.2 Identify persons with medical condition/s or medications that may affect the quality of the bload product 5. ti To protect the health of the VNRBD 5.4. To fulfill ethical requirement The blood service facility shall have procedures to ensure that the following requirements are met for all potential VNRBDs: ey 44 Manual of Standards for Blood Service Facilities

Section 5: The Voluntary Non-Renumerated Blood Donors 5.4.2 53.4.3 a. VNRBDs shall be informed of donation process, transfusion transmitted infections (TTIs) and the VNRBD’s responsibility in blood safety, whether written or oral, or both before donation to allow for informed consent and self-exclusion, This shall be a routine step in VNRBD selection in every blood donation. b. VNRBDs shall be informed of the risk-factors associated with HIV, hepatitis B, hepatitis C, malaria and syphilis (TTIs). c. VNRBDs shall be informed of the importance of honesty in providing information. d. VNRBDs shall be informed of the importance of refraining from blood donation if they believe that their blood is not suitable for transfusion. As such, they shall notify the concerned BSF even after they have already donated blood. e. VNRBDs shall acknowledge (in writing) that they have read the abovementioned information. Informed Consent by VNRBD ; Written informed consent for donation is a legal and ethical requirement. This implies one’s willingness to donate blood given by a mentally competent person “who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence, or intimidation”. The information given to the VNRBD shall include the donation process, and risks involved. The VNRBD shall be encouraged to ask questions and have them answered and be allowed to give or refuse consent for donation. For potential VNRBDs 16 to 17 years old, written informed assent of the VNRBD and written informed consent of the parents or legal guardians have to be obtained before donation, Notification of Abnormal Findings and Test Results of VNRBD The BSF shall establish the procedure of notifying all VNRBDs (including pre-surgery autologous donors with medically signifi- cant abnormality detected during screening, or as a result of labo- ratory testing, or blood recipient follow-up. It shall have a sys- tem and procedure for managing information regarding VNRBD’s Manual of Standards for Biood Service Facilities

Section 5: The Voluntary Non-Renumerated Blood Donors 5.5 suitability, either from the VNRBD him/herself and/or from an- other party. For autologous donors who are deferred, both the VNRBD and the referring physician shall be notified. All deferred VNRBDs shall be counseled by the designated trained personnel. Care of Voluntary Non-Remunerated Blood Donors 5.5.1 5.5.2 5.5.3 The BSF shall institute policies and procedures of maintaining privacy and confidentiality of information obtained during VNRBD screening and blood testing. During blood donation, the VNRBD shail be attended on a one- on-one basis and observed closely for adverse reactions. The BSF shall have guidelines and procedures for managing donation related adverse reactions and be capable of providing immediate medical care both in the facility and in the MBD site. These adverse events shall be documented, assessed, investigated and monitored. Post-donation Counseling All VNRBDs shall receive post-donation counseling and instructions on post-phlebotomy self-care. | AI] AG Manual of Standards for Blood Service Facilities

Section 6 : Blood Collection, Testing, Processing, Storage, issuance and Transport Section 6 Blood Collection, Testing, Processing, Storage, Issuance and Transport The Blood Service Facility is ultimately responsible for the correct and safe procedures for collection, testing, preparation, handling, storage, issuance and transport of all blood products. Blood shall be collected, tested, and processed using Good Manufacturing Practices (GMP) guided by Quality Manual and Work Instructions. 6.1. Blood Collection 6.1.1 6.1.2 6.1.3 Training of Phiebotomists Medical and paramedical personnel and volunteers shall undergo basic blood donor phlebotomy training recognized by the Philippine Blood Coordinating Council (PBCC). Phlebotomy Prepare all materials needed before phiebotomy. Make sure that all materials used are sterile. Each Blood Bag shall be inspected <..vigually for damage or evidence of contamination prior to its use and immediately after filling. Such examination shall include inspection for breakage of seals and abnormal discoloration. Where any defect is observed, the container shall not be used, or if defective after filling, shall be properly handled and disposed of. Defective supplies shall be immediately labeled “DEFECTIVE MATERIAL” and separated from the rest of the supplies in a designated place prior to proper disposal. The Work Instruction shall describe in detail the phlebotomy technique with special attention to skin disinfection and preparation. To prevent bacterial contamination, reinsertion of a needle is not allowed. A new blood bag, therefore, shall be used if the first attempt is unsuccessful. Labeling and Recording Proper labeling of blood bags must be done during blood collection using the barcode stickers of the NVBSP information system. The following information shall be captured in the NVBSP information system: 1. Unique Blood Donation number OE) Manual of Standards for Blood Service Facilities 49 oo

Section 6 : Blood Collection, Testing, Processing, Storage, issuance and Transport 6.2. 2. Date and Time of collection 3. Name or Initial of Phlebotomist The said information is linked to a set of barcode stickers containing identical donation numbers which shall be placed on the DHQ, sample tubes, and blood bags, including satellite bags. All unused barcode stickers from each set of stickers are attached to the DHQ for accounting. In the absence of IBBIS, labeling shall be done using ball point pen containing the abovementioned information. 6.1.4 Duration of Donation The duration of whole blood donation shall be noted. A whole blood donation longer than 15 minutes shall not be processed into platelet concentrate and cryoprecipitate or Anti Hemophilic Factor (AHF )-rich plasma. 6.1.5 Blood Samples for Testing Blood sample for serologic screening shail be collected from the donor bag into the sample tube or sample pouch, if available. Evacuated tube shall be used in the collection of specimen so as not to comprimise the sterility of the blood units. The identity of the sample tubes shall be ensured through barcoding. 6.1.6 Volume of Whole Blood Collection The volume of blood collected shall be 450 + 10% plus anticoagulant. For BSFs with pediatric transfusions, blood maybe collected using quadruple packs (50m1 x 4). 6.1.7 Submission and Precessing of Blood from Blood Collection Units Specimen for testing and appropriate form/s together with the blood unit/s collected from the BCU shall be sent to the Blood Center, while observing the Blood Cold Chain. Testing of Blood Donor Units 6.2.1 Determination of ABO Blood Group The ABO grouping shall be determined for all blood units. Forward and Reverse Typing shall use the tube method or the method acceptable to NVBSP. The slide method is not acceptable. OO Au 50 Manual of Standards for Blood Service Facilities

Section 6 : Blood Collection, Testing, Processing, Storage, Jssuance and Transport 6.2.2 6.2.3 6.2.4 6.2.5 All blood units with discrepant blood types shall be quarantined in a designated blood bank refrigerator until the discrepancy is resolved. An integrally attached segment of the blood bag shall be retested which shall be compared to the VNRBD’s previous donation record, if available. Determination of Rk (D) Blood Group Rh (D) typing shall use the tube method or the method accpetable to NVBSP, If initially (D) negative, test for weak D antigens (Du) shall be performed. Appropriate negative Rh (D) control (6% albumin) shall be performed. Testing for additional Rh (D) factors and other antigens is optional. Red Cell Antigen and Antibody Screen Blood units may be tested for atypical red blood cell antibody. 6.2.3.1 Antigen - Red cell phenotyping may be determined for blood donor units. 6.2.3.2 Antibody - It is highly recommended that blood donor units be tested for clinically-significant antibodies. Transfusion-Transmissible Infections (TTIs) All blood units from healthy VNRBD shall test negative for the following: HBsAg, HCV antigen and/or HCV antibody, HIV 1 and 2 antigen and antibody, Syphilis and Malaria methods as recommended by the National Council for Blood Services (NCBS) Technical Committee (NCBSTC). Rapid diagnostic platforms shall not be used for screning of blood units for TTIs. Blood units tested non-reactive for HBsAg, HCV antigen and/or HCV antibody, and HIV 1 and 2 antigen and antibody may undergo Nucleic Acid Testing (NAT) if available. A BSF in a locality may do additional screening tests for prevalent infections if technical skills are available and/or if the epidemiologic situation warrants. Introduction of New Mandatory Tests for Other Infectious Agents The NCBS or DOH authority shall require new mandatory tests only after a systematic study and evaluation of the following important factors: the prevalence of the disease, the risk of transmission through blood transfusion, and cost benefit of such introduction. Manual of Standards for Blood Service Facilities a1 Ac

Section 6 : Blood Collection, Testing, Processing, Storage, issuance and Transport 6.3 6.2.6 Issuance of Untested or Partially Tested Blood Unit No untested or partially tested blood unit shall be issued by the BSF, except in cases of extreme emergency. Blood centers may be liable if they do not follow standard procedures. 6.2.7 Testing Methods and Kits BSF shall procure reagents, blood bags and other supplies which are registered with FDA, evaluated by designated NRL and recommended by NCBSTC. 6.2.8 Control Reagents Control reagents supplied by the manufacturer and/or a third party control shall be used as required. All test results shall be validated by the Quality Officer or his/her designate. 6.2.9 Confirmation of the Test Results Blood units found to be reactive in any of the TTIs shall be labeled ‘NOT FOR TRANSFUSION AND FOR CONFIRMATORY TESTING’ and quarantined in a separate cold storage area. All blood units reactive for the above tests (TTI) shall be referred to NRL-NVBSP in Research Institute for Tropical Medicine — (RITM) for confirmatory testing subject to guidelines issued by the DOH. These blood units shall be transported properly at the required range of temperatures of +2°C to +10°C. The NRL-NVBSP in RITM shall inform the referring BSF of the test results within five (5) working days and shall properly dispose these blood units. Quality Procedures shall clearly state the manner of informing the blood collecting facility, the donor, the AIDS Registry, NEC. 6.2.10 Issuance of Test Results Results of serological tests are for BSF use only. No printed or written results, whether positive or negative, shall be issued by any BSF. Blood Component Preparation The type and quantity of blood components which shall be supplied by the lead Blood Service Facilities, designated hospital blood banks with blood center capabilities and blood centers shall depend on the requirements of hospitals, dialysis centers and other end user facilities. LC] CC 52 Manual of Standards for Blood Service Facilities

Section 6 : Blood Collection, Testing, Processing, Storage. {ssuance and Transport All blood components shall be prepared under strict aseptic technique using sterile pyrogen-free equipment and solutions. The use of sterile connecting device that allows transfer of components without breakage of the seal is recommended, 6.3.1 Handling and Storage of Blood Components (Refer to Tables 3.1 and 3.2 under Section 3-The Blood Products Specification) The BSF shall have a process to ensure that blood components, samples and critical materials are handled, stored and transported in a manner that prevents damage, limits deterioration and meets requirements contained in reference standards. 6.3.1.1 Segregation of Blood Components The BSF shall ensure the appropriate segregation of blood and components according to these categories: untested, tested, cross matched, quarantined, and for disposal. Under each category the units of blood are separated according to type of component (whole blood or packed red blood cells) and blood type (ABO and Rh). These categories and blood types shall be clearly labeled. 6.3.1.2 Access to storage areas and authorization to remove contents shall be controlled according to SOP/ Work Instructions of the BSF. 6.3.2 List of Blood Components and Description 6.3.2.1 Whole Blood and Red Blood Cell Components 1. Whole Blood (WB): WB is collected in an anticoagulant/ preservative solution and is not further processed. This shall not be used as a source of platelets or labile coagulation factors. Packed Red Blood Cell (Red Blood Ceil Concentrate): are Red cells concentrated by the removal of most of the plasma from sedimented or centrifuged WB. N 3. Leukocyte Reduced Red Blood Cells (Leuko- reduced packed RBC): RBCs prepared by a method known to retain at least 85% of the original red cells and reduce the leukocyte number in the final component to <5x10*. Ce] Manual of Standards for Blood Service Facilities 53 AC]

Section 6 : Blood Collection, Testing, Processing, Storage, |ssuance and Transport 4, 5. Washed Red Blood Cells (RBC Washed): RBCs remaining after washing with a volume of 0.9 NSS using a method known to remove almost all of the plasma. Depending on the method used, the preparation may contain variable quantities of leukocytes and platelets from the original unit. Apheresis Red Blood Cells Leukocyte Reduced (Red Blood Cells Pheresis, Leukocyte-Reduced): RBCs in anticoagulant or in anticoagulant and storage solution that have been prepared by automated cytapheresis that have been leukocyte reduced by a method known to retain at least 85% of the original red cells and to reduce the leukocyte number in the final component to <5xi0*, 6.3.5.2 Plasma Components L. 2. Fresh Frozen Plasma (FFP): Plasma separated from whole blood of an individual VNRBD collected within 15 minutes and placed at (-30)°C or colder within 6 to 8 hours of collection from the VNRBD. Cryoprecipitated AHF (Cryoprecipitate): The cold - insoluble portion of plasma processed from FFP thawed at +2°C to +6°C overnight, centrifuged, precipitate is collected and stored at (-30)°C or colder and shall be re-frozen within 1 hour. 6.3.5.3 Platelet Components i. Platelet Concentrate (Plt Conc): A suspension of platelets in plasma prepared by centrifugation of whole blood from a VNRBD and placed at +20°C to +24°C within 6 to 8 hours of collection and stored at +20°C to +24°C with constant agitation. Pooled Platelets (Platelets Pooled): Two or more units of platelet concentrate that have been combined into one unit depending on the patient’s requirement. Platelets Leukocyte-Reduced (Platelets Leukocyte- Reduced): Platelets Leukocyte-Reduced are prepared by a method known to reduce the leukocyte pumber to < 8.3 x 10° in at least 95% of the components sampled. CIE} Dio 54 Manual of Standards for Blood Service Facilities

Section 6 : Blood Collection, Testing, Processing, Storage, issuance and Transport 6.3.5.4 _components not collected.

Pooled Platelets Leukocyte-Reduced (Platelets Leukocyte-Reduced Pooled): A suspension of platelets in plasma that has been leukocyte-reduced. The leukocyte reduction process can take place either before or after the pooling process. Apheresis Platelets (Platelets Pheresis): A suspension of platelets in plasma prepared by cytapheresis. WB undergoes centrifugation in a cell separator, with the return to the donor of components not collected. Apheresis Platelets Leukocyte-Reduced (Platelets Pheresis Leukocyte-Reduced): Platelets collected by apheresis that is prepared by a method known to reduce the residual leukocyte number to <5 x 10% in 95% of the components sampled. Apheresis Granulocytes (Granulocytes Pheresis): A suspension of granulocytes in plasma prepared by cytapheresis with the return to the donor of Apheresis Granulocytes/ Platelets (Granulocytes/ Platelets Pheresis): A suspension of granulocytes in plasma prepared by cytapheresis, with the concurrent collection of platelets. Irradiated Blood Components Irradiated blood components are those that have been exposed to 25g4 gamma irradiation to inactivate T lymphocytes which are responsible for Graft versus Host transfusion reaction. These shall include the following: bo APHERESIS GRANULOCYTES, IRRADIATED (Granulocytes Pheresis, Irradiated) APHERESIS GRANULOCYTES/PLATELETS, IRRADIATED (Granulocytes/ Platelets Pheresis, Irradiated) PLATELETS, IRRADIATED (Platelets, Irradiated) POOLED PLATELETS, IRRADIATED (Platelets Pooled, Irradiated) Manual of Standards for Blood Service Facilities 55 no

Section 6 : Blood Collection, Testing, Processing, Storage. issuance and Transport 6.4 5. APHERESIS PLATELETS, IRRADIATED (Platelets Pheresis, Irradiated) 6. APHERESIS PLATELETS, IRRADIATED LEUKOCYTE-REDUCED (Platelets Pheresis, Leukocyte-Reduced, Irradiated) 7. RED BLOOD CELLS, IRRADIATED (Red Blood Cells, Irradiated) 8. RED BLOOD CELLS, IRRADIATED LEUKOCYTE-REDUCED (Red Blood Cells Leukocyte-Reduced, Irradiated) 9. APHERESIS RED BLOOD CELLS, IRRADIATED (Red Blood Cells Pheresis, Irradiated) 10. WHOLE BLOOD, IRRADIATED (Whole Blood, Irradiated) Issuance and Transport of Blood Units 6.4.1 Quarantine There shall be a system to clearly identify and quarantine the following products: Blood units with discrepant ABO/Rh grouping shall be quarantined until the inconsistency is resolved. » Blood units found reactive to any disease screening test shall be labeled “FOR CONFIRMATORY TESTING AND NOT FOR TRANSFUSION” and quarantined until results of confirmatory testing from NRL-RITM determine their true results. 6.4.2 Validation of Blood Units prior to Issuance The following information requires validation before the blood or blood component is cleared for issuance: + Results of TTI screening tests Results of ABO and Rh grouping Complete data on the blood unit label Confirmation, if for autologous transfusion, when applicable The two authorized Medical Technologists on duty shall validate the above information by crosschecking the laboratory forms with the appropriate logbooks. CC) im 56 Manual of Standards for Blood Service Facililies

Section 6 : Blood Collection, Testing, Processing, Storage, |ssuance and Transport 6.4.3 6.4.4 6.4.5 6.4.6 6.4.7 6.4.8 Packing and Issuance + Blood and blood components shall be inspected before packing with special attention to signs of contamination or significant hemolysis, change in color, presence of blood clots, or leakage. Blood units exhibiting these changes shall not be packed or issued. Issuance Process + There shall be a system to document the approval of issuance with specific personnel in charge. There shall be a list of details which has to be verified. by the personnel approving the issuance of the blood unit. » There shall be a system for a second verification before issuance Packaging, issuance and Transport Each blood unit for packaging, issuance and transport to requesting hospital(s) or BSF shall carry with it the instruction material with clear and brief instructions on how the product shall be used. This brief instruction shall include the following: » Name of blood product + Volume and required storage temperature Specific content/s + Procedures for thawing or warming (when applicable) Records of Collection and Distribution The BSF shall have policies and procedures to ensure that documents are identified, reviewed, approved, retained and that records are created, stored and archived in accordance with record retention policies. (Refer to Annex 6) Distribution and Payment for Blood Products Blood products shall be distributed directly to hospitals and other end user facilities. Only BSF or hospital personnel shall be authorized to deliver or receive the blood units. Payments, when necessary, shall be paid by the hospital directly to the issuing BSF. Transport of Blood Products Blood units shall be inspected thoroughly before they are packed for distribution. OE] 79 Manual of Standards fer Blood Service Facilities

Section 6 ; Blood Collection, Testing, Processing, Storage, issuance and Transport Cold chain shall be followed during transport and distribution of the blood products (Teble 3.1, page 9). Components ordinarily stored at room temperature (+ 20°C to +24°C) shall be transported also at +20°C to +24°C Blood products stored at +2°C to +6°C shall be transported at +2°C to +10°C. Frozen components shall be transported with dry ice to maintain their frozen state. Blood units shall be packed and distributed using blood transport boxes. 6.4.9 Reissue and Re-designation Blood units which have been returned to the issuing or releasing BSF within 30 minutes may be reissued provided that the following conditions are met and documented in the appropriate logbooks and records by the personnel-in-charge: . The sterility of the blood product is maintained + The product has been stored in the proper temperature At least two sealed segments of the integral donor tubing remained intact

The records clearly document the return and reissue in a appropriate logbooks : a The BSF personnel shall inspect the product prior to its reissue 6.4.10 Unsuitable Blood Products All blood products which have been found unsuitable for transfusion shall be labeled, documented and be disposed of as follows: + Blood units found reactive to serological tests These shall be labeled “FOR CONFIRMATORY TESTING AND NOT FOR TRANSFUSION” and shall be sent to NRL- NVBSP . + Blood units confirmed positive for TTIs These shall be labeled ‘NOT FOR TRANSFUSION - FOR OTHER SCIENTIFIC PURPOSES’ and shall be utilized by RITM for appropriate scientific purposes. + Wasted and Outdated blood products Hemolyzed, contaminated or punctured blood units shall be labeled “NOT FOR TRANSFUSION -— FOR DISPOSAL” and shall be sterilized prior to disposal as waste products (Refer to Section 8 Waste Management) 2 58 Manual of Standards for Blood Service Facilities OO

Section 6 : Biacd Collection, Testing, Processing, Storage, {ssuance and Transport 6.5 Labeling Each BSF shall have a labeling process or system that shall include steps taken to identify the original unit, any component and component modifications; complete the required reviews, and attach the appropriate labels. 6.5.1 Unique Blood Donation Identification Number/ Barcode In each BSF, every donation shall be assigned a unique blood donation ID number/ bar code. This shall be permanently attached during blood collection to: 6.5.1.1 Donor History Questionnaire All blood units including their satellite bag/s 6.5.1.2 6.5.1.3 All blood sample tubes 6.5.2 Content of each Label 6.5.2.1 Unique blood donation number, barcode 6.5.2.2 Name of blood center/ BSP 6.5.2.3 Type and volume of the blood product 6.5.2.4 ABO and Rh group 6.5.2.5 Type and volume of anticoagulant 6.5.2.6 Required storage temperature 6.5.2.7 Date of collection- ee 6.5.2.8 Date of expiration 6.5.2.9 Additional information: irradiated, etc. (if appropriate) 6.5.3 Additional Labels The following label shall be attached to these specific blood products: 6.5.3.1 Products modified by open method systems shall be labeled “TRANFUSE WITHIN 24 HOURS” Products found reactive to disease screening tests shall 6.5.3.2 be labeled “FOR CONFIRMATORY TESTING AND NOT FOR TRANSFUSION” 6.5.6.5 Products found unsuitable for transfusion such as in outdated units or damaged bags shall be labeled “NOT FOR TRANSFUSION - FOR OTHER SCIENTIFIC PURPOSES”; and properly disposed accordingly. 6.5.6.5 Products for Autologous transfusion shall bear the patient's name & labeled “FOR AUTOLOGOUS USE ONLY” Manual of Standards for Blood Service Facilities

Section 7 : The Clinical Use of Blood Section 7 The Clinical Use of Blood Transfusion of a blood product, no matter how carefully it has been collected and prepared, transfusion, therefore, shall be given only w Only the specific bloo clinical indications. always carries some risk to the recipient. hen absolutely necessary for specific d component needed shall be Blood transfused. (Refer to Philippine Clinical Practice Guideline for the Rational Use of Blood and Blood Products and Strategies for Implementation). 7.4 Clinical Indications for Specific Bloed Products Table 7.1 Indications for Transfusion of Blood and Blood Products Blood and Bleed Products Composition Indications

Whole Blood (WB) All cellular and plasma components. granulocytes and labile clotting factors (VILL vWE, and Factor V) Deficient in active platelets, Actively bleeding patient (more than 25-30% blood loss or about 2 liters) with sympto- matic deficit in oxygen- carrying capacity and shock WB (less than 5 days old in CPDA, or less than 4 days old in CPD) used mainly in neonatal exchange transfusion.

Packed Red Blood Cells (PRBC} RBC which has been depleted of much plasma Leucocytes can be further reduced using leukocyte filters Patients with symptomatic deficit of oxygen-carrying capacity e.g. severe or chronic anemia not corrected by iron, vitamin B12 or folic acid. For Exchange Transfusion in neonates use RBC (less than 5 days old in CPDA, or less than 4 days old CPD. If volume expansion also is needed, may use with isotonic saline. If coagulation factors are also needed, may use with FFP or specific component. Manual of Standards for Blood Service Facilities

Section 7: The Clinical Use of Blood Blood and Blood Products Composition Indications 3, Washed Red Cells RBC, no plasma; no plasma proteins; minimal platelets. 70-80% WBC removed if manual wash; 90% WBC removed if automated wash. Use only for those requiring repeated transfusions who develop febrile or allergic transfusion reactions 4. Platelet Concentrate (PC) At least 5.5x10" platelets in 50-70 ml plasma; depending on centrifugation rate, may contain many lymphocytes or some red cells. Treatment or prevention of bleeding due to deficient platelet number (<20x10% L); Abnormal platelet function or both Example: sepsis, DIC, renal failure, coagulation, splenomegaly Patients about to undergo major surgery with platelets <50x107/L Long term supportive treatment of conditions with bone marrow depression 7.2 Samples and Requests for Blood Products The recipient and his/her blood sample shall be positively identified at the time of sample extraction for blood typing and compatibility testing. A complete, a ccurate and legibly filled-in blood request form(s) shall be submitted to the blood bank at least 24 hours before anticipated need. In case of emergency need of blood, the request shall be sent immediately. The prescribing practice for elective surgical procedures which will require blood transfusion shall be based on the Maximum Blood Ordering Schedule (MBOS) as agreed upon by the Hospital Blood Transfusion Committee (HBTC). 7.3 Pre-Transfusion testing of Patient’s Blood Blood sample submitted for compatibility testing shall be tested for ABO and Rh blood group. Screening for unexpected or atypical antibodies to red cell antigens is highly recommended. HO 64 Manual of Standards for Blood Service Facilities OO

Section 7 : The Clinical Use of Blood 7.4 7.5 the hospital. Selection of compatible blood product(s) for transfusion shall be based on the Philippine Clinical Practice Guidelines. Recipients shall receive ABO group-specific whole blood or ABO group-compatible red cell products. The HBTC shall have a policy for the use of Rh-positive red cell products in Rh negative recipients. Before issue, recipient’s serum or plasma shall be tested compatible against a sample of donor cells from an integrally attached segment of the blood product. The crossmatch shall use tube method or a method acceptable to NVBSP that demonstrate ABO compatibility and detects clinically significant antibodies to red cell antigens. The crossmatch shall be performed in all three phases (saline, albumin or Low Ionic Strength Solution, thermal phase, and anti-human globulin) including an auto control. Slide method is not acceptable. Blood Issuance and Handling Blood shall be issued from the hospital blood bank only when the patient is ready for transfusion. Any preparation and verification steps shall be performed according to the source facility and policies and procedures of Blood shall not be allowed in the ward refrigerator at any time. From time of issue to the ward, a 30-minute period is acceptable for any returned, intact blood and blood product. Blood shall be transported in appropriate containers with proper temperature-monitoring devices. Minimizing Adverse Bloed Transfusion Reactions (BTR) 7.5.1 Careful clerical check of the information on the blood unit label and the patient’s identification to ensure that the “right” blood unit is administered to the “right” patient 7.5.2 Careful inspection of the safety of blood product packaging 7.5.3 Close monitoring of patient undergoing transfusion, with mandatory presence of medical or trained nursing staff for the first 15 minutes. 7.5.4 Use of appropriately stored blood product 7.5.5 Elective transfusion shall be done during hours when there is full complement of medical staff OO Manual of Standards for Blood Service Facilities 65 nea

Section 7 : The Clinical Use of Blood 7.6 7.7 7.8 Management of Adverse BTRs The BSF shall have written standard operating procedures (SOPs) for the identification, management, investigation and reporting of suspected transfusion reactions and other transfusion-related adverse events. Hospital Blood Transfusion Committee (HBTC) The establishment of an active HBTC shall be the responsibility of the Medical Director or Chief of Hospital. The members shall be committed to the function of HBTC as stated in the Implementing Rules and Regulations of RA 7719. Hemovigilance Involves surveillance of the entire comprehensive process from the collection of blood from the VNRBDs to transfusion to the recipients. This shall collate information on VNRBDs and recipients into an integrated NVBSP information system which shall provide monitoring trends to factors affecting transfusion safety. Any deviations from the accepted-blood component indications and established MSBOS in the blood requisition and utilization shall be reported and investigated by the HBTC. Reporting systems on the transfusion related diseases, accidents, errors, near misses, transfusion reactions and any complications of transfusions shall be in place so that risks and trends are identified and appropriately managed. AH 66 Manual of Standards for Blood Service Facilities

Section 8 : Environmental Management and Biosafety Section 8 Environmental Management and Biosafety Each BSF shall institutionalize a system of Environmental Management and Biosafety to ensure the protection of the environment and safety of the staff, clients and community. 8.1 Management of the Environment and Biosafety 8.1.1 The BSF Head or supervisor shall be responsible for the protection and safety of the environment, staff, clients and community. A system shall be designed which provides for sanitation and cleanliness, orderliness and labeling, waste management, fire safety, and accident & emergency preparedness. It shall be the management’s responsibility to identify or designate an individual as Biosafety Officer of the BSF. 8.2 Responsibility of the Biosafety Officer (BO) The BO shall institute compliance to the established policies, guidelines and procedures set by the management to ensure safety and protection of the environment, staff, clients and community. He/She shail be responsible in bringing to the management’s attention BSF’s unsafe working conditions and identify opportunities to minimize biohazards in the BSF. 8.3 Sanitation and Cieanliness There shall be written procedures and safe work practices of the staff which are documented in maintaining cleanliness, sanitation and safety in the BSF. The documented procedures and safe work practices shall be reviewed periodically by the Hospital Biosafety Committee (HBC). 8.4 Orderliness and Labeling The BSF shall sort, label, arrange and store all materials being used in the BSF according to order and frequency of use. These procedures shall be contained in a manual and shall be available at the workstations for dissemination to all the staff. Manual af Standards for Blood Service Facilities 69 oo

Section 8 ; Environmental Management and Biosafety 8.5 8.6 8.7 8.8 Solid Waste Management The BSF shall develop, establish and implement a system for proper solid waste management. There shall be step by step procedures for the proper disposal of solid wastes and shall conform with the guidelines set by the DOH and Department of Environment and Natural Resources (DENR). Liquid Waste Management The BSE shall develop, establish and implement a system for proper liquid waste management. There shall be procedures in the disposal of liquid wastes and shall conform with the guidelines set by the DOH and Department of Environment and Natural Resources (DENR). Fire Safety The BSF shall establish and implement a system to address the hazards and consequences of fires. There shall be procedures in the prevention, management and safety in case of fire. Accidents and Emergency Preparedness The BSF shall establish and implement a contingency plan for dea ling with laboratory accidents, emergencies, natural, man-made disasters, and other type of emergencies. The BSF shall record in the Accident Book all laboratory accidents and shall be analyzed periodically to determine the need to modify laboratory SOP’s, to prevent similar incidents from occurring and to reduce risks to the staff. me OO 70 Manual of Standards for Blood Service Facilities

Section 9 : Documents and Records Section 9 Documents and Records The BSF shall have policies, processes, and procedures to ensure that documents are identified, reviewed, approved, and retained and that records are created, stored, and archived in accordance with record retention policies. 9.1 9.2 Documents The BSF shall have a process for document control that includes the following elements: 9.1.1 A master list of documents, including policies, processes, procedures, labels, and forms that relate to the requirements of this Manual of Standards for BSF. 9.1.2 Use of standardized formats for all policies, processes, and procedures. 9.1.3 Reviewzand approval of new and revised documents before use. 9.1.4 Annual review of each policy, process, and procedure by an authorized individual, 9.1.5 Use of only current and valid documents. Appropriate and applicable documents shall be available at all locations where activities essential te meeting the requirements of this Manual of Standards for BSF are performed. 9.1.6 Identification, appropriate recall and archival of obsolete documents. Records The BSF shall ensure identification, collection, indexing, access, filing, storage, and disposition of records as required by Reference Standards in, Annex 5, Retention of Blood Service Facility (BSF) Records. 9.2.1 Facility Records Records shall be complete, properly stored, retrievable in a period of time, appropriate to the circumstances, and protected from accidental or unauthorized destruction or modification. Manual of Standards for Blood Service Facilities

Section 9: Documents and Records 9.2.2 9.2.3 9.2.4 9.2.5 9.2.1.1 Copies of Records Before the destruction of the original records, the BSF shall have a process to ensure that copies of records are identified as such. Copies of records shall be verified as containing the original content and shall be legible, complete, and accessible. A system designed to prevent unauthorized access and ensure confidentiality of records shall be established and followed. The record system shail make it possible to trace any unit of blood, and blood products from iis source to final disposition; to review the records applying to the specific component, and to investigate adverse events manifested by the recipient. 9.2.3.1 The system shall ensure that the donor number and donation identification number are unique and shall match with each other. The actual result of each test observed shall be recorded immediately and the final interpretation shall be recorded upon completion of testing.

7 Electronic Records There shall be processes and procedures to support the management of computer systems. 9.2.5.1 There shall be a process in place for routine back up of all critical data. 9.2.5.1.1 Procedures shall be in place to ensure that data are retrievable and usable. 9.2.5.1.2 If possible, back up data shall be stored in an off-site location. OH AIC 74 Manual of Standards for Blood Service Facilities

Annex 1: Blood Donor History Questionnaire Department of Health NATIONAL VOLUNTARY BLOOD SERVICES PROGRAM (BSF Name and Address} Blood Donor History Questionnaire Date : Venue Name Date of Birth :_/ i Age : Gender :O)Male Lremate Civil Status E-mail address : Contact number: Occupation Nationality Preferred Mailing Address CQ) Home Address : Number, Street and Subdivision Barangay Zip Code: Town? District City! Province OQ) Office Address Floor Bullding Name Number and Street Zip Code: Barangay Town District City/ Province Type of Donor :OVotunteer O21 Others Method of Collection : O) Whole Blood (Conventional) QlApheresis — Instructions: All donors must read the donor educational materials provided by the Blood Service Facility staff before answering. Yes No Are you 1. Feeling healthy today? 2. Currently taking medication? Have you taken any medication from the deferral list? 3. Have you received any vaccination? In the past three days 4. Have you taken aspirin or anything that has aspirin in it? Manual of Standards for Blood Service Facilities 77 A

Annex 1: Blood Donor History Questionnaire Yes No 5 QUESTION No. 5, FOR FEMALE DONORS: In the past 1 and % months (6 weeks) . Have you been pregnant or are you pregnant now? Last Menstrual Period: In the past 12 weeks have you 6. Donated blood, platelet or plasma? In the past 12 months have you 7. Had a blood transfusion? 8. Had surgical operation, dental extraction? 9. Had a tattoo, ear or body piercing, accidental contact with blood, needle-stick, and acupuncture? 10.Had sexual contact with high risk individuals? 11. Had sexual contact with anyone in exchange for material or monetary gain? 12. Had sexual contact with a person who has worked abroad? 13. Engaged in casual sex? 14. Lived with a person who has hepatitis? 15. Have you been imprisoned? 16.Have any of your relatives had Creutzfeldt-Jakob (Mad Cow} disease? a Have you ever 17. Lived outside your place of residence? —— 18. Lived outside the Philippines? 19. Used needles to take drugs, steroids, or anything not prescribed by your doctor? 20. Used clotting factor concentrates? 21.Had a positive test for the HIV virus, Hepatitis virus, Syphilis or Malaria? 22. Had Hepatitis? 23. Had malaria? 24. Been told to have or treated for genital wart. syphilis, gonorrhea or other Sexually Transmissible infections? 25. Had any type of cancer, for example Leukemia? 26. Had any problems with your heart and lungs? 27. Had a bleeding condition or a blood disease? 28. Are you giving blood because you wanted to be tested for HIV or Hepatitis virus? 29. Are you aware that if you have the HIV/Hepatitis virus, you can give it to someone else though you may fee! well and have a negative HIV/ Hepatitis test? BSFs may choose to add local questions here. Donor's Signature OO 78 Manual of Standards for Blood Services Facilities OI

_ Annex 4 : Blood Donor History Questionnalre Donoer’s Informed Consent I certify that I am the person referred to in all the entries, which were read and well understood by me. It is my free and voluntary act to donate my blood, aware of its risks during and after extraction. The same have been explained to me in understandable language and dialect that I speak. I am voluntarily giving my blood through ( name of BSF ). I understand that my blood will be tested for Blood Type, Hemoglobin, Malaria, Syphilis, Hepatitis B, Hepatitis C and HIV* and no official result will be issued to me. If found reactive, I agree to be referred to the appropriate facility for counseling and further management. I certify that I have to the best of my knowledge, truthfully answered the above questions. Donor’s Signature *Note: You may include other specific tests done in your BSF ee ee a rea CONFIDENTIAL UNIT EXCLUSION (CUE): If at any point during or after your blood donation your blood is not suitable for transfusion, please inform the Blood Service Facility staff. Please use your Blood Donation ID Number and the Segment Number written below in identifying your blood donation. Contact number of Blood Service Facility Segment Number Place Barcode Sticker of Donation ID No. here: VN Manual of Standards for Blood Service Facilities

Annex 1 : Blood Donor History Quastionnaire For Blood Bank Use Only Physical Examination Body weight : {kg} Blood Pressure : General Appearance : / Pulse Rate Skin Temp: HEENT : Remarks Q) Accepted Q) Temporarily Deferred Q Permanently Deferred Reason for Deferral Heart and Lungs : Volume mL Place Barcode Sticker of Denation ID Ne. here: Va Blood Bank Officer For Phlebotomist use only: Test Result Screened by: Blood Bag: (S)Single/ (D) Double/ (7) Triple Blood Type Segment Number: Time Sarted: Time Ended: Phlebotomist: Hemoglobin . 80 Manual of Standards for Btood Service Facilities

ANNEX 2: Reguest for Blood Compatibillty Testing Name of Blood Service Facility REQUEST FOR BLOOD COMPATIBILITY TESTING (BSF Form No. _ } Name of Recipient: Ward/ Room Na.: Date: Recipient’s Identification No: _ Health Record No. (HRN) (If any): Age: Gender; Diagnosis/ Procedure: If emergency, please check appropriate box or boxes as needed. () Cross matched — 3 phases and fully screened blood (at least 3 hours) Because of the extreme need of blood, I hereby direct the blood bank to issuance the following: Group “O” blood UNCROSSMATCHED ABO Type specific blood UNCROSSMATCHED Grossmatched blood SALINE PHASE ONLY SL. Crossmatched blood SALINE AND ALBUMIN PHASE ONLY Blood NOT SCREENED for malaria, VDRL, HIV Ab, HBsAg and HCV Ab Blood NOT SCREENED for HIV Ab, HBsAg and HCV Ab Blood NOT SCREENED for HIV Ab and HCV Ab Crossmatched and screened blood with MINOR INCOMPATIBILITY INR RNR NNN we SS SS Justification for emergency issuance of blood Attending Physician Manual of Standards for Blood Service Facilities

ANNEX 3: Blood Transfusion Form Name of Healthcare Facility BLOOD TRANSFUSION FORM (BSF Form No. __ } Name of Patient: Lastname First Name Health Record No. (HRN) / Identification No.: Middle Name Age: Sex: Blood Type: Ward/ Room/ Bed: Blood Unit Serial Number: Expiry Date Blood Type (ABO/ RH) : Issued by Type of Component: ( ) Whole Blood € ) ~~ Platelet Concentrate ( ) Red Blood Cells ( ) Cryoprecipitate () Plasma € ) 9 Others: Result of Blood Crossmatching: Cross matching Done By: Date/ Time: oon Name/ Signature and Title

Emergency Testing Uncrossmatched Crossmatched Saline Phase Only Saline and Albumin Phase Only Saline, Albumin and Antigiobulin Phase ABO/ Rh Compatible NR wee Se YS ES Blood Unit Received By: Date/ Time: Name/ Signature and Title Appearance of Unit Checked By: , RN (Staff Nurse) » RN (Head Nurse) , RN (Nurse Supervisor) MD (Physician-on-Duty) _Date/ Time: BLOOD TRANSFUSION RECORD Patient’s Vital Signs: BP: PR: RR: Temp: OO 82 Manual of Standards for Blood Service Facilities mi

ANNEX 3: Blood Transfusion Form Transfusion Started By: Date/Time: Name/ Signature and Title Transfusion Completed/ Stopped: Date/Time: Name/ Signature and Title Date/Time: Transfusion Set Removed By: Name/ Signature and Title Remarks: () Transfusion completed without immediate transfusion reactions noted ( ) Transfusion stopped with transfusion reactions noted ( ) Fever ( ) Nausea ( ) Flushes ( ) Chills ( ) Vomiting ( j) Rashes ( ) Others: Vital Signs: BP PR. RR Temp. () Fortransfusion reaction studies Prepared by: Signature over Printed Name, Title/ Designation Date: Manual of Standards for Blood Service Facilities

ANNEX 4: Alphabetical List of Equipment/instruments Name of Healthcare Facility ALPHABETICAL LIST OF EQUIPMENT/ INSTRUMENTS BSF Ferm No. Equipment/ Instruments Activity Number (5) Activities Agglutination viewer 1,1 For ABO/Rh grouping and compatibility testing Air conditioning unit

Apheresis machine with

AVR Autoclave Balance 5.1 Analytical balance 5.2 Rough balance, top loading Barcoding machine Blood collection set 7.1 Blood collection couch or bed 7.2 Spring scale for blood units 7.3 Surgical instruments: forceps, scissors 7.4 Tube sealer 7.5 Tray carrier for blood units 7.6 Mechanical device for agitation of blood bags Computer with printer, UPS, AVR, internet access Centrifuge 9.1 Clinical centrifuge 3.3 - 3.4, 9.2, 10.2.21 1-10 3, 4, 6, 7, 9.2, 10 3.1.1 3.4.1 4,2 4.1 2, 6, 9, 10 4, 6.1-6.2, 6.3.2, 6.3.5, 10.3 Advocacy and health education and counseling: One-on-one or in group (s) Medical history and physical examination Pre-donation donor screening 3.1 Hemoglobin determination 3.1.1 CuSO, method 3.1.2 Cyanmethemog- lobin method 3.2 Hematocrit determination 3.2.1 Microhematocrit method a 3.3 ABO grouping (tube method) 3.3.1 Forward grouping 3.3.2 Reverse grouping 3.4 Rh grouping (tube method) Blood collection 4.4 Phlebotomy 4.2 Labeling 4.3 Post-donation care Storage and transport of blood to testing blood bank/ center 5.1 Temporary storage of blood prior to transport 5,2 Packaging of blood units Post-donation testing 6.1 Repeat ABO grouping (forward and reverse, tube method) al OU 84 Manual of Standards for Blood Service Facilities

ANNEX 4 : Alphabetical List of Equipment/Instruments Equipment/ Instruments Activity Number (S) Activities 9.2 Microhematocrit 6.2 Rh typing (tube method) centrifuge with reader (3.2 6.3 Tests for transfusion- 9.3. Refrigerated transmissible diseases centrifuge with AVR {7.1 6.3.1 Malaria parasite 6.3.1.1 Quantita- 10. Freezer tive buffy 10.1 Plasma freezer coat (-30°C) with AVR 743 method 10.2 Ultralow freezer 6.3.1.2 Thick and (-80°C) with AVR 7147.15 thin smear 10.3. Blast Freezer (-50°C} (7.1.3 6.3.2 Syphilis 6.3.2.1 RPR card test 11. EIA equipment set with 6.3.2.2 VDRL AVR 6,.3,3-6.3.5 slide test 11.1 Reader 6.3.3 Hepatitis B surface 11.2 Washer antigen 11.3 Incubator (including 6.3.3.1 Enzyme heating block) immuno- 11.4 Printer ounvi bs

assay -_- (EIA) 12. Generator (power) 4,5, 6,7, 10 6.3.3.2 Immuno- chromatog- 13. Laboratory oven (dry heat |6, 7, 10 raphy assay sterilizer) 6.3.4 Hepatitis C anti- body 14. Microscope (binocular) 6.3.4.1 Particle equipped with: agglutina- 14.1 Oil immersion tion (PA) objective (OIO) 6.3.1.1 6.3.4.2 Enzyme immuno- 15. Pipettor 6.3, 9.2, 10.2 assay 16. Plasma extractor Tiida, 7.1.3 (EIA) 6.3.5 HIV antibody 17. Plasma thawer FAB 6.3.5.1 Particle agglutina- 18. Photometer tion (PA) 18.1 Blood hemoglobin test photometer (portable) 13.1.2 6.3.5.2 Enzyme 18.2 Spectrophotometer 3.1.2 immuno- assay (EIA) Manual of Standards for Blood Service Facilities 85 HH

ANNEX 4: Alphabetical List of Equipment/Instruments Equipment/ Instruments Activity Number (S) Activities 19, Pyconometer for CuSO, [3.1.1 7. Provision of whole blood and method components 7.1 Preparation of components 20. Red cell washer 3.3-3.4, 9,2, 10.2.2.1, 10.3 from whole blood by manual procedure, open or 21. Refrigerator 5, 7, 10 close system 21.1 Blood bank 7.1.1 Red blood cell refrigerator controlled 7.1.2 Platelet concentrate at 1-6°C, with 7.1.3 Fresh frozen plasma temperature recorder, 7.1.4 Cryoprecipitate alarm system and LS Cryosupernate AVR 7.2 Collection of blood 21.2 Reagent refrigerator components by apheresis with laboratory 7.3. Collection of blood for thermometer and AVR/3, 6, 9.2, 10 directed donations 22, Rotator 8. Validation and packaging 22.1 Serologic rotator 8.1 Counterchecking (RPR or VDRL} 6.3,3-6.3.5 8.2 Packaging 22.2 Platelet rotator-or —- agitator 72 9. Transport and issuance 9.1 Computerization or 23. Serofuge 3,3-3.4, 9.2, 10.2.2.1, 10.3 documentation 9.2 Compatibility testing 24. Shaker for PA 6.3,.3-6.3.5 9.2.1 ABO grouping, tube method 25. Sphygmomanometer 2,4 9.2.2 Rh typing, tube method 26. Spring scale 4.1 9.2.3 Cross matching, three phases 27. Stethoscope 2,4 10. Special services for category B 28. Stopwatch or timer 9.2 hospital-based BB/ BC only 10.1 Preparation of components 29. Tachometer 6.3, 7, 10 10.1.1 Washed RBC 10.1.2 Leucocyte reduced 30. Thermometer RBC by filtration 30.1 Clinical thermometer/2, 10.2.1 10.2 Investigation of transfusion 30.2 Laboratory thermometer 30.3 Room thermometer 5,7 1,7 ’ , 16 reaction 10.2.1 Clinical assessment 10.2.2 Laboratory work-up FIC} 86 Manual of Standards for Blood Service Facilities OC

ANNEX 4: Alphabetical List of Equipment/Instruments Equipment/ Instruments Activity Number (S) Activities 31.*TV monitor with video 10.2.2.1 Repeat cassette player i, 4 compati- bility 32. Incubator testing 32.1 Set at 56 °C for 10,2.2.2 Free VDRL 6.3.2 hemogl- 32.2 Set at 37°C for EIA [6.3.3-6.3.5 obin and 32.3 Set at 37 °C for cross bilirubin matching 9.2.3, 10.2.2.1, 10.3 determi- nation in 33, Weighing scale serum 33.1 Calibrate up to 500 10.2.2.3. Free kilograms for donors [2 hemog- 33.2 Calibrated up to 500 lobin and grams for blood units [4.1 hemosi- derin determi- nation in urine 10.2.2.4 Bacteri- ologic exami- nation of donor unit and recipient blood samples 10.3 Antibody screening/ detection 10.3.1 Direct and indirect antiglobulin tests 10.3.2 Antibody identification LEGEND * — Optional

Only for BB/ BC with component collection by aphresis Manual of Standards for Blood Service Facilities 87 OI

ANNEX 5: Retension of Blood Service Facility (BSF) Records Retension of Blood Service Facility (BSF) Records Alt records relevant to the operation of the Blood Service Facility (BSF) shall be kept for a minimum of 5 years or as required by law. A, Records that should be retained for indefinite period include: 1. Blood Donor Session Records 1.1 Donor’s identifying information Medical history and physical examination Written consent Interpretations of laboratory screening tests Status of deferral or notification to donors of permanent deferral i. 1. 1. 1. Ae Wh Blood Processing Records 2.1 Information te identify facilities that carry out any part of the preparation of blood components and functions performed 2.2 Information from any intermediate facility if it retains the units and identification of the collecting facility Records of Blood and Components Received from Outside Facilities

3.1 Numeric or alphanumeric identification of blood units and identification of the collecting facility Records of Disposition of Blood and Blood Components 4.1 Names, signatures, initials or identification code of those authorized to sign or initial or review reports and records Therapeutic Apheresis Procedures and Donor Hemapheresis Clinical Records Records of Issue for Transfusion 6.1 Notification to recipients of potential exposure to disease transmissible by blood 6.2 Record of notification to transfusing facility of previous receipt of units from donors subsequently found positive for HIV Records of Patient with Adverse Transfusion rection 7.1 ABO and Rh types 7.2 Sever adverse reactions to donation transfusion Cit] Ol] 88 Manual of Standards for Blood Service Facilities

ANNEX 5: Retension of Blood Service Facility (BSF) Records B. Records i. 7.3. Compatibility test interpretation and clinically significant unexpected antibodies found in patients that should be retained fer five (5) years include: Standard operating procedures 1.1 Technical manuals, procedures and publications done by the facility 1.2 Biosafety manual including procedures for biological, chemical safety and monitoring records of training and compliance 1.3 Documentation of staff qualifications and competency Records of storage and inspection of blood and blood components 2.1 Blood and blood component inspection during storage and prior to issue 2.2 Storage temperatures and control testing Records of quality control and quality assessment 3.1 Proficiency testing surveys and any corrective actions taken 3.2 Control testing of reagents and calibration of equipment and instruments Records of voluntary blaod donors who have been temporarily deferred for the protection of the potential recipient Records of all laboratory screening tests on blood samples of donors who are temporarily deferred Manual of Standards for Biaod Service Facilities 89 ne

Abbreviations Ab Ag ABD AIDS AHF AHG Anti-HBe Anti-HBs A.O. AVR BB/ BC BCU BP BRL BS BSF CMV CPD CPDA-1 CPDA-2 DAPE DOH DMM DTMH Dp" DPDP DTI EIA ELISA EVF FASCP FDA FPCP FPSHBT FPSP FFP Antibody Antigen Autologous Blood Donation Acquired Immune Deficiency Syndrome Anti-Hemophilic Factor Anti-Human Globulin Hepatitis B Core Antibody Hepatitis B Surface Antibody Administrative Order Automatic Voliage Regulator Blood Bank / Blood Center Blood Collection Unit Blood Pressure Bureau of Research and Laboratory Blood Station Blood Service Facility Cytomegalovirus Citrate Phosphate Dextrose anticoagulant Citrate Phosphate Dextrose Adenine-1 anticoagulant Citrate Phosphate Dextrose Adenine-2 anticoagulant Diploma in Applied Parasitology and Entomology Department of Health Diploma in Medical Microbiology Diploma in Tropical Medicine and Hygiene D variant (weak D) Diplomate, Philippine Society of Pathologists Department of Trade and Industry Enzyme Immunoassay Enzyme-linked Immunosorbent Assay Erythrocyte Volume Fraction Fellow, American Society of Clinical Pathology Food and Drugs Administration Fellow, Philippine College of Physicians Fellow, Philippine Society of Hematology and Blood Transfusion Fellow Philippine Society of Pathologists Fresh Frozen Plasma Manual of Standards for Blood Service Facilities

Abbreviations GMP GVHD HBlg HBV HBsAg HBTC Het HCV HCV Ab HIV HIV Ab Hgb HLA IEC IgG IRR ITP KVA MBOS MGM NCBSTC NCR NKTI NRL NVBSP OHFSR PA PAMET PBCC PBHBT PC PRC PRC PSHBT PSP QA Good Manufacturing Practices Graft-Venous-Host Disease Hepatitis B Immunoglobulin Hepatitis B Virus Hepatitis B Surface Antigen Hospital Blood Transfusion Committee Hematocrit Hepatitis C Virus Hepatitis C Virus Antibody Human Immunodeficiency Virus Human Immunodeficiency Virus Antibody Hemoglobin Human Lymphocyte Antigen Information Education Communication Immunoglobulin Implementing Rules and Regulations Immune Thrombocytopenic Purpura Kilovolt Amperes Maximum Blood Ordering Schedule Master in Government Management Nationa Council for Blood Services Technical Committee National Capital Region National Kidney and Transplant Institute National Reference Laboratory National Voluntary Blood Services Program Office for Health Facilities, Standards and Regulation Particle Agghitination Test Philippine Association of Medical Technologists Philippine Blood Coordinating Council Philippine Board of Hematology and Blood Transfusion Platelet Concentrate Philippine Red Cross Professional Regulation Commission Philippine Society of Hematology and Blood Transfusion Philippine Society of Pathologists, Inc. Quality Assurance HH 94 Manual of Standards for Blood Service Facilities

Abbreviations QBC Qc R.A. RBC RITM RMT RN RPM RPR SAG-M SLMC SPPS SOP STD SY TB TTI -UPS VDRL VNRBD vWF WB WHO Quantitative Buffy Coat Quality Contro! Republic Act Red Blood Cells Research Institute for Tropical Medicine Registered Medical Technologist Registered Nurse Revolutions per Minute Rapid Plasma Reagin Card Test Sodium Adenine Glucose-Mannito! anticoagulant St. Luke’s Medical Center Stable Plasma Protein Solution Standard Operating Procedure Sexually Transmitted Diease Syphillis Tuberculosis Transfusion Transmitted Infections Uninterrupted Power Source or o_ Venereal Disease Research Laboratory Slide Test Voluntary Non-Remunerated Blood Donors von Willerband Factor Whole Blood World Health Organization Manual of Standards for Biaod Service Facilities 95 ial

Glossary ADDITIVE SOLUTION. A solution added to whole blood used to extend its shelf life; usually contains adenine, dextrose and other nutritional components ACT. Republic Act 7719 otherwise known as the “National Blood Services Act of 1994”. AGGLUTINATION, Visible clumping as evidence of the interaction of red blood cells with antibody directed towards the antigen on the red blood cells. ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS). A set of serious clinical ailments resulting from severe immune dysfunction caused by infection with the human immunodeficiency virus (HIV) ANTIGLOBULIN TEST. Detects antibody or complements bound to the red cell. Direct antiglobulin test is used to diagnose conditions in which the patient’s red cells have been sensitized in vivo as in the hemolytic disease of the newborn, autoimmune hemolytic anemia, drug induced hemolytic anemia and transfusion reactions. The Indirect antiglobulin method is used to detect in vitro sensitization; and is used in antibody screening, phenotyping and crossmatching. ANTIBODY. Proteins produced by the immune system in response to the presence of a foreign substance, an antigen or immunogen, with the capability to react specifically with the inducing antigen or immunogen. _ ANTICOAGULANT. A substance used to prevent coagulation or clotting of blood ANTIGEN. Foreign substance that may induce the immune system to produce antibodies. These antibodies specifically react with the antigen. APHERESIS. Blood collection procedure in which whole blood is removed, a selected component separated and the remainder returned to the donor. ANTI-HEMOLYTIC FACTOR. Also known as Factor VII, the coagulation factor deficient in Hemophilia A, usually prepared from plasma or pools of plasma and packaged in lyophilized form. ATYPICAL ANTIBODY. Antibody to red cell antigens other than the natural or expected group ABO antibodies. AUTOLOGOUS DONATION. A blood donation in which the donor and the recipient are the same person. BAR CODE. A series of marks on preprinted packaging or labeling materials that may be visually inspected or read by an optical scanning device. Manual of Standards for Blood Service Facilities 99 ac

Glossary BIOHAZARD. Substance derived from biological sources such as blood or body fluid, capable of transmitting pathogenic organisms. BLOOD. Refers to whole blood (WB) and not processed inte products/ components. BLOOD BAGS. Sterile, sturdy plastic bags containing anticoagulants which are especially designed for blood collection and transfusion. Blood bags can either be single or multiple types and have an integral sterile needle and collection tubing. BLOOD BANK/ CENTER. A blood service facility with capability to recruit and screen blood donors, collect, process, store, transport and issue blood for transfusion and provide information and/or education on blood transmissible diseases. BLOOD BANKING EQUIPMENT. Essential laboratory machines, instruments and their accessories used in the different steps in the blood banking process such as those used to centrifuge blood or separate blood into its various components; preserve blood or blood components in cold storage or freezer; and perform blood tests such as hemoglobin tests and screening tests for blood transmissible diseases. These equipment also include those used in specific supportive processes such as sterilization and sanitary disposal of blood and blood products. BLOOD COLLECTION UNIT, A blood service facility duly authorized by the “—~Department of Health to recruit and screen dotidrs and collect blood. BLOOD COMPONENTS. Specific cellular or liquid products of human blood. The components are obtained by processing in the blood bank, such as centrifugation, precipitation, etc. Examples are red blood cells, FFP, cryoprecipitate, platelet, BLOOD DERIVATIVES. Refer to blood products which are obtained from fractionation of plasma (Albumin, protein fractions, immunoglobulin, Factor VIII, etc.) BLOOD COLLECTION COUCH. Blood collection couch is another term for Blood collection table or bed. It is a furniture upon which the donor sits or reclines during blood collection. BLOOD PRODUCT. Any therapeutic substance prepared from human blood, includes both blood components and derivatives. BLOOD SERVICE FACILITY (BSF). Any unit, office, institution providing any of the blood transfusion services, which can be a blood bank/ center category A and B (non-hospital and hospital-based), a blood collection unit or a blood station, BLOOD TRANSFUSION SERVICES, A set of activities and functions related to blood transfusion such as, but not limited to, motivation and recruitment of i 100 Manual of Standards for Blood Service Facilities DEI

Glossary donors, blood collection, testing and screening of donor blood, preparation of blood products, storage and distribution of blood and products, inventory control and quality assurance. BLOOD TRANSMISSIBLE DISEASES. Diseases which may be transmitted through blood transfusion, including, but not limited to HIV Infection, Hepatitis B, Hepatitis C, Malaria and Syphilis. BLOOD STATION. A blood services facility which can be sited in either a government of private hospital or a Philippine Red Cross Chapter which has not been licensed as a blood bank/ center but has been authorized by the Department to store and issue blood and blood products, and whenever necessary perform compatibility testing, as in emergency blood transfusion. CALIBRATION. A comparison of a measurement of a parameter on a piece of equipment with a standard measurement prescribed to ensure the proper function of the equipment. CITRATE. Component of anticoagulant composed of citric acid and a base. Citrate binds calcium and prevents coagulation. CITRATE PHOSPHATE DEXTROSE. Anticoagulant that is used in routine blood ___ collection; allows a 21-day storage period. CITRATE PHOSPHATE DEXTROSE ADENINE. Anticoagulant used in the routine blood collection; allows a 35-day storage period. CLOSED SYSTEM. A mechanism in which the blood units are processed in plastic bags connected to satellite bag and sealed from the external environment preventing contamination. COMPATIBILITY TESTING. Although this term is frequently used synonymously with crossmatching, it includes selecting the proper ABO group and Rh type and eliminating incompatible immunologic reactions through crossmatching. COMPETENT. Capable to do a certain task or job according to set standards and standard procedures. COMPETENCY ASSESSMENT. A method which documents the performance abilities of the personnel performing the various tasks within the blood service facility. Competency assessment/testing programs should test technical skills and knowledge. OO 101 AR Manual of Standards for Blood Service Facilities

Glossary CONTROL. A device, compound or solution which has one or more accurately known characteristics and which is used for the purpose of verifying the accuracy and precision of measurements of these characteristics in unknown similar objects by being treated in the same manner as the unknown. CROSSMATCHING. A test for blood group incompatibility in which the serum of the recipient is tested with the red blood cells of the perspective donor. CRYOPRECIPITATE. The cold insoluble portion of fresh frozen plasma that is frozen and thawed under controlled condition. CRYOSUPERNATE. A residual plasma refrozen after the removal of cryoprecipitate. CYTAPHERESIS. The collection of specific blood cells, requiring an instrument capable of processing sufficiently large volumes of whole blood for a satisfactory yield of the desired component. D (Rh,). The major antigen in the Rh group system. DECONTAMINATION. A procedure that eliminates or reduces microbial contamination to a safe level with respect to the transmission of infection. DEPARTMENT. The Department of Health: DIASTOLIC BLOOD PRESSURE. The blood pressure in a large artery during the period when the cavities of the heart dilate and fill with blood. This is the lower number in a blood pressure reading. DISINFECTANT. An agent that kills microorganisms capable of producing an infection. DISINFECTION. A procedure that kills pathogenic microorganisms but not necessarily their spores. Chemical germicides formulated as disinfectants are used on inanimate surfaces (medical devices, etc.) and should not be used on skin, tissue or any part of the body. DISPOSAL. The act of eliminating or sequestering indefinitely or permanently either treated or untreated waste. DONATION NUMBER. The unique identification number that is issued in advance for each blood donor which must be linked to the donor’s name on the register, the donor’s form, allt blood bags, including satellite blood packs and all blood sample containers. DY. <A weak phenotype of Rh, (D) antigen of the Rh blood group system. HE} 102 Manual of Standards for Blood Service Facilities

Glossary ELISA. An assay in which the antigen of antibody is bound to a solid support and unknown antibody or antigen in the specimen is then specifically bound and detected by an enzyme-substrate system. ENDEMIC, A disease that is prevalent in a particular geographic area throughout the year. ENZYME. An organic catalyst in a biochemical reaction. In the ELISA test, the enzyme acts upon a specific substrate to create a colored end product that is measured, and reflects the amount of enzyme bound in the reaction. ERYTHROPOIJESIS. The process of red blood cell production in the bone marrow. EXTERNAL CONTROL. Control sera, with known values or reactivity, derived from source Other than the test kit. These controls are included in test runs to monitor performance such as lot-to-lot variation, etc. FRESH FROZEN PLASMA (FFP). The liquid portion of whole blood after separation from the cellular components which is frozen within 6 to 8 hours from blood collection to maintain viability of clotting factors. The product usually is about 250 ml in volume and is used to treat multiple clotting factor deficiencies. FORWARD GROUPING. Test in which unknown red blood cells are mixed with antisera of known specificity to determine the presence or absence of antigens on the red blood cells. Agglutination with the reagent indicated the presence of the antigen. HEMOLYSIS. The disruption of the red blood cell membrane resulting in a issuance of hemoglobin into the plasma or cell suspension medium. HEMOVIGILANCE. Defined as the detection, gathering and analysis of information regarding untoward and unexpected effects of blood donation and transfusion HEPARIN. An anticoagulant but not preservative; used when blood is to be filtered for the removal of lymphocytes. HIGH-RISK BEHAVIOR. Refers to a particular behavior and lifestyle predisposing to the occurrence of a particular condition or illness. HIV-1. Human Immunodeficiency Virus type |, the causative agent of AIDS. Initially called HTLV-IE or LAV HIV-2. Human Immunodeficiency Virus Type 2, also associated with AIDS and sharing parial homology with HIV-1. Manual of Standards for Blood Service Facilities 193 HA

Giossary HIV POSITIVE. Refers to laboratory evidence of exposure to human immunodeficiency virus. Such people have had repeatedly reactive screening tests for HIV antibody and confirmed by supplemental tests for HIV antibody or persons positive for HIV antigen. IMMUNE RESPONSE. The reaction of the body following an exposure to an antigen, This can result in either cellular response or the formation of antibody or both. IMMUNOCOMPROMISED. Defect in immune system resulting in decreased resistance to infection or diminished immune response. INCINERATION, Use of high temperature to convert combustible solid waste material into residual ash and gases, which are vented to the atmospheres. It is utilized as a treatment technique for almost all types of infectious waste. INFORMED CONSENT.Refers to an agreement to testing which is obtained after informing the blood donors of processes involved in blood donation, including testing and reporting of positive test results. This is required by ethical rules and legal issuances. IgG-SENSITIZED RED BLOOD CELLS. These are red blood cells coated with IgG used to confirm-any negative antiglobulin test ant to evaluate the antiglobulin reagent. IN-HOUSE CONTROL. Control sera of defined reactivity prepared in the investigator’s own laboratory. In-house controls are often prepared by pooling several specimens together, determining the test result, and aliquoting for routing use as a control. INTERNAL CONTROL. The positive and negative control sera included in a test kit. INTERNAL QUALITY ASSESSMENT. Assessment of performance done by the staff within the BSP. LEUCOCYTE-REDUCED BLOOD COMPONENT. A blood component that has a reduced number of leucocytes either by filtration, deglycerolization of frozen red cells, washing or centrifugation. MALARIA. A parasitic disease caused by Plasmodia that can be transmitted by transfusion. MEAN. In ELISA, the average value of a set of optical density (OD) readings or absorbance values and cut-off values (COV). CIC 104 Manual of Standards for Blood Service Facilities CI

Glossary MOBILE BLOOD DONATION (MBD). A blood donation session conducted in a temporary site away from the location of the Blood Collection Unit or Blood Bank/ Center. NORMAL SALINE SOLUTION (NSS). 0.9% Sodium Chloride solution. OPTICAL DENSITY, The units expressed by a spectrophotometer or an ELISA reader representing the quantity of light adsorbed by the colored end product of the reaction. OD/ COV RATIO, The test optical density (O.D.) reading divided by the cut-off (C.O.) value of that run. OPEN SYSTEM. A procedure in which the transfer container, not integrally attached to the blood pack is used to obtain a component from the blood pack. The blood pack is breached resulting in potential or actual contamination. The shelf life is 24 hours after the procedure. PACKED RED BLOOD CELLS (PRBC). Blood component consisting mainly of red cell mass produced when most of the plasma is removed following sedimentation or centrifugation. PARALLEL TESTING. A comparison of performance of new lots of kits with the previous lots done at the same time and utilizing common control material. Parallel testing is also performed on serial samples to obtain results on the same run for comparison. PHENOTYPE. The detectable or expressed characteristics of genes. PHERESIS. See Apheresis. PHLEBOTOMY. The process of withdrawing blood from the circulatory system from a vein. PLASMA. The fluid component of uncoagulated blood after cells are removed. PLASMA DERIVATIVE. Human plasma proteins prepared under pharmaceutical manufacturing conditions, such as: albumin, coagulation factor concentrates, and immunoglobulins. PLAMAPHERESIS. A pheresis procedure in which plasma is removed from whole blood with the cellular elements returned to the donor. CIO 105 no Manual of Standards for Blood Service Facilities

Giossary PLATELET CONCENTRATE. A blood component which contains platelets as the major cellular element. It is prepared from plasma by differential centrifugation or obtained direct from the donor by apheresis. PREDEPOSIT AUTOLOGOUS DONATION. Donation of one or more units of blood prior to an elective surgical procedure by a person for his or her use during or after the procedure. PROFICIENCY TESTING. External evaluation of performance by the use of unknown test samples. PYCNOMETER. A device used to measure the specific gravity of Copper Sulfate solution. PYROGEN-FREE. Free from fever-producing protein substances of antibodies. QUALITY. The consistent and reliable performance of services and manufacture of blood products in conformity with the specified standards. QUALITY ASSURANCE (QA). The combination of activities necessary for every blood service facility to ensure quality blood products and quality blood services for “theit-patients, donors, fellow employees, hospitals, doctors, the community, and the regulatory agencies, It is a part of the broader and continuous quality improvement process which ensures that quality will benefit the organization and its end-users. UALITY CONTROL (QC). Part of the quality assurance system which consists of q ¥ ¥ retrospective tests or other measures that should provide satisfactory results before proceeding further in a given process and which demonstrates compliance to certain defined limits and specifications. QUARANTINE. The sequestration of materials and blood products, whether physically or by a system, while awaiting a decision on their suitability for further processing or use. REAGENTS. Substances employed to detect or measure another substance or convert one substance to another by means of the reaction that it causes. In blood banking, the reagents used are those necessary to measure nemoglobin; screen for blood transmissible diseases such as HIV, hepatitis, malaria, syphilis, among other; identify blood groupings; and perform crossmatching and other immunohematologic examinations. RECIPIENT. The person or a patient who receives a transfusion of whole blood or its products. mie 106 Manual! of Standards for Blood Service Facilities OO

Glossary Rh FACTOR. A blood group antigen, named after Rhesus monkey, originally identified because and antibody agglutinated the erythrocytes of all rhesus monkeys, 85% of Caucasians and over 99% of Asians. Rb NEGATIVE. A blood type characterized by the absence of D (Rh,) antigen and its variant DY from the surface of red blood cells. Rh POSITIVE. A blood type characterized by the presence of D (Rh,) antigen and its variant DY from the surface of red blood cells. RETROVIRUS. Virus that uses an enzyme reverse transcriptase to transcribe an RNA genome into DNA. REVERSE GROUPING. Serologic test in which serum containing unknown ABO antibody(les} is tested with red blood cells or known ABO group A, B and sometimes A, red blood cells are used. SECRETARY OF HEALTH. The Secretary of Health or any other person to whom the Secretary delegates the responsibility of carrying out the provisions of this Act. SENSITIVITY. The capacity of a procedure to diagnose a positive case as postitive (very low false positive); also.the_ability of the reagent or test to detect very-—— small amounts of analyte, or the ability of a reagent or test to detect all or most infected individuals correctly. SERUM. The straw-colored fluid remaining when blood has clotted and cellular components are separated. SPECIFICITY. The ability of a procedure or reagent to identify all negative correctly (very low false postitive). SPECTROPHOTOMETER. The instrument used to measure absorbance of light at a specific wavelength. SPHYGMOMANOMETER. An instrument used to obtain a person’s systolic and diastolic blood pressure. STANDARD OPERATING PROCEDURES. The enumeration of steps in a procedure, A set of documents or detailed protocols of procedures performed within the laboratory / blood bank which should be compiled in a Manual. STARTING MATERIAL. The starting material for component preparation is whole blood or the products of apheresis collected from donors. Manual of Standards for Blood Service Facilities 107 HH

Glossary STERILE. Free from viable microorganisms. STERILIZATION.A procedure that effectively kills all microorganisms including bacterial spores. SYMPTOM. A subjective complaint by the patient usually indicating a disturbance of body function, a disorder or disease. SYSTOLIC BLOOD PRESSURE. The blood pressure in a large artery during which the heart is contracting to propel blood to the circulatory system. The upper number of a blood pressure reading. TEST RUN. A group of specimens processed together with the reagent and in-house controls in one batch. THERAPEUTIC PHLEBOTMY. Removal of blood from a vein for treatment purposes, as in the case of polycythemia. TRANSFUSION. The administration of blood or blood component to person through the intravenous route. TRANFUSION REACTION/ COMPLICATION. Any adverse reaction following the infusion of blood or blood component. a VACCINE. Any preparation intended for active immunological prophylaxis. VALIDATION. A procedure that shows a piece of equipment of process does what it is supposed to do. It assures that a process will consistently procedure a product according to requirements. VENIPUNCTURE. See Phiebotomy. VOLUNTARY NON-REMUNERATED BLOOD DONOR (VNRBD). An individual who donates blood on one’s own volition or imitiative and not induced, directly or indirectly, in any manner whatsoever, by any monetary compensation nor blood relations/ obligations. WASTE. A useless or worthless byproduct, as from a manufacturing process. This refers to waste generated by the BSF, and are classified into hazardous and non- hazardous. WHOLE BLOOD. A unit of blood not further processed, containing all the cellular and liquid components, collected into an approved container containing an anticoagulant-preservative solution. See Blood. Ae 108 Manual of Standards for Blood Service Facilities I

References American Association of Blood Banks 2005, Technical Manual, 15th Edition. Brecher ME fed.}, Bethesda MD, USA. American Association of Blood Banks 2006, Standards for Blood Banks and Transfusion Services, 24th Edition. Silva MA (ed.} Bethesda MD, USA. Council of Europe, Guide to the Preparation, Use and Quality Assurance of Blood Components, 12th edition “Manual of Standards on Quality Management System in the Clinical Laboratory”, 1* Ed., 2008. Department of Health, Administrative Order 2008-0008, “Rules and Regulations Governing the Regulation of Blood Service Facilties”, 2008 Department of Health-Bureau of Research and Laboratories 1996, Manual of Standards for Blood Banks and Blood Centers in the Philippines, Manila, Philippines. International Council for Commonality in Blood Banking, ISBT 128 Nomenclature, Ist Edition 2010, ISBN 13:978-1-1933243-16-0. ISBT: 1- 933243-16-3 (www.iccbba.org/isbtl28introbooklet. pdf) International Society of Blood Transfusion General Assembly 2006, Amended Code of Ethics in Blood Donation and Blood Transfusion, Laboratory Biosfety Guidelines, 3" Ed., 2004. Canada National Blood Center of Malaysia (Kuala Lumpur}, Quality Procedure (2001) World Health Organization 2005, Safe Blood and Blood Products: Manual on the Management, Maintenance, and Use of Blood Cold Chain Equipment. ISBN 92 4 154673 5. NLM Classification: WH 460. 20051211, Geneva 27, Switzerland. OL) Manual of Standards for Blood Service Facilities 111 min

ACKNOWLEDGEMENTS Technical Working Group Ms. Ma. Cecile C. Amaro Medical Technologist II Rizal Medical Center Mr. Sixte P. Arlegui III Medical Technologist Veteran’s Memorial Medical Center Mr. Salvador P. Aydante Jr. Medical Technologist Ill National Voluntary Blood Services Program Dr. Manuel L. Barnes Blood Bank Head Veteran's Memorial Medical Center Ms. Nenita Cafiafranca os Bacteriologist LE National Center for Health Facility Development Ms. Ma. Rizalina Chua Metropolitan Hospital St. Luke’s Medical Center Dr. Ma. Lourdes U. Concepcion Pathologist Philippine Children’s Medical Center Mr. Antonio Domasian Blood Bank Medical Technologist Philippine Children’s Medical Center Ms. Marietta Go Medical Technologist HI Bureau of Health Facilities and Services Mr. Renato Hapan Quality Officer Philippine Red Cross Manual of Standards for Blood Service Facilities 4415 AIH

Dr. Carlota B. Manzano Biood Bank Head Dr. Jose B, Lingad General Hospital Dr. Tomas P. Maramba Consultant National Voluntary Blood Services Program Dr. Angelina L. Mirasol Internist Hematologist Philippine Society of Hematology and Blood Transfusion Dr. Christie Monina M. Nalupta Director -— National Blood Services Philippine Red Cross Dr. Elizabeth Y. Arcellana-Nuqui Pathologist/ Chairperson Chairperson, National Counci of Blood Services - Technical Committee Dr. Imelda Marie Fremielie. Flores-Palacol Blood Program Coordinator Provincial Health Office of Laguna Dr. Winifredo A. Pernia Medical Specialist III Philippine Blood Center Dr. Pedrite Y. Tagayuna Medical Specialise IIT National Voluntary Blood Services Program Ms. Adoracion Sevilleja Medical Technologist III National Kidney and Transplant Institute Dr. Milagros M. Viacrucis Regional Blood Program Coordinator Center for Health Development - Southern Mindanao Ms. Cristina G. Yanzon Medical Technologist Bicol Regional Blood Center Cr 116 Manual of Standards for Blood Service Facilities

Ms. Fiorinda Tuvillo Development Management Officer National Center for Health Facility Development Scientific Committee and Secretariat Ms. Marites B. Estrella Technical Component Manager Global Fund Round 6-HIV Project-Blood Safety Component Ms. Anna Leah D. Dipatuan Site Implementation Officer Global Fund Round 6-H1YV Project-Blood Safety Component Ms. Christine C. Gezon National Center for Health Facility Development Department of Health Mr. Ramil Esguerra Liaison Officer AIDS Society of the Philippines Mr. Jose Bayani Velasco Monitoring and Evaluation Coordinator AIDS Society of the Philippines and Blood Safety Component Staff Global Fund Round 6 -HIV Project Manual of Standards for Blood Service Facilities 117 A