![](media/image1.png){width="0.3993055555555556in" height="0.375in"}

National HIV Reference Laboratory

Check List for Annual WHO Accreditation

**1.Introduction.**

![](media/image2.png){width="5.701388888888889in"
height="5.875in"}Laboratory services are an essential component in the
diagnosis and treatment of persons infected with the human
immunodeficiency virus (HIV), in HIV screening of blood for transfusion,
in surveillance for HIV infection, and in HIV/AIDS related research.
Presently, the laboratory infrastructure for HIV testing and quality
assurance remain weak in most countries in Africa. There is therefore an
urgent need to strengthen the laboratory. The establishment of
accreditation systens will help countries to improve, and strengthen the
capacity of their laboratories.

Accreditation provides documentation that the laboratory has the
capability and the capacity to detect, identify, and promptly report HIV
that may be present in clinical and research specimens. The
accreditation process further provides a learning opportunity, a
mechanism for identifying resource and training needs, a measure of
progress, and a link to the WHO/AFRO HIV Laboratory Network.

Accreditation of Reference National HIV Laboratories is reviewed
annually by the WHO Regional Office and is based on laboratory
performance during the immediately preceding 12 months relying on
complete data, usually from the past 1-13 months to 1 month prior to
evaluation. Accreditation is given for the upcoming calendar year.

> **2.Six criteria for accreditation.**

1.  **Test results are reported by the laboratory on at least 80% of HIV
    specimens within 7 days of receipt.**

This criterion may be met for all negative specimens and positive
specimens which need a second test or third tests for result
confirmation according to WHO strategy used.

2.  **Serology tests are performed on more than 150 specimens weekly.**

Fully active HIV laboratories that maintain the appropriate screening
weekly and test 250 specimens monthly of any origin for any HIV viruses
are deemed to meet this criterion.

3.  **The accuracy of HIV screening result among all specimen is over
    90%.**

> Accuracy is determined by the agreement in test results on all HIV
> specimen screened by the National Laboratory with the externall
> quality assurance run during the 12-month review period.

4.  **Internal quality control (QC) procedures in HIV serology are
    practised for all the test runs.**

> Ordinarily, each HIV test kit has a set of positive and negative
> controls that are to be included in each test run. These controls
> included with the test kit are considered internal control, while any
> other controls included in the run are referred to as external
> controls. QC data sheets and summaries of corrective action are
> retained for documentation and discussion with reviewer.

5.  **The score on the most recent WHO approved proficiency test is over
    90%.**

Proficiency test (PT) results must be reported within 15 days of panel
receipt to receive full credit.

6.  **The score from the annual on-site review of laboratory operating**
    **procedures and practices is at least 95%.**

For Laboratories with consistently high annual scores, the Regional
Laboratory Coordinator may waive the on-site review upon satisfactory
completion of the annual checklist by the laboratory.

A Laboratory that achieves less than the passing score on any one of the
applicable criteria will work with the HIV Regional OfficeLaboratory
Coordinator to:

![](media/image2.png){width="5.701388888888889in" height="5.875in"}•
Identify areas where improvement is needed.

> • Develop and implement a work plan.
>
> • Monitor laboratory progress.
>
> • Provide for re-testing where required.
>
> • Continue steps to achieve full accreditation.

A Laboratory that fails to achieve a passing PT test score within 6
months after annual review is deemed non-accredited and arrangements
must be made for an accredited Laboratory to perform duplicate tests on
all specimens.

**This checklist is designed primarily for Laboratories in countries
that perform HIV screening. Applicable components of criteria 2-6 may be
used for Laboratories in other public health-related activities.**

The checklist consists of four parts. **Part I** summarizes the findings
of the review and the data on which accreditation is based. **Part II**
provides a worksheet to calculate and record laboratory performance for
**criteria** **#1** through **#6** for the immediately preceding 12
months where data is complete. (Selection of the most recent 12-month
period, rather than the most recent calendar year as a basis for
calculation, provides an assessment of current performance and permits
review of laboratories at any time during the calendar year.) **Part
III** provides a profile of the laboratory and serves to identify
resource needs. **Part IV** is a checklist for evaluation of laboratory
operating procedures and practices for **criterion** **6**

This checklist does not include all laboratory activities or all
situations. It is intended to serve as a guide. The experienced reviewer
is expected to ask detailed questions and make additional suggestions as
appropriate to assure high quality laboratory performance.

![](media/image1.png){width="0.3993055555555556in" height="0.375in"}

National HIV Laboratory

Check List for Annual WHO Accreditation

***Laboratories are to be notified in advance of the accreditation
review and provided a copy of this form to assist in gathering
information.***

  --------------------------------------------------- -- -- -- ---- -- -- ------- ------ ----------- --------------- --------- --------- -------
  Dates of Review:                                                                                   Accreditation                       
                                                                                                     for Calendar                        
                                                                                                     Year:                               

  Laboratory:                                                                                                                            

  Address:                                                                                                                               

  Phone:                                                                          Fax:                               E-mail:             

  Head of Department:                                                                                                                    

  ![](media/image2.png){width="5.701388888888889in"                                                                                      
  height="5.875in"}Head of Laboratory:                                                                                                   

  Technical Supervisor:                                                                                                                  

  Reviewers:                                                                                                                             

  Name of National Accrediting Authority and current                                                                                     
  accreditation status:                                                                                                                  

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

**Part I: Summary of Review**

**Recommendations (check one):**

> Accredit: Laboratory meets all criteria
>
> Provisionally accredit: Laboratory passed the most recent proficiency
> test, but failed to achieve one or more of the remaining criteria
>
> Do not accredit: Laboratory did not pass the most recent proficiency
> test

**Findings:**

  ----------- ---------------------------------------------------------- --------
  **1.**      Test results on at least 80% of all HIV specimens are      **%**
              reported within 7 days:                                    

  **2.**      Tests are performed on at least 3000 specimens annually    

  **3.**      Accuracy of HIV screening is over 95%:                     **%**

  **4.**      Internal quality control procedures are implemented at     
              least monthly:                                             

  **5.**      Result on most recent HIV PT is over 95%:                  **%**

  **6.**      Score on annual on-site review is at least 95%:            **%**

                                                                         

  Annual HIV                                                             **%**
  screening                                                              
  rate is:                                                               
  ----------- ---------------------------------------------------------- --------

*.*

+-----------------------------------------------------------------------+
| *SUMMARY, Comments and recommendations**:***                          |
|                                                                       |
| ![](media/image2.png){width="5.701388888888889in" height="5.875in"}   |
+-----------------------------------------------------------------------+

**Part II: Laboratory Performance in Previous 12 Months**

  ----------------- ------- ------- -- ------- -- ------- ----- ------- ------- -------- --
  Dates from:       **/**   **/**                 to            **/**   **/**            

                    *d*     *m*        *y*                *d*           *m*     *y*      
  ----------------- ------- ------- -- ------- -- ------- ----- ------- ------- -------- --

+-----+---------------------------------------------------------+------+
| 1   | **Percentage of HIV Test Results Reported within 7      | *    |
| .   | Days: (criteria 1)**                                    | *%** |
+-----+---------------------------------------------------------+------+
| 1   | Number of HIV specimens tested:                         |      |
| .   |                                                         |      |
+-----+---------------------------------------------------------+------+
| 2   | Number with screening test results reported within 7    |      |
| .   | days:                                                   |      |
+-----+---------------------------------------------------------+------+
| !   |                                                         |      |
| []( |                                                         |      |
| med |                                                         |      |
| ia/ |                                                         |      |
| ima |                                                         |      |
| ge2 |                                                         |      |
| .pn |                                                         |      |
| g){ |                                                         |      |
| wid |                                                         |      |
| th= |                                                         |      |
| "5. |                                                         |      |
| 701 |                                                         |      |
| 388 |                                                         |      |
| 888 |                                                         |      |
| 888 |                                                         |      |
| 889 |                                                         |      |
| in" |                                                         |      |
| he  |                                                         |      |
| igh |                                                         |      |
| t=" |                                                         |      |
| 5.8 |                                                         |      |
| 75i |                                                         |      |
| n"} |                                                         |      |
+-----+---------------------------------------------------------+------+
| *Co |                                                         |      |
| mme |                                                         |      |
| nts |                                                         |      |
| and |                                                         |      |
| rec |                                                         |      |
| omm |                                                         |      |
| end |                                                         |      |
| ati |                                                         |      |
| ons |                                                         |      |
| **: |                                                         |      |
| *** |                                                         |      |
+-----+---------------------------------------------------------+------+

+-----+---------------------------------------------------------+------+
| 2   | **Total Number of Specimens Tested for HIV: (Last 12    |      |
| .   | months)**                                               |      |
+-----+---------------------------------------------------------+------+
|     |                                                         |      |
+-----+---------------------------------------------------------+------+
| 2.1 | > Specimens tested for HIV from: Diagnosis:             |      |
+-----+---------------------------------------------------------+------+
| 2.2 | > Specimens tested for HIV from: Surveillance:          |      |
+-----+---------------------------------------------------------+------+
| 2.3 | > Specimens tested for HIV from: Special surveys:       |      |
+-----+---------------------------------------------------------+------+
| 2.4 | > Specimens tested for HIV from: Other:                 |      |
+-----+---------------------------------------------------------+------+
|     |                                                         |      |
+-----+---------------------------------------------------------+------+
| *Co |                                                         |      |
| mme |                                                         |      |
| nts |                                                         |      |
| and |                                                         |      |
| re  |                                                         |      |
| com |                                                         |      |
| men |                                                         |      |
| dat |                                                         |      |
| ion |                                                         |      |
| s:* |                                                         |      |
+-----+---------------------------------------------------------+------+

+-----+---------------------------------------------------------+------+
| **3 | **Accuray: Percent HIV concordance by external quality  | *    |
| .** | control :**                                             | *%** |
+-----+---------------------------------------------------------+------+
| >   | > Number of proficiency testing HIV screening test      |      |
| 3.1 | > done:                                                 |      |
+-----+---------------------------------------------------------+------+
| >   | > Number of specimen sent for PT from the regional      |      |
| 3.2 | > reference laboratory:                                 |      |
+-----+---------------------------------------------------------+------+
| >   | > Percentage of concordance results by PT with the      | *    |
| 3.3 | > regional reference laboratory:                        | *%** |
+-----+---------------------------------------------------------+------+
|     |                                                         |      |
+-----+---------------------------------------------------------+------+
| *DE |                                                         |      |
| SCR |                                                         |      |
| IBE |                                                         |      |
| ACT |                                                         |      |
| ION |                                                         |      |
| TA  |                                                         |      |
| KEN |                                                         |      |
| FOR |                                                         |      |
| ANY |                                                         |      |
| SP  |                                                         |      |
| ECI |                                                         |      |
| MEN |                                                         |      |
| NOT |                                                         |      |
| CON |                                                         |      |
| FIR |                                                         |      |
| MED |                                                         |      |
| BY  |                                                         |      |
| Q   |                                                         |      |
| C:* |                                                         |      |
|     |                                                         |      |
| *Co |                                                         |      |
| mme |                                                         |      |
| nts |                                                         |      |
| and |                                                         |      |
| rec |                                                         |      |
| omm |                                                         |      |
| end |                                                         |      |
| ati |                                                         |      |
| ons |                                                         |      |
| **: |                                                         |      |
| *** |                                                         |      |
+-----+---------------------------------------------------------+------+

+-----+---------------------------------------------------------+------+
| **4 | **Routine Internal Quality Control Procedures           |      |
| .** | Implemented:**                                          |      |
+-----+---------------------------------------------------------+------+
|     | 4.1 Monitoring of control values                        |      |
+-----+---------------------------------------------------------+------+
|     | 4.2 Monitoring with internal standards                  |      |
+-----+---------------------------------------------------------+------+
| !   | 4.3 Monitoring quality of each new batches of kits      |      |
| []( |                                                         |      |
| med |                                                         |      |
| ia/ |                                                         |      |
| ima |                                                         |      |
| ge2 |                                                         |      |
| .pn |                                                         |      |
| g){ |                                                         |      |
| wid |                                                         |      |
| th= |                                                         |      |
| "5. |                                                         |      |
| 701 |                                                         |      |
| 388 |                                                         |      |
| 888 |                                                         |      |
| 888 |                                                         |      |
| 889 |                                                         |      |
| in" |                                                         |      |
| he  |                                                         |      |
| igh |                                                         |      |
| t=" |                                                         |      |
| 5.8 |                                                         |      |
| 75i |                                                         |      |
| n"} |                                                         |      |
+-----+---------------------------------------------------------+------+
|     | 4.4 Documentation of internals controls and kits        |      |
|     | validation                                              |      |
+-----+---------------------------------------------------------+------+
|     |                                                         |      |
+-----+---------------------------------------------------------+------+
| *DE |                                                         |      |
| SCR |                                                         |      |
| IBE |                                                         |      |
| R   |                                                         |      |
| ESU |                                                         |      |
| LTS |                                                         |      |
| (%  |                                                         |      |
| of  |                                                         |      |
| sp  |                                                         |      |
| eci |                                                         |      |
| men |                                                         |      |
| col |                                                         |      |
| lec |                                                         |      |
| ted |                                                         |      |
| for |                                                         |      |
| QC, |                                                         |      |
| %   |                                                         |      |
| of  |                                                         |      |
| c   |                                                         |      |
| onc |                                                         |      |
| ord |                                                         |      |
| anc |                                                         |      |
| e)* |                                                         |      |
|     |                                                         |      |
| *co |                                                         |      |
| mme |                                                         |      |
| nts |                                                         |      |
| and |                                                         |      |
| re  |                                                         |      |
| com |                                                         |      |
| men |                                                         |      |
| dat |                                                         |      |
| ion |                                                         |      |
| s:* |                                                         |      |
+-----+---------------------------------------------------------+------+

+-----+------------------------------------------------+---+---+------+
| **5 | **Result of Most Recent HIV Proficiency        |   |   | *    |
| .** | Test:**                                        |   |   | *%** |
+-----+------------------------------------------------+---+---+------+
| >   | > Date of panel receipt:                       | * | * |      |
| 5.1 |                                                | * | * |      |
|     |                                                | / | / |      |
|     |                                                | * | * |      |
|     |                                                | * | * |      |
+-----+------------------------------------------------+---+---+------+
| >   | > Date of test report:                         | * | * |      |
| 5.2 |                                                | * | * |      |
|     |                                                | / | / |      |
|     |                                                | * | * |      |
|     |                                                | * | * |      |
+-----+------------------------------------------------+---+---+------+
|     |                                                |   |   |      |
+-----+------------------------------------------------+---+---+------+
| *Co |                                                |   |   |      |
| mme |                                                |   |   |      |
| nts |                                                |   |   |      |
| and |                                                |   |   |      |
| rec |                                                |   |   |      |
| omm |                                                |   |   |      |
| end |                                                |   |   |      |
| ati |                                                |   |   |      |
| ons |                                                |   |   |      |
| **: |                                                |   |   |      |
| *** |                                                |   |   |      |
+-----+------------------------------------------------+---+---+------+

  --------------------------------------------------------------- -------
  **Annual HIV Screening Rate:**                                  **%**

  **Annual HIV Confirmation Rate:**                               **%**

  total number of sera screened annually                          

  total number of HIV positive sera screened annually             

  total number of confirmed HIV positive sera annually            
  --------------------------------------------------------------- -------

**Part III: Laboratory Profile**

+-----+----------------------------------------------------------------+
| 1   | **Staff**                                                      |
| .   |                                                                |
+-----+----------------------------------------------------------------+
| 1   | > Number of scientific and technical staff assigned to HIV     |
| .   | > laboratory: Please list according to function, indicating    |
|     | > years of HIV laboratory experience and proportion of current |
|     | > working time spent on HIV-related activities.                |
+-----+----------------------------------------------------------------+

  --------------------------------------------------- --------------------- ------------- --------- ------------
  **Names of staff**                                  **Position Title or   **Full-time   **% of    **Years of
                                                      Duties**              or            time      experience
                                                                            Part-time**   spent     in HIV Lab**
                                                                                          working   
                                                                                          on HIV**  

                                                                                                    

                                                                                                    

                                                                                                    

                                                                                                    

  ![](media/image2.png){width="5.701388888888889in"                                                 
  height="5.875in"}                                                                                 

                                                                                                    

                                                                                                    

                                                                                                    

                                                                                                    

                                                                                                    

                                                                                                    

  *COMMENTS AND RECOMMENDATIONS:*                                                                   
  --------------------------------------------------- --------------------- ------------- --------- ------------

+-----+---------------------------------------------------------+------+
| 2   | **Space** (provide floor plan or sketch of laboratories |      |
| .   | if possible)                                            |      |
+-----+---------------------------------------------------------+------+
| 1   | > Total m^2^ available:                                 |      |
| .   |                                                         |      |
+-----+---------------------------------------------------------+------+
| 2   | > Number of rooms:                                      |      |
| .   |                                                         |      |
+-----+---------------------------------------------------------+------+
| 3   | > Separate room for molecular biology                   |      |
| .   |                                                         |      |
+-----+---------------------------------------------------------+------+
|     |                                                         |      |
+-----+---------------------------------------------------------+------+
| *CO |                                                         |      |
| MME |                                                         |      |
| NTS |                                                         |      |
| AND |                                                         |      |
| RE  |                                                         |      |
| COM |                                                         |      |
| MEN |                                                         |      |
| DAT |                                                         |      |
| ION |                                                         |      |
| S:* |                                                         |      |
+-----+---------------------------------------------------------+------+

**Part IV: Laboratory Operating Procedures and Work Practices**

+-----+------------------------------------------------+-------+------+
| 1   | **Space ***:* **9 points**                     | **Sco |      |
| .   |                                                | re:** |      |
+-----+------------------------------------------------+-------+------+
| 1   | > Space is used efficiently with appropriate   |       |      |
| .   | > equipment placement: 3                       |       |      |
+-----+------------------------------------------------+-------+------+
| 2   | > Space configuration is adequate and          |       |      |
| .   | > consistent with good laboratory practices: 3 |       |      |
+-----+------------------------------------------------+-------+------+
| 3   | > Space is clean and well kept 3               |       |      |
| .   |                                                |       |      |
+-----+------------------------------------------------+-------+------+
|     |                                                |       |      |
+-----+------------------------------------------------+-------+------+
| *CO |                                                |       |      |
| MME |                                                |       |      |
| NTS |                                                |       |      |
| AND |                                                |       |      |
| RE  |                                                |       |      |
| COM |                                                |       |      |
| MEN |                                                |       |      |
| DAT |                                                |       |      |
| ION |                                                |       |      |
| S:* |                                                |       |      |
|     |                                                |       |      |
| !   |                                                |       |      |
| []( |                                                |       |      |
| med |                                                |       |      |
| ia/ |                                                |       |      |
| ima |                                                |       |      |
| ge2 |                                                |       |      |
| .pn |                                                |       |      |
| g){ |                                                |       |      |
| wid |                                                |       |      |
| th= |                                                |       |      |
| "5. |                                                |       |      |
| 701 |                                                |       |      |
| 388 |                                                |       |      |
| 888 |                                                |       |      |
| 888 |                                                |       |      |
| 889 |                                                |       |      |
| in" |                                                |       |      |
| he  |                                                |       |      |
| igh |                                                |       |      |
| t=" |                                                |       |      |
| 5.8 |                                                |       |      |
| 75i |                                                |       |      |
| n"} |                                                |       |      |
+-----+------------------------------------------------+-------+------+

+-----+------------------------------------------------+-------+------+
| 2   | **Staff** *score maximum* **4 points**         | **Sco |      |
| .   |                                                | re:** |      |
+-----+------------------------------------------------+-------+------+
| 1   | > Staff are effectively assigned: 2            |       |      |
| .   |                                                |       |      |
+-----+------------------------------------------------+-------+------+
| 2   | > The number of trained staff are adequate to  |       |      |
| .   | > handle the workload: 2                       |       |      |
+-----+------------------------------------------------+-------+------+
|     |                                                |       |      |
+-----+------------------------------------------------+-------+------+
| *CO |                                                |       |      |
| MME |                                                |       |      |
| NTS |                                                |       |      |
| AND |                                                |       |      |
| RE  |                                                |       |      |
| COM |                                                |       |      |
| MEN |                                                |       |      |
| DAT |                                                |       |      |
| ION |                                                |       |      |
| S:* |                                                |       |      |
+-----+------------------------------------------------+-------+------+

+-----+------------------------------------------------+-------+------+
| 3   | **Supervision** *score maximum* **9 points**   | **Sco |      |
| .   |                                                | re:** |      |
+-----+------------------------------------------------+-------+------+
| 1   | > The lines of supervision and accountability  |       |      |
| .   | > are clear: 3                                 |       |      |
+-----+------------------------------------------------+-------+------+
| 2   | > Supervisor critically reviews test results:  |       |      |
| .   | > 3                                            |       |      |
+-----+------------------------------------------------+-------+------+
| 3   | > Tests results are properly recorded 3        |       |      |
| .   |                                                |       |      |
+-----+------------------------------------------------+-------+------+
|     |                                                |       |      |
+-----+------------------------------------------------+-------+------+
| *CO |                                                |       |      |
| MME |                                                |       |      |
| NTS |                                                |       |      |
| AND |                                                |       |      |
| RE  |                                                |       |      |
| COM |                                                |       |      |
| MEN |                                                |       |      |
| DAT |                                                |       |      |
| ION |                                                |       |      |
| S:* |                                                |       |      |
+-----+------------------------------------------------+-------+------+

+-----+------------------------------------------------+-------+------+
| 4   | **Sera Specimens** *score maximum* **28        | **Sco |      |
| .   | points**                                       | re:** |      |
+-----+------------------------------------------------+-------+------+
| 1   | Appropriate written protocol for processing    |       |      |
| .   | specimens is available: 4                      |       |      |
+-----+------------------------------------------------+-------+------+
| 2   | Specimens are processed by centrifugation: 4   |       |      |
| .   |                                                |       |      |
+-----+------------------------------------------------+-------+------+
| 3   | Plasma are stored at --20^o^C if not screened  |       |      |
| .   | on same day as processed: 4                    |       |      |
+-----+------------------------------------------------+-------+------+
| 4   | All potentially infected clinical materials    |       |      |
| .   | are processed in a biological safety cabinet:  |       |      |
|     | 4                                              |       |      |
+-----+------------------------------------------------+-------+------+
| 5   | Original specimens (in original containers)    |       |      |
| .   | are appropriately labeled and stored at        |       |      |
|     | --20^o^C for at least 12 months: 4             |       |      |
+-----+------------------------------------------------+-------+------+
| 6   | Plasma products extracts are discarded within  |       |      |
| .   | 12 months of confirmation of result:**4**      |       |      |
+-----+------------------------------------------------+-------+------+
| 7   | Specimens, and other potentially infectious    |       |      |
| .   | materials are stored separately from           |       |      |
|     | non-infectious materials in designated         |       |      |
|     | freezers and refrigerators: 4                  |       |      |
+-----+------------------------------------------------+-------+------+
|     |                                                |       |      |
+-----+------------------------------------------------+-------+------+
| *CO |                                                |       |      |
| MME |                                                |       |      |
| NTS |                                                |       |      |
| AND |                                                |       |      |
| RE  |                                                |       |      |
| COM |                                                |       |      |
| MEN |                                                |       |      |
| DAT |                                                |       |      |
| ION |                                                |       |      |
| S:* |                                                |       |      |
+-----+------------------------------------------------+-------+------+

+-----+------------------------------------------------+-------+------+
| 5   | **Biosafety and containment of HIV** *score    | **Sco |      |
| .   | maximum* **26 points**                         | re:** |      |
+-----+------------------------------------------------+-------+------+
| 1   | > Employees have been instructed in biosafety: |       |      |
| .   | > 4                                            |       |      |
+-----+------------------------------------------------+-------+------+
| 2   | > Written instructions are available to all    |       |      |
| .   | > employees: 4                                 |       |      |
+-----+------------------------------------------------+-------+------+
| 3   | > Biosafety practices are enforced, including: |       |      |
| .   |                                                |       |      |
+-----+------------------------------------------------+-------+------+
|     | > ![]                                          |       |      |
|     | (media/image2.png){width="5.701388888888889in" |       |      |
|     | > height="5.875in"}a. Hand washing: 1          |       |      |
+-----+------------------------------------------------+-------+------+
|     | > b\. Pipetting with aid of mechanical device: |       |      |
|     | > 1                                            |       |      |
+-----+------------------------------------------------+-------+------+
|     | > c\. Routine use of gloves and lab coats 1    |       |      |
+-----+------------------------------------------------+-------+------+
|     | > d\. No eating, drinking, smoking, or storage |       |      |
|     | > of food in laboratory 1                      |       |      |
+-----+------------------------------------------------+-------+------+
|     | > e\. Decontaminating all infectious or        |       |      |
|     | > clinical waste before discarding: 1          |       |      |
+-----+------------------------------------------------+-------+------+
|     | > f\. Decontaminating lab work surfaces: 1     |       |      |
+-----+------------------------------------------------+-------+------+
| 4   | > Biosafety cabinets and clean air cabinets    |       |      |
| .   | > are used for potentially infected and clean  |       |      |
|     | > materials, respectively: 4                   |       |      |
+-----+------------------------------------------------+-------+------+
| 5   | > Safety cabinets are maintained as            |       |      |
| .   | > recommended, including filter changes, and   |       |      |
|     | > dates recorded: 4                            |       |      |
+-----+------------------------------------------------+-------+------+
| 6   | > A written inventory is available of all      |       |      |
| .   | > stored sera and materials that potentially   |       |      |
|     | > contain HIV 4                                |       |      |
+-----+------------------------------------------------+-------+------+
|     |                                                |       |      |
+-----+------------------------------------------------+-------+------+
| *CO |                                                |       |      |
| MME |                                                |       |      |
| NTS |                                                |       |      |
| AND |                                                |       |      |
| RE  |                                                |       |      |
| COM |                                                |       |      |
| MEN |                                                |       |      |
| DAT |                                                |       |      |
| ION |                                                |       |      |
| S:* |                                                |       |      |
+-----+------------------------------------------------+-------+------+

+-----+------------------------------------------------+-------+------+
| 6   | **Equipment** *score maximum* **12 points**    | **Sco |      |
| .   |                                                | re:** |      |
+-----+------------------------------------------------+-------+------+
| 1   | > Equipment is functioning and in good         |       |      |
| .   | > condition: 3                                 |       |      |
+-----+------------------------------------------------+-------+------+
| 2   | > Equipment is maintained periodically as      |       |      |
| .   | > recommended and dates recorded: 3            |       |      |
+-----+------------------------------------------------+-------+------+
| 3   | > Equipment location is conducive to optimal   |       |      |
| .   | > performance: 3                               |       |      |
+-----+------------------------------------------------+-------+------+
| 4   | > Records are kept on daily temperature        |       |      |
| .   | > readings of incubators, refrigerators, and   |       |      |
|     | > freezers: 3                                  |       |      |
+-----+------------------------------------------------+-------+------+
|     |                                                |       |      |
+-----+------------------------------------------------+-------+------+
| *CO |                                                |       |      |
| MME |                                                |       |      |
| NTS |                                                |       |      |
| AND |                                                |       |      |
| RE  |                                                |       |      |
| COM |                                                |       |      |
| MEN |                                                |       |      |
| DAT |                                                |       |      |
| ION |                                                |       |      |
| S:* |                                                |       |      |
+-----+------------------------------------------------+-------+------+

+-----+------------------------------------------------+-------+------+
| 7   | **Supplies** *score maximum* **12 points**     | **Sco |      |
| .   |                                                | re:** |      |
+-----+------------------------------------------------+-------+------+
| 1   | Current inventories are maintained: 3          |       |      |
| .   |                                                |       |      |
+-----+------------------------------------------------+-------+------+
| 2   | Adequate time is allowed for replenishing      |       |      |
| .   | supplies: 3                                    |       |      |
+-----+------------------------------------------------+-------+------+
| >   | All reagents are stored in good condition 3    |       |      |
| 7.3 |                                                |       |      |
+-----+------------------------------------------------+-------+------+
| >   | A Buffer stock equal to three months supplies  |       |      |
| 7.4 | is available 3                                 |       |      |
+-----+------------------------------------------------+-------+------+
|     |                                                |       |      |
+-----+------------------------------------------------+-------+------+
| *CO |                                                |       |      |
| MME |                                                |       |      |
| NTS |                                                |       |      |
| AND |                                                |       |      |
| RE  |                                                |       |      |
| COM |                                                |       |      |
| MEN |                                                |       |      |
| DAT |                                                |       |      |
| ION |                                                |       |      |
| S:* |                                                |       |      |
+-----+------------------------------------------------+-------+------+