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Journal of the Academy of Hospital Administration

Documentation and Records in a Blood Transfusion Service/Blood Bank

Author(s): Rama Bhasin*

Vol. 12, No. 2 (2001-07 - 2001-12)

Documentation and Record form one of the important quality system essentials in any blood bank/blood transfusion service. To be compliance with this essential facilities must have a process to ensure that documents (policies process descriptions and procedures) are identified, approved, implemented and retained. Forms must be designed, to effectively capture outcomes. These forms must also be controlled, and the records stored and archived in a useable condition for a specified period of time.

Blood Bank documents / Records like all medical information must not be released or made available to unauthorised persons. The system should ensure confidentiality of donor and patients records. One major concern in records is identification for legal or investigational purposes, of persons responsible for each process.

Documentation and Records involve every aspect of blood banking ie, donor recruitment, donor selection, donor recall, blood collection, blood components processing, storage, transportation of blood and blood components, screening of blood for TTI'S, adverse reactions to blood transfusion, issue of and transfusion of blood and blood component to the patient

Standard operating procedures (SOP) manual is the most important document in any BTS. It should cover every significant action of the organisation

which effect the quality of products or its services including record keeping, validation and documentation written SOP's should be available at each work station/area and should vary in format and contents according to the task to be performed.

Specific examples of SOP included:

  • Donor Registration and interview
  • Donor selection and blood collection (Phlebotomy)
  • Testing of blood for transfusion Transmitted infections(TTI'S)
  • Preparation of blood components and storage
  • Quality monitoring of equipment
  • Quality monitoring of laboratory techniques
  • Training of staff

In this article procedure and format of donor selection criteria are being provided. Examples of donor registration questionnaire forms and self exclusion forms for high risk behaviour donors are provided (annexure 1 and 2). Remaining aspects of documentation and records in a Blood Transfusion Service will be covered in other issues.

Criteria for Selection of Blood Donors

1. General: Do not draw blood from a person more than once in three months. The donor should be in good health, mentally alert and physically fit. The donors should fulfil the following requirements.

  1. Age:Between 18 to 60 years.
  2. Weight : Minimum acceptable weight is 100 1bs or 45 kgs for 5 ft height. For every inch increase in height added weight of 1 pound is accepted. 55kg. Can donate blood, unrelated to height.(One can safely donate 3 c.c. /1b of body weight 7 c.c./kg. Body weight.)
  3. Hb:> 12.5 gm for females and > 13.5 gm for males
  4. Temperature: Should be normal (not exceeding 370 C)
  5. Pulse rate: Should be between 50-100 per minute, regular
  6. Blood pressure: Systolic between 90-200 Hg.Diastolic between 50-100 mm Hg.
  7. Heart: There should be no murmurs or arrhythmias
  8. Lungs: Donor should be free acute respiratory disease, Lungs should be clear.
  9. Liver and spleen: Should not be palpable.
  10. Skin infection: Donor should be free from any skin disease at the site of phlebotomy
  11. Arms and forearms of the donor should be free from skin punctures or scars indicative of professional blood donors or addiction to self injected narcotics.
  12. Donor should be free from any disease transmissible by blood transfusion, in so far as can be determined by history and examination as indicated above.

Temporary Deferral

Any person who appears to be under the influence of alcohol or any hypnotic drug, suffering from any mental disorder or who does not appear to be providing reliable answers to medical history questions are deferred. Do not draw blood from a donor in following conditions before the expiry of the period of deferment.

Infectious Diseases

  1. Viral Hepatitis: Reject any donor who has
    • a positive history of viral hepatitis in the past, one year.
    • Close contact with an individual with hepatitis within the past 1 year.
    • Tatooing within 1 year
  2. Tuberculosis : Unfit till 2 years after finishing complete therapy.
  3. Malaria : H/o malaria in past 3 months
  4. Herpes Infection : Defer during attack.
  5. Syphilis : Defer till 1 year after complete treatment.
  6. Chicken pox : Defer till 3 months after recovery.

Surgical Procedure

  1. Minor Surgery : Donor with history of minor surgery,even tooth extraction during a period of 72 hours prior to donation should not be taken
  2. Major Surgery : Unfit till 6 months
  3. Pregnancy :Unfit till 1 year after delivery.
  4. Lactation : Unfit for one year after delivery.
  5. Abortion : Unfit for 6 month after abortion.
  6. Menstruation : Temporarily unfit during menses.

Medications

  1. Antibiotics - defer till 5 days after full course of antibiotics
  2. Hypertensives - defer till donor taking anti- hypertensives has controlled blood pressure within normal limits and no side effects.
  3. Isoretinoin (Acutane) - taken orally for acne-defer for one month after last dose (as+teratogenic)
  4. Finasteride (Proscar)- taken for Benign hyperplasia of Prostate - defer for one month after last does

Immunization

I) Those receiving attenuated vaccines for measles, cholera, typhoid, plague, polio, mumps, diptheria, tetanus, toxoid should be excluded for 2 weeks after immunization.

  1. Attenuated rubella : Excluded for 8 weeks.
  2. Therapeutic Rabies Vaccine: Excluded for one year.
  3. Passive Immunization - Excluded for 1 year.

Hazardous occupation

  1. Donor engaged in hazardous occupation should be deferred unless recovery period of 24 hours can be given.
  2. For Flight Crew : Recovery period of 72 hours.

Permanent Defferral

Persons with following conditions are not accepted for blood donation.

  1. A confirmed positive test of HBs Ag.
  2. An intravenous drug abuser.
  3. Malignant disease.
  4. Epilepsy or any history of seizures.
  5. Renal disease.
  6. Any cardiac disease
  7. Ulcerative colitis.
  8. Multiple sclerosis (disseminated)
  9. Raynaud's disease.
  10. Sarcoidosis.
  11. Injections with human pituitary derived growth hormone (pitu-=h-GH.) Deferral is not necessary if donor has only been given recombinant growth hormone.
  12. Blood disorder (except Iron deficiency Anaemia which can be corrected.)
  13. Any chronic illness or rheumatoid arthritis.
  14. Mental disease.
  15. Leprosy.
  16. Diabetes: Unfit if on insulin treatment. Those on oral hypoglycemic treatment in well controlled Diabetes without any vascular complication of the disease may be accepted.
  17. Allergy : History of allergy to any drug. Unfit in cases of severe allergy because they might sensitise the patient for short period. Seasonal allergy acceptable during symptom free period.
  18. AIDS HIV positive test. S/S of AIDS/HIV Infection : Swollen glands. Infection Night sweats/fever. Prolonged diarrhoea Persistent cough Skin rashes/lesions.
  19. Any person of high risk behaviour is deferred:
    • Male homosexuals or bisexuals.
    • Injecting drug users.
    • Any person with history of STD
    • Prostitutes.
    • Jail inmates.
    • Sexual contact with any of above
  20. Drugs and medications: Several medicines taken by the donor are not harmful to the recipient. Deferrals for most of the drugs is based on the nature of the disease process, not on the properties of the drugs itself. Anybody taking parenteral medication with exception of vitamins or oral contraceptives is to be rejected. Donors taking the following medicines are not taken Anti-convulsants, Anti-arrhythmics, Anti-inflammatory drugs. Anti-coagulants/Digitalis Insulin/Marihuana/ Hypnoties/Vasodilators Hormonal replacement/ Etretinate (Tegison)- for psoriasis-(permanent deferral as blood levels are maintained for years are teratogenic)
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