Manual of Standards for Blood Collection Units in the Philippines

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, MD Michael Angelo J. Marquez, Jr., MD Administration and Document Preparation Agripina C. Serapio Salina O. Go, BS Chem. Wilbur E. Marlori Cristina T. Narciso, RMT Teodoro M. Fajardo, RMT Reynaldo R. Velasco Pompeyo R. Fontanilla EmilyV. Flores Luz M. Ramos, BSMT PROJECT MANAGEMENT AND EDITORIAL GROUP Criselda G. Abesarnis, MD, FPSP Marietta C. Baccay, MD, FPSP Marilyn C. Barza, MD, FPSP Andres S. Bonifacio, MD, FPSP (PSP) Norma N. Chang, RMT

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Manuel M. Dayrit, MD, MSc Cecilia J. Francisco, MD (PNRC) Raymundo W. La, MD, FPSP (PSP) Tomas P. Maramba, MD, FPSP,MPH Agnes Medenilla, RMT Gloria. L. Tan, MD, DPSP

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REFERENCES 1. Australia Code of Good Manufacturing Practice for Therapeutic Goods ( Blood and Blood Product), 2nd Edition 1995 2. Blood Product Issue Policies, Red Cross Blood Bank Victoria, 1994. 3. Guidelines for the Selection of Blood Donors, Australian Red Cross, National Blood Transfusion Center, April 1994. 4. and various Procedural Manuals of the Red Cross Blood Bank Victoria Grateful acknowledgement is given to Dr. Gordon S. Whyte for providing the Australian documents. 5. Standards for Blood Banks and Transfusion Services, American Association of Blood Banks, 16th Edition 1994 6. Code of Federal Regulations (Food and Drugs ),' USA, Parts 600 to 799, as of April 1, 1993. 7. Guidelines for Blood Transfusion Service, United Kingdom, Amendment 1, 2nd Ed. 1994 8. WHO Documents 8.1 Resolution WHO 28.72 The 28th World Health Assembly, 29 May 1975 8.2

Consensus Statement on How to Achieve a Safe and Adequate Blood Supply by Recruitment and Retention of Voluntary, Non-Remunerated Blood Donors 1993 WHO/ . LBS/93/2, WHO/GPNlNF/93.1

8.3

Consensus Statement on Accelerated Strategies to Reduce the Risk of Transmission of HIV by Blood Transfusion, 1989 WHO/GPNlNF/89.13, WHO/LAB/89.6

8.4

Guidelines for the Appropriate Use of Blood 1989 WHO/GPNINF/89.18, WHO/LAB/89.10

9. other US AABB Documents: 9.1 American Association of Blood Banks (1976). Seminar on Performance Evaluation. Presented at the 29th Annual Meeting, San Francisco,California: 121 133 9.2

Walker, R.H. et al (1993). Technical Manual, 11th Ed. American Association of Blood Banks, Arlington, Virginia

9.3

Taswell, H.F. & Saed, S.M. (1980). Principles and Practice of Quality Assurance in Blood Bank, American Association of Blood Banks, Washington, D.C.

9.4

Dixon, M.R. et al (1987). Selection of Method and Instrument for Blood Banks. AABB, Arlington, Virginia: 1 - 109

9.5

Nance, S.T. (1989).lmmune Destruction of Red Blood Cells. Ariington,VA. American Association of Blood Bank : 227 • 261

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9.6

Nance, S.T. (1991). Clinical and Basic Services Aspect of Immunohematology, American Association of Blood Bank, Arlington, Virginia: 73 -107 and 179 - 199

10.

Bender, J.L., Anhalt, J.P. et al (1992). Quality Assurance Programs. Technical Manuals, NCClS Document GP2-A2 2nd ed. 12 (10): 1

Clinical laboratory

11.

Calam, G.B. (1992). Quality Assurance, An Administrative Means to a Managerial End. Clinical lab. Management Review 6 (5): 426

12.

College of American Pathologists (1989). Guidelines for laboratory Safety

13.

Constantine, N.T., Callahan, J.D. & Watts, D.M. (1992). Retroviral Testing Essentials for Quality Control for laboratory Diagnosis, CRC Press, Florida, USA

14.

Constantine, N.T., Groen, G.V. et al (1994). Sensitivity of HIV-Antibody Assays mined by Seroconversion Panel. AIDS 8: 1715 - 1720

15.

Garcia, L.S., Bullock, S.L., Fritsch, T.R., et al (1993). Slide Preparation and Staining of Blood Films for the laboratory Diagnosis of Parasitic Diseases, NCClS Document 15-T12 (15)

16.

Green, R.E., Ford, D.S., Condon, J.A., et al (1987). Basic Blood Grouping Technique & Procedures, 2nd Ed. Victorian Immunohematology Group

17.

Hoeltge, GA, Pollock, P.G., Reinharat, P.A. (1991). Waste Management Systems. cal laboratory Waste Management NCClS Document GP5-T 11 (22): 8 - 13

18.

Howanitz, P.J. et al (1987).

19.

Issitt, P.O. (1984). Applied Blood Group Serology. Ed. : 31 - 37

20.

Klein, R.E., Conley, J.E., Mackinney, K. et al (1986), Temperature, Monitoring & Recording in Blood Banks, NCClS Document 11 O-T 6 (19)

21.

Kelton, J.G., Heddle, N.M. & Blajchman, M.A. (1984). Blood Transfusion, A Conceptual Approach, Churchill Livingstone, N.Y.

22.

levine, P. (1967).Blood Group Antigens and Antibodies as Applied to Compatibility Testing. Ortho Diagnostic Inc.: 1 -12

23.

Mollison, P.L., Engelfriet, C.P. & Contreras (1989). Blood Transfusion in Clinical Medicine. Blackwell Scientific Publication, 9th ed.: 710 - 785

24.

National Committee for Clinical laboratory Standards (1989). Reference Procedure for Qualitative Determination of Hemoglobin in Blood 4 (3): 54 - 62 Second Ed. Document M 29-T2 11 (14)

25.

National Committee for Clinical laboratory Standards (1991). Protection of laboratory Workers from Infectious Diseases Transmitted by Blood, Body Fluids and Tissue.

26.

National Committee for Clinical laboratory Standards (1991).Protection of laboratory Workers from Instrument Biohazards Proposed Guidelines 11 (5)

Deter-

Clini-

laboratory Quality Assurance. Mc Graw Hill Inc.

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Montgomery Scientific Publication 3rd

27. National Archives and Records Administration (1985). Code of Federal Regulations Food and Drugs 21 28. National Committee for Clinical Laboratory Standards (1992). Testing: Principles and Definitions Document C-24-A 11 (6)

Internal Quality Control

29. Passey, R.B.(1993).CLlA's Quality Assurance: A Study in Total Devotion 25 (5):45-48 30. Programmed Instruction Course for Medical Technologists (1965). Immunohematology: Principles and Practice. Ortho Diagnostic Inc. 31. Quinley, E.D. (1993). Compatibility Testing. In Immunohematology Principles and Practice. J.B. Lippincott Company, Philadelphia: 335 - 338; 1191 - 1206 32. Rossi, E.C., Simon, T.L. & Moss, G.S. (1991). Principles of Transfusion Medicine, William and Wilkins: 709 - 751 33. Schochetman, G., George, J.R. (1992): AIDS Testing: Methodology and Management Issues. Springer-Verlog 48 - 89 and 189 - 196 34. Tamashiro, H., Maskill, W., Emmanuel, J. et al (1993). Reducing The Cost of HIV Antibody Testing. The Lancet: Public Health 342: 87 - 89 35. Tiehen, A. (1993). Competency Assessment in the Transfusion Service. Medical Laboratory Observer: 35 - 42 36. TIetz, NW. Rodgerson, D.O. & Laessig, R.H. (1992). Are Clinical Laboratory Proficiency Tests as Good as They Can Be? 38 (4): 473 37. Tsu, V.D. et al (1991). Health Technology Direction: Major Equipment for Peripheral Laboratory Program for Appropriate Technology in Health 11 (1) 38. Turgeon, M.L. (1989). Fundamentals of Immunohematology: Theory and Technique. Lea & Farbriger:'3 -317 39. DOH Issuances and Manual: 39.1

Administrative Order No. 9 (1995). Rules and Regulations Implementing Republic Act No. 7719 otherwise known as the "National Blood Services Act of 1994": 1 - 31

39.2

Manual of Standards for Blood Banks and Blood Centers in the Philippines. Bureau of Research and Laboratories. Department of Health (February 1996)

39.3

Administrative Order NO.4 s. 1996. Standards for Blood Banks and Blood Centers in the Philippines.

39.4

Environmental Health ServiceslDOH (1994). Manual on Hospital Waste Management: 1 - 76

39.5

National Voluntary Blood Services Unit/Department of Health (October 1996). Five Year Strategic Plan for the National Voluntary Blood Services Program of the Philippines.

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j()H-CfNTRAl UBRARV Date: The Director Bureau of Research and Laboratories Departmenf of Healfh San Lazaro Compound Sta. Cruz. Manila

Subject: Comments and/or Reactions to this First Edition of the Standards for consideration/ incorporation in subsequent editions Please specify page number(s), Section and Item Number(s).

Name: Address and Telephone No.

Dep8rtmen1 of Health

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62:5.\3 Ho46.45. _M31c 1997 I. Manualof alaifdards tor, blood collectJon unit--' _ _

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ISBN 971-91605-2-7 .