Souza, Roberta Kelly L.; Coan, Etienne W.; Anghebem, Mauren I.

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ORIGINAL ARTICLE • J. Bras. Patol. Med. Lab. 56 • 2020 • https://doi.org/10.5935/1676-2444.20200027 copiar

Nonconformities in the pre-analytical phase identified in a public health laboratory

Autoría SCIMAGO INSTITUTIONS RANKINGS

RESUMEN

Introducción:

Las no conformidades detectadas en la fase preanalítica de las pruebas enviadas a los laboratorios centrales (Lacen) del estado culminan en pérdida de datos epidemiológicos de gran importancia para la salud pública, además de perjudicar la vigilancia en salud. Objetivos: Este estudio intentó identificar las no conformidades preanalíticas más frecuentes registradas por el Lacen/PR y las mayores dificultades encontradas por unidades primarias y regionales de salud en el registro de pruebas en el sistema administrador del ambiente de laboratorio (GAL).

Resultados:

Del total de 132.765 pruebas realizadas en 2017, el análisis de datos del sistema GAL-Paraná identificó 9.723 descartes de muestras en desacuerdo. Las no conformidades más frecuentes fueron: solicitud rechazada por la gerencia de GAL pues la muestra está fuera de la fecha de caducidad (28%) y muestra inadecuada para el análisis solicitado (28%).

Discusión:

Al identificar los puntos débiles de esa etapa del proceso, la mayor dificultad detectada fue la solicitud de la prueba correcta. Conclusión: Los datos indican la necesidad de fortalecer las capacidades y la mejora del proceso preanalítico, para garantizar la seguridad del paciente y de los datos epidemiológicos.

Palabras clave:
fase preanalítica; salud pública; servicios laboratoriales de salud pública; control de calidad

Nonconformity	no. of records	Frequency (%)
Inadequate storage	181	2
Lipemic sample	2	0.02
Sample with illegible identification	0	0
Sample with inadequate identification	44	0.5
Contaminated sample	32	0.3
Sample disagreeing with request	33	0.3
Sample at inadequate temperature	35	0.4
Sample received after the collection period	271	3
Hemolyzed sample	77	0.8
Sample unsuitable for the requested analysis	2,694	28
Insufficient volume sample	1,370	14
Sample not corresponding to the indicated	76	0.8
Sample with no identification	16	0.2
Leaked sample	75	0.8
Absence of clinical epidemiological criteria for test conduction	660	7
Incorrect sample registry	358	4
Inadequate collection	36	0.4
Diagnosis made with another method/clinical specimen	290	3
Test previously carried out	172	2
Lack of kit	15	0.2
Patient identification different from sample and request	31	0.3
Technical incident	0	0
Method not used	36	0.4
Inadequate filling of request form/epidemiological record	121	1.3
Container broken during transport	9	0.1
Container with no sample	17	0.2
Request canceled by GAL management due to expiration of the screening period	2,708	28
Illegible request	0	0
Improper request	7	0.1
Request received with no sample	357	4
Request with no identification of the responsible professional	0	0
Total	9,723	100

RS	Most frequent nonconformity	Percentage^* * percentage of total nonconformities at the RS;
1^st RS Paranaguá	Sample unsuitable for the requested analysis	43
2^nd RS Metropolitana de Curitiba	Sample unsuitable for the requested analysis	24
3^rd RS Ponta Grossa	Request canceled by GAL management due to expiration of the screening period	37
4^th RS Irati	Lack of kit	43
5^th RS Guarapuava	Sample unsuitable for the requested analysis	33
6^th RS União da Vitória	Sample unsuitable for the requested analysis	27
7^th RS Pato Branco	Sample unsuitable for the requested analysis	42
8^th RS Francisco Beltrão	Sample unsuitable for the requested analysis	35
9^th RS Foz do Iguaçu	Request canceled by GAL management due to expiration of the screening period	31
10^th RS Cascavel	Sample unsuitable for the requested analysis	32
11^th RS Campo Mourão	Request canceled by GAL management due to expiration of the screening period	23
12^th RS Umuarama	Sample unsuitable for the requested analysis	44
13^th RS Cianorte	Sample unsuitable for the requested analysis	26
14^th RS Paranavaí	Sample unsuitable for the requested analysis	28
15^th RS Maringá^# # data from the Maringá Municipal Department of Health, because they are not provided at the 15th RS.	Sample unsuitable for the requested analysis	29
16^th RS Apucarana	Request canceled by GAL management due to expiration of the screening period	38
17^th RS Londrina	Request canceled by GAL management due to expiration of the screening period	32
18^th RS Cornélio Procópio	Sample unsuitable for the requested analysis	22
19^th RS Jacarezinho	Sample unsuitable for the requested analysis	29
20^th RS Toledo	Insufficient volume sample	40
21^st RS Telemaco Borba	Sample unsuitable for the requested analysis	28
22^nd RS Ivaiporã	Sample unsuitable for the requested analysis	42

Assay	Method	Material	Collection period
Leptospirosis, culture	Culture	Whole blood (heparin)	Up to seven days after symptom onset
Leptospirosis, molecular biology	Real-time PCR	Whole blood (EDTA)	Up to seven days after symptom onset
Leptospirosis, IgM	Immunoenzymatic assay	Serum	At the first contact with patient

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E-mail: jbpml@sbpc.org.br

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[1] CORRESPONDING AUTHOR: Mauren Isfer Anghebem, 0000-0003-3436-9482. e-mail: mauren.isfer@ufpr.br