Clinical Biochemistry Process Improvement Project using Checklists and 5 Whys

Submitted By: Dr. Lakshmi Vaswani

Project Year: 2018

Project Team Members: Dr. Lakshmi Vaswani (Assistant Pathologist), Dr. Rupali Parikh (Associate Pathologist)

Organization/ Location: Clinical Laboratory, Biochemistry Department, in an Urban, Tertiary care Multi-specialty Hospital in South Mumbai, Maharashtra, India

Type of Laboratory: Clinical Laboratory

Project Problems or Process Failures:

  1. It was observed that the turnaround time (TAT) for serum electrolytes processed on the COBAS b221 was increasing beyond the established expected TAT, which prompted complaints from the physicians in the ICU.
  2. A root cause analysis (RCA) was performed using checklists and the 5 Whys tool and we obtained the following potential causes for delay :


Project Objectives/goals:

To find a way to ensure reagent levels and waste containers are checked properly before every shift, considering it is a 24/7, 365 days per year laboratory.

Project design/ steps:

  1. Had a combined meeting with Technical Supervisors, who predominantly oversee the work in the morning shift, and the junior technicians on rotation duties who are actively working on the analyzers, to decide an effective way to ensure checking.
  2. Designed a checklist for each analyzer detailing the reagents that needed to be checked for each instrument and the waste container, with a signature at the end of each shift to ensure accountability.
  3. The checklists were mounted on the front of the analyzers for easy visibility.


clinical biochem cobas b221 pic - 25oct2018-1602359502933575002..jpg

Results / Lessons Learned:

The checklist was started in the last week of September 2018 and is renewed monthly. Initially it took a little getting used to, however, the process ensured that since the checklist was placed directly on the analyzer, it caught the eye of the technicians working on the analyzers, so that it was difficult to miss. It served as a constant reminder for them to check the items on the list and made it easy for younger, more inexperienced technicians and technicians who had recently joined the team to follow the process.

It also made it easier for the Technical Supervisors while troubleshooting instrument errors, or while ensuring availability of reagent stock for upcoming weekends or public holidays, where the juniors would be on call.

It helped keep track of the reagent consumed and increased the frequency of waste disposal, thereby reducing instrument errors or breakdowns due to this reason. This helped us to maintain our TATs for the concerned tests.


Although checking an analyzer before loading a sample batch to process should be something that is done on autopilot, initial training of new recruits needs processes to ensure habit formation. Checklists serve as effective tools to ensure compliance.

The most common answer we get when asking about failures in system checks in a 24/7 hospital-based lab with many technicians working on multiple analyzers, is the assumption that someone else will do it. A checklist with signatures ensures accountability.