A Study on Good Laboratory Practice in Hospitals with Reference to Specimen Collection and Handling for Microbiological Studies

Introduction

The present work focused on study of practices adopted at research hospitals for laboratory testing with reference to microbial tests. Nowadays, the reliability, responsibility and quantity tests carried out by laboratories are under scanner.

In this study, the authors planned to assess the protocols followed at research hospitals. The authors took up BLDEA’s Shri B M Patil Medical College Hospital as the study area and studied the standard operating procedures (SOP) followed at its pathological laboratory. The study assessed the records and intended to recommend, if required, the guidelines to be followed for obtaining results of high quality, based on the guidelines laid down by agencies like National Accreditation Board for Hospitals and Healthcare Providers, International Organization for Standards, and World Health Organization. The objectives of the present study were to find out the errors and violations that commonly occur in laboratories, to study the implementation of Good Laboratory Practice (GLP) compliance and procedure adopted in collecting specimen from patients and to study Quality Assurance Programs at pathological laboratories of the hospital.

Atalgi, AC et al., (2015) conducted a study on research center practice and expounded the significance of GLP. They opined that, inthe current period of quickly including innovation and proof dependent on medication, Good laboratory practice (GLP) will assume a significant job in guaranteeing consistency, dependability, reproducibility and nature of research center tests. It gives lab outline work to design, perform, screen, record and report their exercises.¹ Vijayaraghawan R et al., (2014) completed the investigation on GLP guided in scholastic and clinical examination guaranteeing security and well- being. Research center testing is a science, expertly led with thorough statistical examination, quality control and broad oversight.²

Wayne Jiang (2017) carried out the study under investigation of good research center practice in explanatory lab. They concentrated for the most part on investigation of IR-4 systematic labs in consistence with EPA (Enforcement Policies Address) of Good laboratory practice measures. This incorporated testing offices, convention and SOP, technique improvement, strategy approval, test examination, stockpiling, dependability, study, linearity, exactness, accuracy, breaking point of location and cut-off of quantization and chronicles.³ Indian Council of Medical Research, New   Delhi text book had published an archive for Good clinical laboratory practice (GCLP). In this report, it was very much stressed the significance and need of GLP or GCLP. It is important to all research centers to embrace rules and attract standard working systems to guarantee quality and reproducibility of the test directed.

Great clinical laboratory practices need to be followed by all the laboratories wherein checks are executed on herbal examples for locating, information attention and exploration, as examples: Microbiology and serology, Hematology and blood banking, Molecular Biology and Molecular pathology, Clinical pathology, Clinical organic chemistry, Immunology (Immunohematology and Immunobiochemistry).⁴ Vijayaraghawan (2009) carried out the investigation on creature model in pre- clinical examination and bio clinical exploration of SOP and good manufacturing practices (GMP) grumbles. They mostly considered the objective of GLP was to help the bio-clinical research facility researchers to acquire consequences of high caliber.⁵ Selvakumar R (2010) has mentioned that the investigation of good laboratory practices should be utilized by all the labs where tests were carried out on organic examples for finding, understanding consideration, illness control and examination.

This publication intends to talk about new and existing acknowledged rules for GCLP.⁶ Ezzelle J et al., (2008) finished the research on guidelines on good clinical laboratory practices. A lot of good clinical laboratory practice norms that grasp both of exploration and clinical parts of GLP were created using an assortment of gathered administrative and direction material.⁷ Basu S et al., (2005) carried out a study on quality control of culture media in microbiology laboratory. Any predominant microbiology research facility relies on the way of media utilized. Nature of the media straight forwardly impacts the perceptions and derivation drawn from the social attributes of microorganisms, checking of various boundaries of media, for example, development supporting qualities, physical attributes, gel quality and bunch pollution can assist in surveying their quality.⁸

Smilja Kalenic et al., (2009) carried out a study on the role of microbiology laboratories in healthcare associated infection prevention reported that healthcare associated infections are huge problem around the world and increase grimness and morality of hospitalized patients simply by increasing fee in human services. Having microbiology research center as a piece of clinic symptomatic labs is a gigantic favorable position for HAI anticipation and control.⁹ Dibyajyoti Saha et al., (2017) did the examination on good laboratory practice: design and utility. Great laboratory practice is a fundamental piece of good assembling practice of schedule M to the drugs and cosmetic standard. It includes various great practices in the quality control (QC) research facility which are required to do an examination with a characterized level of exactness and accuracy.¹⁰ Susan M et al., (2011) worked on good laboratory practice in Biology and microbiological lab contemplates. For the most part, good laboratory practices (GLP) and standard operating procedures (SOP) are providing rules for appropriate activity of supplies, systems of support, and sanitation, revealing structures and related exercises. These practices are routinely utilized everywhere scholarly and in research-based foundations. Erroneous presumption and assumed duties can prompt security risks, cause harm to gear, loss of frame work and confounding with respect to activities and oversight. This report addresses the advancement of the “who, when, what, how and where” strategies and SOPs that establish GLP.¹¹ Ravi GS et al., (2019) completed the examination on good laboratory practice is a lot of rules to manage the non-clinical exploration research facilities engaged with the testing to survey their security under lab conditions, which is characterized according to organization for economic co-activity and improvement standards.¹² Prescriptions and Healthcare Products Regulatory Agency (MHRA) Guidance for GLP offices on the usage and systems for upkeeps of a hazard based quality assurance program.¹³ Madoka Sasaki et al., (2009) performed studies on good laboratory practice (GLP) status in Asian international location and on its implementation in non-medical well-being concentrates in pharmaceutical medication advancements to non- clinical research to assess the work in development. Need to confirm to good laboratory practice, the Organization for Economic Cooperation and Development (OECD) has set up mutual acceptance of data (MAD) of non- scientific safety study information.¹⁴ Md. Shariful Alam Jilani et al., (2007) completed the examination about preparing of SOP for microbiology laboratory.

Microbiology lab has clearly become a vital and indivisible segment of current medication and general well-being. Microbiology research centers assume a significant job in the conclusion, treatment, forecast and checking of transmittable sicknesses. Along these lines a dependable, reproducible, inexpensive and quick research will be a fundamental need for providing a quality healthcare.¹⁵

Materials and Methods

The present work was based on the survey and cross checking of some procedures through which laboratory testing were dealt. The authors used books of standard operating procedure and guidelines for assessing the practices followed at the hospital laboratories. Authors used laboratory facilities for testing reproducibility and precision of the procedures. The data was collected from the survey conducted and from various laboratory experiments, referring journals, text books, and internet browsing. Sample size calculation was carried out with 95% belief level and margin of error ±5 %, at level of 284 (~200) subjects to permit the study to decide the results of the study on GLP with reference to the specimen collection and handling of microbiological studies, by using formula:

N= Z²p (1-p)/d²

Where,

Z=statics at five percentage level of significance

D=is margin of mistakes

P= is anticipated occurrences rate 50%

Type of study: Simple random sample were used to collect samples from labs.

Method of collection data

·  Data were collected initially through survey/ questionnaire according to OECD guidelines.¹⁶ (annexure I).

·  Data was also generated through the study conducted at Shri B. M. Patil Medical College, Vijaypur through check list prepared according to WHO guidelines.¹⁷ (annexure II).

Prospective observational study have been completed in the tertiary care hospital among in patients which required and collecting sample, identification of diagnostic lab test report and to make sure that all the inclusion criteria are met. All in patient case files were referred, rather to see microbiological lab test are prescribed or not. If prescribed, then significance of that test and whether it is reported according to GLP guidelines were checked. Out of 200 cases, most of the cases were applied GLP guidelines, all over the diagnostic condition of the microbiology lab studies and mainly according to the guidelines of the GLP which was used to study regarding collection the statistical data mainly inter laboratory study comparison of lab maintenance. The study is mainly about the appropriate use of GLP guidelines which shows indicate (implementation of GLP) 182 (91%) possibly indicate (partial implementation of GLP) 14 (7%) not indicated (GLP not implemented) 4(2%). The study was conducted according to GLP guidelines for the study of clinical and non–clinical study of about specimen collection and practice of microbiological procedures, the laboratory hygiene and lab diagnostic report system relevant to diagnostic labs, lab maintenance study and safety implementation. The laboratory sample such as blood, sputum, urine and other samples collection procedure was followed all precautionary majors which were mentioned in GLP guidelines.

Statistical analysis

All characteristics have been summarized descriptively. For non- stop variables, the summary facts of N, simply, standard Deviation (SD) was used. For categorical data, the variety and percentage are used in data summaries and data was analyzed by Chi square test for association, using t assessments by ANOVA (Analysis Of Variance).

Results

Total number of 200 patients were included in the study, 114 were males and females were 86. In this study, total 200 cases underwent several diagnostic tests such as aerobic culture - 28 (14%), blood - 13 (6%), Brucella agglutination test - 16 (8%), Chikungunya - 5 (2.5%), Dengue fever - 37 (18.5%), Gram stain - 18 (9%), HBsAg (Spot test) – 23 (11.5%), HBeAg (Spot Test) – 1 (0.5 %), HCV - 8 (4%), HIV – 13 (6.5%), Malaria - 1 (0.5%), Widal test – 7 (3.5%), Weil Felix test - 21(10.5%), Zinc Stain - 10 (5%) (Tables 1 to 4 and Figures 1 to 5). The appropriate use of GLP guidelines for which the cases are distributed and parameters are given in Table 1 to 6 and Figures 1 to 5.

  Discussion

The main objectives of the present study were errors and violations usually occur in laboratories, to study the implementation of GLP compliance and procedure adopted in collecting specimen from patients and to study the quality assurance procedures at pathological laboratories of hospital. The studies aboutmicrobiological lab investigation according to good laboratory practice guidelines were applied according to the previous work carried out by other authors R. Vijayaraghawan et.al, (2014), Basu S. et.al, (2005), Smilja Kalenic et.al., (2009), Dibyajyoti Saha et.al., (2017), Madoka Sasaki et.al., (2009), Md. Shariful Alam Jilani et.al, (2007) and the present work yielded similar assessment results. They are most recent of the guidelines that are applied for clinical and non-clinical trial studies.

Conclusion

The above study good laboratory practice with the reference to specimen collection and handling of microbiological studies concludes that purpose of the study was to study the practice of GLP guidelines. The present method employed for the study was found to be more reliable and reproducible. The most important feature of the present study is method of data collection, carried out by specimen collection, questioner surveys, cross section study and various laboratory experiments. The results are based on observational lab investigation studies and maintenance procedures. The authors agree that GLP can be one of the criteria in ensuring protection of the laboratory and participant but we strongly encouraged in GLP as vital criteria for all the ones involved criteria for all the factors involved in educational and medical research according to guidelines study of microbiological lab diagnostic investigation.