afb microscopy network evaluation guide: a systematic ... · senior advisor for planning,...

Dr. John Ridderhof

Senior Advisor for Planning, Laboratory Science, Policy and Practice Program

Office

CDC's Office of Surveillance, Epidemiology and Laboratory

Services

December 1, 2012

AFB Microscopy Network

Evaluation Guide:

A systematic approach to Smear Microscopy Network

Accreditation

Disclaimer” The findings and conclusions in this presentation

have not been formally disseminated by [the Centers for

Disease Control and Prevention/the Agency for Toxic

Substances and Disease Registry] and should not be construed

to represent any agency determination or policy."

Microscopy Network Evaluation Guide

Content

STANDARDS AND TOOLS FOR EVALUATION OF AFB-MICROSCOPY NETWORK............................................. 2

Preface............................................................................................................................................... 5

I. Introduction ............................................................................................................................ 6

II. Principles and Contents of the Accreditation Tool ...................................................................... 8

III. Standards for Accreditation of an AFB-Microscopy Network ....................................................... 9

IV. Resource Documents ..............................................................................................................13

V. Checklists ...............................................................................................................................17

Assessment of policies and procedures at the national level .............................................................17

Validation of policies and procedures at national, intermediate and peripheral levels ........................17

VI. How Countries Can Use the Accreditation Tool .........................................................................18

VII. Development of an Accreditation Program 22

Background

• Global Laboratory Initiative (GLI) rollout in

Capetown, 2007

• GLI Business Plan proposal (5.3) “Task force to

develop a strategy and proposal for international

accreditation of national TB reference laboratories

and TB microscopy networks”

• TBCARE projects for GLI accreditation projects

• Accreditation Task force, August 5-6, 2010 at KIT

• Distribute “draft” network evaluation guidance

Capetown, December 2012

Rationale

• >37,000 microscopy laboratories in the 22 TB

high burden countries

• Microscopy network management addressed

by numerous GLI and WHO technical resources

• Evidence of weak network management

despite increased support

• Strengthening network management requires

systematic evaluation and incentives

• New diagnostics will require functional country

laboratory networks

GLI Guidance, Tools, Programs

Principles

• Accreditation Program will be based on GLI/WHO

guidelines for microscopy methods, including EQA

• Countries required to have documented policies, plans,

and procedures that address supervision, training and

support for the network

• The Accreditation program will review that country

policies sufficiently address quality practices and that

the polices are carried out throughout the system

• The standards and checklists will be published to

provide immediate guidance and a consolidated

technical resource with pertinent GLI tools

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Standards: Laboratory Network Accreditation (1)


� Standard 1. The TB microscopy network structure, its services to

the NTP, its management, future expansion and appropriate use

(balanced with that of other available TB laboratory methods), are

defined in a strategic plan.

� Standard 2. A national AFB-microscopy manual with standard

operating procedures exists, and is accessible in some format at all

microscopy laboratories.

� Standard 3. There is documented and recent evidence of complete

coverage of the population by AFB-microscopy laboratories,

organized as a network.

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� Standard 4. Qualifications and number of staff required for

performing AFB-microscopy and its EQA are appropriate and

complemented by job descriptions and training curricula with

sufficient emphasis on competence.

� Standard 5. External quality assessment targets all laboratories

and includes regular supervision visits.

� Standard 6. Globally standardized recording and reporting formats

for AFB-microscopy and its quality assurance are used at all levels

of the network.

� Standard 7. The NRL manager or laboratory specialist of the NTP

ensures excellent control over microscopy network supplies and

equipment

10 |



� Standard 8. A policy regarding the role of the private sector and its

microscopy laboratories within the NTP exists and there is

documented evidence of its implementation.

� Standard 9. A dedicated budget is available for the microscopy

network, ensuring continuous and country-wide availability of free,

quality assured AFB-microscopy.

� Standard 10. AFB-microscopy laboratories are safe for the staff

and the community.

� Standard 11. A national policy exists for referral of specimens from

patients at risk for HIV-associated TB and/or MDR-TB for additional

TB diagnostic testing.

Structure of Standards

Standard 2. A national AFB-microscopy manual with standard operating procedures exists, and is

accessible in some format at all microscopy laboratories.

Measure for standard #2 - The national Standard Operating Procedures (SOPs) or guidelines are available

and followed at all levels. Internal and external quality assurance policies and procedures are covered in

this manual or separately, clearly stating the process and responsibilities at various levels of the microscopy

network. The operating procedures and policies respect global guidelines with the exception of minor

deviations per national preferences.

Rationale: An effective network requires that every microscopy laboratory has accessible and

comprehensive information outlining all of the technical procedures and processes necessary to perform

their tasks.

Resources

2. A national AFB-microscopy

manual with standard operating procedures

exists, and is accessible in some format at all


WHO Policy Statement: Same-day Diagnosis of Tuberculosis by Microscopy

(http://whqlibdoc.who.int/publications/2011/9789241501606_eng.pdf)

WHO Policy Statement: Fluorescent Light-emitting diode (LED) Microscopy for Diagnosis of

Tuberculosis (http://whqlibdoc.who.int/publications/2011/9789241501613_eng.pdf)

Policy on Definition of a New Sputum Smear-positive TB Case

(http://www.who.int/entity/tb/laboratory/policy_sputum_smearpositive_tb_case/en/index.html)

Policy on Reduction of Number of Smears for the Diagnosis of Pulmonary TB

(http://www.who.int/entity/tb/laboratory/policy_diagnosis_pulmonary_tb/en/index.html)

Instructional Poster for ZN AFB Microscopy

(http://wwwn.cdc.gov/dls/ila/documents/AFBSmearStaining.pdf)

Acid-Fast Direct Smear Microscopy Training Package

(http://wwwn.cdc.gov/dls/ila/acidfasttraining/)

Standard Operating Procedures

(http://www.tbcare1.org/publications/toolbox/sops/)

Checklist---National Level

Standard 2. A national AFB-microscopy manual with standard operating procedures exists, and is accessible in some format at all


A national AFB-microscopy manual with standard operating procedures exists Y/N

Operating procedures and policies respect global guidelines on main points Y/N

SOPs and/or job aids for AFB-microscopy are included in the manual or are in separate documents and in accordance with the

national manual

Y/N

Diagnostic algorithms show the place of microscopy besides other techniques Y/N

Preparation of AFB stains observes international guidelines Y/N

- Staining solution formulations are adequate with appropriate technique

- Detailed description of internal quality control procedures (in particular for new staining solutions) is included

There is a policy for bio-safety, including waste management

There is a policy for revision/upgrading of laboratory guidelines and SOPs

How Can Countries Use the Network Evaluation Guidance?

Phase 1. Reviewing existing policies, guidance and

support for the network:

Phase 2. Adherence to guidelines and technical execution

of the tests, including quality:

Phase 3. Microscopy network EQA conduct

Phase 4. Linkage with other tests and referral system

Proposed Accreditation Program

� Formal WHO and GLI-aligned program is necessary to

provide objective and consistent assessments

� External review required to overcome current

disincentives to appropriately monitor performance

� Review of the system will require peer reviewers with

TB expertise (e.g. EQA, microscopy, standard forms,

protocols)

� Proposed process of:

� Offsite review of existing policies

� Followed by structured 1-2 week review of random stratified

sample of laboratories

�

Acknowledgements

Network Evaluation Guide Project TeamArmand Van Deun (Union) – Project Lead

Marijke Becx-Bleumink – (Union)

Jerold Sholten (KNCV)

Sabira Tahseen (Pakistan NRL)

Chris Gilpin (WHO)

Pawan Angra (CDC)

John Ridderhof (CDC)

and

Global Laboratory Initiative Core Group

Glen Fine (CLSI)