OSE Feedback and action required

Documentation of any significant problems (technical, operational, others) and feedback for corrective action during On-site Evaluation (OSE) is necessary to formulate plans with the District TB Officer (DTO), Senior TB Laboratory Supervisor (STLS), Medical Officer (MO), Intermediate Reference Laboratory (IRL), National Reference Laboratory (NRL) and Laboratory Technician (LT) to improve the quality of smear microscopy.

Checklists for OSE

• OSE is done through comprehensive checklists.
• The checklist must be used by NRL, IRL and District TB Center (DTC) STLS and a shorter version by DTO/ Medical Officer TB Center (MOTC) during each OSE visit to document observations and corrective action.
• The checklists contain open, non-leading questions and recommended observations along with objective criteria for acceptable practices so that the supervisor can assess how well the technician understands proper procedures.

Feedback

Feedback is the process of communicating results of External Quality Assurance (EQA) to the original laboratory, including suggestions for possible causes of errors and remedies.

TB Unit On-site Evaluation (TU-OSE) Checklist and Feedback

The observations in TU-OSE Checklist, including observation of five positive and negative slides must be documented (Figure 1). Corrective actions must be discussed by the STLS with LT and checklist should be signed by MO of DMC.

1: Write smear and grade
2: Tick appropriate column
3: Tick if good; write ‘U’ if under-decolourized, ‘O’ if over-decolourized
4: Tick if good; write ‘B’ if too big, ‘S’ if too small
5: Tick if good; write ‘K’ if too thick, ‘N’ if too thin
6: Tick appropriate column

Figure 1: Review of five positive and five negative slides by STLS and instructions to fill observations in TU-OSE Checklist; Source: RNTCP Laboratory Network Guidelines

Action Required based on TU-OSE Checklist

The STLS should:

• Enter the summary of ‘action required’ in the Supervision Register before leaving the DMC
• Submit the summary report of DMCs under him to DTO on a monthly basis
• Maintain separate files for checklists including summary reports of each DMC in respective TU and submitted for review by higher level supervisors including on-site evaluation visits by the IRL to the district.

The DTO should:

• Give monthly feedback to the MO in-charge of the respective DMC
• Send summary of results of checklists for each DMC in the district once every quarter for analysis by the respective CMO/ DMO and IRL.

Checklist IRL OSE and NRL OSE and Feedback

• On-site quarterly evaluation report of DTCs visited by IRL team should be given to concerned State TB Officer (STO), IRL and NRL using an IRL OSE Checklist.
• OSE Checklist for NRL Laboratory Personnel to IRL is prepared using a NRL OSE Checklist.
• The IRLs will submit a consolidated quarterly report to the concerned STO and NRL. In turn, the NRL will submit a consolidated quarterly report to the Central TB Division.
• A comprehensive list of all operational elements to be observed will help to ensure consistency in laboratory evaluations and provide immediate feedback to the technicians to facilitate rapid corrective action, as well as serve as documentation of the visit and record of current conditions and actions needed.
• All potential sources of error should be investigated, including quality of stains and staining procedure, quality of microscopes, and administrative procedures that may contribute to recording errors and corrective actions provided (Figure 2).
• All problems contributing to errors must be resolved.
• Possible causes of errors, and suggested evaluation steps are provided in Annexure K.
• Remedial training must be provided for technicians unable to properly identify AFB in smears.

Figure 2: Documentation of corrective actions in IRL-OSE Checklist )RNTCP Laboratory Network Guidelines)

Action Required for IRL/NRL-OSE Checklist

A state level consolidated summary will be prepared by the respective IRL every quarter from the district summaries for submission to STO and NRL. The DTO/ CMO of the district is to submit an action taken report on the team’s recommendations to the STO within a month of the IRL visit.

Resources

RNTCP Laboratory Network Guidelines.

Assessment