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TQM / Accreditation

Welcome everyone.

The purpose of this area will be to provide information regarding the quality management aspect of our laboratory programs and ultimately what role it will play in the achieving of accreditation.

As with all areas within the BMT lab forum, contributions are not based on literature format, but rather on information content. It is the sharing of information/communication that is important to the group, with all contributions considered relevant.

The first contribution to this forum will be to provide a general description of TQM/Accreditation and list some possible topics for discussion.

Posted documents: Total Quality Management
Accreditation
FACT Inspection

 

   TOTAL QUALITY MANAGEMENT (TQM)

Total Quality Management is a management process of continuous improvement - a process of continuously striving to exceed customer or client expectations. It applies to not only external clients, such as patients, but also to our internal clients, such as our clinical and collection programs. TQM includes Quality Assurance, Quality Control and Quality Improvement.

Discussion Topics
  • Development of a Quality Management Plan

Mission Statement, Values/Goals, Policies and Procedures.

  • Benchmarking / Performance Indicators

Canadian BMT lab programs need comparative information, how do individual programs/processes vary from other programs within Canada and around the world.

Why Benchmark - gain insight into the best practices and use this to implement improvements in all areas of our programs.

Examples: CD34+ selection data / cryopreservation methods

Combine these examples with outcome measurement, such as patient engraftment data, and Canadian laboratory programs would have valuable information useful in determining processing procedures.

 

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   ACCREDITATION

TQM defines quality as meeting or exceeding the needs of your clients. Whether it is FACT, AABB or standardization to meet possible future Canadian regulations, accreditation appears to fit the "client centered approach".

Obtaining accreditation can appear to be a long and difficult task, but with the sharing of information through this forum, hopefully the accreditation preparation workload and time frame can be minimized.

Discussion Topics
  • Accreditation Preparation

Key steps the laboratory performs to help in preparation for accreditation.
  • Inspectors Perspective

FACT / AABB inspectors perspective on the inspection process.
  • External Testing Laboratories

ASHI accreditation for tissue typing labs - a requirement for FACT accreditation
  • Canadian Regulations

Who/When/What


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   FACT Inspection - Inspector's Perspective


The foundation for the Accreditation of Hematopoietic Cell Therapy developed standards for processing facilities in 1996. Currently many Canadian BMT laboratories are reviewing these standards or preparing for the accreditation process.
As a member of a FACT accredited facility and a FACT inspector, I have prepared an overview of the inspection process. Hopefully this will help Canadian facilities to prepare for the FACT accreditation and inspection process.

Note: the FACT Accreditation and Inspection process is contained in the FACT Accreditation Manual, First Edition, 1996. This document is developed as a guidance tool for facilities preparing for inspection and is produced from a BMT Lab member perspective.

The FACT inspection is composed of three main parts, introductory meeting, laboratory inspection and exit meeting.


Introductory Meeting

Inspectors are introduced to the program member.
Who should attend: Laboratory Director, Laboratory supervisor, Q.A. member.

Inspectors will talk about the inspection process, including inspection schedule, and might ask for additional documentation omitted from the original application.


Inspection

The laboratory inspection can be a long process, usually consisting of one day, 8:00 to 4:00. The process consists of ensuring the laboratory meets all standards outlined in the FACT inspection checklist. Once again, this is an overview of the process with attention to some of the more critical points of the inspection.

  1. Tour of the facility.

    2. Inspector might look at:

    1. Storage Area - security, inventory log, posting of who/what to do in case of freezer failure, temperature monitoring, quarantine area.

    2. Laboratory processing area - space, patient file (security)

    3. Transport - dry shippers (labelling, temperature monitoring)

  2. FACT Checklist - main part of inspection

Notes: have a room booked for inspector to review documentation. Lab Director/Supervisor should be available to answer questions or retrieve requested documentation.
As an inspector, I would give the facility a list of documentation during the introductory meeting.

Example:

Documentation List

Purpose:

To facilitate the inspection process and ensure inspectors have documentation required to complete the inspection checklist.

  1. SOP Manual
  2. Quality Management Plan
  3. Safety Manual
  4. Employee Training Files
  5. Patient File (one of the patients submitted to FACT with original application)
  6. Equipment/Reagent Quality Assurance Records
  7. Outcome Measurement - engraftment data
  8. Component Tracking Documentation (program communication)
    • Physician order form
    • Collection report
    • Processing report/data report
    • Issue report
    • Transport report
    • Infusion report
    • Engraftment data report
    • Program meeting minutes

 Some of the critical points during the main checklist inspection:

  1. Program communication

    2. Program meeting minutes - who/what/when (who attended/what was discussed/when do meetings take place)
    Forms/Reports - should demonstrate that all aspects of program (clinical, collection and processing) are linked (Example - component tracking documentation)

  2. Labels

    3. Addressed (collection, processing and if transported receiving facility), expiry date. (additional information as outlined in checklist)
  3. Transport

    4. Dry Shippers - validated twice annually/labelling
    Temperature monitoring - before and after transport
  4. Quality Management - program should include documentation for equipment, reagents, personnel. (validation/competency/proficiency/calibration)

  5. Processing Review - inspector might review an actual processing if performed that day. (SOP manual open and technologist is following SOP/is training documentation available for that technologist to perform SOP)

These are just some of the possible inspection procedures, the inspector is to review all standards outlined in FACT checklist.


Exit Meeting

Inspectors and program members meet to review key inspection findings. The inspection team does not make accreditation decisions. Team members submit reports to FACT.

Additional Notes:

  1. Make effort to address findings on-site and to possibly clarify issues.
  2. Prepare introductory letter/information for inspectors and leave at inspectors hotel.
    (Inspectors usually arrive the night before - letter can include facility information, when they are expected, where to meet, and possible transportation to facility)

I hope this document helps in preparing your facility for accreditation/inspection, if you have any questions concerning this document of the inspection process do not hesitate to contact me.

One final note: within the BMT lab group we have additional inspectors (FACT/AABB) and their perspectives will be prepared and posted in the future.

Submitted by: Mike Halpenny, CBS/Ottawa Centre

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