Normative evaluation of blood banks in the Brazilian Amazon region in respect to the prevention of transfusion-transmitted malaria

Freitas, Daniel Roberto Coradi; Duarte, Elisabeth Carmen

doi:10.1016/j.bjhh.2014.09.002

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Original Articles • Rev. Bras. Hematol. Hemoter. 36 (6) • Nov-Dec 2014 • https://doi.org/10.1016/j.bjhh.2014.09.002 copy

Normative evaluation of blood banks in the Brazilian Amazon region in respect to the prevention of transfusion-transmitted malaria

Authorship SCIMAGO INSTITUTIONS RANKINGS

Objective:

To evaluate blood banks in the Brazilian Amazon region with regard to structure and procedures directed toward the prevention of transfusion-transmitted malaria (TTM).

Methods:

This was a normative evaluation based on the Brazilian National Health Surveillance Agency (ANVISA) Resolution RDC No. 153/2004. Ten blood banks were included in the study and classified as 'adequate' (≥80 points), 'partially adequate' (from 50 to 80 points), or 'inadequate' (<50 points). The following components were evaluated: 'donor education' (5 points), 'clinical screening' (40 points), 'laboratory screening' (40 points) and 'hemovigilance' (15 points).

Results:

The overall median score was 49.8 (minimum = 16; maximum = 78). Five blood banks were classified as 'inadequate' and five as 'partially adequate'. The median clinical screening score was 26 (minimum = 16; maximum = 32). The median laboratory screening score was 20 (minimum = 0; maximum = 32). Eight blood banks performed laboratory tests for malaria; six tested all donations. Seven used thick smears, but only one performed this procedure in accordance with Ministry of Health requirements. One service had a Program of External Quality Evaluation for malaria testing. With regard to hemovigilance, two institutions reported having procedures to detect cases of transfusion-transmitted malaria.

Conclusion:

Malaria is neglected as a blood–borne disease in the blood banks of the Brazilian Amazon region. None of the institutions were classified as 'adequate' in the overall classification or with regard to clinical screening and laboratory screening. Blood bank professionals, the Ministry of Health and Health Surveillance service managers need to pay more attention to this matter so that the safety procedures required by law are complied with.

Health evaluation; Malaria; Blood banks; Donor selection; Blood safety

Sector/activity	Weight	No. of items	Score range	Classification
Education	0.5	1	0	Inadequate
			5	Adequate
			0–20	Inadequate
Clinical screening	4	10	>20–32	Partially adequate
			>32–40	Adequate
			0–20	Inadequate
Laboratory screening	4	5	>20–32	Partially adequate
			>32–40	Adequate
			0	Inadequate
Hemovigilance	1.5	2	7.5	Partially adequate
			15	Adequate
			0–50	Inadequate
Final classification	–	18	form 50 to 80	Partially adequate
			≥80	Adequate

Sector/activity	Item evaluated	Score	RDC 153/2004 item
Donor education	Provide educational materials to donors containing information about transfusion-transmitted malaria.	10.0	B.4
Clinical screening	Interview the donor individually in a private place.	1.0	B.2 and B.5
	Have standards operational procedures for clinical screening of donors containing malaria exclusion criteria.	1.0	A.11, B.5.2.6.2 and P.1
	Use the criterion of travel to risk area to reject donations, i.e. reject candidates coming from high malaria risk areas as per API.	1.0	B.5.2.6.2
	Use the criterion of living in a risk area to reject donations, i.e. reject candidates living in high-risk areas as per API.	1.0	B.5.2.6.2
	Use the criterion of prior history of malaria to reject donations, i.e.: (a) Reject candidates who have had malaria in the 12 months prior to donation; (b) Reject candidates who have had fever in the last 30 days; (c) Reject candidates who have had suspected malaria in the last 30 days.	None=0 1–2 = 0.5 3 = 1.0	B.5.2.6.2
	Have a training program that has clinical screening for malaria as part of its contents.	1.0	P.2
	Use a standardized screening form (questionnaire) that assesses travel to risk areas.	1.0	A.12, B.5.2.6.2 and B.6.4
	Use a standardized screening form (questionnaire) that assesses living in a risk area.	1.0	A.12, B.5.2.6.2 and B.6.4
	Use a standardized screening form (questionnaire) that assesses prior history of malaria. –malaria 12 months prior to donation; –fever in the last 30 days; –suspected malaria in the last 30 days.	None = 0 1–2 = 0.5 3 = 1.0	A.12, B.5.2.6.2 and B.6.4
	Existence of a warning mechanism capable of preventing donation by donor who is ineligible owing to risk of malaria, as per the criteria used by the blood bank.	1.0	N.3 and N.6.f
Laboratory screening	Perform laboratory screening on all donors, as required by RDC 153, i.e. perform parasite testing on all donors living in or who have traveled to areas with medium or low API, i.e. API <50.	4.0	B.5.2.6.2
	Have written procedures for test performance in accordance with the following references: –Thick smear: as per Ministry of Health Malaria Diagnosis Manual. –Immunoenzymatic test: as per the manufacturer's instructions.	2.0	A.11 and P.1
	Having a training program on the performance of laboratory tests.	1.0	P.2
	Have written procedures for test performance in accordance with the following references: –Thick smear: the Ministry of Health Malaria Diagnosis Manual recommends that a negative result be given after at least 200 fields have been evaluated. –Immunoenzymatic test: as per the manufacturer's instructions.	2.0	A.11 and P.1
	Have an External Quality Evaluation program for malaria testing.	1.0	A.14
Hemovigilance	Have procedures to detect donors who have suspected or confirmed malaria following donation.	5.0	A.10
	Have procedures to detect recipients suspected of having malaria transmitted by blood products produced by the service.	5.0	A.11 and A.17

Blood banks in malaria endemic areas Activities to prevent transfusion-transmitted malaria
Education		Clinical screening	Laboratory screening	Surveillance
Structures
	Professionals trained and educational material available to clearly inform donors of the risk to blood recipients becoming infected with malaria through transfusions	Professionals trained and material available to evaluate the risk of donors being infected with Plasmodium (written instructions, up-to-date API chart, standardized forms)	Professionals trained and material available to perform laboratory tests (adequate algorithms, written instructions, external quality evaluation, standardized forms)	Professionals trained and material available to identify and investigate suspected TTM cases and detect suspected malaria cases following donation (case definition, standardized forms, flowcharts)
Processes
	Donors receive educational materials and guidance on their contents	Donors adequately assessed regarding: (a) Traveling to areas with API > 49; (b) Living in areas with API > 49; (c) Prior history of malaria	All donors not excluded during clinical screening have blood sample tested for the presence of the 3 Plasmodium species prevalent in Brazil, as per written instructions	All suspected TTM cases are investigated adequately Blood banks are informed of any donors suspected of having malaria following donation
Intermediate results
	Donors understand the risks and are sufficiently aware to be able to answer clinical screening questions adequately and honestly and are proactive in providing information	Donors at increased risk according to the established criteria are prevented from donating	Plasmodium-infected donors are identified and the blood products are discarded Donors are informed of their test results and referred for a doctor's appointment	TTM investigation is completed and positive cases ate treated Donors suspected of having malaria following donation are detected and blood products are discarded
Final results
	Maximum reduction in the number of contaminated blood products available for therapeutic use	Maximum reduction in the number of TTM cases	No TTM related mortality among recipients

Sector/activity		Weighted scores for blood banks										Median
Sector/activity		A	B	C	D	E	F	G	H	I	J	Median
Education		0.0	5.0	0.0	0.0	0.0	0.0	0.0	5.0	0.0	0.0	0.0
	Classification	I	A	I	I	I	I	I	A	I	I
Clinical screening		28.0	26.0	24.0	20.0	16.0	26.0	32.0	32.0	16.0	30.0	26.0
	Classification	PA	PA	PA	I	I	PA	I	PA	I	PA
Laboratory screening		20.0	32.0	0.0	28.0	28.0	28.0	8.0	20.0	0.0	8.0	20.0
	Classification	I	PA	I	PA	PA	PA	I	I	I	I
Hemovigilance		0.0	15.0	0.0	0.0	7.5	0.0	0.0	0.0	0.0	7.5	0.0
	Classification	I	A	I	I	PA	I	I	I	I	PA
Maximum score		100	100	100	100	100	100	100	100	100	88.0^a a Two laboratory screening items were not evaluated because they were outsourced activities.	–
Score obtained		48.0	78.0	24.0	48.0	51.5	54.0	40.0	57.0	16.0	51.7	49.8
	Final classification	I	PA	I	I	PA	PA	I	PA	I	PA

Sector/activity	Item evaluated	Blood banks										n^a a Number of blood banks adequately complying with the item.
Sector/activity	Item evaluated	A	B	C	D	E	F	G	H	I	J
Donor education	Provide educational material to donors containing information about the risk of malaria transmission	0.0	10	0.0	0.0	0.0	0.0	0.0	10	0.0	0.0	2
Donor education	Subtotal	0.0	10	0.0	0.0	0.0	0.0	0.0	10	0.0	0.0
Clinical screening	Interview the donor individually in a private place	1.0	1.0	1.0	1.0	1.0	1.0	1.0	1.0	1.0	1.0	10
	Have SOP for clinical screening of donors containing malaria exclusion criteria	1.0	0.0	0.0	0.0	0.0	0.0	1.0	1.0	1.0	1.0	5
	Use the criterion of travel to risk area to reject donations	1.0	0.0	1.0	1.0	0.0	1.0	1.0	1.0	0.0	1.0	7
	Use the criterion of living in a risk area to reject donations	1.0	0.0	1.0	0.0	0.0	1.0	1.0	0.0	0.0	1.0	5
	Use the criterion of prior history of malaria to reject donations	0.5	1.0	0.5	0.5	0.5	1.0	1.0	0.5	0.0	0.5	3
	Have a training program that has clinical screening for malaria as part of its contents	1.0	1.0	0.0	0.0	1.0	0.0	0.0	1.0	1.0	1.0	6
	Use a standardized screening form (questionnaire) that assesses travel to risk areas	0.0	1.0	1.0	1.0	1.0	1.0	1.0	1.0	0.0	1.0	8
	Use a standardized screening form (questionnaire) that assesses living in a risk area	0.0	1.0	0.0	0.0	0.0	0.0	0.0	1.0	0.0	0.0	2
	Use a standardized screening form (questionnaire) that assesses prior history of malaria	0.5	0.5	0.5	0.5	0.5	0.5	1.0	0.5	0.0	0.0	1
	Existence of a warning mechanism capable of preventing donation by donor who is ineligible owing to risk of malaria, as per the criteria used by the blood bank	1.0	1.0	1.0	1.0	0.0	1.0	1.0	1.0	1.0	1.0	9
	Subtotal	7.0	6.5	6.0	5.0	4.0	6.5	8.0	8.0	4.0	7.5
Laboratory screening	Perform laboratory screening on all donors as required by RDC 153	4.0	4.0	0.0	4.0	4.0	4.0	0.0	4.0	0.0	0.0	6
	Have written procedures for test performance in accordance with the following references: -Thick smear: as per Ministry of Health Malaria Diagnosis Manual. -Immunoenzymatic test: as per the manufacturer's instructions	0.0	0.0	0.0	2.0	2.0	2.0	0.0	0.0	0.0	2.0	4
	Having a training program on the performance of laboratory tests	1.0	1.0	0.0	1.0	1.0	1.0	0.0	1.0	0.0	^b b Not evaluated because these are outsourced activities.	6
	Have written procedures to test performance in accordance with the following references: – Thick smear: the Ministry of Health Malaria Diagnosis Manual recommends that a negative result be given after at least 200 fields have been evaluated – Immunoenzymatic test: as per the manufacturer's instructions	0.0	2.0	0.0	0.0	0.0	0.0	2.0	0.0	0.0	^b b Not evaluated because these are outsourced activities.	2
	Have an External Quality Control program (Proficiency) for malaria testing	0.0	1.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	1
	Subtotal	5.0	8.0	0.0	7.0	7.0	7.0	2.0	5.0	0.0	2.0
Hemovigilance	Have procedures to detect donors who have suspected or confirmed malaria following donation	0.0	5.0	0.0	0.0	5.0	0.0	0.0	0.0	0.0	0.0	2
	Have procedures to detect recipients suspected of having malaria transmitted by blood products produced by the service	0.0	5.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	5.0	2
	Subtotal	0.0	10	0.0	0.0	5.0	0.0	0.0	0.0	0.0	5.0

Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular R. Dr. Diogo de Faria, 775 cj 114, 04037-002 São Paulo/SP/Brasil, Tel. (55 11) 2369-7767/2338-6764 - São Paulo - SP - Brazil
E-mail: secretaria@rbhh.org

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[1] *Corresponding author at: Universidade de Brasília (UnB), Campus Universitário Darcy Ribeiro, Núcleo de Medicina Tropical, 70910-900 Brasília, DF, Brazil. E-mail address: danielcoradi@gmail.com (D.R.C. Freitas).