**Laboratory Assessment**

**I. Objectives**

> **General objective:**
>
> To rapidly assess the functional laboratory capacity for diagnosis of
> priority diseases for surveillance.
>
> **Specific objectives:**
>
> To employ a standardised tool for brief laboratory assessments to
> obtain easily available information about laboratory capability at all
> levels as part of the overall assessment of national surveillance
> systems.
>
> To identify weaknesses in laboratory provision for priority disease
> detection and devise improvements ensuring that clinical specimens and
> information flow smoothly from district to provincial and national
> levels.
>
> To enable the development of a plan of action to strengthen laboratory
> capacity for surveillance and control of priority diseases.

**II. Key steps in carrying out the laboratory assessment:**

***[Step I]{.underline}:*** Review of documentation and information in
the country

> 1\. Obtain pertinent documents from previous laboratory assessments
> performed in the country before assessment
>
> 2\. National laboratory system (both public and private)
>
> a\. Review the national laboratory services policy
>
> b\. Description of organizational units within Ministry of Health
> (e.g. health centre, district, regional, national)
>
> c\. Description of organizational units for other Ministries that have
> health care functions (e.g. Ministry of Education or Scientific
> Research). University medical schools often provide laboratory
> services and are valuable resources that should not be overlooked
>
> d\. Description of laboratories in the private sector. These include
> both independent labs and those in private hospitals. If a national
> accrediting organization for laboratories exists, consult this agency
> for information about the type and number of private laboratories.

***[Step II]{.underline}:*** Adaptation and modification of proposed
generic questionnaire

> The protocol recommends a generic tool for assessment, that needs to
> be modified for each level of the health system. This should take into
> account the degree of sophistication of the assessed level, as well as
> the type of laboratory facility to be assessed. These vary widely from
> country to country. Relevant questions would need to be identified for
> each level of laboratory assessed within the country. A careful review
> of each question is important and these should be modified or deleted
> as appropriate.
>
> Train assessors in the use of the laboratory assessment tool and how
> to perform the associated brief laboratory inspection. The time spent
> administering the questionnaire and inspecting the laboratory may vary
> greatly, depending on the type of laboratory and the level of the
> health care system, and this should be taken into account.

***[Step III]{.underline}*:** The field assessment

> **3.1.** Using a representative sample of laboratories at each level
> in both public and private organizations, assess the following:
>
> 1\. Building facilities and utility services
>
> 2\. Laboratory equipment
>
> 3\. Laboratory Staff
>
> a\. Number (level of training)
>
> b\. Supervision
>
> 4\. Reagents
>
> 5\. Tests performed
>
> a\. Name of test
>
> b\. Number per month
>
> 6\. Laboratory management
>
> a\. Hours of service
>
> b\. Procedure manuals
>
> c\. Specimen collection, labelling and handling
>
> d\. Reporting procedures
>
> e\. Quality control procedures and programme
>
> 1\) Internal and external quality assurance and proficiency\
> programmes
>
> 2\) Equipment maintenance and repair
>
> 3\) Supply procurement and management
>
> f\. Safety.
>
> **3.2.** Inspect the laboratory and complete the inspection form to
> validate data reported in the interview.
>
> a\. Accessioning and reporting
>
> b\. Manuals
>
> c\. Equipment and reagents
>
> d\. Safety.

***[Step IV]{.underline}:*** Data analysis and report writing

Analyse data from country-wide laboratory assessment in regard to:

> a\. Overall function of surveillance system
>
> b\. Identification of specific laboratories deserving detailed
> laboratory assessment with a view to delineating and enhancing their
> role in the surveillance system.
>
> The report writing could be done as part of the overall national
> surveillance system assessment report or separately if required.
>
> **Note**: Follow-up assessments can also measure qualitative and
> quantitative changes in types of tests performed, number of each test
> performed per month and changes in proficiency by examining quality
> control data from internal controls and results of testing panels from
> reference labs.

**Laboratory Assessment Tool**

**Checklist for diagnostic laboratory assessment**

> General Information

+----------------------+-----------------------------------------------+
| **Name of the        |                                               |
| laboratory**         |                                               |
+----------------------+-----------------------------------------------+
| **Address of the     |                                               |
| laboratory**         |                                               |
|                      |                                               |
| Telephone/fax/e-mail |                                               |
+----------------------+-----------------------------------------------+
| **Level of the       | Health Facility\                              |
| laboratory**         | Provincial/State/Regional\                    |
|                      | National\                                     |
|                      | Community/District                            |
+----------------------+-----------------------------------------------+
| **Affiliation of the | Public\                                       |
| Laboratory**\        | Private\                                      |
| (more than one may   | Academic Institution\                         |
| be applicable,\      | NGO or Religious Institution                  |
| e.g. Private and     |                                               |
| Academic)            |                                               |
+----------------------+-----------------------------------------------+
| **Name of head of    |                                               |
| Laboratory**         |                                               |
+----------------------+-----------------------------------------------+
| **Name of Laboratory |                                               |
| Director**           |                                               |
+----------------------+-----------------------------------------------+

> Building facilities and utility services

+----------------------------------+-----------------------------------+
| How is the state of the building |                                   |
|            good           medium |                                   |
|           poor∗                  |                                   |
+----------------------------------+-----------------------------------+
| Is the laboratory in a           |                                   |
| free-standing building           |                                   |
|                or part of larger |                                   |
| structure                        |                                   |
+----------------------------------+-----------------------------------+
| Does the laboratory perform      |                                   |
| tests for:                       |                                   |
+----------------------------------+-----------------------------------+
| Bacteriology\                    | Yes       No\                     |
| Virology\                        | Yes       No \                    |
| Mycobacteriology\                | Yes       No \                    |
| Parasitology\                    | Yes       No \                    |
| Mycology                         | Yes       No                      |
+----------------------------------+-----------------------------------+
| Cell culture facility?           | Yes       No                      |
+----------------------------------+-----------------------------------+
| Is the laboratory connected to   | Yes       No                      |
| hospital service?                |                                   |
+----------------------------------+-----------------------------------+
| How many rooms with bench space  | Number:                           |
| are there in the laboratories    |                                   |
| checked above?                   |                                   |
+----------------------------------+-----------------------------------+
| What % of the working day do you |                                   |
| have the following services      |                                   |
| available?                       |                                   |
+----------------------------------+-----------------------------------+
| Electricity\                     | \<50%       50-95%                |
| Running water\                   | 95-100%   \                       |
| Gas (including bottled)          | \<50%       50-95%                |
|                                  | 95-100%   \                       |
|                                  | \<50%       50-95%                |
|                                  | 95-100%                           |
+----------------------------------+-----------------------------------+
| Is there a back-up power source  | Yes       No                      |
| in case of power failure\        |                                   |
| (e.g. emergency generator)?      |                                   |
+----------------------------------+-----------------------------------+
| ***If Yes,*** what systems are   |                                   |
| protected?                       |                                   |
+----------------------------------+-----------------------------------+
| Refrigerators/freezers\          | Yes       No \                    |
| Ventilation/AC\                  | Yes       No\                     |
| Computers\                       | Yes       No\                     |
| Other                            | Yes       No\                     |
|                                  | Not applicable                    |
+----------------------------------+-----------------------------------+
| What ventilation is provided?    |                                   |
+----------------------------------+-----------------------------------+
| Windows                          | Yes        No                     |
|                                  |                                   |
| Electrically-powered ventilation | Yes       No                      |
| (exhaust, not fans) system or\   |                                   |
| air-conditioning                 |                                   |
+----------------------------------+-----------------------------------+

  ------------------------------ ---------------- ------------------------
  What types of communications   tick all         Number
  systems are available?         applicable       

  Post                           Yes       No      

  Telephone                      Yes       No      

  Fax                            Yes       No      

  Satellite phone                Yes       No      

  E-mail (no. computers)         Yes       No      

  Internet (no. computers)       Yes       No      
  ------------------------------ ---------------- ------------------------

> Laboratory equipment

  ----------------------------- ---------------- ------------------------
  **Type and number of items    **Present**      **Number**
  available in your                              
  laboratory**                                   

  Refrigerator                  Yes       No     

  Freezing at --20°C            Yes       No     

  Freezing at --70°C            Yes       No     

  Microscope with oil-immersion Yes       No     
  objective                                      

  Slides and coverslips         Yes       No     

  Scale or balance              Yes       No     

  Candle jars                   Yes       No     

  Other Anaerobe jar            Yes       No     

  Magnifying lens               Yes       No     

  Loop/needle handles           Yes       No     

  0.01and 0.001ml calibrated    Yes       No     
  loops                                          

  Bunsen burner                 Yes       No     

  If no Bunsen burner, Electric Yes       No     
  heater or alcohol lamp to                      
  sterilise loops and needles                    

  Petri dishes (glass)          Yes       No     

  Petri dishes (disposable)     Yes       No     

  Test tube racks               Yes       No     

  Staining facilities-sink and  Yes       No     
  slide rack                                     

  Adequate glassware for media  Yes       No     
  preparation (flasks,                           
  graduated cylinders, etc.)                     

  Wash bottles                  Yes       No     

  pH paper                      Yes       No     

  pH meter                      Yes       No     

  Manual pipettes (e.g.         Yes       No     
  Eppendorf)                                     

  Water distillation system     Yes       No     

  Low-speed centrifuge ( hand   Yes       No     
  or electrically powered)                       

  Autoclave - manually          Yes       No     
  controlled                                     

  Autoclave - electrically      Yes       No     
  controlled                                     

  Hot air oven                  Yes       No     

  Inverted microscope           Yes       No     

  Fluorescent microscope        Yes       No     

  Electron microscope           Yes       No     

  ELISA plate reader            Yes       No     

  Electrically-powered          Yes       No     
  waterbath                                      

  Warm air incubator            Yes       No     

  CO~2~ incubator               Yes       No     

  CO~2~ tanks                   Yes       No     

  Liquid nitrogen storage       Yes       No     

  ELISA washer                  Yes       No     

  Safety cabinet- level 1       Yes       No     
  (operator protection.                          
  Open-fronted, unrecirculated                   
  airflow away from operator)                    

  Safety cabinet- level 2       Yes       No     
  (protects operator and                         
  material from contamination.                   
  Open fronted, filtered supply                  
  and exhaust air)                               

  Safety cabinet- level 3       Yes       No     
  (protects operator, material                   
  and environment from                           
  contamination-enclosed,                        
  negative pressure, HEPA                        
  filtered air supply and                        
  exhaust)                                       

  Are all equipment             Yes       No     
  functioning?\                                  
  (Ask this question after each                  
  equipment item,\                               
  if response is NO, record                      
  below)                                         

  If no, what items of                           
  equipment are not                              
  functioning?                                   
  ----------------------------- ---------------- ------------------------

> Laboratory staff and supervision for all microbiology\
> and serology labs

  ----------------------------- ------------ --------------- -------------------------
  **Number of staff in each     **Number**                   **% of staff available in
  category**                                                 lab**

  Supervisors ---                                            
  Medical/Scientific                                         

  Supervisors --- Technical                                  

  Technologist/Technical (doing                              
  tests)                                                     

  Laboratory assistants (not                                 
  doing tests)                                               

  Clerical                                                   

  What is the highest level of                               
  microbiology training                                      
  achieved by technical staff                                
  performing diagnostic tests?                               
  (state number of staff for                                 
  each option)                                               

  In-laboratory training only                                

  Diploma course or specific                                 
  training course                                            

  Degree level                                               

  Other (briefly describe):                                  

  Has training been conducted   Yes                          
  for your laboratory staff in  No                           
  the past year?                                             

  ***If Yes***, indicate the                                 
  type of training and the                                   
  number of staff trained                                    

  Formal training at national                Yes       No    
  lab                                                        

  Formal training on-site                    Yes       No    

  International training                     Yes       No    

  **Laboratory staff                                         
  supervision**                                              

  Who usually decides which                                  
  tests to perform when the                                  
  samples first arrive in the                                
  laboratory?                                                

  The requesting clinician                   Yes       No    

  The technician                             Yes       No    

  Microbiologist/supervisor                  Yes       No    

  Laboratory protocol                        Yes       No    

  Who makes decisions about                                  
  further testing if indicated?                              

  The technician                             Yes       No    

  Microbiologist/supervisor                  Yes       No    

  Are ALL tests reviewed before              Yes       No    
  results sent for reporting?                                

  ***If Yes***, who reviews the                              
  results of tests (or test                                  
  runs)?                                                     

  Only the technician                        Yes       No    
  performing the test                                        

  Another member of the                      Yes       No    
  technical staff                                            

  A supervisor/medical                       Yes       No    
  microbiologist                                             

  Are ALL tests reviewed before              Yes       No    
  results sent for reporting?                                

  ***If Yes***, who reviews the                              
  final report before it is                                  
  sent to the requesting                                     
  clinician or other                                         
  appropriate recipient?                                     

  Only the technician                        Yes       No    
  performing the test                                        

  Another member of the                      Yes       No    
  technical staff                                            

  A supervisor/medical                       Yes       No    
  microbiologist                                             
  ----------------------------- ------------ --------------- -------------------------

> Reagents

  -------------------------------------- --------------------------------
  What proportion of your reagents do    
  you obtain from:                       

  A commercial supplier                  \%

  From another laboratory                \%

  Prepared in-house                      \%

  What type of water is used for         
  preparation of media and reagents?     

  Deionized                              Yes       No 

  Distilled                              Yes       No 

  Distilled and deionized                Yes       No 

  Tap water                              Yes       No 
  -------------------------------------- --------------------------------

> Tests performed at the laboratory

  -----------------------------------------------------------------------
  *The following table lists a number of diseases and diagnostic tests.
  Please note which tests are performed in your laboratory. For each
  disease, note whether or not you test any of the named specimens by any
  of the listed tests. (If you do not perform any tests for meningitis,
  for example,**tick** in the \"No\" column for all. If you perform a
  Gram stain on CSF for meningitis, but none of the other tests, **tick**
  in the \" Yes\" column for Gram stain, and \"No\" for the other
  meningitis tests.) Please give the approximate number/month of each
  test you perform.*

  -----------------------------------------------------------------------

  ------------------ --------------- -------------------- ---------- -------- ------------------------
  **Disease**        **Specimen      **Assay Performed**  **Yes **   **No**   **Number/\
                     type**                                                   Month**

  **Meningitis**     CSF             a\. Cell count                            

                                     b\. Latex                                 
                                     agglutination                            

                                     c\. Gram stain                            

                                     d\. Culture                               

                                     e\. Identification                        
                                     tests                                    

                                     f\. A-M                                   
                                     susceptibility                           

                     *S. pneumoniae* Optochin disks                            

                     *N.             Sugar fermentations                       
                     meningitidis*                                            

                     *H. influenzae* X, V, XV factors                          

                     Blood           Blood Culture and                         
                                     tests b, e, f above                      

  **Dysentery**      Faeces          Microscopy of wet                         
                                     preparation                              

                                     Culture                                   

                                     Identification tests                      

                                     A-M susceptibility                        

  **Watery diarrhea  Faeces          Microscopy of wet                         
  (cholera)**                        preparation                              

                                     Culture-TCBS                              

                                     Culture-Alk. Peptone                      

                                     Serotyping                                

  **Plague**         Bubo aspirate,  Stain                                     
                     sputum, blood                                            

                                     Culture                                   

                                     A-M susceptibility                        

  **Tuberculosis**   Sputum, CSF     Z-N staining                              

                                     Rhodamine/Auramine                        
                                     staining and                             
                                     fluorescent                              
                                     microscopy                               

                                     Culture                                   

                                     A-M Susceptibility                        

  **Malaria**        Blood           Thick/Thin film                           
                                     microscopy                               
  ------------------ --------------- -------------------- ---------- -------- ------------------------

+-------+----------+-------------+-----+-----+-----------------------+
| *     | Serum    | IgM by EIA  |     |     |                       |
| *Meas |          |             |     |     |                       |
| les** |          |             |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
|       |          | Other       |     |     |                       |
|       |          | serological |     |     |                       |
|       |          | test        |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
|       | Throat   | Virus       |     |     |                       |
|       | swab,    | isolation   |     |     |                       |
|       | conj     |             |     |     |                       |
|       | unctival |             |     |     |                       |
|       | swab     |             |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
| **Y   | Serum    | IgM         |     |     |                       |
| ellow |          |             |     |     |                       |
| fe    |          |             |     |     |                       |
| ver** |          |             |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
|       | Blood,   | Virus       |     |     |                       |
|       | pos      | isolation   |     |     |                       |
|       | t-mortem |             |     |     |                       |
|       | liver    |             |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
| **FU  | Blood,   | Culture     |     |     |                       |
| O/PUO | faeces   |             |     |     |                       |
| (su   |          | Ide         |     |     |                       |
| spect |          | ntification |     |     |                       |
| ty    |          | tests       |     |     |                       |
| phoid |          |             |     |     |                       |
| or    |          | A-M         |     |     |                       |
| bruc  |          | sus         |     |     |                       |
| ellos |          | ceptibility |     |     |                       |
| is)** |          |             |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
|       | Serum    | Serological |     |     |                       |
|       |          | tests       |     |     |                       |
|       |          | (Widal,     |     |     |                       |
|       |          | brucella    |     |     |                       |
|       |          | a           |     |     |                       |
|       |          | gglutinins) |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
| **H   | Serum    | Anti-HAV    |     |     |                       |
| epati |          | IgM         |     |     |                       |
| tis** |          |             |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
|       |          | Anti-HBc    |     |     |                       |
|       |          | IgM         |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
|       |          | Anti-HbsAg  |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
|       |          | Anti-HCV    |     |     |                       |
|       |          | IgM         |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
|       |          | Anti-HEV    |     |     |                       |
|       |          | IgG         |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
| **    | Serum    | IgM         |     |     |                       |
| Viral |          |             |     |     |                       |
| ha    |          |             |     |     |                       |
| emorr |          |             |     |     |                       |
| hagic |          |             |     |     |                       |
| f     |          |             |     |     |                       |
| evers |          |             |     |     |                       |
| (a    |          |             |     |     |                       |
| ny)** |          |             |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
|       | Serum,   | Virus       |     |     |                       |
|       | other    | detection   |     |     |                       |
|       | tissue   |             |     |     |                       |
|       | s        |             |     |     |                       |
|       | pecimens |             |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
| **    | Faeces   | Virus       |     |     |                       |
| Acute |          | isolation   |     |     |                       |
| fl    |          |             |     |     |                       |
| accid |          |             |     |     |                       |
| p     |          |             |     |     |                       |
| araly |          |             |     |     |                       |
| sis** |          |             |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
|       |          | Virus       |     |     |                       |
|       |          | typing      |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
| **    | Serum    | IgG by EIA  |     |     |                       |
| HIV** |          |             |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
|       | Blood    | Viral load  |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+
|       |          | Virus       |     |     |                       |
|       |          | isolation   |     |     |                       |
+-------+----------+-------------+-----+-----+-----------------------+

> Laboratory management

  ----------------------- ----------- ----------------------------------------
  What are the normal                 
  hours/days of service               
  of the laboratory?                  

  Number of days per week \<5         
                          5         6 
                                  7   

  Hours per day           \<6         
                          6-10        
                              11-23   
                               24     

  If no 24-hour service,              Yes  No
  is out-of-hours or                  
  emergency service                   
  available?                          

  If there is 24-hour                 Number
  service, number of                  
  staff at the following              
  times:                              

  5 PM to 12 AM                       

  12 AM to 7 AM                       

  How does the laboratory             
  inform existing or                  
  potential clients about             
  the services it offers?             

  Verbally only                       Yes       No 
  (informal)                          

  Printed list/Brochure               Yes       No 

  Does the technical                  Yes       No 
  staff have access to                
  typed or written                    
  protocols (Standard                 
  Operating Procedures)               
  for performing each                 
  test?                               
  ----------------------- ----------- ----------------------------------------

> Specimen collection, labelling and handling

  -------------------- --------------- --------- ----------- ----------------------------
  Proportion of                        \<20%                 
  samples collected on                                       
  site                                 20-50%                
                                                             
                                       50-80%                
                                                             
                                       \>80%                 

  Does the laboratory                                        Yes       No 
  use standardised                                           
  request forms to                                           
  order laboratory                                           
  tests?                                                     

  Do request forms                                           Yes       No 
  contain **ALL** of                                         
  the following                                              
  patient information:                                       
  specimen source,                                           
  date and time of                                           
  collection, type of                                        
  test requested?                                            

  Do request forms                                           Yes       No 
  provide details or a                                       
  link which enable                                          
  the lab to contact                                         
  the patient?                                               

  Are specimens that                                         Yes       No 
  are received                                               
  labelled with the                                          
  patient's name and                                         
  unique identifiers?                                        

  Does the laboratory                                        Yes       No 
  provide a unique                                           
  accession number for                                       
  all specimens?                                             

  Does the laboratory                                        Yes       No 
  have a                                                     
  logbook/electronic                                         
  record of all                                              
  specimens sent for                                         
  diagnostic testing?                                        

  Are specimens                                              Discarded           Stored
  discarded after                                            
  testing, or are they                                       
  stored?                                                    

  Are standard                                               Yes       No 
  criteria used for                                          
  discarding specimens                                       
  with prolonged                                             
  transit times (time                                        
  of collection to                                           
  time of processing                                         
  in lab)?                                                   

  Does the laboratory                                        Yes       No 
  during evening/night                                       
  shifts accept                                              
  specimens?                                                 

  ***If Yes***, how                                          
  are the following                                          
  samples handled?                                           

  **Specimen**         **Plated                  ***If no*,  
                       immediately**             held at     
                                                 (*tick*     
                                                 one)**      

  CSF                  Yes        No             4≡ Ambient  
                                                 temp. 35≡   

  Blood culture        Yes        No             4≡ Ambient  
                                                 temp. 35≡   

  Urine                Yes        No             4≡ Ambient  
                                                 temp. 35≡   

  Does you laboratory                                        Yes       No 
  refer bacteriology                                         
  isolates or serum                                          
  samples to the                                             
  Ministry of Health                                         
  or a reference                                             
  laboratory?                                                

  ***If Yes***, reason                                       
  for referral                                               
  (***tick*** all)                                           

  Confirmation                                               Yes       No 

  Identification of                                          Yes       No 
  Unknown ? organism                                         

  Test not performed                                         Yes       No 
  on site                                                    

  ***If Yes***, then                                         
  by what method?                                            

  By regular post                                            Yes       No 
  service                                                    

  By special messenger                                       Yes       No 

  Courier service                                            Yes       No 

  Other (describe):                                          

  ***If Yes***, number                                       
  of sample sent per                                         
  month?                                                     

  Types of transport                                         
  media used                                                 
  (***tick*** all that                                       
  apply)                                                     

  Trans-isolate                                              Yes       No 

  Amies                                                      Yes       No 

  Stuart                                                     Yes       No 

  Cary and Blair                                             Yes       No 

  Blood agar slants                                          Yes       No 

  Viral transport                                            Yes       No 
  medium                                                     

  Other (describe):                                          
  -------------------- --------------- --------- ----------- ----------------------------

> Reporting procedures

  --------------------------- -------------- ---------------- --------------------------------
  Are records kept of the                                     Yes       No 
  number and type of tests                                    
  performed and results?                                      

  Does the laboratory use                                     Yes       No 
  standardised forms to                                       
  report lab results?                                         

  Does the laboratory have a                                  Yes       No 
  list of diseases that are                                   
  supposed to be reported to                                  
  the Ministry of Health?                                     

  ***If no***, does the lab                                   Yes       No 
  staff know what diseases                                    
  should be reported?                                         

  Does the lab provide                                        
  regular reports of patients                                 
  with notifiable diseases to                                 
  any of the following\                                       
  Ministry of Health                                          
  offices/institutions?                                       
  (***tick*** all that apply)                                 

  District Health Office                                      Yes       No 

  State Health Office                                         Yes       No 

  Central Laboratory                                          Yes       No 

  National Communicable                                       Yes       No 
  Disease Program                                             

  If reports are submitted,                                   
  how frequently?                                             

  Weekly                                                      Yes       No 

  Monthly                                                     Yes       No 

  Quarterly                                                   Yes       No 

  Other                                                       Yes       No 

  If reports are submitted,                                   
  by what means are they                                      
  sent?                                                       

  Line list                                                   Yes       No 

  Telephone                                                   Yes       No 

  FAX                                                         Yes       No 

  Other (describe):                                           

  Do you keep register of                                     Yes       No 
  persons with notifiable                                     
  diseases?                                                   

  ***If Yes***, is the                                        Yes       No 
  register computerised?                                      

  If computerised, are                                        Yes       No 
  back-up copies (hard copies                                 
  or disc) of data made and                                   
  archived?                                                   

  **Quality control                                           
  procedures and programs**                                   

  Is information gathered                                     Yes       No 
  about laboratory                                            
  turn-around times for                                       
  specimens (time from                                        
  receipt of specimen to                                      
  issue of the report)?                                       

  Does the laboratory use any                                 Yes       No 
  system for internal quality                                 
  control?                                                    

  Are internal controls                                       Yes       No 
  included in each test run?                                  

  ***If Yes***, is the                                        Yes       No 
  performance of these                                        
  internal controls recorded                                  
  and monitored over time?                                    

  Does the laboratory                                         Yes       No 
  participate in any external                                 
  quality assurance or                                        
  proficiency schemes?                                        

  ***If Yes***, what                                          
  programs?                                                   

  Bacteriology Unknown ?s                                     Yes       No 

  HIV/Hepatitis panels                                        Yes       No 

  Antimicrobial                                               Yes       No 
  susceptibility                                              

  Other (specify)                                             Yes       No 

  Does your laboratory keep                                   Yes       No 
  records of deliveries of                                    
  reagents and materials?                                     

  Does your laboratory have a                                 Yes       No 
  system for regularly                                        
  monitoring of quantities of                                 
  reagents and materials so                                   
  that there is warning if                                    
  stocks become low?                                          

  Does the laboratory have                                    Yes       No 
  problems obtaining and                                      
  maintaining most supplies                                   
  of essential reagents and                                   
  materials?                                                  

  ***If Yes***, what is the                                   
  most important reason for                                   
  not maintaining an adequate                                 
  stock of reagents and                                       
  supplies?                                                   

  Information about how to                                    Yes       No 
  obtain materials                                            

  Long delay ordering and                                     Yes       No 
  delivery of materials                                       

  Lack of funds                                               Yes       No 

  Inconsistent demand for                                     Yes       No 
  test from physicians                                        

  Is the functioning of ALL                                   Yes       No 
  electrical or mechanical                                    
  equipment routinely                                         
  monitored and recorded                                      
  (e.g. microscope                                            
  calibration, checking                                       
  temperatures of                                             
  refrigerators or                                            
  incubators, calibration of                                  
  pipettes or handling                                        
  devices, autoclave                                          
  function, etc.)?                                            

  Are calibration,                                            Yes       No 
  maintenance and service                                     
  records kept?                                               

  **Safety**                                                  

  Does the laboratory staff                                   Yes       No 
  receive training in                                         
  laboratory safety?                                          

  Is there a safety manual                                    Yes       No 
  easily accessible to the                                    
  laboratory the staff?                                       

  What methods are used for                                   
  solid waste disposal?                                       

  Autoclaving                                                 Yes       No 

  Incineration                                                Yes       No 

  Burial with no                                              Yes       No 
  pre-treatment                                               

  Other (briefly describe):                                   

  What methods are used for                                   
  liquid waste disposal?                                      

  No treatment                                                Yes       No 

  Autoclaving                                                 Yes       No 

  Chemical disinfection                                       Yes       No 

  Other (briefly describe):                                   

  Is there a safety officer                                   Yes       No 

  Is there a safety SOP                                       Yes       No 

  Are new staff offered                                       Yes       No 
  immunisation                                                

  What protective                                             
  clothing/equipment is                                       
  available for laboratory                                    
  staff? (***tick*** all)                                     

  Gloves - latex                                              Yes       No 

  Gloves - other                                              Yes       No 

  Lab coats                                                   Yes       No 

  Safety glasses/visors                                       Yes       No 

  Other (briefly describe):                                   

  Are gloves worn for all                                     Yes       No 
  manipulations of specimens,                                 
  organisms, and reagents?                                    

  ***If Yes***, type of                                       
  gloves                                                      

  Latex                                                       Yes       No  

  Other                                                       Yes       No  

  ***If no***, are they worn                                  

  Only for designated                                         Yes       No  
  procedures OR                                               

  By the decision of the                                      Yes       No  
  technician performing a                                     
  test?                                                       

  If the respondent has said                                  
  ***Yes*** to any question                                   
  for Antimicrobial (A-M)                                     
  susceptibility testing,\                                    
  please indicate which                                       
  method was used:                                            

  Disk diffusion                                              Yes       No  

  Agar dilution                                               Yes       No  

  Broth dilution                                              Yes       No  

  E-Test                                                      Yes       No  

  Any anti-TB susceptibility                                  Yes       No  
  testing method                                              

  Do use any internationally                                  Yes       No  
  recognised standards for                                    
  definitions of                                              
  resistance/susceptibility                                   
  (e.g., NCCLS, Stokes, DIN,                                  
  SGRA)                                                       

  ***If Yes*** , then which                                   
  one(s)?                                                     

  If the laboratory performs                                  
  tests for any sexually                                      
  transmitted diseases, e.g.                                  
  syphilis, gonorrhoea,                                       
  chancroid, please enter the                                 
  information in the                                          
  following table                                             

  **Disease**                 **Specimen     **Assay          **Number/Month**
                              type**         performed**      

                                                              

                                                              

                                                              

  If the laboratory performs                                  
  any other virological                                       
  assays using enzyme                                         
  immunoassay, other                                          
  serological assays, virus                                   
  isolation or detection                                      
  (including molecular tests,                                 
  e.g., PCR), please list on                                  
  the table below. Please                                     
  append sheet if too                                         
  numerous to fit on table                                    

  **Disease**                 **Specimen     **Assay          **Number/Month**
                              type**         performed**      

                                                               

                                                               

                                                               
  --------------------------- -------------- ---------------- --------------------------------

** **

Laboratory Inspection

+-----------------------------------------------------------------------+
| **Laboratory Inspection**                                             |
|                                                                       |
| Inspect the laboratory and complete the following form. Be courteous  |
| by first asking permission to open refrigerators, freezers, media     |
| storage closets and incubators to examine items contained therein.    |
| Some of the information collected during a walk-through will be used  |
| to verify information provided on the questionnaire. Make additional  |
| Notes as required, e.g. general cleanliness and organization of the   |
| laboratory, staff activity level, workload (specimens and inoculated  |
| plates present), and special facilities. Obtain copies of standard    |
| forms where indicated.                                                |
+-----------------------------------------------------------------------+

> Accessioning and reporting

  -------------------------- ------------------- --------------- ----------------------------------
  Review accessioning                                            
  logbook(s) if available.                                       
  Roughly calculate the                                          
  number of specimens                                            
  submitted over a one-month                                     
  period. Record number:                                         
  *samples/month*                                                

  Review forms submitted                                         \<50%     \> 50%
  with specimens. What                                           
  proportion of specimens                                        
  received are labelled with                                     
  the patient's name and                                         
  unique identifiers?                                            

  Are copies of report forms                                     Yes       No  
  available?                                                     

  ***If Yes***, obtain                                           
  copies of standardised                                         
  reports forms that are                                         
  used                                                           

  **Manuals**                                                    

  **Type of manual**         **Available**       **Date of last  
                                                 revision**      

  Test Procedures            Yes       No        \< 1 year       
                                                 **   ** 2-5     
                                                 years\          
                                                 \> 5 years      
                                                 **  ** no date  

  Safety                     Yes       No        \< 1 year       
                                                 **   ** 2-5     
                                                 years\          
                                                 \> 5 years      
                                                 **  ** no date  

  Quality control            Yes       No        \< 1 year       
                                                 **   ** 2-5     
                                                 years\          
                                                 \> 5 years      
                                                 **  ** no date  

  **Equipment and reagents**                                     

  Briefly look to see if                                         Yes       No  
  reported number and type                                       
  of equipment items is                                          
  consistent with those                                          
  reported on the                                                
  questionnaire. Are                                             
  findings generally                                             
  consistent with responses                                      
  above?                                                         

  Inspect equipment to see                                       
  if performance indicators                                      
  (e.g., temperatures) are                                       
  regularly recorded                                             

  **Equipment item**         **Sheet present**   **Temps.        
                                                 Recorded (per   
                                                 cent            
                                                 complete)**     

  Refrigerators              Yes       No        0%              
                                                 1-50%           
                                                 \>50%           

  Freezers                   Yes       No        0%              
                                                 1-50%           
                                                 \>50%           

  Incubators                 Yes       No        0%              
                                                 1-50%           
                                                 \>50%           

  Inspect prepared reagents,                                     
  dehydrated media,                                              
  antibiotic susceptibility                                      
  disks and prepared media                                       
  to see if dates are                                            
  recorded for the date                                          
  prepared or opened and to                                      
  see if expiration dates                                        
  have passed.                                                   

  Proportion of reagents                         None    \<      
  labelled appropriately?                        50%      \>50%  

  Expiration dates found?                        None    \<      
                                                 50%      \>50%  

  For reagents with dates -                      None    \<      
  percent outdated?                              50%             
                                                 \>50%           

  Inspect bacteriological                                        
  media, both prepared and                                       
  dehydrated, and reagents                                       
  for signs of                                                   
  deterioration, e.g.                                            
  drying, discoloration,                                         
  hemolysis                                                      

  Deterioration noted in                         None    \< 50%  
  bacteriological media                                 \>50%    

  **Safety**                                                     

  If biosafety hood is                           Yes       No    
  present, is it                                          No     
  operational?                                   hood            

  Is a                                           Yes       No \  
  certification/inspection                       Not applicable  
  sticker present?                                               

  ***If Yes***, date of                          \< 1 year  **\  
  certification?                                 **\>1 year \    
                                                 Not applicable  

  Inspect laboratory for                                         
  presence of biosafety                                          
  equipment (gloves, sharps                                      
  containers, safety                                             
  glasses)                                                       

  Gloves present                                 Yes       No    

  Sharps containers                              Yes       No    

  What proportion of staff                       \<1-50%         
  are wearing gloves while                       \>50% ** \      
  performing procedures?                         **None          
                                                 Unknown         

  Inspect equipment used for                     Yes       No    
  the disposal of biological                                     
  wastes, e.g. autoclaves,                                       
  incinerator. Is the                                            
  hazardous waste disposal                                       
  system operational?                                            
  -------------------------- ------------------- --------------- ----------------------------------