Procedure:-

Enlisted below are the procedures:

Step 1: Reception of Application

Any Blood Establishment that intends to collect, process, test, store or distribute blood and blood component applies for registration with the Blood Transfusion Authority before initiating operations. The application process involves submission of the application form along with mandatory documents.

Step 2: Creation of Blood Establishment File

The Authority creates a file for each Blood Establishment with the application form and mandatory documents and, in compliance with the requirements for registration, the inspection team conducts an on-site inspection. All documents collected or received from a Blood Establishment are regularly filed in the Blood Establishment File.

Step 3: Authorization Inspection

The essential actions included in the licensing inspection procedure are subdivided into those carried out before, during and after inspection.

Pre-Inspection:

Enlisted below are the main points:

• The inspection team assesses the scope and range of functions of the Blood Establishments by thoroughly reviewing the Blood Establishment File.
• The inspection team makes the Blood Establishments aware of:
  • The objectives and scope of the inspection
  • The inspection checklist to be used during inspection
  • The date, time, duration and schedule for meetings

During Inspection:

During inspections, the inspection team:

• Verifies the information included in the Blood Establishment File through a review of the mandatory documents on-site
• Interviews staff to determine their competence
• Visits facility and observes/surveys the actual performance of collection, testing, processing, storage and distribution of blood and blood components
• Fills out the inspection checklist

Post-Inspection:

Upon completion of the inspection, the inspection team:

• Conducts a meeting with the responsible person of the Blood Establishment to summarize its findings. The team presents its observations and preliminary findings, including areas of non-compliance as identified during the inspection along with supportive facts. In the event of any serious non-compliance which puts the quality and safety of the blood or blood components at risk; the inspector may order the immediate cessation of the establishment’s operations
• Prepares a provisional summary statement that reflects the findings of the inspection conducted including a short description of the Blood Establishment by area. All non-compliances are listed (even if corrective actions have taken place straight away) and reference to the law, rules and regulations mentioned
• Indicates an approximate date for the availability of the written inspection report

Step 4: Evaluation of Findings

The evaluation of findings is based on the law, rules and regulations in force, with non-compliances, if observed, categorized as described below. The inspection report is prepared accordingly and sent to the Licensing Board for decision-making.

Step 5: Decision

The decision, based on the evaluation of inspection, may be either authorization, proposition of corrective actions or cessation of the operations of the establishment, temporarily or permanently. The decision is undertaken through a Licensing Board. The Board conducts periodic meetings (monthly). In-charges of inspected Blood Establishments may be invited for clarification on a case by case basis.

• Authorization:
  The PBTA issues a license to the Blood Establishment.
• Proposition of Corrective Actions:
  Depending on the overall performance and the type(s) of non-compliances observed, the PBTA proposes corrective measures with a certain time frame.   If required, a re-inspection may be scheduled.
• Cessation of Operations:
  In the event of any serious non-compliance which puts the quality and safety of the blood or blood components at risk; the establishment’s operations may be ceased temporarily or permanently.

Step 6: Submission of Report

The inspection team sends the inspection report to the Blood Establishment within a week after inspection. The conclusions clearly identify non-compliances, classified as critical, major or other according to the preceding definitions. The inspector also provides a clear statement about the outcome of the inspection and, if required, a date by which the Blood Establishment is to submit an action plan (which includes a time schedule for rectifying the non-compliances).

Step 7: Plan for Corrective Action

It is generally accepted that for major non-compliances the Blood Establishment must respond within 14 days; in case of ‘other’ significant non-compliances, within 30 days of inspection. The response includes the specific steps which have been or will be taken to correct the failures mentioned above and to prevent their recurrence. In case of critical non-compliances corrective actions must be taken by the Blood Establishment without delay.

If corrective actions cannot be completed within the prescribed timeframe, the inspected Blood Establishment should state the reason for the delay and the time within which the corrections will be completed (the authority will decide upon the acceptability of the given time period). After this the Blood Establishment has to report about the final corrections. Based on the evaluation of the action plan, the Secretary Blood Transfusion Authority takes one of the following courses of actions:

• License is issued to the Blood Establishment
• A second site visit by the inspection team is authorized
• Additional information regarding corrective actions is requested from the Blood Establishment before authorization