National Survey on Biosafety in Clinical Tuberculosis Laboratories in Korea

Chang-Ki Kim; Hyukmin Lee; Dongeun Yong; Young Ah Kim

doi:10.3343/lmo.2017.7.4.189

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Kim, Lee, Yong, and Kim: National Survey on Biosafety in Clinical Tuberculosis Laboratories in Korea

Original Article

Clinical Microbiology

Laboratory Medicine Online 2017; 7(4): 189-195.

Published online: 14 September 2017

DOI: https://doi.org/10.3343/lmo.2017.7.4.189

National Survey on Biosafety in Clinical Tuberculosis Laboratories in Korea

Chang-Ki Kim, M.D.¹, Hyukmin Lee, M.D.², Dongeun Yong, M.D.², Young Ah Kim, M.D.³

¹Seoul Clinical Laboratories, Seoul, Korea.

²Department of Laboratory Medicine, Research Institute of Bacterial Resistance, Yonsei University College of Medicine, Seoul, Korea.

³Department of Laboratory Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.

Corresponding author: Young Ah Kim. Department of Laboratory Medicine, National Health Insurance Service Ilsan Hospital, 100 Ilsan-ro, Ilsandong-gu, Goyang 10444, Korea. Tel: +82-31-900-0908, Fax: +82-31-900-0925, yakim@nhimc.or.kr

Received 10 January 2017 Revised 20 March 2017 Accepted 20 March 2017

Laboratory Medicine Online

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Workers in the microbiology laboratories are continuously exposed to the risk of laboratory-associated infections. Tuberculosis (TB) is a frequent laboratory-acquired infection owing to production of cough-generated aerosols with ease and high infectivity of Mycobacterium tuberculosis. This study aims to investigate the current situation of biosafety in Korean TB laboratories.

Methods

We conducted a nationwide survey of laboratories in hospitals conducting TB tests using questionnaires about their facility and management standards.

Results

We analyzed data from 52 hospitals nationwide that have a capacity of 100–2,000 beds, of which only two laboratories conduct high risk drug-susceptibility testing on cultured isolates among other test items, whereas six laboratories perform only direct sputum-smear microscopy. The remaining laboratories performed moderate-risk activities/tests, like sample processing for culture. In the majority of these laboratories, there are laboratory medicine specialists who are fully in charge of health checkup programs for laboratorians. The facility and management standards vary widely according to the size of the hospital and risk of TB tests.

Conclusions

Our survey results about the current situation of TB laboratories could be useful as baseline data for preparing biosafety guidelines for all TB laboratories in Korea.

Keywords: Survey, Biosafety, Laboratory-associated infection, Mycobacterium tuberculosis

Figures and Tables

Table 1

Characteristics of TB laboratories in medical institutions (N=52)

Items	Results
Type	Superior general hospital (20), general hospital (31), no response (1)
Beds	< 500 beds (12), 500–1,000 beds (32), > 1,000 beds (8)
Locations	Seoul (15), Gyeonggi-do (15), Busan (8), Incheon (3), Daejeon (3), Gyeongsangbuk-do (3), Gyeongsangnam-do (1), Daegu (1), Ulsan (1), Jeollanam-do (1), Jeju-do (1)
LM specialists	Yes (42), No (10)
HCU items	Chest X-ray only (39) Chest X-ray plus TST (4) Chest X-ray plus IGRA (4) Chest X-ray plus blood test (1) TST only (1) IGRA only (1) No response (2)
BSC	Class I (2), Class II A1 (10), Class II A2 (17), Class II B1 (5), Class II B2 (13), Class II A2 plus Class II B2 (1), no response (4)
Separate space for sputum collection	Yes (4), No (48)

Abbreviations: TB, tuberculosis; N, number; LM specialist, laboratory medicine specialists who are in full charge of the microbiological laboratory; HCU items, test items of health checkup programs for laboratorians; TST, tuberculin skin test; IGRA, interferon-gamma release assay; BSC, biosafety cabinet.

Table 2

The distribution of tuberculosis laboratories by level of risk

Risk level of TB Laboratories^*	Laboratory activities	Number of TB Laboratories
Low	Direct smear microscopy; preparation of specimens for automated nucleic acid amplification test	6
Moderate	Processing and concentration of specimen for inoculation on primary culture media; direct DST using sputum; culture manipulation for identification	44
High	DST or line-probe assay on cultured isolates	2

^*Modified from World Health Organization criteria [7].

Abbreviations: TB, tuberculosis; DST, drug-susceptibility testing.

Table 3

Compliance of facility standards in Korean tuberculosis laboratories

Items		Rate of ‘yes’ (%)
Items		Low (N = 6)	Moderate (N=44)	High (N=2)	Total (N = 52)
Laboratory set-up	Separation between laboratory and general area	83	98	100	96
	Gates with locking device	67	66	50	65
	Space for lab coat before access to laboratory	17	59	100	56
	Access door for delivery of equipment	67	89	100	87
Experiment area	Walls are impervious to liquids and resistant to chemicals	50	55	50	54
	Individual lockers outside the laboratory	67	93	100	90
	Restroom outside the laboratory	67	98	100	94
	Sufficient storage space	33	73	100	69
	Sufficient laboratory space	17	73	100	67
	Area for food intake outside the laboratory	100	86	100	88
Air regulation	TB laboratory with negative-pressure airflow	0	50	100	46
	Laboratory windows cannot open to the exterior (If opened to the exterior, it should be fitted with screens to prevent insects)	80	82	50	80
	Windows are opened only if no forced ventilation system	50	61	0	59
Biosafety for workers	There are sinks for hand washing	83	91	100	90
	Sinks for hand washing are located at access area	67	66	50	65
	Eye washes available in laboratory	17	73	100	67
Experimental instruments	High-pressure sterilizer is installed	83	91	100	90
	The performance of all sterilizers are regularly monitored with biological or chemical indicator	83	98	100	96
	Biosafety cabinets (BSC) are installed	100	98	100	98
	The location of BSC is adequate not to disturb airflow	67	89	50	85
	Centrifuges have covers to prevent leakage	83	98	100	96
	Tables are impervious to liquids and resistant to chemicals, disinfectants, and heat	83	93	100	94
	Laboratory furniture can support anticipated loads and usage	100	100	100	100
	Spaces between furniture and equipment are accessible for cleaning	67	77	50	75
	Equipments are regularly cleaned and decontaminated	100	95	100	96
	Prompt decontamination of equipment after any spill or splash of potentially infectious material with appropriate disinfectant	100	100	100	100
	Equipments are decontaminated before external transfers for routine maintenance or repair	100	93	100	94
Disposal of waste	Solid waste: autoclave or equipment for chemical treatment are installed for sterilization	83	93	100	92
Disposal of waste	Waste water: autoclave or equipment for chemical treatment are installed for sterilization	67	98	100	94

Table 4

Compliance of management standards in Korean tuberculosis laboratories

Items		Rate of ‘yes’ (%)
Items		Low (N = 6)	Moderate (N = 44)	High (N = 2)	Total (N = 52)
Access to laboratory	Restricted access to authorized personnel	33	89	50	81
	Entry of children is not permitted	67	95	100	92
	All persons entering the laboratory are advised of the potential hazards	100	100	100	100
	Biohazard symbols including infectious agents, the name and phone number of the supervisor are posted	83	91	100	90
Activity within work zone	Perform tests within work zone and wash hands after end of tests and when leaving the laboratory	100	100	100	100
	Use automatic pipettes when performing tests	83	91	100	90
	Use procedures to minimize the creation of aerosols	100	100	100	100
	All procedures generating an aerosol are conducted within a biosafety safety cabinet (BSC) or other physical containment devices	83	100	100	98
	Disposable loop is used for inoculation and an electric incinerator is used in BSC	83	84	100	85
	Eating, smoking, applying cosmetics and storing food for human consumption are not permitted	100	100	100	100
	Food is stored outside the laboratory area in cabinets or refrigerators designed for this purpose	100	98	100	98
	Plants, animals, and clothes irrelevant to the experiment are banned	100	100	100	100
	An effective integrated pest management program is followed	33	75	100	71
	Reusable experimental apparatus are always autoclaved before use	83	93	100	92
	Sample containers are durable and leak proof and transported with the lid closed	100	100	100	100
	Protective clothing is removed before entering general area	17	82	100	75
	Decontamination of work surfaces after completion of work and whenever any infectious contaminations occur	100	100	100	100
Securing of biosafety	Knowledge about domestic standards of biosafety level 2 laboratory	17	80	100	73
	Report to Korean CDC according to biosafety regulations	17	36	0	33
	Biohazard symbols are posted in storage spaces (freezer or refrigerator) that contain infectious microorganisms	33	75	100	71
	Formation of biosafety committee and appointment of the persons in charge	0	45	50	40
	Periodic education for technicians about biosafety	33	57	0	53
	Inspection of the process of biosafety level 2 laboratory by person in charge	0	66	100	61
	Records concerning the installation and operation of facilities are maintained	100	100	100	100
	Documentation and report systems for laboratory associated infections or accidents	100	100	100	100
	Laboratory biosafety manuals for decontamination of spill incidents with infectious materials	67	100	100	96
	Incidents that may result in exposure to infectious materials are reported to the laboratory supervisor for medical evaluation and documents are preserved	100	100	100	100
	Spill cleanup kit is available	50	95	100	90
	Prescribed biosafety management regulations	50	75	100	73
	Transport of infectious microorganisms according to domestic and international regulations	50	86	100	83
	Baseline serum samples of laboratorians are stored and regular medical checkup provided	33	48	0	45
	No pregnant women permitted in the laboratory	67	61	50	62
	Laboratory personnel are offered available immunization for agents handled	33	59	0	54
Personal protective equipment	Private lab gown is used	17	73	100	67
	Lab gowns are stored in laboratory dedicated cabinet	0	70	50	62
	Wearing gloves when handling infectious materials, surface, or instruments	83	100	100	98
	Gloves are disposed and hands washed after completion of work	100	98	100	98
	Protective eye wear worn for procedures with potential to create splashes of infectious microorganism	83	100	100	98
	Used protective eye wear are disposed or autoclaved	83	100	100	98
	Slippers that fully cover the front and rear of feet are worn	33	89	100	83
	A manual of personal protective equipment and education is provided	100	100	100	100
Disposal of waste	Storage of wastes in separate places or containers before disposal	100	100	100	100
	All wastes from biological activities are disposed	83	82	100	83
	Established waste disposal regulations are followed	100	100	100	100

Notes

This article is available from http://www.labmedonline.org

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