Quantification of Pre-analytical Quality Indicators in a Clinical Laboratory and Formulating the Lean Six Sigma DMAIC Strategy

Introduction : Quality control of the laboratory has gained increased importance in the present years. 70 % of the errors in the clinical laboratory occur in the pre-analytical phase. With various guidelines to gauge the quality of the laboratory, Six Sigma Metrics remains by far the most difficult benchmark that a laboratory can achieve. We aimed to quantify the performance of the quality indicators of the routine clinical Biochemistry laboratory in the pre-analytical phase in the form of sigma metrics and devise measures and identify steps to decrease the percentage of errors by defining the DMAIC approach. Materials and Methods : One year retrospective data was collected from January, 2020 to December, 2020 from the data entry register and pre-analytical variables were quantified. Defects Per Million and sigma metric were calculated for each pre-analytical indicator. DMAIC approach was applied and post intervention sigma scores for the month of Jananuary, 2021, February, 2021 and March, 2021 were calculated. Results : Postinterventional analysis was done on a month-to-month basis to monitor the trend and also to ensure corrective action can be taken without delay. Out of 5 quality indicators which were quantified, the pre versus post sigma scores (March’21) are as follows: missing location of the patient (Sigma 4 versus 3.6), missing registration number (Sigma 3.7 versus 4.3) and both registration number and location missing (Sigma 3.6 versus 4.0), Homolysed sample (4.2 versus 4.6), insufficient sample volume (sigma 3.9 versus 4.7). Encouraging results in the form of improved Sigma scores were seen in four of the quality indicators except for the fact that the patient location were still missing in the forms and hence warrants continuous monitoring.

Nosocomial Infection in the Neonatal Ward of a Tertiary Care Hospital: The Role of Active Surveillance in the Control of Klebsiella pneumoniae Outbreak.

Aim: To describe an outbreak which occurred in a neonatal ward and the role of active surveillance in the control of further outbreaks. Study Design: Cross Sectional Observational Study. Place and Duration of Study: Lady Hardinge Medical College and Associated Hospitals, between May 2013 and June 2014. Methodology: The Infection Control Team (ICT) conducts active surveillance in the neonatal ward (NNW) routinely every year. The data regarding the above mentioned period were analysed and infection rates were calculated on monthly basis and compared. Attack rate was calculated as number of patients who acquired hospital acquired infections/ total number of admissions during that month. Results: A sudden increase in bloodstream infection (BSI) from 2 cases to 16 cases were observed over a period of 2 months (November 2013, and December 2013). Therefore an outbreak was suspected. Sixteen cases of primary blood stream infections caused by ceftazidime/ amoxicillin – clavulanic acid -resistant Klebsiella pneumoniae were observed over a two month period. Case definition was made. Recommendations for Infection control practices with immediate effect were sent. The ICT visited NNW and main labour room. Relevant samples were collected and Klebsiella species was isolated from suction tubing, baby cot, feeding katori, fingertip of health care worker (HCW) and soap sludge. Bacterial identification and antimicrobial susceptibility testing was performed by using the automated Vitek 2 instrument. The antibiogram of Klebsiella species from the samples and cases was found to be similar. It was found that NNW staff was changed recently without any training in Infection control practices. There was breach in Infection control practices. Conclusion: Active surveillance plays a very important role in detection of early onset of outbreak. All the HCWs including resident doctors, nursing and subsidiary staff and others must be trained in Infection control practices before they are posted to high risk areas.

Prevalence of Hepatitis B and Hepatitis C Infections in HIV Infected Patients Attending a Tertiary Care Hospital in North-East India.

Aims: To study the co infection of Hepatitis B (HBV) and/or Hepatitis C virus (HCV) in Human Immunodeficiency Virus (HIV) infected patients attending tertiary care teaching hospital in North East India. Study Design: This study was a cross sectional study. Place and Duration of the Study: Department of Microbiology, Guwahati Medical College & Hospital, Guwahati, Assam, India for a period of one year (August 2010- July 2011) Methodology: Serum samples of 180 HIV positive patients were collected randomly who gave consent to participate in the study and were tested for hepatitis B surface antigen (HBsAg) and anti-HCV antibodies by enzyme linked immunosorbent assay (ELISA) method. The retrospective demographic data of the subjects were collected. Results: Out of 180 HIV positive patients (126 males and 54 females), 22 (12.2%) cases were HBsAg positive and 8 (4.4%) were anti-HCV positive. Triple infection with HBV, HCV and HIV was not found in any patient. The commonest mode of transmission for HIV alone (113/180; 75.3%) and HIV-HBV co infection (18/22; 81.8%) was sexual route, and for HIV-HCV co infected patients, Intravenous Drug Use (IDU) was the commonest route of transmission (4/8; 50%). Concomitant infection of HIV and HBV was found to be significantly more in the symptomatic group (59.1%) compared to asymptomatic group (4.5%) (P value < 0.001). CD4+ T-lymphocyte count less than 200/μl was seen in 11 of 30 co-infected cases (36.7%). Conclusion: Co infection with HBV and HCV is a common problem in HIV infected patients in India. Hence, all HIV patients need to be routinely screened for markers such as HbsAg for hepatitis B and Anti HCV for HCV infection so as to take early treatment initiative to prevent the morbidities.